111 results on '"James, Stefan"'
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2. Introduction
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James, Stefan, additional and Roffi, Marco, additional
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- 2018
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3. ST-segment elevation MI
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Cheong, Adrian P., primary, Steg, Gabriel, additional, and James, Stefan K., additional
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- 2018
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4. Randomized trials fit for the 21st century. A joint opinion from the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation
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Bowman, Louise, Weidinger, Franz, Albert, Michelle A., Fry, Edward T. A., Pinto, Fausto J., Achenbach, Stephan, Casadei, Barbara, Collins, Rory, Devereaux, Philip J., Douglas, Pamela S., Frobert, Ole, Goto, Shinya, Grines, Cindy, Harrington, Robert A., Haynes, Richard, Hochman, Judith S., Charney, Leon H., James, Stefan, Kirchhof, Paulus, Komajda, Michel, Lam, Carolyn S. P., Landray, Martin, Maggioni, Aldo, McMurray, John, Medhurst, Nick, Mehran, Roxana, Neal, Bruce, Rydén, Lars, Thiele, Holger, Van Gelder, Isabelle, Wallentin, Lars, Yusuf, Salim, Zannad, Faiez, and Repositório da Universidade de Lisboa
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© The Author(s) 2022. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. When citing this article, a citation from any of the journals listed is appropriate. For commercial re-use, please contact journals.permissions@oup.com, Randomized controlled trials are the cornerstone for reliably evaluating therapeutic strategies. However, during the past 25 years, the rules and regulations governing randomized trials and their interpretation have become increasingly burdensome, and the cost and complexity of trials has become prohibitive. The present model is unsustainable, and the development of potentially effective treatments is often stopped prematurely on financial grounds, while existing drug treatments or non-drug interventions (such as screening strategies or management tools) may not be assessed reliably. The current ‘best regulatory practice’ environment, and a lack of consensus on what that requires, too often makes it unduly difficult to undertake efficient randomized trials able to provide reliable evidence about the safety and efficacy of potentially valuable interventions. Inclusion of underrepresented population groups and lack of diversity also remain among the challenges.
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- 2022
5. ST-segment elevation myocardial infarction
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Cheong, Adrian, primary, Steg, Gabriel, additional, and James, Stefan K, additional
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- 2015
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6. Essential pharmacology of antithrombotic agents
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Cuisset, Thomas, primary, James, Stefan K., additional, Rubboli, Andrea, additional, Rasmussen, Lars H., additional, Agnelli, Giancarlo, additional, and Lip, Gregory Y. H. L, additional
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- 2014
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7. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC)
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Ibanez, Borja, James, Stefan, Agewall, Stefan, Antunes, Manuel J, Bucciarelli-Ducci, Chiara, Bueno, Héctor, Caforio, Alida L P, Crea, Filippo, Goudevenos, John A, Halvorsen, Sigrun, Hindricks, Gerhard, Kastrati, Adnan, Lenzen, Mattie J, Prescott, Eva, Roffi, Marco, Valgimigli, Marco, Varenhorst, Christoph, Vranckx, Pascal, and Widimský, Petr
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610 Medicine & health - Published
- 2018
8. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology
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Montalescot, Gilles, Sechtem, Udo, Achenbach, Stephan, Andreotti, Felicita, Arden, Chris, Budaj, Andrzej, Bugiardini, Raffaele, Crea, Filippo, Cuisset, Thomas, Di Mario, Carlo, Ferreira, J Rafael, Gersh, Bernard J, Gitt, Anselm K, Hulot, Jean-Sebastien, Marx, Nikolaus, Opie, Lionel H, Pfisterer, Matthias, Prescott, Eva, Ruschitzka, Frank, Sabaté, Manel, Senior, Roxy, Taggart, David Paul, van der Wall, Ernst E, Vrints, Christiaan J M, Zamorano, Jose Luis, Baumgartner, Helmut, Bax, Jeroen J, Bueno, Héctor, Dean, Veronica, Deaton, Christi, Erol, Cetin, Fagard, Robert, Ferrari, Roberto, Hasdai, David, Hoes, Arno W, Kirchhof, Paulus, Knuuti, Juhani, Kolh, Philippe, Lancellotti, Patrizio, Linhart, Ales, Nihoyannopoulos, Petros, Piepoli, Massimo F, Ponikowski, Piotr, Sirnes, Per Anton, Tamargo, Juan Luis, Tendera, Michal, Torbicki, Adam, Wijns, William, Windecker, Stephan, Valgimigli, Marco, Claeys, Marc J, Donner-Banzhoff, Norbert, Frank, Herbert, Funck-Brentano, Christian, Gaemperli, Oliver, Gonzalez-Juanatey, José R, Hamilos, Michalis, Husted, Steen, James, Stefan K, Kervinen, Kari, Kristensen, Steen Dalby, Maggioni, Aldo Pietro, Pries, Axel R, Romeo, Francesco, Rydén, Lars, Simoons, Maarten L, Steg, Ph Gabriel, Timmis, Adam, Yildirir, Aylin, G. Montalescot, U. Sechtem, S. Achenbach, F. Andreotti, C. Arden, A. Budaj, R. Bugiardini, F. Crea, T. Cuisset, C. Di Mario, J. R. Ferreira, B. J. Gersh, A. K. Gitt, J.-S. Hulot, N. Marx, L. H. Opie, M. Pfisterer, E. Prescott, F. Ruschitzka, M. Sabate, R. Senior, D. P. Taggart, E. E. van der Wall, C. J. M. Vrint, J. L. Zamorano, H. Baumgartner, J. J. Bax, H. Bueno, V. Dean, C. Deaton, C. Erol, R. Fagard, R. Ferrari, D. Hasdai, A. W. Hoe, P. Kirchhof, J. Knuuti, P. Kolh, P. Lancellotti, A. Linhart, P. Nihoyannopoulo, M. F. Piepoli, P. Ponikowski, P. A. Sirne, J. L. Tamargo, M. Tendera, A. Torbicki, W. Wijn, S. Windecker, M. Valgimigli, M. J. Claey, N. Donner-Banzhoff, H. Frank, C. Funck-Brentano, O. Gaemperli, J. R. Gonzalez-Juanatey, M. Hamilo, S. Husted, S. K. Jame, K. Kervinen, S. D. Kristensen, A. P. Maggioni, A. R. Prie, F. Romeo, L. Ryden, M. L. Simoon, P. G. Steg, A. Timmi, A. Yildirir, University of Zurich, and Montalescot, G
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Male ,medicine.medical_specialty ,Acute coronary syndrome ,Cardiotonic Agents ,Angina pectoris ,anti-ischaemic drugs ,medicine.medical_treatment ,610 Medicine & health ,Coronary Artery Disease ,Fractional flow reserve ,Myocardial ischaemia ,Coronary revascularization ,GUIDELINES ,Risk Assessment ,2705 Cardiology and Cardiovascular Medicine ,Angina ,Coronary artery disease ,Electrocardiography ,Coronary artery bypass surgery ,Percutaneous Coronary Intervention ,Internal medicine ,Myocardial Revascularization ,Humans ,Medicine ,Angina, Stable ,cardiovascular diseases ,Myocardial infarction ,Coronary Artery Bypass ,Aged ,Evidence-Based Medicine ,Primary Health Care ,business.industry ,Coronary flow reserve ,Percutaneous coronary intervention ,Prognosis ,medicine.disease ,Cardiac Imaging Techniques ,Risk factors ,CHRONIC STABLE ANGINA ,Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,10209 Clinic for Cardiology ,Cardiology ,Stable coronary artery disease ,Female ,Cardiology and Cardiovascular Medicine ,business ,Risk Reduction Behavior - Abstract
99mTc : technetium-99m 201TI : thallium 201 ABCB1 : ATP-binding cassette sub-family B member 1 ABI : ankle-brachial index ACC : American College of Cardiology ACCF : American College of Cardiology Foundation ACCOMPLISH : Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension ACE : angiotensin converting enzyme ACIP : Asymptomatic Cardiac Ischaemia Pilot ACS : acute coronary syndrome ADA : American Diabetes Association ADP : adenosine diphosphate AHA : American Heart Association ARB : angiotensin II receptor antagonist ART : Arterial Revascularization Trial ASCOT : Anglo-Scandinavian Cardiac Outcomes Trial ASSERT : Asymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial AV : atrioventricular BARI 2D : Bypass Angioplasty Revascularization Investigation 2 Diabetes BEAUTIFUL : Morbidity-Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction BIMA : bilateral internal mammary artery BMI : body mass index BMS : bare metal stent BNP : B-type natriuretic peptide BP : blood pressure b.p.m. : beats per minute CABG : coronary artery bypass graft CAD : coronary artery disease CAPRIE : Clopidogrel vs. Aspirin in Patients at Risk of Ischaemic Events CASS : Coronary Artery Surgery Study CCB : calcium channel blocker CCS : Canadian Cardiovascular Society CFR : coronary flow reserve CHARISMA : Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilization, Management and Avoidance CI : confidence interval CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease Epidemiology Collaboration CMR : cardiac magnetic resonance CORONARY : The CABG Off or On Pump Revascularization Study COURAGE : Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation COX-1 : cyclooxygenase-1 COX-2 : cyclooxygenase-2 CPG : Committee for Practice Guidelines CT : computed tomography CTA : computed tomography angiography CV : cardiovascular CVD : cardiovascular disease CXR : chest X-ray CYP2C19*2 : cytochrome P450 2C19 CYP3A : cytochrome P3A CYP3A4 : cytochrome P450 3A4 CYP450 : cytochrome P450 DANAMI : Danish trial in Acute Myocardial Infarction DAPT : dual antiplatelet therapy DBP : diastolic blood pressure DECOPI : Desobstruction Coronaire en Post-Infarctus DES : drug-eluting stents DHP : dihydropyridine DSE : dobutamine stress echocardiography EACTS : European Association for Cardiothoracic Surgery EECP : enhanced external counterpulsation EMA : European Medicines Agency EASD : European Association for the Study of Diabetes ECG : electrocardiogram Echo : echocardiogram ED : erectile dysfunction EF : ejection fraction ESC : European Society of Cardiology EXCEL : Evaluation of XIENCE PRIME or XIENCE V vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization FAME : Fractional Flow Reserve vs. Angiography for Multivessel Evaluation FDA : Food & Drug Administration (USA) FFR : fractional flow reserve FREEDOM : Design of the Future Revascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease GFR : glomerular filtration rate HbA1c : glycated haemoglobin HDL : high density lipoprotein HDL-C : high density lipoprotein cholesterol HR : hazard ratio HRT : hormone replacement therapy hs-CRP : high-sensitivity C-reactive protein HU : Hounsfield units ICA : invasive coronary angiography IMA : internal mammary artery IONA : Impact Of Nicorandil in Angina ISCHEMIA : International Study of Comparative Health Effectiveness with Medical and Invasive Approaches IVUS : intravascular ultrasound JSAP : Japanese Stable Angina Pectoris KATP : ATP-sensitive potassium channels LAD : left anterior descending LBBB : left bundle branch block LIMA : Left internal mammary artery LDL : low density lipoprotein LDL-C : low density lipoprotein cholesterol LM : left main LMS : left main stem LV : left ventricular LVEF : left ventricular ejection fraction LVH : left ventricular hypertrophy MACE : major adverse cardiac events MASS : Medical, Angioplasty, or Surgery Study MDRD : Modification of Diet in Renal Disease MERLIN : Metabolic Efficiency with Ranolazine for Less Ischaemia in Non-ST-Elevation Acute Coronary Syndromes MERLIN-TIMI 36 : Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes: Thrombolysis In Myocardial Infarction MET : metabolic equivalents MI : myocardial infarction MICRO-HOPE : Microalbuminuria, cardiovascular and renal sub-study of the Heart Outcomes Prevention Evaluation study MPI : myocardial perfusion imaging MRI : magnetic resonance imaging NO : nitric oxide NSAIDs : non-steroidal anti-inflammatory drugs NSTE-ACS : non-ST-elevation acute coronary syndrome NYHA : New York Heart Association OAT : Occluded Artery Trial OCT : optical coherence tomography OMT : optimal medical therapy PAR-1 : protease activated receptor type 1 PCI : percutaneous coronary intervention PDE5 : phosphodiesterase type 5 PES : paclitaxel-eluting stents PET : positron emission tomography PRECOMBAT : Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease PTP : pre-test probability PUFA : polyunsaturated fatty acid PVD : peripheral vascular disease QoL : quality of life RBBB : right bundle branch block REACH : Reduction of Atherothrombosis for Continued Health RITA-2 : Second Randomized Intervention Treatment of Angina ROOBY : Veterans Affairs Randomized On/Off Bypass SAPT : single antiplatelet therapy SBP : systolic blood pressure SCAD : stable coronary artery disease SCORE : Systematic Coronary Risk Evaluation SCS : spinal cord stimulation SES : sirolimus-eluting stents SIMA : single internal mammary artery SPECT : single photon emission computed tomography STICH : Surgical Treatment for Ischaemic Heart Failure SWISSI II : Swiss Interventional Study on Silent Ischaemia Type II SYNTAX : SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery TC : total cholesterol TENS : transcutaneous electrical neural stimulation TERISA : Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina TIME : Trial of Invasive vs. Medical therapy TIMI : Thrombolysis In Myocardial Infarction TMR : transmyocardial laser revascularization TOAT : The Open Artery Trial WOEST : What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing Guidelines summarize and evaluate all evidence available, at the time of the writing process, on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome, as well …
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- 2013
9. Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)
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European Association, for Percutaneous Cardiovascular Interventions, Wijns, William, Kolh, Philippe, Danchin, Nicolas, Di Mario, Carlo, Falk, Volkmar, Folliguet, Thierry, Garg, Scot, Huber, Kurt, James, Stefan, Knuuti, Juhani, Lopez-Sendon, Jose, Marco, Jean, Menicanti, Lorenzo, Ostojic, Miodrag, Piepoli, Massimo F, Pirlet, Charles, Pomar, Jose L, Reifart, Nicolaus, Ribichini, Flavio L, Schalij, Martin J, Sergeant, Paul, Serruys, Patrick W, Silber, Sigmund, Sousa Uva, Miguel, Taggart, David, ESC Committee, for Practice Guidelines, Vahanian, Alec, Auricchio, Angelo, Bax, Jeroen, Ceconi, Claudio, Dean, Veronica, Filippatos, Gerasimos, Funck-Brentano, Christian, Hobbs, Richard, Kearney, Peter, McDonagh, Theresa, Popescu, Bogdan A, Reiner, Zeljko, Sechtem, Udo, Sirnes, Per Anton, Tendera, Michal, Vardas Panos, E, Widimsky, Petr, EACTS Clinical Guidelines, Committee, Alfieri, Ottavio, Dunning, Joel, Elia, Stefano, Kappetein, Pieter, Lockowandt, Ulf, Sarris, George, Vouhe, Pascal, von Segesser, Ludwig, Agewall, Stefan, Aladashvili, Alexander, Alexopoulos, Dimitrios, Antunes, Manuel J, Atalar, Enver, Brutel de la Riviere, Aart, Doganov, Alexander, Eha, Jaan, Fajadet, Jean, Ferreira, Rafael, Garot, Jerome, Halcox, Julian, Hasin, Yonathan, Janssens, Stefan, Kervinen, Kari, Laufer, Gunther, Legrand, Victor, Nashef Samer, A M, Neumann, Franz-Josef, Niemela, Kari, Nihoyannopoulos, Petros, Noc, Marko, Piek, Jan J, Pirk, Jan, Rozenman, Yoseph, Sabate, Manel, Starc, Radovan, Thielmann, Matthias, Wheatley, David J, Windecker, Stephan, and Zembala, Marian
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myocardial ,revascularization ,medicine.medical_specialty ,business.industry ,Judgement ,Medizin ,MEDLINE ,Conflict of interest ,EuroSCORE ,Evidence-based medicine ,medicine.disease ,Coronary artery bypass surgery ,Cardiothoracic surgery ,Internal medicine ,medicine ,Cardiology ,Medical emergency ,Cardiology and Cardiovascular Medicine ,Risk assessment ,business - Abstract
Guidelines and Expert Consensus Documents summarize and evaluate all available evidence with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition, taking into account the impact on outcome and the risk–benefit ratio of diagnostic or therapeutic means. Guidelines are no substitutes for textbooks and their legal implications have been discussed previously. Guidelines and recommendations should help physicians to make decisions in their daily practice. However, the ultimate judgement regarding the care of an individual patient must be made by his/her responsible physician(s). The recommendations for formulating and issuing ESC Guidelines and Expert Consensus Documents can be found on the ESC website (http://www.escardio.org/knowledge/guidelines/rules). Members of this Task Force were selected by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) to represent all physicians involved with the medical and surgical care of patients with coronary artery disease (CAD). A critical evaluation of diagnostic and therapeutic procedures is performed including assessment of the risk–benefit ratio. Estimates of expected health outcomes for society are included, where data exist. The level of evidence and the strength of recommendation of particular treatment options are weighed and graded according to predefined scales, as outlined in Tables 1 and 2 . View this table: Table 1 Classes of recommendations View this table: Table 2 Levels of evidence The members of the Task Force have provided disclosure statements of all relationships that might be perceived as real or potential sources of conflicts of interest. These disclosure forms are kept on file at European Heart House, headquarters of the ESC. Any changes in conflict of interest that arose during the writing period were notified to the ESC. The Task Force report received its entire financial support from the ESC and EACTS, without any involvement of the pharmaceutical, device, or surgical industry. ESC …
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- 2010
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10. Meeting Report
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Daemen, Joost, Simoons, Maarten L., Wijns, William, Bagust, Adrian, Bos, Gert, Bowen, James M., Braunwald, Eugene, Camenzind, Edoardo, Chevalier, Bernard, Dimario, Carlo, Fajadet, Jean, Gitt, Anselm, Guagliumi, Giulio, Hillege, Hans L., James, Stefan, Jüni, Peter, Kastrati, Adnan, Kloth, Sabine, Kristensen, Steen D., Krucoff, Mitchell, Legrand, Victor, Pfisterer, Matthias, Rothman, Martin, Serruys, Patrick W., Silber, Sigmund, Steg, Philippe G., Tariah, Ibrahim, Wallentin, Lars, and Windecker, Stephan W.
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360 Social problems & social services ,610 Medicine & health - Published
- 2009
11. ESC Forum on Drug Eluting Stents European Heart House, Nice, 27-28 September 2007
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Daemen, Joost, Simoons, Maarten L, Wijns, William, Bagust, Adrian, Bos, Gert, Bowen, James M, Braunwald, Eugene, Camenzind, Edoardo, Chevalier, Bernard, Dimario, Carlo, Fajadet, Jean, Gitt, Anselm, Guagliumi, Giulio, Hillege, Hans L, James, Stefan, Jüni, Peter, Kastrati, Adnan, Kloth, Sabine, Kristensen, Steen D, Krucoff, Mitchell, Legrand, Victor, Pfisterer, Matthias, Rothman, Martin, Serruys, Patrick W, Silber, Sigmund, Steg, Philippe G, Tariah, Ibrahim, Wallentin, Lars, Windecker, Stephan W, Aimonetti, A, Allocco, D, Baczynska, A, Bagust, A, Berenger, M, Bos, G, Boam, A, Bowen, J M, Braunwald, E, Calle, J P, Camenzind, E, Campo, G, Carlier, S, Chevalier, B, Daemen, J, de Schepper, J, Di Bisceglie, G, Dimario, C, Dobbels, H, Fajadet, J, Farb, A, Ghislain, J C, Gitt, A, Guagliumi, G, Hellbardt, S, Hillege, H L, Ten Hoedt, R, Isaia, C, James, S, de Jong, P, Jüni, P, Kastrati, A, Klasen, E, Kloth, S, Kristensen, S D, Krucoff, M, Legrand, V, Lekehal, M, Lenarz, L, Ni Mhullain, F, Nagai, H, Patteet, A, Paunovic, D, Pfisterer, M, Potgieter, A, Purdy, I, Raveau-Landon, C, Rothman, M, Serruys, P W, Silber, S, Simoons, M L, Steg, P G, Tariah, I, Ternstrom, S, Van Wuytswinkel, J, Waliszewski, M, Wallentin, L, Wijns, W, and Windecker, S W
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Udgivelsesdato: 2009-Jan
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- 2009
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12. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk
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Urban, Philip, Mehran, Roxana, Colleran, Roisin, Angiolillo, Dominick J, Byrne, Robert A, Capodanno, Davide, Cuisset, Thomas, Cutlip, Donald, Eerdmans, Pedro, Eikelboom, John, Farb, Andrew, Gibson, C Michael, Gregson, John, Haude, Michael, James, Stefan K, Kim, Hyo-Soo, Kimura, Takeshi, Konishi, Akihide, Laschinger, John, Leon, Martin B, Magee, P F Adrian, Mitsutake, Yoshiaki, Mylotte, Darren, Pocock, Stuart, Price, Matthew J, Rao, Sunil V, Spitzer, Ernest, Stockbridge, Norman, Valgimigli, Marco, Varenne, Olivier, Windhoevel, Ute, Yeh, Robert W, Krucoff, Mitchell W, and Morice, Marie-Claude
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610 Medicine & health ,3. Good health - Abstract
Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
13. Within and beyond 12-month efficacy and safety of antithrombotic strategies in patients with established coronary artery disease. Two companion network meta-analyses of the 2022 joint clinical consensus statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Association for Acute CardioVascular Care (ACVC) and European Association of Preventive Cardiology (EAPC)
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Eliano Pio Navarese, Antonio Landi, Angelo Oliva, Raffaele Piccolo, Victor Aboyans, Dominick Angiolillo, Dan Atar, Davide Capodanno, Keith A A Fox, Sigrun Halvorsen, Stefan James, Peter Jüni, Vijay Kunadian, Sergio Leonardi, Roxana Mehran, Gilles Montalescot, Josef Niebauer, Susanna Price, Robert F Storey, Heinz Völler, Pascal Vranckx, Stephan Windecker, Marco Valgimigli, Oliva, Angelo/0000-0003-0561-7563, Juni, Peter/0000-0002-5985-0670, Storey, Robert/0000-0002-6677-6229, Leonardi, Sergio/0000-0002-4800-6132, Navarese, Eliano Pio, Landi, Antonio, Oliva, Angelo, Piccolo, Raffaele, Aboyans, Victor, Angiolillo, Dominick, Atar, Dan, Capodanno, Davide, Fox, Keith A. A., Halvorsen, Sigrun, James, Stefan, Juni, Peter, Kunadian, Vijay, Leonardi, Sergio, Mehran, Roxana, Montalescot, Gilles, Niebauer, Josef, Price, Susanna, Storey, Robert F., Voller, Heinz, VRANCKX, Pascal, Windecker, Stephan, and Valgimigli, Marco
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Antithrombotics ,Pharmacology (medical) ,Cardiology and Cardiovascular Medicine ,Network meta-analysis ,610 Medicine & health ,Coronary artery disease - Abstract
Aims To appraise all available antithrombotic treatments within or after 12 months following coronary revascularization and/or acute coronary syndrome in two network meta-analyses. Methods and results Forty-three (N = 189 261 patients) trials within 12 months and 19 (N = 139 086 patients) trials beyond 12 months were included for efficacy/safety endpoints appraisal. Within 12 months, ticagrelor 90 mg bis in die (b.i.d.) [hazard ratio (HR), 0.66; 95% confidence interval (CI), 0.49–0.88], aspirin and ticagrelor 90 mg (HR, 0.85; 95% CI, 0.76–0.95), or aspirin, clopidogrel and rivaroxaban 2.5 mg b.i.d. (HR, 0.66; 95% CI, 0.51–0.86) were the only treatments associated with lower cardiovascular mortality, compared with aspirin and clopidogrel, without or with greater bleeding risk for the first and the other treatment options, respectively. Beyond 12 months, no strategy lowered mortality; compared with aspirin; the greatest reductions of myocardial infarction (MI) were found with aspirin and clopidogrel (HR, 0.68; 95% CI, 0.55–0.85) or P2Y12 inhibitor monotherapy (HR, 0.76; 95% CI: 0.61–0.95), especially ticagrelor 90 mg (HR, 0.54; 95% CI, 0.32–0.92), and of stroke with VKA (HR, 0.56; 95% CI, 0.44–0.76) or aspirin and rivaroxaban 2.5 mg (HR, 0.58; 95% CI, 0.44–0.76). All treatments increased bleeding except P2Y12 monotherapy, compared with aspirin. Conclusion Within 12 months, ticagrelor 90 mg monotherapy was the only treatment associated with lower mortality, without bleeding risk trade-off compared with aspirin and clopidogrel. Beyond 12 months, P2Y12 monotherapy, especially ticagrelor 90 mg, was associated with lower MI without bleeding trade-off; aspirin and rivaroxaban 2.5 mg most effectively reduced stroke, with a more acceptable bleeding risk than VKA, compared with aspirin. Registration URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifiers: CRD42021243985 and CRD42021252398.
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- 2023
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14. Dapagliflozin in patients with myocardial infarction without diabetes or prior heart failure.
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James S, Storey RF, and Oldgren J
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- Humans, Benzhydryl Compounds adverse effects, Glucosides adverse effects, Heart Failure diagnosis, Heart Failure drug therapy, Myocardial Infarction diagnosis, Myocardial Infarction drug therapy, Diabetes Mellitus diagnosis, Diabetes Mellitus drug therapy, Diabetes Mellitus epidemiology
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- 2024
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15. Antithrombotic therapy in patients with acute coronary syndrome: similarities and differences between a European expert consensus document and the 2023 European Society of Cardiology guidelines.
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Landi A, Aboyans V, Angiolillo DJ, Atar D, Capodanno D, Fox KAA, Halvorsen S, James S, Jüni P, Leonardi S, Mehran R, Montalescot G, Navarese EP, Niebauer J, Oliva A, Piccolo R, Price S, Storey RF, Völler H, Vranckx P, Windecker S, and Valgimigli M
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- Humans, Fibrinolytic Agents therapeutic use, Consensus, Acute Coronary Syndrome drug therapy, Cardiology
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Antithrombotic therapy represents the cornerstone of the pharmacological treatment in patients with acute coronary syndrome (ACS). The optimal combination and duration of antithrombotic therapy is still matter of debate requiring a critical assessment of patient comorbidities, clinical presentation, revascularization modality, and/or optimization of medical treatment. The 2023 European Society of Cardiology (ESC) guidelines for the management of patients with ACS encompassing both patients with and without ST segment elevation ACS have been recently published. Shortly before, a European expert consensus task force produced guidance for clinicians on the management of antithrombotic therapy in patients with ACS as well as chronic coronary syndrome. The scope of this manuscript is to provide a critical appraisal of differences and similarities between the European consensus paper and the latest ESC recommendations on oral antithrombotic regimens in ACS patients., Competing Interests: Conflict of interest: V.A. reports speakers honoraria from Amgen, Novartis and Pfizer and is consultant/advisory board for Bayer Healthcare, NovoNordisk, Sanofi, AstraZeneca, Boehringer Ingelheim and BMS, outside the submitted work. D.J.A. declares that he has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma, Pfizer, Sanofi and Vectura, outside the present work; D.J.A. also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions and Scott R. MacKenzie Foundation.. D.C. declares that he has received consulting and speaking fees from Amgen, Boehringer Ingelheim, Biotronik, Daiichi Sankyo, and Sanofi Aventis outside the present work. SH has received speaking fees from Boehringer Ingelheim, BMS, Pfizer and Sanofi, outside the submitted work. S.J. reported grants from AstraZeneca outside the submitted work. P.J. serves as an unpaid steering committee member of trials funded by Abbott Vascular, AstraZeneca, Biotronik, Biosensors, St Jude Medical, Terumo, and The Medicines Company; receives institutional research grants from Appili Therapeutics, AstraZeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company; and receives institutional honoraria for participation in advisory boards or consulting from Amgen, Ava, and Fresenius, but has not received personal payments by any pharmaceutical company or device manufacturer. S.L. reports grants and personal fees from AstraZeneca, Daiichi Sankyo, Bayer, Pifezer/BMS, ICON, Chiesi, and Novonordisk, all outside the submitted work. R.M. reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity, 1% in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse), all outside the submitted work. G.M. reports institutional research funds or fees from Abbott, Amgen, AstraZeneca, Ascendia, Bayer, BMS, Boehringer Ingelheim, Boston Scientific, Celecor, CSL Behring, Idorsia, Lilly, Novartis, Novo, Opalia, Pfizer, Quantum Genomics, Sanofi, Terumo, outside the submitted work. E.P.N. reports research grants from Abbott and Amgen and lecture fees/honoraria from Amgen, AstraZeneca, Bayer, Pfizer, and Sanofi-Regeneron, outside the submitted work. R.F.S. reports institutional research grants/support from AstraZeneca and Cytosorbents; personal fees from Alfasigma, AstraZeneca, Chiesi, Cytosorbents, Daiichi Sankyo, Idorsia, Novartis, Novo Nordisk, Pfizer, PhaseBio and Tabuk; all outside the submitted work. P.V. reports personal fees from Bayer, personal fees from Daiichi Sankyo, and personal fees from CLS Behring, outside the submitted work. S.W. reports research and educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. S.W. serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol-Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. K.A.A.F. has received grants and personal fees from Bayer/Janssen and AstraZeneca and personal fees from Sanofi/Regeneron and Verseon, outside the submitted work. M.V. reports grants and/or personal fees from Astra Zeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceuticals-Ltd, Universität Basel Department Klinische Forschung, Vifor, Bristol-Myers-Squib SA, Biotronik, Boston scientific, Medtronic, Vesalio, Novartis, Chiesi, PhaseBio, outside the submitted work. The other authors report no relationships relevant to the contents of this paper to disclose., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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16. European Society of Cardiology Quality indicators for the care and outcomes of adults undergoing transcatheter aortic valve implantation.
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Ali N, Aktaa S, Younsi T, Beska B, Batra G, Blackman DJ, James S, Ludman P, Mamas MA, Abdel-Wahab M, Borregaard B, Iung B, Joner M, Kunadian V, Modine T, Neylon A, Petronio AS, Pibarot P, Popescu BA, Sabaté M, Stortecky S, Teles RC, Treede H, and Gale CP
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Background and Aims: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI)., Methods: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs., Results: We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry., Conclusion: We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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17. Regional assessment of availability for transcatheter aortic valve implantation in Sweden: a long-term observational study.
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Nilsson K, Lindholm D, Backes J, Bjursten H, Hagström H, Lindbäck J, Pétursson P, Settergren M, Sarno G, and James S
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Background: Transcatheter aortic valve implantation (TAVI) is an increasingly important treatment option for patients with severe aortic stenosis. Its best implementation is debated, as few centres with high volumes are associated with better outcomes, while centralisation might lead to an inferior availability of treatment for patients living far away. The aim of this study was to investigate the implementation of TAVI in Sweden with a focus on regional differences in terms of availability, short-term mortality and waiting times., Methods: All patients undergoing TAVI between 2008 and 2020 from the Swedish Transcatheter Cardiac Intervention Registry (SWENTRY) were included. SWENTRY was linked to the National Cause of Death Registry and to publicly available geospatial data from Statistics Sweden., Results: A total of 7280 patients were included. Over time, TAVI interventions increased markedly, while surgical aortic valve replacement (SAVR) remained constant. There were no statistically significant regional differences in incidence between counties with or without a local TAVI centre (p = 0.7) and no clustering tendencies around regions with a local TAVI centre (p = 0.99). Thirty-day mortality improved over time without evidence of regional differences. No regional differences in waiting time from decision to intervention were found for TAVI centre regions and non-TAVI centre regions (p = 0.7)., Conclusion: This nationwide study indicated no regional differences in terms of availability, short-term mortality or waiting times. An organisation with a few specialised centres was found to be sufficient to provide national coverage of TAVI interventions., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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18. Comparison between ticagrelor and clopidogrel in myocardial infarction patients with high bleeding risk.
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Tjerkaski J, Jernberg T, Alfredsson J, Erlinge D, James S, Lindahl B, Mohammad MA, Omerovic E, Venetsanos D, and Szummer K
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- Humans, Ticagrelor adverse effects, Clopidogrel adverse effects, Platelet Aggregation Inhibitors adverse effects, Hemorrhage chemically induced, Ischemia drug therapy, Myocardial Infarction, Stroke epidemiology
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Aims: Ticagrelor is associated with a lower risk of ischemic events than clopidogrel. However, it is uncertain whether the benefits of more intensive anti-ischemic therapy outweigh the risks of major bleeding in patients who have a high bleeding risk (HBR). Therefore, this study compared ticagrelor and clopidogrel in myocardial infarction (MI) patients with HBR., Methods and Results: This study included all patients enrolled in the SWEDEHEART registry who were discharged with dual antiplatelet therapy using ticagrelor or clopidogrel following MI between 2010 and 2017. High bleeding risk was defined as a PRECISE-DAPT score ≥25. Information on ischemic events, major bleeding, and mortality was obtained from national registries, with 365 days of follow-up. Additional outcomes include major adverse cardiovascular events (MACE), a composite of MI, stroke and all-cause mortality, and net adverse clinical events (NACE), a composite of MACE and bleeding. This study included 25 042 HBR patients, of whom 11 848 were treated with ticagrelor. Ticagrelor was associated with a lower risk of MI, stroke, and MACE, but a higher risk of bleeding compared to clopidogrel. There were no significant differences in mortality and NACE. Additionally, when examining the relationship between antiplatelet therapy and bleeding risk in 69 040 MI patients, we found no statistically significant interactions between the PRECISE-DAPT score and treatment effect., Conclusions: We observed no difference in NACE when comparing ticagrelor and clopidogrel in HBR patients. Moreover, we found no statistically significant interactions between bleeding risk and the comparative effectiveness of clopidogrel and ticagrelor in a larger population of MI patients., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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19. Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).
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Aktaa S, Batra G, James SK, Blackman DJ, Ludman PF, Mamas MA, Abdel-Wahab M, Angelini GD, Czerny M, Delgado V, De Luca G, Agricola E, Foldager D, Hamm CW, Iung B, Mangner N, Mehilli J, Murphy GJ, Mylotte D, Parma R, Petronio AS, Popescu BA, Sondergaard L, Teles RC, Sabaté M, Terkelsen CJ, Testa L, Wu J, Maggioni AP, Wallentin L, Casadei B, and Gale CP
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- Humans, Aortic Valve surgery, Registries, Randomized Controlled Trials as Topic, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation methods
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Aims: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI)., Methods and Results: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform., Conclusion: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies., One-Sentence Summary: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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20. Antithrombotic treatment strategies in patients with established coronary atherosclerotic disease.
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Valgimigli M, Aboyans V, Angiolillo D, Atar D, Capodanno D, Halvorsen S, James S, Jüni P, Kunadian V, Landi A, Leonardi S, Mehran R, Montalescot G, Navarese EP, Niebauer J, Oliva A, Piccolo R, Price S, Storey RF, Völler H, Vranckx P, Windecker S, and Fox KAA
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- Humans, Fibrinolytic Agents adverse effects, Blood Coagulation, Coronary Artery Disease diagnosis, Coronary Artery Disease drug therapy
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Multiple guidelines and consensus papers have addressed the role of antithrombotic strategies in patients with established coronary artery disease (CAD). Since evidence and terminology continue to evolve, the authors undertook a consensus initiative to guide clinicians to select the optimal antithrombotic regimen for each patient. The aim of this document is to provide an update for clinicians on best antithrombotic strategies in patients with established CAD, classifying each treatment option in relation to the number of antithrombotic drugs irrespective of whether the traditional mechanism of action is expected to mainly inhibit platelets or coagulation cascade. With the aim to reach comprehensiveness of available evidence, we systematically reviewed and performed meta-analyses by means of both direct and indirect comparisons to inform the present consensus document., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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21. Is the TIME study on antihypertensive therapy and chronotropic effects on cardiovascular outcomes a pragmatic trial?
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Dal-Ré R and James SK
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- Humans, Antihypertensive Agents adverse effects, Time and Motion Studies, Cardiovascular Diseases diagnosis, Cardiovascular Diseases drug therapy, Cardiovascular Diseases prevention & control, Cardiovascular System
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- 2023
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22. Leveraging electronic health records to streamline the conduct of cardiovascular clinical trials.
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Khan MS, Usman MS, Talha KM, Van Spall HGC, Greene SJ, Vaduganathan M, Khan SS, Mills NL, Ali ZA, Mentz RJ, Fonarow GC, Rao SV, Spertus JA, Roe MT, Anker SD, James SK, Butler J, and McGuire DK
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- Humans, Randomized Controlled Trials as Topic, Electronic Health Records, Cardiovascular Diseases, Routinely Collected Health Data
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Conventional randomized controlled trials (RCTs) can be expensive, time intensive, and complex to conduct. Trial recruitment, participation, and data collection can burden participants and research personnel. In the past two decades, there have been rapid technological advances and an exponential growth in digitized healthcare data. Embedding RCTs, including cardiovascular outcome trials, into electronic health record systems or registries may streamline screening, consent, randomization, follow-up visits, and outcome adjudication. Moreover, wearable sensors (i.e. health and fitness trackers) provide an opportunity to collect data on cardiovascular health and risk factors in unprecedented detail and scale, while growing internet connectivity supports the collection of patient-reported outcomes. There is a pressing need to develop robust mechanisms that facilitate data capture from diverse databases and guidance to standardize data definitions. Importantly, the data collection infrastructure should be reusable to support multiple cardiovascular RCTs over time. Systems, processes, and policies will need to have sufficient flexibility to allow interoperability between different sources of data acquisition. Clinical research guidelines, ethics oversight, and regulatory requirements also need to evolve. This review highlights recent progress towards the use of routinely generated data to conduct RCTs and discusses potential solutions for ongoing barriers. There is a particular focus on methods to utilize routinely generated data for trials while complying with regional data protection laws. The discussion is supported with examples of cardiovascular outcome trials that have successfully leveraged the electronic health record, web-enabled devices or administrative databases to conduct randomized trials., Competing Interests: Conflict of interest H.G.C.V.S. leads trials with routinely available data, with funding from the Canadian Institutes of Health Research and the Heart and Stroke Foundation of Canada. S.J.G. has received research support from the Duke University Department of Medicine Chair’s Research Award, American Heart Association, Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, Pfizer, and Sanofi; has served on advisory boards for Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, and Sanofi; and serves as a consultant for Amgen, Bayer, Bristol Myers Squibb, Merck, and Vifor. M.V. has received research grant support, served on advisory boards, or had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Chiesi, Cytokinetics, Lexicon Pharmaceuticals, Merck, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health, and participates on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. S.S.K. reported grants from the American Heart Association and the National Institutes of Health outside the submitted work. N.L.M. reports research grants awarded to the University of Edinburgh from Abbott Diagnostics and Siemens Healthineers outside the submitted work and honoraria from Abbott Diagnostics, Siemens Healthineers, Roche Diagnostics, and LumiraDx. Z.A.A. reports institutional research grants to Columbia University—Abbott, Cardiovascular Systems, Inc and serves as a consultant at Abbott, Abiomed, AstraZeneca, and Shockwave. R.J.M. reported receiving personal fees from Novartis International AG, Amgen Inc, Boehringer Ingelheim, Bayer AG, and Merck & Co, Inc and receiving research support and honoraria from Abbott Laboratories, American Regent, Inc, Amgen Inc, AstraZeneca, Bayer AG, Boehringer Ingelheim/Eli Lilly & Company, Boston Scientific Corporation, Cytokinetics, Inc, FAST BioMedical, Gilead Sciences, Inc, Innolife, Medtronic PLC, Merck & Co, Inc, Novartis International AG, Relypsa, Inc, Respicardia, Windtree Therapeutics, Inc, and ZOLL Medical Corporation outside the submitted work. G.C.F. reports research support from the National Institutes of Health and consulting for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Eli Lilly, Janssen, Medtronic, Merck, Novartis, and Pfizer. S.V.R. reported receiving institutional research funding from Bayer and the National Heart, Lung, and Blood Institute outside the submitted work. J.A.S. is a consultant to Bayer, Janssen, Merck, Bristol Meyers Squibb, Kineksa, Novartis, Terumo, and United Healthcare. He receives grant support from Janssen, Abbott Vascular, and Bristol Meyers Squibb. He holds the copyright to the Peripheral Artery Questionnaire, Kansas City Cardiomyopathy Questionnaires, and the Seattle Angina Questionnaire. He serves on the Board of Blue Cross/Blue Shield of Kansas City. M.T.R. reports grants from the American College of Cardiology, American Heart Association, Bayer Pharmaceuticals, Familial Hypercholesterolemia Foundation, Ferring Pharmaceuticals, Myokardia, and Patient Centered Outcomes Research Institute; grants and personal fees from Amgen, AstraZeneca, and Sanofi Aventis; personal fees from Janssen Pharmaceuticals, Elsevier Publishers, Regeneron, Roche-Genetech, Eli Lilly, Novo Nordisk, Pfizer, and Signal Path; and is an employee of Verana Health. S.D.A. declares grants or personal fees from Vifor Int, Bayer, Boehringer Ingelheim, Servier, Abbott Vascular, Cardiac Dimensions, Actimed, Astra Zeneca, Amgen, Bioventrix, Janssen, Respicardia, V-Wave, Brahms, Cordio, and Occlutech, outside the submitted work. S.K.J. has received institutional research/grant support from AstraZeneca, Bayer, Janssen, and Novartis. J.B. has served as a consultant to Abbott, Adrenomed, Arena Pharma, Array, Amgen, Applied Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Cardior, CVRx, Eli Lilly, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Sequana Medical, V-Wave Limited, and Vifor. D.K.M. reports honoraria for clinical trial leadership from Ventyx, Boehringer Ingelheim, Sanofi, Merck & Co, Pfizer, Akebia, AstraZeneca, Novo Nordisk, Esperion, AbbVie, Lilly USA, Eidos, Arena, Dynavax, Lexicon, Otsuka, and CSL Behring, and honoraria for consultancy from Lilly USA, Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Altimmune, Intercept, Merck & Co, Novo Nordisk, Applied Therapeutics, Metavant, Sanofi, Afimmune, CSL Behring, and Bayer. All other authors report no conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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23. Nationwide cardiovascular risk categorization: applying the European Society of Cardiology guidelines to the Swedish National Diabetes Register.
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Eliasson B, Ekelund J, Holmberg CN, Wolden ML, Matthiessen KS, and James S
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- Humans, Sweden epidemiology, Hypoglycemic Agents therapeutic use, Risk Factors, Heart Disease Risk Factors, Glucose therapeutic use, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 drug therapy, Cardiovascular Diseases diagnosis, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, Cardiology, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
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Aims: The 2021 European Society of Cardiology (ESC) guidelines recommend that patients with type 2 diabetes (T2D) with a very high cardiovascular disease (CVD) risk receive cardiovascular (CV)-protective glucose-lowering medication (glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter-2 inhibitors). This analysis compared previous prescribing practices with the ESC recommendations., Methods and Results: Patients in the Swedish National Diabetes Register (NDR) with T2D, aged 18-90 years, not receiving CV-protective glucose-lowering medication in 2017 were identified, and the ESC criteria for very high CVD risk were applied. The composite outcome of major adverse CV events (MACEs; defined as CV death, non-fatal stroke or non-fatal myocardial infarction) during 2017 was calculated, and the number of MACE avoided with semaglutide, an example of a CV-protective glucose-lowering medication, was estimated for patients with a certain CV risk score. Of the 320 028 patients in the NDR with T2D who were not receiving CV-protective glucose-lowering medication, 129 512 patients had a very high CVD risk. Patients with a very high CVD risk had a high incidence of MACE (75.4 events/1000 person-years), which was higher in those with atherosclerotic CVD (ASCVD) with and without elevated glycated haemoglobin (>9%; 136.5 and 90.8 events/1000 person-years, respectively). If patients with a very high CVD risk, according to the ESC, and ASCVD received semaglutide, 803 MACE may have been avoided in 2017., Conclusions: This analysis highlights differences between previous prescribing practices in Sweden and the 2021 ESC guidelines and offers strategies to prioritize CV-protective glucose-lowering medication for patients who would benefit most., Competing Interests: Conflict of interest: B.E. has received personal fees from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Mundipharma, Navamedic, Novo Nordisk, and RLS Global, and grants and personal fees from Sanofi. C.N.H. is an employee of Novo Nordisk Scandinavia AB. M.L.W. and K.S.M. are employees of Novo Nordisk A/S. S.J. reports no personal conflicts of interest. Their institution has received research from Amgen, AstraZeneca, Bayer, Janssen, Novartis, and Novo Nordisk., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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24. Within and beyond 12-month efficacy and safety of antithrombotic strategies in patients with established coronary artery disease: two companion network meta-analyses of the 2022 joint clinical consensus statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Association for Acute CardioVascular Care (ACVC), and European Association of Preventive Cardiology (EAPC).
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Navarese EP, Landi A, Oliva A, Piccolo R, Aboyans V, Angiolillo D, Atar D, Capodanno D, Fox KAA, Halvorsen S, James S, Jüni P, Kunadian V, Leonardi S, Mehran R, Montalescot G, Niebauer J, Price S, Storey RF, Völler H, Vranckx P, Windecker S, and Valgimigli M
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- Humans, Ticagrelor adverse effects, Clopidogrel therapeutic use, Fibrinolytic Agents adverse effects, Rivaroxaban adverse effects, Network Meta-Analysis, Purinergic P2Y Receptor Antagonists adverse effects, Aspirin, Hemorrhage chemically induced, Coronary Artery Disease, Myocardial Infarction drug therapy, Stroke prevention & control, Cardiology
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Aims: To appraise all available antithrombotic treatments within or after 12 months following coronary revascularization and/or acute coronary syndrome in two network meta-analyses., Methods and Results: Forty-three (N = 189 261 patients) trials within 12 months and 19 (N = 139 086 patients) trials beyond 12 months were included for efficacy/safety endpoints appraisal. Within 12 months, ticagrelor 90 mg bis in die (b.i.d.) [hazard ratio (HR), 0.66; 95% confidence interval (CI), 0.49-0.88], aspirin and ticagrelor 90 mg (HR, 0.85; 95% CI, 0.76-0.95), or aspirin, clopidogrel and rivaroxaban 2.5 mg b.i.d. (HR, 0.66; 95% CI, 0.51-0.86) were the only treatments associated with lower cardiovascular mortality, compared with aspirin and clopidogrel, without or with greater bleeding risk for the first and the other treatment options, respectively. Beyond 12 months, no strategy lowered mortality; compared with aspirin; the greatest reductions of myocardial infarction (MI) were found with aspirin and clopidogrel (HR, 0.68; 95% CI, 0.55-0.85) or P2Y12 inhibitor monotherapy (HR, 0.76; 95% CI: 0.61-0.95), especially ticagrelor 90 mg (HR, 0.54; 95% CI, 0.32-0.92), and of stroke with VKA (HR, 0.56; 95% CI, 0.44-0.76) or aspirin and rivaroxaban 2.5 mg (HR, 0.58; 95% CI, 0.44-0.76). All treatments increased bleeding except P2Y12 monotherapy, compared with aspirin., Conclusion: Within 12 months, ticagrelor 90 mg monotherapy was the only treatment associated with lower mortality, without bleeding risk trade-off compared with aspirin and clopidogrel. Beyond 12 months, P2Y12 monotherapy, especially ticagrelor 90 mg, was associated with lower MI without bleeding trade-off; aspirin and rivaroxaban 2.5 mg most effectively reduced stroke, with a more acceptable bleeding risk than VKA, compared with aspirin.Registration URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifiers: CRD42021243985 and CRD42021252398., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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25. Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency.
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Szymański P, Weidinger F, Lordereau-Richard I, Himmelmann A, Arca M, Chaves J, Lee C, Jonker C, Kotecha D, O'Kelly J, Plueschke K, Ryś A, Segec A, Wallentin L, Veltrop R, and James S
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- Humans, Registries, Cardiology
- Abstract
Real world data (RWD) refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of this vast amount of data is an important complement to that obtained from conventional randomised controlled trials (RCT). Real world data has been used for healthcare quality improvements, to conduct clinical trials, to support drug and device development, and to inform medical guidelines. The utility of RWD may be facilitated by common data models, which standardise format and content, and allow data from different health systems to be analysed together. The European Society of Cardiology (ESC) supports the use of RWD in collaboration with national cardiac societies, regulatory authorities, and industry to encourage continuous quality of care improvements at the hospital and country level, to conduct registry-based randomised clinical trials (R-RCT) and to facilitate safety surveillance of novel drugs and devices. The European Medicines Agency (EMA) is developing systems and processes to enable the use of RWD that can help in trial planning, defining clinical contexts, and enhancing outcome assessments. RWD can also contribute to the measurement of the impact of regulatory actions, such as contraindications or restriction of indications by looking at medicines use patterns over time across European Member States. A number of other initiatives from the European Commission and the EMA are underway to strengthen the EU's health security framework, and foster the collection and utilisation of RWD., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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26. Cost-effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease: a European economic evaluation of the THEMIS trial.
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Steg PG, Bhatt DL, James SK, Darlington O, Hoskin L, Simon T, Fox KM, Leiter LA, Mehta SR, Harrington RA, Himmelmann A, Ridderstråle W, Andersson M, Bueno H, De Luca L, Tank A, Mellström C, and McEwan P
- Subjects
- Humans, Aspirin, Coronary Artery Disease diagnosis, Coronary Artery Disease drug therapy, Coronary Artery Disease epidemiology, Cost-Benefit Analysis, Percutaneous Coronary Intervention, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology, Ticagrelor therapeutic use
- Abstract
Aims: To conduct a health economic evaluation of ticagrelor in patients with type 2 diabetes and coronary artery disease (CAD) from a multinational payer perspective. Cost-effectiveness and cost-utility of ticagrelor were evaluated in the overall effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS) trial population and in the predefined patient group with prior percutaneous coronary intervention., Methods and Results: A Markov model was developed to extrapolate patient outcomes over a lifetime horizon. The primary outcome was incremental cost-effectiveness ratios (ICERs), which were compared with conventional willingness-to-pay thresholds [€47 000/quality-adjusted life-year (QALY) in Sweden and €30 000/QALY in other countries].Treatment with ticagrelor resulted in QALY gains of up to 0.045 in the overall population and 0.099 in patients with percutaneous coronary intervention (PCI). Increased costs and benefits translated to ICERs ranged between €27 894 and €42 252/QALY across Sweden, Germany, Italy, and Spain in the overall population. In patients with prior PCI, estimated ICERs improved to €18 449, €20 632, €20 233, and €13 228/QALY in Sweden, Germany, Italy, and Spain, respectively, driven by higher event rates and treatment benefit., Conclusion: Based on THEMIS results, ticagrelor plus aspirin compared with aspirin alone may be cost-effective in some European countries in patients with T2DM and CAD and no prior myocardial infarction (MI) or stroke. Additionally, ticagrelor is likely to be cost-effective across European countries in patients with a history of PCI., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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27. Is the ESC blowing its own trumpet or should it have a deserved fanfare? The impact and power of registry data.
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de Belder MA, Deanfield J, James S, and Oldgren J
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- Humans, Registries
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- 2022
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28. Benchmarking Observational Analyses Before Using Them to Address Questions Trials Do Not Answer: An Application to Coronary Thrombus Aspiration.
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Matthews AA, Dahabreh IJ, Fröbert O, Lindahl B, James S, Feychting M, Jernberg T, Berglund A, and Hernán MA
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- Benchmarking, Humans, Thrombectomy methods, Treatment Outcome, Coronary Thrombosis therapy, Myocardial Infarction, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction therapy
- Abstract
To increase confidence in the use of observational analyses when addressing effectiveness questions beyond those addressed by randomized trials, one can first benchmark the observational analyses against existing trial results. We used Swedish registry data to emulate a target trial similar to the Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) randomized trial, which found no difference in the risk of death or myocardial infarction by 1 year with or without thrombus aspiration among individuals with ST-elevation myocardial infarction. We benchmarked the emulation against the trial at 1 year and then extended the emulation's follow-up to 3 years and estimated effects in subpopulations underrepresented in the trial. As in the TASTE trial, the observational analysis found no differences in risk of outcomes by 1 year between groups (risk difference = 0.7 (confidence interval, -0.7, 2.0) and -0.2 (confidence interval, -1.3, 1.0) for death and myocardial infarction, respectively), so benchmarking was considered successful. We additionally showed no difference in risk of death or myocardial infarction by 3 years, or within subpopulations by 1 year. Benchmarking against an index trial before using observational analyses to answer questions beyond those the trial could address allowed us to explore whether the observational data can be trusted to deliver valid estimates of treatment effects., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.)
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- 2022
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29. Effects of early myocardial reperfusion and perfusion on myocardial necrosis/dysfunction and inflammation in patients with ST-segment and non-ST-segment elevation acute coronary syndrome: results from the PLATelet inhibition and patients Outcomes (PLATO) trial.
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Batra G, Renlund H, Kunadian V, James SK, Storey RF, Steg PG, Katus HA, Harrington RA, Gibson CM, Budaj A, Siegbahn A, and Wallentin L
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- Humans, Biomarkers, Coronary Angiography methods, Electrocardiography, Growth Differentiation Factor 15, Inflammation, Interleukin-6, Myocardial Reperfusion, Troponin T, Acute Coronary Syndrome, Myocardial Infarction, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction surgery
- Abstract
Aims: Restoration of myocardial blood flow and perfusion during percutaneous coronary intervention (PCI) measured using Thrombolysis in Myocardial Infarction (TIMI) flow grade (TFG) and perfusion grade (TMPG) is associated with improved outcomes in acute coronary syndrome (ACS). Associations between TFG/TMPG and changes in biomarkers reflecting myocardial damage/dysfunction and inflammation is unknown., Methods and Results: Among 2606 patients included, TFG was evaluated in 2198 and TMPG in 1874 with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment ACS (NSTE-ACS). Biomarkers reflecting myocardial necrosis [troponin T (TnT)], myocardial dysfunction [N-terminal prohormone brain natriuretic peptide (NT-proBNP)], inflammation [interleukin-6 (IL-6) and C-reactive protein (CRP)], and oxidative stress/ageing/inflammation [growth differentiation factor-15 (GDF-15)] were measured at baseline, discharge, and 1- and 6-month post-randomization. Associations between TFG/TMPG and changes in biomarker levels were evaluated using the Mann-Whitney-Wilcoxon signed test. In total, 1423 (54.6%) patients had STEMI and 1183 (45.4%) NSTE-ACS. Complete reperfusion after PCI with TFG = 3 was achieved in 1110 (85.3%) with STEMI and in 793 (88.5%) with NSTE-ACS. Normal myocardial perfusion with TMPG = 3 was achieved in 475 (41.6%) with STEMI and in 396 (54.0%) with NSTE-ACS. Levels of TnT, NT-proBNP, IL-6, CRP, and GDF-15 were substantially lower at discharge in patients with complete vs. incomplete TFG and STEMI (P < 0.01). This pattern was not observed for patients with NSTE-ACS. Patients with normal vs. abnormal TMPG and NSTE-ACS had lower levels of NT-proBNP at discharge (P = 0.01)., Conclusions: Successful restoration of epicardial blood flow in STEMI was associated with less myocardial necrosis/dysfunction and inflammation. Attainment of normal myocardial perfusion was associated with less myocardial dysfunction in NSTE-ACS., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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30. Myocardial infarction after elective percutaneous coronary intervention-which cardiac troponin cut-off to use?
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Eggers KM, James SK, and Lindahl B
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- Humans, Troponin, Myocardial Infarction, Percutaneous Coronary Intervention
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- 2022
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31. Causes, pattern, predictors, and prognostic implications of new hospitalizations after transcatheter aortic valve implantation: a long-term nationwide observational study.
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Nilsson K, Buccheri S, Christersson C, Koul S, Nilsson J, Pétursson P, Renlund H, Rück A, and James S
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- Aged, 80 and over, Female, Hospitalization, Humans, Male, Prognosis, Risk Factors, Treatment Outcome, Aortic Valve Stenosis complications, Aortic Valve Stenosis surgery, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Aims: The aim of this study was to investigate the pattern, causes, and predictors of all new hospitalizations in patients who underwent transcatheter aortic valve implantation (TAVI)., Methods and Results: The nationwide Swedish TAVI registry was merged with other mandatory healthcare registries, which enabled the analysis of all TAVI procedures, new hospital admissions, and death between the years 2008 and 2017. A total of 2821 patients underwent TAVI with a mean of 2.5 hospitalizations during a mean follow-up of 2.2 years. Hospitalizations were associated with worse prognosis. Heart failure (HF) was the most common cause of hospitalization with 19% having at least one hospitalization due to HF causing, 16% of all-cause admissions, and 50% of cardiovascular admissions. Male gender, age >90 years, high Charlson Comorbidity Index, atrial fibrillation, present neurologic disease, severe renal impairment, peripheral vascular disease, New York Heart Association class IV, mild or moderate mean aortic valve gradients, and pulmonary hypertension were associated with an increased risk for all-cause hospitalizations or death. For cardiovascular hospitalization or death, the pattern was similar, with the addition of impaired systolic left ventricular function as a predictor., Conclusion: Multiple hospitalizations after TAVI are common and are often caused by HF. Reducing the rate of HF hospitalizations is important to mitigate the burden on the healthcare system due to new hospitalizations after TAVI., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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32. Pre-operative heart failure worsens outcome after aortic valve replacement irrespective of left ventricular ejection fraction.
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Thilén M, James S, Ståhle E, Lindhagen L, and Christersson C
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- Adult, Aged, Aortic Valve surgery, Humans, Stroke Volume, Ventricular Function, Left, Heart Failure complications, Heart Failure epidemiology, Heart Valve Prosthesis
- Abstract
Aims: Left ventricular ejection fraction (LVEF) affects the outcome of aortic valve replacement (AVR) in aortic stenosis (AS). The study aim was to investigate the prognostic importance of concomitant cardiovascular disease in relation to pre-operative LVEF., Methods and Results: All adult patients undergoing AVR due to AS 2008-14 in a national register for heart diseases were included. All-cause mortality and hospitalization for heart failure during follow-up after AVR, stratified by preserved or reduced LVEF (≤50%), were derived from national patient registers and analysed by Cox regression. During the study period, 10 406 patients, median age 73 years, a median follow-up of 35 months were identified. Preserved LVEF was present in 7512 (72.2%). Among them, 647 (8.6%) had a history of heart failure (HF) and 1099 (14.6%) atrial fibrillation (AF) before the intervention. Pre-operative HF was associated with higher mortality irrespective of preserved or reduced LVEF: hazard ratio (HR) 1.64 [95% confidence interval (CI) 1.35-1.99] and 1.58 (95% CI 1.30-1.92). Prior AF was associated with a higher risk of mortality in patients with preserved but not in those with reduced LVEF: HR 1.62 (95% CI 1.36-1.92) and 1.05 (95% CI 0.86-1.28). Irrespective of LVEF, pre-operative HF and AF were associated with an increased risk of post-operative heart failure hospitalization., Conclusion: In patients planned for AVR, a history of HF or AF, irrespective of LVEF, worsens the post-operative prognosis. Heart failure and AF can be seen as markers of myocardial fibrosis not necessarily discovered by LVEF and the merely use of it, besides symptoms, for the timing of AVR seems suboptimal., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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33. European Society of Cardiology methodology for the development of quality indicators for the quantification of cardiovascular care and outcomes.
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Aktaa S, Batra G, Wallentin L, Baigent C, Erlinge D, James S, Ludman P, Maggioni AP, Price S, Weston C, Casadei B, and Gale CP
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- Delivery of Health Care, Humans, Cardiology, Quality Indicators, Health Care
- Abstract
Aims: It is increasingly recognized that tools are required for assessing and benchmarking quality of care in order to improve it. The European Society of Cardiology (ESC) is developing a suite of quality indicators (QIs) to evaluate cardiovascular care and support the delivery of evidence-based care. This paper describes the methodology used for their development., Methods and Results: We propose a four-step process for the development of the ESC QIs. For a specific clinical area with a gap in care delivery, the QI development process includes: (i) the identification of key domains of care by constructing a conceptual framework of care; (ii) the construction of candidate QIs by conducting a systematic review of the literature; (iii) the selection of a final set of QIs by obtaining expert opinions using the modified Delphi method; and (iv) the undertaking of a feasibility assessment by evaluating different ways of defining the QI specifications for the proposed data collection source. For each of the four steps, key methodological areas need to be addressed to inform the implementation process and avoid misinterpretation of the measurement results., Conclusion: Detailing the methodology for the ESC QIs construction enables healthcare providers to develop valid and feasible metrics to measure and improve the quality of cardiovascular care. As such, high-quality evidence may be translated into clinical practice and the 'evidence-practice' gap closed., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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34. Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease.
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Wang R, Serruys PW, Gao C, Hara H, Takahashi K, Ono M, Kawashima H, O'leary N, Holmes DR, Witkowski A, Curzen N, Burzotta F, James S, van Geuns RJ, Kappetein AP, Morel MA, Head SJ, Thuijs DJFM, Davierwala PM, O'Brien T, Fuster V, Garg S, and Onuma Y
- Subjects
- Coronary Artery Bypass, Humans, Treatment Outcome, Vascular Surgical Procedures, Coronary Artery Disease complications, Coronary Artery Disease surgery, Diabetes Mellitus, Percutaneous Coronary Intervention
- Abstract
Aims: The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes., Methods and Results: The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: -7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: -6.5%, 22.5%, P = 0.227)., Conclusions: The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials., Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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35. Good general health and lack of family history influence the underestimation of cardiovascular risk: a cross-sectional study.
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Grauman Å, Veldwijk J, James S, Hansson M, and Byberg L
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- Cohort Studies, Cross-Sectional Studies, Heart Disease Risk Factors, Humans, Middle Aged, Risk Factors, Cardiovascular Diseases genetics
- Abstract
Aims: Underestimation of cardiovascular risk may interfere with prevention of cardiovascular diseases (CVDs). We investigate whether general health and family history of myocardial infarction (MI) are associated with underestimation of perceived cardiovascular risk, and if the participants' calculated risk modifies that association., Methods and Results: The analysis sample consisted of 526 individuals, 50-64 years old, from a population-based cohort study. Information on general health (poor/fairly good, good, and very good/excellent), family history of MI, and self-perceived risk relative to others of similar age and sex were collected though a web-based survey. Participants were categorized into underestimation (n = 162, 31%), accurate estimation (n = 222, 42%), and overestimation (n = 142, 27%) of cardiovascular risk by comparing calculated Systematic Coronary Risk Estimation (SCORE) with self-perceived risk. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for underestimation vs. accurate estimation of cardiovascular risk were computed using logistic regression (n = 384). Very good general health (OR 2.60, 95% CI 1.10-6.16) and lack of family history (OR 2.27, 95% CI 1.24-4.18) were associated with underestimation of cardiovascular risk. The associations were modified by the participants' calculated risk level; the association was stronger for high-risk individuals; without family history OR 22.57 (95% CI 6.17-82.54); with very good/excellent health OR 15.78 (95% CI 3.73-66.87)., Conclusion: A good general health and the lack of family CVD history can obscure the presence of other risk factors and lead to underestimation of cardiovascular risk, especially for high-risk individuals. It is, therefore, crucial to address the fact that the development of CV disease may be silent and multifactorial., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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36. Debate: Prasugrel rather than ticagrelor is the preferred treatment for NSTE-ACS patients who proceed to PCI and pretreatment should not be performed in patients planned for an early invasive strategy.
- Author
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Crea F, Thiele H, Sibbing D, Barthélémy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Jüni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Siontis GCM, Barbato E, Collet JP, Giannitsis E, Hamm CW, Böhm M, Cornel JH, Ferreiro JL, Frey N, Huber K, Kubica J, Navarese EP, Mehran R, Morais J, Storey RF, Valgimigli M, Vranckx P, and James S
- Subjects
- Clopidogrel, Humans, Prasugrel Hydrochloride therapeutic use, Purinergic P2Y Receptor Antagonists, Ticagrelor therapeutic use, Percutaneous Coronary Intervention
- Published
- 2021
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37. Genetically determined NLRP3 inflammasome activation associates with systemic inflammation and cardiovascular mortality.
- Author
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Schunk SJ, Kleber ME, März W, Pang S, Zewinger S, Triem S, Ege P, Reichert MC, Krawczyk M, Weber SN, Jaumann I, Schmit D, Sarakpi T, Wagenpfeil S, Kramann R, Boerwinkle E, Ballantyne CM, Grove ML, Tragante V, Pilbrow AP, Richards AM, Cameron VA, Doughty RN, Dubé MP, Tardif JC, Feroz-Zada Y, Sun M, Liu C, Ko YA, Quyyumi AA, Hartiala JA, Tang WHW, Hazen SL, Allayee H, McDonough CW, Gong Y, Cooper-DeHoff RM, Johnson JA, Scholz M, Teren A, Burkhardt R, Martinsson A, Smith JG, Wallentin L, James SK, Eriksson N, White H, Held C, Waterworth D, Trompet S, Jukema JW, Ford I, Stott DJ, Sattar N, Cresci S, Spertus JA, Campbell H, Tierling S, Walter J, Ampofo E, Niemeyer BA, Lipp P, Schunkert H, Böhm M, Koenig W, Fliser D, Laufs U, and Speer T
- Subjects
- Humans, Leukocytes, Mononuclear, Cardiovascular Diseases mortality, Inflammasomes genetics, Inflammation genetics, NLR Family, Pyrin Domain-Containing 3 Protein genetics
- Abstract
Aims: Inflammation plays an important role in cardiovascular disease (CVD) development. The NOD-like receptor protein-3 (NLRP3) inflammasome contributes to the development of atherosclerosis in animal models. Components of the NLRP3 inflammasome pathway such as interleukin-1β can therapeutically be targeted. Associations of genetically determined inflammasome-mediated systemic inflammation with CVD and mortality in humans are unknown., Methods and Results: We explored the association of genetic NLRP3 variants with prevalent CVD and cardiovascular mortality in 538 167 subjects on the individual participant level in an explorative gene-centric approach without performing multiple testing. Functional relevance of single-nucleotide polymorphisms on NLRP3 inflammasome activation has been evaluated in monocyte-enriched peripheral blood mononuclear cells (PBMCs). Genetic analyses identified the highly prevalent (minor allele frequency 39.9%) intronic NLRP3 variant rs10754555 to affect NLRP3 gene expression. rs10754555 carriers showed significantly higher C-reactive protein and serum amyloid A plasma levels. Carriers of the G allele showed higher NLRP3 inflammasome activation in isolated human PBMCs. In carriers of the rs10754555 variant, the prevalence of coronary artery disease was significantly higher as compared to non-carriers with a significant interaction between rs10754555 and age. Importantly, rs10754555 carriers had significantly higher risk for cardiovascular mortality during follow-up. Inflammasome inducers (e.g. urate, triglycerides, apolipoprotein C3) modulated the association between rs10754555 and mortality., Conclusion: The NLRP3 intronic variant rs10754555 is associated with increased systemic inflammation, inflammasome activation, prevalent coronary artery disease, and mortality. This study provides evidence for a substantial role of genetically driven systemic inflammation in CVD and highlights the NLRP3 inflammasome as a therapeutic target., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2021
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38. Prognostic impact of baseline inflammatory markers in patients with acute coronary syndromes treated with ticagrelor and clopidogrel.
- Author
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Thomas MR, James SK, Becker RC, Himmelmann A, Katus HA, Cannon CP, Steg PG, Siegbahn A, Lakic T, Storey RF, and Wallentin L
- Abstract
Background: Inflammation plays a major role in the pathophysiology of coronary artery disease. We aimed to determine whether baseline inflammatory markers were associated with clinical outcomes and the observed superiority of ticagrelor compared to clopidogrel in patients with acute coronary syndromes in the PLATO study., Methods: Blood samples were collected from 16,400 patients within 24 hours of the onset of acute coronary syndrome, at the time of random assignment to ticagrelor or clopidogrel in the PLATO study and prior to invasive procedures. The differential white blood cell count and plasma levels of C-reactive protein, interleukin-6 and interleukin-10 were determined and their relationships with clinical outcomes were assessed according to quartiles and using continuous models. The substudy primary endpoint was a composite of cardiovascular death and myocardial infarction., Results: Compared to the lowest quartile, the risk of the primary endpoint was significantly elevated in patients in the highest quartile of white blood cell count (hazard ratio (HR) 1.30; P =0.01), neutrophil count (HR 1.33; P =0.007), monocyte count (HR 1.24; P =0.004), C-reactive protein (HR 1.93; P <0.001) and interleukin-6 (HR 2.29; P <0.001). This was predominantly driven by an association with cardiovascular death. Following adjustment for clinical characteristics, troponin, cystatin C and N-terminal pro-brain-type natriuretic peptide, only white blood cell count and neutrophil count maintained a significant association with the primary endpoint. Ticagrelor had a consistent relative cardiovascular benefit compared to clopidogrel in each quartile of each of the inflammatory markers., Conclusions: Acute coronary syndrome patients with elevated levels of baseline inflammatory markers are at increased risk of adverse cardiovascular events, particularly cardiovascular death. The consistent cardiovascular benefit of ticagrelor compared to clopidogrel tended to confer a greater absolute risk reduction in patients with the highest levels of inflammatory markers, as they were at highest risk., (© The European Society of Cardiology 2019.)
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- 2021
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39. Patient-tailored antithrombotic therapy following percutaneous coronary intervention.
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van der Sangen NMR, Rozemeijer R, Chan Pin Yin DRPP, Valgimigli M, Windecker S, James SK, Buccheri S, Ten Berg JM, Henriques JPS, Voskuil M, and Kikkert WJ
- Subjects
- Dual Anti-Platelet Therapy, Fibrinolytic Agents therapeutic use, Humans, Platelet Aggregation Inhibitors therapeutic use, Acute Coronary Syndrome drug therapy, Percutaneous Coronary Intervention
- Abstract
Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from either shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint on the use of different risk stratification methods alongside clinical judgement in current clinical practice., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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40. Low-density lipoprotein cholesterol reduction and statin intensity in myocardial infarction patients and major adverse outcomes: a Swedish nationwide cohort study.
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Schubert J, Lindahl B, Melhus H, Renlund H, Leosdottir M, Yari A, Ueda P, James S, Reading SR, Dluzniewski PJ, Hamer AW, Jernberg T, and Hagström E
- Subjects
- Cohort Studies, Humans, Sweden epidemiology, Treatment Outcome, Brain Ischemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Myocardial Infarction drug therapy, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Stroke
- Abstract
Aims: Clinical trials have demonstrated that a reduction in low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular (CV) events. This has, however, not yet been shown in a real-world setting. We aimed to investigate the association between LDL-C changes and statin intensity with prognosis after a myocardial infarction (MI)., Methods and Results: Patients admitted with MI were followed for mortality and major CV events. Changes in LDL-C between the MI and a 6- to 10-week follow-up visit were analysed. The associations between quartiles of LDL-C change and statin intensity with outcomes were assessed using adjusted Cox regression analyses. A total of 40 607 patients were followed for a median of 3.78 years. The median change in LDL-C was a 1.20 mmol/L reduction. Patients with larger LDL-C reduction (1.85 mmol/L, 75th percentile) compared with a smaller reduction (0.36 mmol/L, 25th percentile) had lower hazard ratios (HR) for all outcomes (95% confidence interval): composite of CV mortality, MI, and ischaemic stroke 0.77 (0.70-0.84); all-cause mortality 0.71 (0.63-0.80); CV mortality 0.68 (0.57-0.81); MI 0.81 (0.73-0.91); ischaemic stroke 0.76 (0.62-0.93); heart failure hospitalization 0.73 (0.63-0.85), and coronary artery revascularization 0.86 (0.79-0.94). Patients with ≥50% LDL-C reduction using high-intensity statins at discharge had a lower incidence of all outcomes compared with those using a lower intensity statin., Conclusions: Larger early LDL-C reduction and more intensive statin therapy after MI were associated with a reduced hazard of all CV outcomes and all-cause mortality. This supports clinical trial data suggesting that earlier lowering of LDL-C after an MI confers the greatest benefit., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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41. Oxygen therapy in suspected acute myocardial infarction and concurrent normoxemic chronic obstructive pulmonary disease: a prespecified subgroup analysis from the DETO2X-AMI trial.
- Author
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Andell P, James S, Östlund O, Yndigegn T, Sparv D, Pernow J, Jernberg T, Lindahl B, Herlitz J, Erlinge D, and Hofmann R
- Subjects
- Aged, Female, Humans, Male, Myocardial Infarction complications, Myocardial Infarction mortality, Pulmonary Disease, Chronic Obstructive complications, Pulmonary Disease, Chronic Obstructive mortality, Survival Rate trends, Sweden epidemiology, Treatment Outcome, Myocardial Infarction therapy, Oxygen Inhalation Therapy methods, Pulmonary Disease, Chronic Obstructive therapy
- Abstract
Background: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial did not find any benefit of oxygen therapy compared to ambient air in normoxemic patients with suspected acute myocardial infarction. Patients with chronic obstructive pulmonary disease may both benefit and be harmed by supplemental oxygen. Thus we evaluated the effect of routine oxygen therapy compared to ambient air in normoxemic chronic obstructive pulmonary disease patients with suspected acute myocardial infarction., Methods and Results: A total of 6629 patients with suspected acute myocardial infarction were randomly assigned in the DETO2X-AMI trial to oxygen or ambient air. In the oxygen group ( n =3311) and the ambient air group ( n =3318), 155 and 141 patients, respectively, had chronic obstructive pulmonary disease (prevalence of 4.5%). Patients with chronic obstructive pulmonary disease were older, had more comorbid conditions and experienced a twofold higher risk of death at one year (chronic obstructive pulmonary disease: 32/296 (10.8%) vs. non-chronic obstructive pulmonary disease: 302/6333 (4.8%)). Oxygen therapy compared to ambient air was not associated with improved outcomes at 365 days (chronic obstructive pulmonary disease: all-cause mortality hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.50-1.99, P
interaction =0.96); cardiovascular death HR 0.80, 95% CI 0.32-2.04, Pinteraction =0.59); rehospitalisation with acute myocardial infarction or death HR 1.27, 95% CI 0.71-2.28, Pinteraction =0.46); hospitalisation for heart failure or death HR 1.08, 95% CI 0.61-1.91, Pinteraction =0.77]); there were no significant treatment-by-chronic obstructive pulmonary disease interactions., Conclusions: Although chronic obstructive pulmonary disease patients had twice the mortality rate compared to non-chronic obstructive pulmonary disease patients, this prespecified subgroup analysis from the DETO2X-AMI trial on oxygen therapy versus ambient air in normoxemic chronic obstructive pulmonary disease patients with suspected acute myocardial infarction revealed no evidence for benefit of routine oxygen therapy consistent with the main trial's findings., Clinical Trials Registration: NCT02290080.- Published
- 2020
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42. Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes.
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Storey RF, Gurbel PA, Ten Berg J, Bernaud C, Dangas GD, Frenoux JM, Gorog DA, Hmissi A, Kunadian V, James SK, Tanguay JF, Tran H, Trenk D, Ufer M, Van der Harst P, Van't Hof AWJ, and Angiolillo DJ
- Subjects
- Blood Platelets, Humans, Organophosphonates, Platelet Aggregation, Platelet Function Tests, Pyrimidines, Syndrome, Platelet Aggregation Inhibitors, Purinergic P2Y Receptor Antagonists
- Abstract
Aims: To study the pharmacodynamics and pharmacokinetics of selatogrel, a novel P2Y12 receptor antagonist for subcutaneous administration, in patients with chronic coronary syndromes (CCS)., Methods and Results: In this double-blind, randomized study of 345 patients with CCS on background oral antiplatelet therapy, subcutaneous selatogrel (8 mg, n = 114; or 16 mg, n = 115) was compared with placebo (n = 116) (ClinicalTrials.gov: NCT03384966). Platelet aggregation was assessed over 24 h (VerifyNow assay) and 8 h (light transmittance aggregometry; LTA). Pharmacodynamic responders were defined as patients having P2Y12 reaction units (PRU) <100 at 30 min post-dose and lasting ≥3 h. At 30 min post-dose, 89% of patients were responders to selatogrel 8 mg, 90% to selatogrel 16 mg, and 16% to placebo (P < 0.0001). PRU values (mean ± standard deviation) were 10 ± 25 (8 mg), 4 ± 10 (16 mg), and 163 ± 73 (placebo) at 15 min and remained <100 up to 8 h for both doses, returning to pre-dose or near pre-dose levels by 24 h post-dose. LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked ∼30 min post-dose. Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%)., Conclusions: Selatogrel was rapidly absorbed following subcutaneous administration in CCS patients, providing prompt, potent, and consistent platelet P2Y12 inhibition sustained for ≥8 h and reversible within 24 h. Further studies of subcutaneous selatogrel are warranted in clinical scenarios where rapid platelet inhibition is desirable., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2020
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43. Radial artery access is associated with lower mortality in patients undergoing primary PCI: a report from the SWEDEHEART registry.
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Dworeck C, Redfors B, Völz S, Haraldsson I, Angerås O, Råmunddal T, Ioanes D, Myredal A, Odenstedt J, Hirlekar G, Koul S, Fröbert O, Linder R, Venetsanos D, Hofmann R, Ulvenstam A, Petursson P, Sarno G, James S, Erlinge D, and Omerovic E
- Subjects
- Aged, Female, Follow-Up Studies, Hospital Mortality trends, Humans, Male, Radial Artery, Retrospective Studies, Risk Assessment methods, Risk Factors, ST Elevation Myocardial Infarction surgery, Survival Rate trends, Sweden epidemiology, Treatment Outcome, Cardiac Catheterization methods, Percutaneous Coronary Intervention methods, Propensity Score, Registries, ST Elevation Myocardial Infarction mortality
- Abstract
Objectives: The purpose of this observational study was to evaluate the effects of radial artery access versus femoral artery access on the risk of 30-day mortality, inhospital bleeding and cardiogenic shock in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention., Methods: We used data from the SWEDEHEART registry and included all patients who were treated with primary percutaneous coronary intervention in Sweden between 2005 and 2016. We compared patients who had percutaneous coronary intervention by radial access versus femoral access with regard to the primary endpoint of all-cause death within 30 days, using a multilevel propensity score adjusted logistic regression which included hospital as a random effect., Results: During the study period, 44,804 patients underwent primary percutaneous coronary intervention of whom 24,299 (54.2%) had radial access and 20,505 (45.8%) femoral access. There were 2487 (5.5%) deaths within 30 days, of which 920 (3.8%) occurred in the radial access and 1567 (7.6%) in the femoral access group. After propensity score adjustment, radial access was associated with a lower risk of death (adjusted odds ratio (OR) 0.70, 95% confidence interval (CI) 0.55-0.88, P = 0.025). We found no interaction between access site and age, gender and cardiogenic shock regarding 30-day mortality. Radial access was also associated with a lower adjusted risk of bleeding (adjusted OR 0.45, 95% CI 0.25-0.79, P = 0.006) and cardiogenic shock (adjusted OR 0.41, 95% CI 0.24-0.73, P = 0.002)., Conclusions: In patients with ST-elevation myocardial infarction, primary percutaneous coronary intervention by radial access rather than femoral access was associated with an adjusted lower risk of death, bleeding and cardiogenic shock. Our findings are consistent with, and add external validity to, recent randomised trials.
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- 2020
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44. Pentraxin-3 vs C-reactive protein and other prognostic biomarkers in acute coronary syndrome: A substudy of the Platelet Inhibition and Patients Outcomes (PLATO) trial.
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Kontny F, Andersen T, Ueland T, Åkerblom A, Lakic TG, Michelsen AE, Aukrust P, Bertilsson M, Becker RC, Himmelmann A, James SK, Siegbahn A, Storey RF, and Wallentin L
- Subjects
- Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome drug therapy, Aged, Biomarkers blood, Female, Humans, Male, Middle Aged, Prognosis, Risk Factors, Acute Coronary Syndrome blood, C-Reactive Protein metabolism, Platelet Aggregation Inhibitors therapeutic use, Serum Amyloid P-Component metabolism
- Abstract
Aims: We investigated the dynamics, associations with patient characteristics, other biomarkers, and clinical outcomes of pentraxin 3 in acute coronary syndrome., Methods and Results: In multivariate analyses, pentraxin 3 measured in 5154 patients randomised in the Platelet Inhibition and Patients Outcomes (PLATO) trial (NCT00391872) was compared with leukocytes, high-sensitivity C-reactive protein, interleukin-6, cystatin C, N-terminal prohormone brain natriuretic peptide, high-sensitivity troponin T and growth differentiation factor 15 concerning prediction of clinical outcome. Pentraxin 3 peaked earlier than high-sensitivity C-reactive protein and was more strongly correlated with N-terminal prohormone brain natriuretic peptide and high-sensitivity troponin T than with high-sensitivity C-reactive protein. The frequency of cardiovascular death, spontaneous myocardial infarction or stroke by quartiles of pentraxin 3 at admission was 6.1%, 7.3%, 9.7% and 10.7%, respectively ( p <0.0001). The hazard ratio per 50% increase of pentraxin 3 was 1.13 (95% confidence interval: 1.07-1.19), p <0.0001. This association remained significant after stepwise adjustments for leukocytes/high-sensitivity C-reactive protein (1.09 (1.02-1.15)), p =0.009, interleukin-6 (1.07 (1.01-1.14)), p =0.026, and cystatin C (1.07 (1.00-1.13)), p =0.044, but not after adjustment for N-terminal prohormone brain natriuretic peptide, high-sensitivity troponin T and growth differentiation factor 15. Admission pentraxin 3 was also associated with several of the individual endpoint components (cardiovascular death/spontaneous myocardial infarction; p =0.008, cardiovascular death; p =0.026, and spontaneous myocardial infarction; p =0.017), but not with stroke. Pentraxin 3 measured in the chronic phase (i.e. at one month) was still predictive of the composite endpoint in univariate analysis (1.12 (1.04-1.20) per 50% increase) p =0.0024, but not after adjustment for the other biomarkers., Conclusion: Admission level of pentraxin 3 is a modestly stronger predictor than high-sensitivity C-reactive protein and interleukin-6, but not than N-terminal prohormone brain natriuretic peptide or high-sensitivity troponin T, concerning cardiovascular outcome in acute coronary syndrome. Pentraxin 3 is more strongly correlated with N-terminal prohormone brain natriuretic peptide and high-sensitivity troponin T than with high-sensitivity C-reactive protein.
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- 2020
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45. EAPCI Position Statement on Invasive Management of Acute Coronary Syndromes during the COVID-19 pandemic.
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Chieffo A, Stefanini GG, Price S, Barbato E, Tarantini G, Karam N, Moreno R, Buchanan GL, Gilard M, Halvorsen S, Huber K, James S, Neumann FJ, Möllmann H, Roffi M, Tavazzi G, Mauri Ferré J, Windecker S, Dudek D, and Baumbach A
- Subjects
- Acute Coronary Syndrome virology, COVID-19, Cardiology methods, Coronavirus Infections epidemiology, Coronavirus Infections virology, Humans, Infection Control methods, Infection Control standards, Non-ST Elevated Myocardial Infarction therapy, Non-ST Elevated Myocardial Infarction virology, Pandemics, Pneumonia, Viral epidemiology, Pneumonia, Viral virology, ST Elevation Myocardial Infarction therapy, ST Elevation Myocardial Infarction virology, Acute Coronary Syndrome therapy, Cardiology standards, Coronavirus Infections therapy, Pneumonia, Viral therapy
- Abstract
The coronavirus disease 2019 (COVID-19) pandemic poses an unprecedented challenge to healthcare worldwide. The infection can be life threatening and require intensive care treatment. The transmission of the disease poses a risk to both patients and healthcare workers. The number of patients requiring hospital admission and intensive care may overwhelm health systems and negatively affect standard care for patients presenting with conditions needing emergency interventions. This position statements aims to assist cardiologists in the invasive management of acute coronary syndrome (ACS) patients in the context of the COVID-19 pandemic. To that end, we assembled a panel of interventional cardiologists and acute cardiac care specialists appointed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Acute Cardiovascular Care Association (ACVC) and included the experience from the first and worst affected areas in Europe. Modified diagnostic and treatment algorithms are proposed to adapt evidence-based protocols for this unprecedented challenge. Various clinical scenarios, as well as management algorithms for patients with a diagnosed or suspected COVID-19 infection, presenting with ST- and non-ST-segment elevation ACS are described. In addition, we address the need for re-organization of ACS networks, with redistribution of hub and spoke hospitals, as well as for in-hospital reorganization of emergency rooms and cardiac units, with examples coming from multiple European countries. Furthermore, we provide a guidance to reorganization of catheterization laboratories and, importantly, measures for protection of healthcare providers involved with invasive procedures., (This article has been co-published with permission in the European Heart Journal and EuroIntervention. All rights reserved. © 2020 European Society of Cardiology. These articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article.)
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- 2020
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46. Haemorrhagic stroke and major bleeding after intervention with biological aortic valve prosthesis: risk factors and antithrombotic treatment.
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Christersson C, Ståhle E, Lindhagen L, and James S
- Abstract
The majority of patients with severe aortic stenosis are recommended intervention with a surgical biological prosthesis (bioSAVR) or a transcatheter aortic valve intervention (TAVI). The antithrombotic strategies after aortic valve intervention vary and include drugs targeting both platelets and the coagulation cascade. Long-term exposure and changes of antithrombotic treatment influence the risk of both bleeding and thromboembolic events.The aim was to describe an unselected sample of patients who have experienced haemorrhagic stroke and other major bleeding events after biological aortic prosthesis, their antithrombotic treatment and changes of treatments in relation to the bleeding event.All patients performing an bioSAVR or a TAVI 2008-2014 were identified in the SWEDEHEART registry and included in the study ( n = 10 711). The outcome events were haemorrhagic stroke and other major bleeding event. Information of drug exposure was collected from the dispensed drug registry.The incidence rate of any bleeding event was 2.85/100 patient-years the first year after aortic valve intervention. Heart failure and atrial fibrillation were present more often in patients with a first haemorrhagic stroke or other major bleeding event compared to without. The proportion of exposure to warfarin was 28.7% vs. 21.3% in patients with and without a haemorrhagic stroke. Comparable figures were 31.2% vs. 19.0% in patients with and without other major bleeding event. During 1 month prior a haemorrhagic stroke or other major bleeding event 39.4% and 38.0%, respectively, of the patients not previously exposed to antithrombotic treatment started warfarin or single antiplatelet therapy.Major bleeding events are not uncommon after aortic valve intervention with a biological prosthesis. Evaluation of comorbidities and previous bleeding might improve risk stratification for bleeding in these elderly patients. The pattern of change of antithrombotic treatment was similar in the groups with and without a bleeding event and in most patients the antithrombotic regime was unchanged the month before an event., (Published on behalf of the European Society of Cardiology. © The Author(s) 2020.)
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- 2020
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47. Relationship between degree of heparin anticoagulation and clinical outcome in patients receiving potent P2Y12-inhibitors with no planned glycoprotein IIb/IIIa inhibitor during percutaneous coronary intervention in acute myocardial infarction: a VALIDATE-SWEDEHEART substudy.
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Sharma T, Rylance R, Karlsson S, Koul S, Venetsanos D, Omerovic E, Fröbert O, Persson J, James S, and Erlinge D
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- Aged, Aged, 80 and over, Anticoagulants adverse effects, Coronary Thrombosis etiology, Coronary Thrombosis prevention & control, Drug Monitoring, Female, Hemorrhage chemically induced, Heparin adverse effects, Humans, Male, Middle Aged, Myocardial Infarction diagnosis, Myocardial Infarction mortality, Platelet Aggregation Inhibitors adverse effects, Purinergic P2Y Receptor Antagonists adverse effects, Recurrence, Registries, Risk Assessment, Risk Factors, Sweden, Time Factors, Treatment Outcome, Whole Blood Coagulation Time, Anticoagulants administration & dosage, Heparin administration & dosage, Myocardial Infarction therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors administration & dosage, Purinergic P2Y Receptor Antagonists administration & dosage
- Abstract
Aims: Heparin is the preferred choice of anticoagulant in percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). An established dosage of heparin has not yet been determined, but treatment may be optimized through monitoring of activated clotting time (ACT). The aim of this study was to determine the relationship between heparin dose or ACT with a composite outcome of death, MI, or bleeding using data from the registry-based, randomized, controlled, and open-label VALIDATE-SWEDEHEART trial, although patients were not randomized to heparin dose in this substudy., Methods and Results: Patients with MI undergoing PCI and receiving treatment with a potent P2Y12-inhibitor and anticoagulation with heparin, without the planned use of glycoprotein IIb/IIIa inhibitor (GPI), were enrolled in this substudy. The primary endpoint was a composite endpoint of death, MI, and bleeding at 30 days. The individual components and stent thrombosis were analysed separately. We divided patients into groups according to the initial dose of unfractionated heparin during PCI (<70 U/kg, 70-100 U/kg, and >100 U/kg) or ACT (ACT <250 s, 250-350 s, and >350 s) as well as investigating them as continuous variables in Cox proportional hazards models using univariable and multivariable analyses. No major differences were noted between heparin stratified in groups (P = 0.22) or heparin as a continuous variable in relation to the primary composite endpoint hazard ratio (HR) 1.0 confidence interval (CI) (0.99-1.01) for heparin dose/kg. No differences were found between ACT stratified in groups (P = 0.453) or ACT in seconds HR 1.0 CI (0.99-1.00) regarding the primary endpoint. The individual components of death, MI, major bleeding, and stent thrombosis were not significantly different across heparin doses or ACT levels either., Conclusion: We found no association between heparin dose or ACT levels and death, MI bleeding complications, or stent thrombosis. Therefore, there is no strong support for a specific heparin dose or mandatory ACT monitoring in patients treated with potent P2Y12-inhibitors with no planned GPI., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)
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- 2020
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48. Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary.
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Bueno H, de Graeff P, Richard-Lordereau I, Emmerich J, Fox KA, Friedman CP, Gaudin C, El-Gazayerly A, Goldman S, Hemmrich M, Henderson RA, Himmelmann A, Irs A, Jackson N, James SK, Katus HA, Laslop A, Laws I, Mehran R, Ong S, Prasad K, Roffi M, Rosano GM, Rose M, Sinnaeve PR, Stough WG, Thygesen K, Van de Werf F, Varin C, Verheugt FW, and de Los Angeles Alonso García M
- Subjects
- Acute Coronary Syndrome physiopathology, Angina, Unstable therapy, Death, Endpoint Determination methods, Europe epidemiology, Female, Humans, Male, Myocardial Infarction mortality, Percutaneous Coronary Intervention methods, Randomized Controlled Trials as Topic, Reperfusion methods, Risk Assessment, Thrombolytic Therapy methods, Acute Coronary Syndrome therapy, Cardiology organization & administration, Education methods, Myocardial Infarction therapy, Non-ST Elevated Myocardial Infarction therapy, ST Elevation Myocardial Infarction therapy
- Abstract
Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) should be studied separately for therapies aimed at the specific pathophysiology of either condition, particularly for treatment of the acute phase, but can be studied together for other treatments, especially long-term therapy. Unstable angina patients should be excluded from acute phase ACS trials. In general, cardiovascular death and reinfarction are recommended for primary efficacy endpoints; other endpoints may be considered if specifically relevant for the therapy under study. New agents or interventions should be tested against a background of evidence-based therapy with expanded follow-up for safety assessment. In conclusion, new guidance documents for randomized controlled trials in ACS should consider changes regarding patient and endpoint selection and definitions, and trial designs. Specific requirements for the evaluation of novel pharmacological therapies need further clarification.
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- 2019
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49. Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction.
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Erlinge D, Koul S, Omerovic E, Fröbert O, Linder R, Danielewicz M, Hamid M, Venetsanos D, Henareh L, Pettersson B, Wagner H, Grimfjärd P, Jensen J, Hofmann R, Ulvenstam A, Völz S, Petursson P, Östlund O, Sarno G, Wallentin L, Scherstén F, Eriksson P, and James S
- Subjects
- Aged, Anticoagulants therapeutic use, Female, Hemorrhage epidemiology, Heparin therapeutic use, Hirudins, Humans, Male, Myocardial Infarction epidemiology, Platelet Aggregation Inhibitors therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors, Prasugrel Hydrochloride therapeutic use, Purinergic P2Y Receptor Antagonists therapeutic use, Recombinant Proteins therapeutic use, Stents adverse effects, Sweden epidemiology, Thrombosis, Ticagrelor therapeutic use, Antithrombins therapeutic use, Non-ST Elevated Myocardial Infarction drug therapy, Peptide Fragments therapeutic use, Percutaneous Coronary Intervention methods
- Abstract
Background: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use., Methods: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days., Results: A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18, p =0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94, p =0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45, p =0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24, p =0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93, p =0.82)., Conclusion: Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.
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- 2019
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50. Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management: A prespecified subgroup analysis from VALIDATE-SWEDEHEART.
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Völz S, Angerås O, Koul S, Haraldsson I, Sarno G, Venetsanos D, Grimfärd P, Ulvenstam A, Hofmann R, Hamid M, Henareh L, Wagner H, Jensen J, Danielewicz M, Östlund O, Eriksson P, Scherstén F, Linder R, Råmunddal T, Pétursson P, Fröbert O, James S, Erlinge D, and Omerovic E
- Subjects
- Acute Coronary Syndrome complications, Aged, Anticoagulants therapeutic use, Antithrombins therapeutic use, Female, Hemorrhage epidemiology, Heparin therapeutic use, Hirudins, Humans, Male, Myocardial Infarction epidemiology, Non-ST Elevated Myocardial Infarction drug therapy, Peptide Fragments therapeutic use, Percutaneous Coronary Intervention trends, Prospective Studies, Recombinant Proteins therapeutic use, Registries, ST Elevation Myocardial Infarction drug therapy, Treatment Outcome, Acute Coronary Syndrome therapy, Femoral Artery surgery, Percutaneous Coronary Intervention methods, Radial Artery surgery
- Abstract
Aims: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin., Methods and Results: A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43-0.67, p <0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52-0.84, p <0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60, p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75, p <0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint ( p =0.976) or major bleeding ( p =0.801)., Conclusions: Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.
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- 2019
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