249 results on '"James, Stefan"'
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2. Rationale and design of the DAPA-MI trial: Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction.
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James, Stefan, Erlinge, David, Storey, Robert F., McGuire, Darren K., de Belder, Mark, Björkgren, Ida, Johansson, Peter A., Langkilde, Anna Maria, Ridderstråle, Wilhelm, Parvaresh Rizi, Ehsan, Deanfield, John, and Oldgren, Jonas
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Therapies that could further prevent the development of heart failure (HF) and other cardiovascular and metabolic events in patients with recent myocardial infarction (MI) represent a large and unmet medical need. DAPA-MI is a multicenter, parallel-group, registry-based, randomized, double-blind, placebo-controlled phase 3 trial in patients without known diabetes or established HF, presenting with MI and impaired left ventricular systolic function or Q-wave MI. The trial evaluated the effect of dapagliflozin 10 mg vs placebo, given once daily in addition to standard of care therapy, on death, hospitalization for HF (HHF), and other cardiometabolic outcomes. The primary objective of the trial was to determine, using the win-ratio method, if dapagliflozin is superior to placebo by comparing the hierarchical composite outcome of death, HHF, nonfatal MI, atrial fibrillation/flutter, new onset of type 2 diabetes mellitus, HF symptoms as measured by New York Heart Association Functional Classification at last visit, and body weight decrease ≥5% at last visit. Assuming a true win-ratio of 1.20 between dapagliflozin and placebo, 4,000 patients provide a statistical power of 80% for the test of the primary composite outcome. A registry-based randomized controlled trial framework allowed for recruitment, randomization, blinding, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries (in Sweden and the UK) integrated with the trial database. The trial explores opportunities to improve further the outcome of patients with impaired LV function after MI. The innovative trial design of DAPA-MI, incorporating national clinical registry data, has facilitated efficient patient recruitment as well as outcome ascertainment. ClinicalTrials.gov Identifier NCT04564742. [ABSTRACT FROM AUTHOR]
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- 2023
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3. Morbidity and Mortality Associated With Heart Failure in Acute Coronary Syndrome: A Pooled Analysis of 4 Clinical Trials.
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GOODWIN, NATHAN P., CLARE, ROBERT M., HARRINGTON, JOSEPHINE L., BADJATIYA, ANISH, WOJDYLA, DANIEL M., UDELL, JACOB A., BUTLER, JAVED, JANUZZI, JAMES L., PARIKH, PUJA B., JAMES, STEFAN, ALEXANDER, JOHN H., LOPES, RENATO D., WALLENTIN, LARS, OHMAN, E. MAGNUS, HERNANDEZ, ADRIAN F., and JONES, W. SCHUYLER
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• Chronic and de novo HF were common in patients presenting with acute coronary syndrome. • Future ischemic events occur at significant rates as early as 1 month post-discharge. • There is urgent need for improved therapies for the population with ACS-HF. • Studies involving novel therapies in ACS-HF are needed. Heart failure (HF) may complicate acute coronary syndrome (ACS) and is associated with a high burden of short- and long-term morbidity and mortality. Only limited data regarding future ischemic events and rehospitalization are available for patients who suffer HF before or during ACS. A secondary analysis of 4 large ACS trials (PLATO, APPRAISE-2, TRACER, and TRILOGY ACS) using Cox proportional hazards models was performed to investigate the association of HF status (no HF, chronic HF, de novo HF) at presentation for ACS with all-cause and cardiovascular death, major adverse cardiovascular event (MACE), myocardial infarction, stroke, and hospitalization for heart failure (HHF) by 1 year. Cumulative incidence plots are presented at 30 days and 1 year. A total of 11.1% of the 47,474 patients presenting with ACS presented with evidence of acute HF, 55.0% of whom presented with de novo HF. Patients with chronic HF presented with evidence of acute HF at a higher rate than those with no previous HF (40.3% vs 6.9%). Compared to those without HF, those with chronic and de novo HF had higher rates of all-cause mortality (adjusted hazard ratio [aHR] 2.01, 95% confidence interval [CI] 1.72–2.34 and aHR 1.47, 95% CI1.15–1.88, respectively), MACE (aHR 1.47, 95% CI1.31–1-.66 and aHR 1.38, 95% CI1.12–1.69), and HHF (aHR 2.29, 95% CI2.02–2.61 and aHR 1.48, 95% CI 1.20–1.82) at 1 year. In this large cohort of patients with ACS, both prior and de novo HF complicating ACS were associated with significantly higher risk-adjusted rates of death, ischemic events and HHF at 30 days and 1 year. Further studies examining the association between HF and outcomes in this high-risk population are warranted, especially given the advent of more contemporary HF therapies. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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4. Comparison between ticagrelor and clopidogrel in myocardial infarction patients with high bleeding risk
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Tjerkaski, Jonathan, Jernberg, Tomas, Alfredsson, Joakim, Erlinge, David, James, Stefan, Lindahl, Bertil, Mohammad, Moman Aladdin, Omerovic, Elmir, Venetsanos, Dimitrios, and Szummer, Karolina
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- 2023
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5. The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT).
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Bäck, Maria, Leosdottir, Margret, Ekström, Mattias, Hambraeus, Kristina, Ravn-Fischer, Annica, Öberg, Birgitta, Östlund, Ollie, and James, Stefan
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Despite proven benefits of exercise-based cardiac rehabilitation (EBCR), few patients with myocardial infarction (MI) participate in and complete these programs. The Remote Exercise SWEDEHEART study is a large multicenter registry-based cluster randomized crossover clinical trial with a planned enrollment of 1500 patients with a recent MI. Patients at intervention centers will be offered supervised EBCR, either delivered remotely, center-based or as a combination of both modes, as self-preferred choice. At control centers, patients will be offered supervised center-based EBCR, only. The duration of each time period (intervention/control) for each center will be 15 months and then cross-over occurs. The primary aim is to evaluate if remotely delivered EBCR, offered as an alternative to center-based EBCR, can increase participation in EBCR sessions. The proportion completers in each group will be presented in a supportive responder analysis. The key secondary aim is to investigate if remote EBCR is as least as effective as center-based EBCR, in terms of physical fitness and patient-reported outcome measures. Follow-up of major adverse cardiovascular events (cardiovascular- and all-cause mortality, recurrent hospitalization for acute coronary syndrome, heart failure hospitalization, stroke, and coronary revascularization) will be performed at 1 and 3 years. Safety monitoring of serious adverse events will be registered, and a cost-effectiveness analysis will be conducted to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control. The cluster randomized crossover clinical trial Remote Exercise SWEDEHEART study is evaluating if participation in EBCR sessions can be increased, which may contribute to health benefits both on a group level and for individual patients including a more equal access to health care. The study is registered at ClinicalTrials.gov (Identifier: NCT04260958) [ABSTRACT FROM AUTHOR]
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- 2023
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6. Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.
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Vemulapalli, Sreekanth, Simonato, Matheus, Ben Yehuda, Ori, Wu, Changfu, Feldman, Ted, Popma, Jeffrey J., Sundareswaren, Kartik, Krohn, Carole, Hardy, Karen M., Guibone, Kimberly, Christensen, Barbara, Alu, Maria C., Ng, Vivian G., Chau, Katherine H., Chen, Shmuel, Shahim, Bahira, Vincent, Flavien, MacMahon, John, James, Stefan, and Mack, Michael
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Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments. [Display omitted] • Minimum core data elements have not been established for the field of transcatheter mitral valve therapies. • A collaboration of the PASSION-CV, Heart Valve Collaboratory, and STS/ACC TVT Registry has established a set of 127 core data elements based on an extensive systematic review and expert consensus. • Instantiation of core data elements in premarket and postmarket studies of transcatheter mitral interventions will promote consistency, efficiency and quality of data supporting evidence development for quality, regulatory, and clinical applications. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Clinical Outcomes After Surgical Revascularization Using No-Touch Versus Conventional Saphenous Vein Grafts: Mid-Term Follow-Up of Propensity Score Matched Cohorts.
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Weiss, Marc Gjern, Nielsen, Per Hostrup, James, Stefan, Thelin, Stefan, and Modrau, Ivy Susanne
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Previous studies have demonstrated superior patency of no-touch as compared to conventional saphenous vein grafts in coronary artery bypass grafting. We aimed to compare mid-term clinical outcomes of both techniques in a large cohort of routine patients. We identified all patients undergoing nonemergent primary coronary artery bypass grafting with either no-touch or conventional saphenous vein grafts at our institution between 2000 and 2020. Propensity score matching was used to create adjusted cohorts based on 5288 eligible patients. The primary outcome was the combined endpoint of all-cause mortality and repeat revascularization. Secondary outcomes were individual rates of all-cause mortality and repeat revascularization, surgical complications, and short-term mortality. Propensity score matching resulted in cohorts of no-touch (n = 923) and conventional (n = 923) saphenous vein grafted patients with comparable baseline characteristics. Mean follow-up time was significantly shorter for the no-touch compared to the conventional cohort (4.9 ± 2.3 vs 8.3 ± 2.6 years, P < 0.001). Up to 7-year follow-up, neither the rate of the primary composite endpoint nor death differed significantly between the cohorts. The rate of repeat revascularization was significantly higher in patients in the no-touch cohort (12.9% vs 9.3% at 7-year follow-up, P = 0.022. Post-hoc analysis of percutaneous coronary intervention during follow-up revealed comparable rates of saphenous vein graft failure (no-touch 42/923 (4.6%) vs conventional 32/923 (3.5%), P = 0.286). In this large propensity score matched registry study, coronary artery bypass with no-touch compared to conventional saphenous vein grafting did neither enhance mid-term survival nor reduce the rate of repeat revascularization. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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8. Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial.
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Malm, Carl Johan, Alfredsson, Joakim, Erlinge, David, Gudbjartsson, Tomas, Gunn, Jarmo, James, Stefan, Møller, Christian H., Nielsen, Susanne J., Sartipy, Ulrik, Tønnessen, Theis, and Jeppsson, Anders
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The TACSI trial (ClinicalTrials.gov Identifier: NCT03560310) tests the hypothesis that 1-year treatment with dual antiplatelet therapy with acetylsalicylic acid (ASA) and ticagrelor is superior to only ASA after isolated coronary artery bypass grafting (CABG) in patients with acute coronary syndrome. The TACSI trial is an investigator-initiated pragmatic, prospective, multinational, multicenter, open-label, registry-based randomized trial with 1:1 randomization to dual antiplatelet therapy with ASA and ticagrelor or ASA only, in patients undergoing first isolated CABG, with a planned enrollment of 2200 patients at Nordic cardiac surgery centers. The primary efficacy end point is a composite of time to all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months after randomization. The primary safety end point is time to hospitalization due to major bleeding. Secondary efficacy end points include time to the individual components of the primary end point, cardiovascular death, and rehospitalization due to cardiovascular causes. High-quality health care registries are used to assess primary and secondary end points. The patients will be followed for 10 years. The TACSI trial will give important information useful for guiding the antiplatelet strategy in acute coronary syndrome patients treated with CABG. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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9. Antithrombotic treatment strategies in patients with established coronary atherosclerotic disease
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Valgimigli, Marco, Aboyans, Victor, Angiolillo, Dominick, Atar, Dan, Capodanno, Davide, Halvorsen, Sigrun, James, Stefan, Jüni, Peter, Kunadian, Vijay, Landi, Antonio, Leonardi, Sergio, Mehran, Roxana, Montalescot, Gilles, Navarese, Eliano Pio, Niebauer, Josef, Oliva, Angelo, Piccolo, Raffaele, Price, Susanna, Storey, Robert F, Völler, Heinz, Vranckx, Pascal, Windecker, Stephan, and Fox, Keith A A
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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.Graphical AbstractAlgorithm for antithrombotic treatment in patients with established CAD. Treatment preferences within each box are shown from above to below, whereas treatments within the same line are sorted in alphabetical order. Panels A and B refer to non-high bleeding risk (HBR) and HBR patients, respectively. HBR is defined according to the ARC-HBR criteria or a PRECISE-DAPT score ≥25. * for patients at high ischaemic risk and very low bleeding risk. § if the patient is not eligible for above shown treatment options. Box colours indicate composition of antithrombotic regimens (light blue: SAPT; grey: DAPT; and red: DAT). Abbreviations: ARC, Academic Research Consortium; CABG, coronary artery bypass grafting; CAD, coronary artery disease; DAPT, dual antiplatelet therapy; DAT, dual antithrombotic therapy; MI, myocardial infarction; PCI, percutaneous coronary intervention; SAPT, single antiplatelet therapy.
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- 2023
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10. Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)
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Aktaa, Suleman, Batra, Gorav, James, Stefan K, Blackman, Daniel J, Ludman, Peter F, Mamas, Mamas A, Abdel-Wahab, Mohamed, Angelini, Gianni D, Czerny, Martin, Delgado, Victoria, De Luca, Giuseppe, Agricola, Eustachio, Foldager, Dan, Hamm, Christian W, Iung, Bernard, Mangner, Norman, Mehilli, Julinda, Murphy, Gavin J, Mylotte, Darren, Parma, Radoslaw, Petronio, Anna Sonia, Popescu, Bodgan A, Sondergaard, Lars, Teles, Rui C, Sabaté, Manel, Terkelsen, Christian J, Testa, Luca, Wu, Jianhua, Maggioni, Aldo P, Wallentin, Lars, Casadei, Barbara, and Gale, Chris P
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Graphical AbstractEuroHeart = European Unified Registries for Heart Care Evaluation and Randomised Trials, HRQoL = health-related quality of life, TAVI = transcatheter aortic valve implantation.
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- 2023
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11. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction
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Rao, Sunil V., Kirsch, Bodo, Bhatt, Deepak L., Budaj, Andrzej, Coppolecchia, Rosa, Eikelboom, John, James, Stefan K., Jones, W. Schuyler, Merkely, Bela, Keller, Lars, Hermanides, Renicus S., Campo, Gianluca, Ferreiro, José Luis, Shibasaki, Taro, Mundl, Hardi, Alexander, John H., Hengstenberg, Christian, Steinwender, Clemens, Alber, Hannes, Steringer-Mascherbauer, Regina, Schober, Andreas, Auer, Johann, Roithinger, Franz Xaver, von Lewinski, Dirk, Moertl, Deddo, Huber, Kurt, Coussement, Patrick, Hoffer, Etienne, Beauloye, Christophe, Janssens, Luc, Vranckx, Pascal, De Raedt, Herbert, Vanassche, Thomas, Vrolix, Matthias, Rokyta, Richard, Parenica, Jiri, Pelouch, Radek, Motovska, Zuzanna, Alan, David, Kettner, Jiri, Polasek, Rostislav, Cermak, Ondrej, Sedlon, Pavel, Hanis, Jiri, Novak, Martin, Belohlavek, Jan, Horacek, Thomas, Leggewie, Stefan, Wenzel, Philip, vom Dahl, Juergen, Sievers, Burkhard, Pulz, Jan, Schellong, Sebastian, Clemmensen, Peter, Muller-Hennessen, Matthias, Rassaf, Tienush, Falukozi, Jozsef, Ruzsa, Zoltan, Tomcsanyi, Janos, Csanadi, Zoltan, Herczeg, Bela, Koszegi, Zsolt, Vorobcsuk, Andras, Kiss, Robert, Baranyai, Csaba, Dezsi, Csaba, Merkely, Bela, Lupkovics, Geza, Rossini, Roberta, Scherillo, Marino, Sergio Saba, Pier, Calogero Campo, Gianluca, Calo, Leonardo, Nassiacos, Daniele, Quadri, Giorgio, Sciahbasi, Alessandro, Silvio Marenzi, Gian Carlo, Reimers, Bernhard, Perna, Gian Piero, Sacca, Salvatore, Fattore, Luciano, Brunelli, Claudio, Picchi, Andrea, Kuramochi, Takehiko, Kondo, Kazuhisa, Aoyama, Takahiko, Kudoh, Takashi, Yamamoto, Tadashi, Takaya, Tomofumi, Mukai, Yasushi, Fukui, Kazuki, Morioka, Nobuyuki, Ando, Kenji, Yamamuro, Atsushi, Morita, Yasuhiro, Koga, Yasuaki, Watanabe, Tetsuya, Sakamoto, Tomohiro, Shibasaki, Taro, Maebuchi, Daisuke, Takahashi, Akihiko, Yonetsu, Taishi, Kakuta, Tsunekazu, Nishina, Hidetaka, Oemrawsingh, Rohit, Dorman, Reinhart, Oude Ophius, Ton, Prins, Paco, al Windy, N.Y.Y., Zoet-Nugteren, S.K., Hermanides, Rik, van Eck, Martijn, Scherptong, Roderick, Cornel, J.H., Damman, Peter, Bech, Gerhard, Torquay, R., Kietselaer, Bas, Grzelakowski, Pawel, Krzysztof, Dyrbus, Budaj, Andrzej, Miekus, Pawel, Przybylski, Andrzej, Zarebinski, Maciej, Balsam, Pawel, Szachniewicz, Joanna, Gierlotka, Marek, Tycinska, Agnieszka, Iniguez Romo, Andres, Fernandez Ortiz, Antonio, Carrasquer Cucarella, Anna, Sanmartin Fernandez, Marcelo, Sionis, Alessandro, Bueno Zamora, Hector, Ferreiro Gutierrez, Jose Luis, Almenar, Luis, Ferreira Gonzalez, Ignacio, Pascual Figal, Domingo A., Almendro Delia, Manuel, Jimenez Fernandez, Miriam, Skeppholm, Mika, Zedigh, Crister, Angeras, Oskar, Lauermann, Jorg, Erlinge, David, Gustafsson, Robin, Mooe, Thomas, Utreras, Alejandro, James, Stefan, Grimfjard, Per, Pedrazzini, Giovanni, Mach, Francois, Fournier, Stephane, Haegeli, Laurent, Beer, Jurg H., Leibundgut, Gregor, Kobza, Richard, Kaiser, Christoph, Kunadian, Vijay, Al-Lamee, Rasha, Gorog, Diana, Khan, Sohail, Trevelyan, Jasper, Toor, Iqbal, Smith, James, Purushottam, Bhaskar, Treasure, Charles, Arena, Frank, Vedere, Amarnath, Henderson, David, Gilani, Syed, Jones, Alonzo, Carrillo-Jimenez, Rodolfo, Gillespie, Eve, Marhefka, Gregary, Wang, David, Olson, Charles, Bloom, Stephen, Iftikhar, Faizan, Brabham, David, McGinty, John, Thompson, Charles, Talano, James, Ginete, Wilson, Williams, Marcus, Masud, Ali, Ariani, Mehrdad, Bitar, Fahed, Wang, Thomas, and Samuelson, Bradley
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- 2022
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12. Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome.
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Omerovic, Elmir, James, Stefan, Erlinge, David, Hagström, Henrik, Venetsanos, Dimitrios, Henareh, Loghman, Ekenbäck, Christina, Alfredsson, Joakim, Hambreus, Kristina, and Redfors, Björn
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Background: Takotsubo syndrome (TS) is a life-threatening acute heart failure syndrome without any evidence-based treatment options. No treatment for TS has been examined in a randomized trial.Study: design and objectives BROKEN-SWEDEHEART is a multicenter, randomized, open-label, registry-based 2 × 2 factorial clinical trial in patients with TS designed to test whether treatment with adenosine and dipyridamole accelerates cardiac recovery and improves clinical outcomes compared to standard care (study 1); and apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs (study 2). The trial will enroll 1000 patients. Study 1 (adenosine hypothesis) will evaluate two co-primary endpoints: (1) wall motion score index at 48-96 hours (evaluated in the first 200 patients); and (2) the composite of death, cardiac arrest, need for mechanical assist device or heart failure hospitalization within 30 days or left ventricular ejection fraction <50% at 48-96 hours (evaluated in 1000 patients). The primary endpoint in study 2 (apixaban hypothesis) is the composite of death or thromboembolic events within 30 days or the presence of intraventricular thrombus on echocardiography at 48-96 hours.Conclusions: BROKEN-SWEDEHEART will be the first prospective randomized multicenter trial in patients with TS. It is designed as two parallel studies to evaluate whether adenosine accelerates cardiac recovery and improves cardiac function in the acute phase and the efficacy of anticoagulation therapy for preventing thromboembolic complications in TS. If either of its component studies is successful, the trial will provide the first evidence-based treatment recommendation in TS. [ABSTRACT FROM AUTHOR]- Published
- 2023
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13. Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium
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Capodanno, Davide, Mehran, Roxana, Krucoff, Mitchell W., Baber, Usman, Bhatt, Deepak L., Capranzano, Piera, Collet, Jean-Philippe, Cuisset, Thomas, De Luca, Giuseppe, De Luca, Leonardo, Farb, Andrew, Franchi, Francesco, Gibson, C. Michael, Hahn, Joo-Yong, Hong, Myeong-Ki, James, Stefan, Kastrati, Adnan, Kimura, Takeshi, Lemos, Pedro A., Lopes, Renato D., Magee, Adrian, Matsumura, Ryosuke, Mochizuki, Shuichi, O’Donoghue, Michelle L., Pereira, Naveen L., Rao, Sunil V., Rollini, Fabiana, Shirai, Yuko, Sibbing, Dirk, Smits, Peter C., Steg, P. Gabriel, Storey, Robert F., ten Berg, Jurrien, Valgimigli, Marco, Vranckx, Pascal, Watanabe, Hirotoshi, Windecker, Stephan, Serruys, Patrick W., Yeh, Robert W., Morice, Marie-Claude, and Angiolillo, Dominick J.
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Antiplatelet therapy is the mainstay of pharmacologic treatment to prevent thrombotic or ischemic events in patients with coronary artery disease treated with percutaneous coronary intervention and those treated medically for an acute coronary syndrome. The use of antiplatelet therapy comes at the expense of an increased risk of bleeding complications. Defining the optimal intensity of platelet inhibition according to the clinical presentation of atherosclerotic cardiovascular disease and individual patient factors is a clinical challenge. Modulation of antiplatelet therapy is a medical action that is frequently performed to balance the risk of thrombotic or ischemic events and the risk of bleeding. This aim may be achieved by reducing (ie, de-escalation) or increasing (ie, escalation) the intensity of platelet inhibition by changing the type, dose, or number of antiplatelet drugs. Because de-escalation or escalation can be achieved in different ways, with a number of emerging approaches, confusion arises with terminologies that are often used interchangeably. To address this issue, this Academic Research Consortium collaboration provides an overview and definitions of different strategies of antiplatelet therapy modulation for patients with coronary artery disease, including but not limited to those undergoing percutaneous coronary intervention, and consensus statements on standardized definitions.
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- 2023
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14. Nationwide cardiovascular risk categorization: applying the European Society of Cardiology guidelines to the Swedish National Diabetes Register
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Eliasson, Björn, Ekelund, Jan, Holmberg, Cecilia Nagorny, Wolden, Michael Lyng, Matthiessen, Kasper Sommer, and James, Stefan
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Type 2 diabetes, or T2D, causes blood sugar levels to get too high. Nearly one-third of people with T2D also have diseases of the heart and blood vessels, such as heart attacks and strokes. These are known as cardiovascular diseases or events. Some T2D medications can also lower the risk of cardiovascular disease.Using data from national healthcare registries, we looked at how many people with T2D in Sweden had a very high cardiovascular disease risk. Healthcare systems often have limited budgets and may not treat all people with a very high cardiovascular disease risk. So, we looked at ways to identify which patients with T2D would benefit most from treatment. We also estimated how many cardiovascular events may be prevented by giving these patients cardiovascular risk-lowering T2D medication, using a medication called semaglutide as an example.The registry included 348 857 people with T2D, and 91.7% (320 028) were not given cardiovascular risk-lowering T2D medications. Of the people not given medications, 40.5% (129 512) had a very high cardiovascular disease risk. On average, we found that people with a very high cardiovascular disease risk and previous cardiovascular events ended up having more cardiovascular events than those without previous events. People who also regularly had high average blood sugar levels, measured using a marker in the blood called glycated haemoglobin, or HbA1c, had even more cardiovascular events.Giving semaglutide to people with a very high cardiovascular disease risk who have already had a cardiovascular event may prevent around 803 cardiovascular events each year.
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- 2023
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15. 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, Eliano Pio, Landi, Antonio, Oliva, Angelo, Piccolo, Raffaele, Aboyans, Victor, Angiolillo, Dominick, Atar, Dan, Capodanno, Davide, Fox, Keith A A, Halvorsen, Sigrun, James, Stefan, Jüni, Peter, Kunadian, Vijay, Leonardi, Sergio, Mehran, Roxana, Montalescot, Gilles, Niebauer, Josef, Price, Susanna, Storey, Robert F, Völler, Heinz, Vranckx, Pascal, Windecker, Stephan, and Valgimigli, Marco
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Graphical AbstractThe two best-in-class treatments for each outcome. Number needed to treat (NNT) and number needed to harm (NNH) with 95% confidence intervals were generated from the within and beyond 12 months network meta-analyses (NMAs) and adjusted according to baseline risk profile (low and high risks). Best-in-class antithrombotic regimens for patients at high and low risk of all-cause mortality, myocardial infarction, stroke, or major bleeding are presented in hierarchical order in terms of net benefit (NNH/NNT ratio). The average follow-up for the within and beyond 12 months NMA was 12 and 30 months, respectively. * denotes statistically significant differences in the NMA.
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- 2023
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16. Sex-Related Differences in Thrombus Burden in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.
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Manzi, Maria Virginia, Buccheri, Sergio, Jolly, Sanjit S., Zijlstra, Felix, Frøbert, Ole, Lagerqvist, Bo, Mahmoud, Karim D., Džavík, Vladimír, Barbato, Emanuele, Sarno, Giovanna, and James, Stefan
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Women have a worse prognosis after ST-segment elevation myocardial infarction (STEMI) than men. The prognostic role of thrombus burden (TB) in influencing the sex-related differences in clinical outcomes after STEMI has not been clearly investigated. The aim of this study was to assess the sex-related differences in TB and its clinical implications in patients with STEMI. Individual patient data from the 3 major randomized clinical trials of manual thrombus aspiration were analyzed, encompassing a total of 19,047 patients with STEMI, of whom 13,885 (76.1%) were men and 4,371 (23.9%) were women. The primary outcome of interest was 1-year cardiovascular (CV) death. The secondary outcomes of interest were recurrent myocardial infarction, heart failure, all-cause mortality, stroke, stent thrombosis (ST), and target vessel revascularization at 1 year. Patients with high TB (HTB) had worse 1-year outcomes compared with those presenting with low TB (adjusted HR for CV death: 1.52; 95% CI: 1.10-2.12; P = 0.01). In unadjusted analyses, female sex was associated with an increased risk for 1-year CV death regardless of TB. After adjustment, the risk for 1-year CV death was higher only in women with HTB (HR: 1.23; 95% CI: 1.18-1.28; P < 0.001), who also had an increased risk for all-cause death and ST than men. In patients with STEMI, angiographic evidence of HTB negatively affected prognosis. Among patients with HTB, women had an excess risk for ST, CV, and all-cause mortality than men. Further investigations are warranted to better understand the pathophysiological mechanisms leading to excess mortality in women with STEMI and HTB. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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17. 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, Bowman, Louise, Casadei, Barbara, Collins, Rory, Devereaux, Philip J., Douglas, Pamela S., Frobert, Ole, Goto, Shinya, Grines, Cindy, Harrington, Robert A., Haynes, Richard, Hochman, Judith S., James, Stefan, Kirchhof, Paulus, Komajda, Michel, Lam, Carolyn S.P., Landray, Martin, Maggioni, Aldo, McMurray, John, Medhurst, Nick, Neal, Bruce, Rydén, Lars, Thiele, Holger, Van Gelder, Isabelle, Wallentin, Lars, Yusuf, Salim, and Zannad, Faiez
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- 2023
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18. 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, Piotr, Weidinger, Franz, Lordereau-Richard, Isabelle, Himmelmann, Anders, Arca, Marcello, Chaves, Jose, Lee, Charles, Jonker, Carla, Kotecha, Dipak, O'Kelly, James, Plueschke, Kelly, Ryś, Andrzej, Segec, Andrej, Wallentin, Lars, Veltrop, Rogier, and James, Stefan
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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.Graphical AbstractExamples of types of data that can be collected as part of routine care.
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- 2023
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19. Prognostic value of early sustained ventricular arrhythmias in ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention: A substudy of VALIDATE-SWEDEHEART trial
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Demidova, Marina M., Rylance, Rebecca, Koul, Sasha, Dworeck, Christian, James, Stefan, Aasa, Mikael, Hamid, Mehmet, Swahn, Eva, Hambraeus, Kristina, Danielewicz, Mikael, Linder, Rikard, Fröbert, Ole, Grimfjärd, Per, Stewart, Jason, Henareh, Loghman, Andersson, Jonas, Wagner, Henrik, Erlinge, David, and Platonov, Pyotr G.
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Prognostic assessment of ventricular tachycardia (VT) or ventricular fibrillation (VF) in ST-segment elevation myocardial infarction (STEMI) is based mainly on distinguishing between early (<48 hours) and late arrhythmias, and does not take into account its time distribution with regard to reperfusion, or type of arrhythmia.
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- 2023
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20. Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II
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Gyldenkerne, Christine, Maeng, Michael, Kjøller-Hansen, Lars, Maehara, Akiko, Zhou, Zhipeng, Ben-Yehuda, Ori, Erik Bøtker, Hans, Engstrøm, Thomas, Matsumura, Mitsuaki, Mintz, Gary S., Fröbert, Ole, Persson, Jonas, Wiseth, Rune, Larsen, Alf I., Jensen, Lisette O., Nordrehaug, Jan E., Bleie, Øyvind, Omerovic, Elmir, Held, Claes, James, Stefan K., Ali, Ziad A., Rosen, Hans C., Stone, Gregg W., and Erlinge, David
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- 2023
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21. Time Course for Benefit and Risk of Ticagrelor and Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack.
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Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., and Johnston, S. Claiborne
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- 2022
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22. Balance of benefit and risk of ticagrelor in patients with diabetes and stable coronary artery disease according to bleeding risk assessment with the CRUSADE score: Data from THEMIS and THEMIS PCI.
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Ducrocq, Gregory, Bhatt, Deepak L., Lee, Jane J., Kui, Naishu, Fox, Kim M., Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Kiss, Róbert Gábor, James, Stefan, Vinereanu, Dragos, Huber, Kurt, Andersson, Marielle, Himmelmann, Anders, Simon, Tabassome, and Steg, Ph. Gabriel
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Background: The THEMIS trial demonstrated that in high-risk patients with stable coronary artery disease and diabetes without previous myocardial infarction or stroke, ticagrelor, in addition to aspirin, reduced the incidence of ischemic events but increased major bleeding. Identification of patients who could derive the greatest net benefit from the addition of ticagrelor appears important. We used the CRUSADE bleeding risk score to risk stratify the THEMIS population.Methods: The population was divided into tertiles: score ≤22, 23 to 33, and ≥34. In each tertile, primary efficacy (composite of cardiovascular death, myocardial infarction, or stroke) and safety (TIMI major bleeding) outcomes were analyzed. NACE (net adverse clinical events) was defined as the irreversible harm composite, in which all-cause death, myocardial infarction, stroke, amputations, fatal bleeds, and intracranial hemorrhage were counted.Results: Patients in the lower risk tertile experienced fewer ischemic events with ticagrelor than placebo, whereas there was no significant benefit from ticagrelor in the other tertiles (Pinteraction = .008). Bleeding rates were consistently increased with ticagrelor across all tertiles (Pinteraction = .79). Ticagrelor reduced NACE in the first tertile (HR = 0.74, 95% CI = 0.61-0.90) but not in the others (HR = 1.03, 95% CI = 0.86-1.23 and HR = 1.05, 95% CI = 0.91-1.22, respectively; Pinteraction = .012).Conclusions: In patients with stable coronary artery disease and diabetes without a history of myocardial infarction or stroke, only those at the lower end of the bleeding risk spectrum according to the CRUSADE score derived net benefit from ticagrelor. [ABSTRACT FROM AUTHOR]- Published
- 2022
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23. The need for increased pragmatism in cardiovascular clinical trials
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Usman, Muhammad Shariq, Van Spall, Harriette G. C., Greene, Stephen J., Pandey, Ambarish, McGuire, Darren K., Ali, Ziad A., Mentz, Robert J., Fonarow, Gregg C., Spertus, John A., Anker, Stefan D., Butler, Javed, James, Stefan K., and Khan, Muhammad Shahzeb
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The majority of cardiovascular randomized controlled trials (RCTs) test interventions in selected patient populations under explicitly protocol-defined settings. Although these ‘explanatory’ trial designs optimize conditions to test the efficacy and safety of an intervention, they limit the generalizability of trial findings in broader clinical settings. The concept of ‘pragmatism’ in RCTs addresses this concern by providing counterbalance to the more idealized situation underpinning explanatory RCTs and optimizing effectiveness over efficacy. The central tenets of pragmatism in RCTs are to test interventions in routine clinical settings, with patients who are representative of broad clinical practice, and to reduce the burden on investigators and participants by minimizing the number of trial visits and the intensity of trial-based testing. Pragmatic evaluation of interventions is particularly important in cardiovascular diseases, where the risk of death among patients has remained fairly stable over the past few decades despite the development of new therapeutic interventions. Pragmatic RCTs can help to reveal the ‘real-world’ effectiveness of therapeutic interventions and elucidate barriers to their implementation. In this Review, we discuss the attributes of pragmatism in RCT design, conduct and interpretation as well as the general need for increased pragmatism in cardiovascular RCTs. We also summarize current challenges and potential solutions to the implementation of pragmatism in RCTs and highlight selected ongoing and completed cardiovascular RCTs with pragmatic trial designs.
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- 2022
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24. Patients With Bicuspid Aortic Stenosis Demonstrate Adverse Left Ventricular Remodeling and Impaired Cardiac Function Before Surgery With Increased Risk of Postoperative Heart Failure
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Wedin, Johan O., Vedin, Ola, Rodin, Sergey, Simonson, Oscar E., Hörsne Malmborg, Jonathan, Pallin, Johan, James, Stefan K., Flachskampf, Frank A., Ståhle, Elisabeth, and Grinnemo, Karl-Henrik
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- 2022
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25. Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.
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Simonato, Matheus, Vemulapalli, Sreekanth, Ben-Yehuda, Ori, Wu, Changfu, Wood, Larry, Popma, Jeff, Feldman, Ted, Krohn, Carole, Hardy, Karen M., Guibone, Kimberly, Christensen, Barbara, Alu, Maria C., Chen, Shmuel, Ng, Vivian G., Chau, Katherine H., Shahim, Bahira, Vincent, Flavien, MacMahon, John, James, Stefan, and Mack, Michael
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Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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26. International Perspectives on the Impact of the COVID-19 Pandemic on Adherence to Prescribed Dual Antiplatelet Therapy: A Window Into Acute Cardiovascular Care
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Pollack, Charles V., Steg, P. Gabriel, James, Stefan, Jolly, Sanjit, Kosiborod, Mikhail, and Bonaca, Marc P.
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An international panel of expert clinicians and researchers in acute cardiac care was convened to review, describe, and contextualize their varied experiences delivering care and maintaining ongoing research during the first year of the COVID-19 pandemic and beyond. A proposed perspective from which care and outcomes could be viewed was the possibility that without routine follow-up and as-accustomed interactions with their care team, patients at risk of acute atherothrombotic events might be less adherent to prescribed antiplatelet medications. This might be manifested by more emergency coronary events or by an increased (and perhaps unidentifiable) incidence of out-of-hospital cardiovascular deaths related to patient anxiety about presenting to hospital during the pandemic. The experiences of the panel members were similar in many regards, which identified opportunities for improvement in cardiac care the next time there is a substantial disruption of usual practice. Regardless of geography or payor system, there was an identified need for better remote care platforms; but stronger infrastructure and consumer facility with remote care technology, improved provider-patient communication to help ensure adherence to primary and secondary prevention medications, and longer-term prescription fills and no-hassle refills on such medications. Profound disruptions in acute cardiovascular research highlighted the need for redundancy or back-up planning for teams engaged in time-sensitive research, to ensure both continuity of protocols and patient safety.
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- 2022
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27. Time Course for Benefit and Risk of Ticagrelor and Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack
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Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., and Johnston, S. Claiborne
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- 2022
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28. Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes.
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Laudani, Claudio, Greco, Antonio, Occhipinti, Giovanni, Ingala, Salvatore, Calderone, Dario, Scalia, Lorenzo, Agnello, Federica, Legnazzi, Marco, Mauro, Maria Sara, Rochira, Carla, Buccheri, Sergio, Mehran, Roxana, James, Stefan, Angiolillo, Dominick J., and Capodanno, Davide
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The aim of this study was to compare short dual antiplatelet therapy (DAPT) and de-escalation in a network meta-analysis using standard DAPT as common comparator. In patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), shortening DAPT and de-escalating to a lower potency regimen mitigate bleeding risk. These strategies have never been randomly compared. Randomized trials of DAPT modulation strategies in patients with ACS undergoing PCI were identified. All-cause death was the primary outcome. Secondary outcomes included net adverse cardiovascular events (NACE), major adverse cardiovascular events, and their components. Frequentist and Bayesian network meta-analyses were conducted. Treatments were ranked on the basis of posterior probability. Sensitivity analyses were performed to explore sources of heterogeneity. Twenty-nine studies encompassing 50,602 patients were included. The transitivity assumption was fulfilled. In the frequentist indirect comparison, the risk ratio (RR) for all-cause death was 0.98 (95% CI: 0.68-1.43). De-escalation reduced the risk for NACE (RR: 0.87; 95% CI: 0.70-0.94) and increased major bleeding (RR: 1.54; 95% CI: 1.07-2.21). These results were consistent in the Bayesian meta-analysis. De-escalation displayed a >95% probability to rank first for NACE, myocardial infarction, stroke, stent thrombosis, and minor bleeding, while short DAPT ranked first for major bleeding. These findings were consistent in node-split and multiple sensitivity analyses. In patients with ACS undergoing PCI, there was no difference in all-cause death between short DAPT and de-escalation. De-escalation reduced the risk for NACE, while short DAPT decreased major bleeding. These data characterize 2 contemporary strategies to personalize DAPT on the basis of treatment objectives and risk profile. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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29. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
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Johnston, S. Claiborne, Amarenco, Pierre, Aunes, Maria, Denison, Hans, Evans, Scott R., Himmelmann, Anders, Jahreskog, Marianne, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., Nylander, Sven, Röther, Joachim, Wang, Yongjun, THALES Investigators, and Evans, Scott
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- 2021
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30. The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial.
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Böhm, Felix, Mogensen, Brynjölfur, Östlund, Ollie, Engstrøm, Thomas, Fossum, Eigil, Stankovic, Goran, Angerås, Oskar, Ērglis, Andrejs, Menon, Madhav, Schultz, Carl, Berry, Colin, Liebetrau, Christoph, Laine, Mika, Held, Claes, Rück, Andreas, and James, Stefan K.
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Background: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI.Methods and Results: The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) - is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint.Conclusion: This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing. [ABSTRACT FROM AUTHOR]- Published
- 2021
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31. Dapagliflozin in patients with myocardial infarction without diabetes or prior heart failure
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James, Stefan, Storey, Robert F, and Oldgren, Jonas
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- 2024
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32. 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, Gorav, Renlund, Henrik, Kunadian, Vijay, James, Stefan K, Storey, Robert F, Steg, P Gabriel, Katus, Hugo A, Harrington, Robert A, Gibson, C Michael, Budaj, Andrzej, Siegbahn, Agneta, and Wallentin, Lars
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Graphical Abstract
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- 2022
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33. Improved patient care starts with data collection.
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James, Stefan
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- 2023
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34. Randomized comparison of early supplemental oxygen versus ambient air in patients with confirmed myocardial infarction: Sex-related outcomes from DETO2X-AMI.
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Alfredsson, Joakim, James, Stefan K., Erlinge, David, Herlitz, Johan, Fröbert, Ole, Dworeck, Christian, Redfors, Björn, Arefalk, Gabriel, Östlund, Ollie, Jernberg, Tomas, Mars, Katarina, Haaga, Urban, Lindahl, Bertil, Swahn, Eva, Lawesson, Sofia Sederholm, Hofmann, Robin, and DETO2X-SWEDEHEART Investigators
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Background: The purpose of this study is to investigate the impact of oxygen therapy on cardiovascular outcomes in relation to sex in patients with confirmed myocardial infarction (MI).Methods: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction trial randomized 6,629 patients to oxygen at 6 L/min for 6-12 hours or ambient air. In the present subgroup analysis including 5,010 patients (1,388 women and 3,622 men) with confirmed MI, we report the effect of supplemental oxygen on the composite of all-cause death, rehospitalization with MI, or heart failure at long-term follow-up, stratified according to sex.Results: Event rate for the composite endpoint was 18.1% in women allocated to oxygen, compared to 21.4% in women allocated to ambient air (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.65-1.05). In men, the incidence was 13.6% in patients allocated to oxygen compared to 13.3% in patients allocated to ambient air (HR 1.03, 95% CI 0.86-1.23). No significant interaction in relation to sex was found (P= .16). Irrespective of allocated treatment, the composite endpoint occurred more often in women compared to men (19.7 vs 13.4%, HR 1.51; 95% CI, 1.30-1.75). After adjustment for age alone, there was no difference between the sexes (HR 1.06, 95% CI 0.91-1.24), which remained consistent after multivariate adjustment.Conclusion: Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or heart failure in women or men. The observed worse outcome in women was explained by differences in baseline characteristics, especially age. [ABSTRACT FROM AUTHOR]- Published
- 2021
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35. 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, Konrad, Buccheri, Sergio, Christersson, Christina, Koul, Sasha, Nilsson, Johan, Pétursson, Pétur, Renlund, Henrik, Rück, Andreas, and James, Stefan
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Graphical Abstract
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- 2022
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36. Pre-operative heart failure worsens outcome after aortic valve replacement irrespective of left ventricular ejection fraction
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Thilén, Maria, James, Stefan, Ståhle, Elisabeth, Lindhagen, Lars, and Christersson, Christina
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- 2022
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37. Bleeding avoidance strategies in percutaneous coronary intervention
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Capodanno, Davide, Bhatt, Deepak L., Gibson, C. Michael, James, Stefan, Kimura, Takeshi, Mehran, Roxana, Rao, Sunil V., Steg, Philippe Gabriel, Urban, Philip, Valgimigli, Marco, Windecker, Stephan, and Angiolillo, Dominick J.
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For many years, bleeding has been perceived as an unavoidable consequence of strategies aimed at reducing thrombotic complications in patients undergoing percutaneous coronary intervention (PCI). However, the paradigm has now shifted towards bleeding being recognized as a prognostically unfavourable event to the same extent as having a new or recurrent ischaemic or thrombotic complication. As such, in parallel with progress in device and drug development for PCI, there is clinical interest in developing strategies that maximize not only the efficacy but also the safety (for example, by minimizing bleeding) of any antithrombotic treatment or procedural aspect before, during or after PCI. In this Review, we discuss contemporary data and aspects of bleeding avoidance strategies in PCI, including risk stratification, timing of revascularization, pretreatment with antiplatelet agents, selection of vascular access, choice of coronary stents and antithrombotic treatment regimens.
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- 2022
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38. European Society of Cardiology methodology for the development of quality indicators for the quantification of cardiovascular care and outcomes
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Aktaa, Suleman, Batra, Gorav, Wallentin, Lars, Baigent, Colin, Erlinge, David, James, Stefan, Ludman, Peter, Maggioni, Aldo P, Price, Susanna, Weston, Clive, Casadei, Barbara, and Gale, Chris P
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- 2022
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39. Development and validation of an artificial neural network algorithm to predict mortality and admission to hospital for heart failure after myocardial infarction: a nationwide population-based study
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Mohammad, Moman A, Olesen, Kevin K W, Koul, Sasha, Gale, Chris P, Rylance, Rebecca, Jernberg, Tomas, Baron, Tomasz, Spaak, Jonas, James, Stefan, Lindahl, Bertil, Maeng, Michael, and Erlinge, David
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Patients have an estimated mortality of 15–20% within the first year following myocardial infarction and one in four patients who survive myocardial infarction will develop heart failure, severely reducing quality of life and increasing the risk of long-term mortality. We aimed to establish the accuracy of an artificial neural network (ANN) algorithm in predicting 1-year mortality and admission to hospital for heart failure after myocardial infarction.
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- 2022
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40. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure.
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James, Stefan, Erlinge, David, Storey, Robert F., McGuire, Darren K., de Belder, Mark, Eriksson, Niclas, Andersen, Kasper, Austin, David, Arefalk, Gabriel, Carrick, David, Hofmann, Robin, Hoole, Stephen P., Jones, Daniel A., Lee, Kelvin, Tygesen, Hans, Johansson, Peter A., Langkilde, Anna Maria, Ridderstråle, Wilhelm, Rizi, Ehsan Parvaresh, and Deanfield, John
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BODY weight ,CONFIDENCE intervals ,MYOCARDIAL infarction ,DIABETES ,CARDIOVASCULAR diseases ,RANDOMIZED controlled trials ,RISK assessment ,COMPARATIVE studies ,DAPAGLIFLOZIN ,BLIND experiment ,DESCRIPTIVE statistics ,SODIUM-glucose cotransporter 2 inhibitors ,STATISTICAL sampling ,ODDS ratio ,HEART failure - Abstract
In patients with acute myocardial infarction (MI), therapies that could further reduce the risk of adverse cardiovascular and metabolic outcomes are needed. In this international registry-based, randomized, double-blind trial, patients without prior diabetes or chronic heart failure, presenting with acute MI and impaired left ventricular systolic function, were randomly assigned 10 mg of dapagliflozin or placebo, given once daily. The primary outcome was the hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last visit using the win ratio analysis method. The key secondary outcome was the same hierarchical composite excluding the body weight component. We enrolled 4017 patients of whom 2019 were assigned to dapagliflozin and 1998 to placebo. The analysis of the primary hierarchical composite outcome resulted in significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% confidence interval [CI], 1.20 to 1.50; P<0.001). The win ratio outcome, which was adopted in a change of analysis during trial performance because of low event accrual, was mainly driven by the added cardiometabolic outcomes. The composite of time to cardiovascular death/hospitalization for heart failure occurred in 50/2019 (2.5%) patients assigned to dapagliflozin and 52/1998 (2.6%) patients assigned to placebo (hazard ratio, 0.95; 95% CI, 0.64 to 1.40). The rates of other cardiovascular events were low, with differences between the groups not reaching nominal statistical significance. No safety concerns were identified. In patients with acute MI as noted above, after approximately 1 year of treatment with dapagliflozin there were significant benefits with regard to improvement in cardiometabolic outcomes but no impact on the composite of cardiovascular death or hospitalization for heart failure compared with placebo. (Funded by AstraZeneca; ClinicalTrial.gov number, NCT04564742.) [ABSTRACT FROM AUTHOR]
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- 2024
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41. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack
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Johnston, S. Claiborne, Amarenco, Pierre, Aunes, Maria, Denison, Hans, Evans, Scott R., Himmelmann, Anders, Jahreskog, Marianne, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., Nylander, Sven, Röther, Joachim, and Wang, Yongjun
- Abstract
Supplemental Digital Content is available in the text.
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- 2021
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42. Helicobacter pylori screening in clinical routine during hospitalization for acute myocardial infarction.
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Wärme, Jonatan, Sundqvist, Martin, Mars, Katarina, Aladellie, Layth, Pawelzik, Sven-Christian, Erlinge, David, Jernberg, Tomas, James, Stefan, Hofmann, Robin, and Bäck, Magnus
- Abstract
Background: Potent antithrombotic therapy has significantly improved prognosis for patients with acute myocardial infarction (AMI), however, at a price of increased bleeding risk. Chronic gastric infection with Helicobacter pylori (Hp) commonly causes upper gastrointestinal bleeding and is proposed as a risk factor for subsequent bleeding post AMI. The prevalence of active Hp in a current AMI population and the feasibility of Hp screening as part of routine clinical care are unclear.Objective: To determine the prevalence of active Hp infection in a contemporary AMI cohort and to establish the feasibility of Hp diagnosis as part of routine clinical MI care.Design: Multicenter, prospective cohort study.Setting: Two university hospitals in Stockholm, Sweden.Participants: Patients admitted for AMI between November 6, 2019 and April 4, 2020. After written informed consent, Hp diagnostics was performed with a bedside urea breath test (Diabact, Mayoly Spindler) incorporated into routine care during the hospitalization period.Exposure: Positive test for Hp infection.Main Outcomes and Measures: The primary outcome was the prevalence of Hp infection. Secondary aims included predictive factors in patient characteristics and outcomes which were obtained from linkage with national registries. Predefined subgroup analyses included stratification for proton pump inhibitor use and infarct type.Results: Three hundred and ten consecutive AMI patients (median age 67; 23% female; 41% ST-elevation MI [STEMI]) were enrolled. Overall, the Hp prevalence was 20% (95%CI, 15.5-24.7). Hp positive status was significantly more common in smokers compared with nonsmokers (36% vs 21%, respectively; P < .05) and in patients presenting with STEMI compared with Non-STEMI (26% vs 15%, respectively; P = .02). The latter observation remained significant after multivariable adjustment. After exclusion of 97 subjects with current proton pump inhibitor use, the Hp prevalence was 24% (95%CI, 18.9-31.0).Conclusions: Active Hp infection is common in a contemporary AMI population and may represent a modifiable risk factor for upper gastrointestinal bleeding, which has been hitherto disregarded. Hp screening as part of clinical routine during AMI hospitalization was feasible. A future randomized trial is needed to determine whether routine Hp screening and subsequent eradication therapy reduces bleeding complications and improves prognosis.Key Points: Question: Is Helicobacter pylori (Hp) infection sufficiently common in patients with acute myocardial infarction (AMI) to consider systematic screening, and can Hp diagnostics be performed during AMI hospitalization?Findings: In this multicenter prospective cohort study of 310 consecutive AMI patients, Hp infection was established in at least 20% of patients. Infected patients were significantly more likely to be active smokers and to present with ST-elevation MI. Meaning: Hp screening as part of clinical routine during AMI hospitalization was feasible. Given the high Hp prevalence detected, Hp diagnostics and eradication to reduce bleeding complications and to improve prognosis after AMI should be further investigated. [ABSTRACT FROM AUTHOR]- Published
- 2021
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43. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial
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Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Birve, Filip, Ladenvall, Per, Molina, Carlos A., and Johnston, S. Claiborne
- Abstract
IMPORTANCE: Prior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported separately, raising concerns about safety and efficacy in this subgroup. OBJECTIVE: To evaluate the efficacy and safety of ticagrelor plus aspirin in patients with moderate ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 4 to 5). DESIGN, SETTING, AND PARTICIPANTS: The THALES trial was a randomized trial conducted at 414 hospitals in 28 countries in January 2018 and December 2019. This exploratory analysis compared patients with moderate stroke (baseline NIHSS score of 4 to 5) with patients with less severe stroke (NIHSS score of 0 to 3). A total of 9983 patients with stroke were included in the present analysis, after excluding 2 patients with NIHSS scores greater than 5 and 1031 patients with transient ischemic attack. Data were analyzed from March to April 2021. INTERVENTIONS: Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily on days 2 to 30) or placebo within 24 hours after symptom onset. All patients received aspirin, 300 to 325 mg, on day 1 followed by aspirin, 75 to 100 mg, daily on days 2 to 30. Patients were observed for 30 additional days. MAIN OUTCOMES AND MEASURES: The primary outcome was time to stroke or death within 30 days. The primary safety outcome was time to severe bleeding. RESULTS: In total, 3312 patients presented with moderate stroke and 6671 presented with less severe stroke. Of those in the moderate stroke group, 1293 (39.0%) were female, and the mean (SD) age was 64.5 (10.8) years; of those in the less severe stroke group, 2518 (37.7%) were female, and the mean (SD) age was 64.8 (11.2) years. The observed primary outcome event rate in patients with moderate stroke was 7.6% (129 of 1671) for those in the ticagrelor group and 9.1% (150 of 1641) for those in the placebo group (hazard ratio, 0.84; 95% CI, 0.66-1.06); the primary outcome event rate in patients with less severe stroke was 4.7% (158 of 3359) for those in the ticagrelor group and 5.7% (190 of 3312) for those in the placebo group (hazard ratio, 0.82; 95% CI, 0.66-1.01) (P for interaction = .88). Severe bleeding occurred in 8 patients (0.5%) in the ticagrelor group and in 4 patients (0.2%) in the placebo group in those with moderate stroke compared with 16 patients (0.5%) and 3 patients (0.1%), respectively, with less severe stroke (P for interaction = .26). CONCLUSIONS AND RELEVANCE: In this study, patients with a moderate ischemic stroke had consistent benefit from ticagrelor plus aspirin vs aspirin alone compared with patients with less severe ischemic stroke, with no further increase in the risk of intracranial bleeding or other severe bleeding events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03354429
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- 2021
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44. Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin.
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Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., Wang, Yongjun, Johnston, S. Claiborne, and THALES Steering Committee and Investigators*
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- 2020
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45. Findings on Coronary Angiographies in Patients With Rheumatoid Arthritis and Ischemic Heart Disease: Are They Different From Patients Without Rheumatoid Arthritis?
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Holmqvist, Marie, Mantel, Ängla, Wållberg‐Jonsson, Solveig, James, Stefan, Jernberg, Tomas, and Askling, Johan
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Patients with rheumatoid arthritis (RA) are at increased risk of coronary artery disease (CAD) and seem to develop more severe acute coronary syndromes (ACS) than the general population. Because few studies have investigated the CAD distribution in the context of acute or stable CAD in RA, the objective was to investigate whether this risk is due to a different distribution and severity of coronary stenoses (versus non‐RA), resulting in clinical manifestation of CAD. We performed a population‐based study using linkages of nationwide clinical, health, and demographics registers. We compared 1 cohort of patients with RA, and 1 matched cohort of patients without RA, undergoing a first coronary angiography from 2006 through 2015. Cardiovascular (CV) characteristics and the presence and distribution of clinically significant stenoses were compared (through odds ratios [ORs]), stratified by indication (stable CAD, ST‐elevation myocardial infarction [STEMI], and non–ST‐elevation ACS [NSTACS]), using logistic regression. We identified 2,985 patients with RA and 10,290 patients without RA who underwent a first coronary angiography. A higher proportion of patients with RA (75% versus 69%) had STEMI and NSTACS as indication for angiography. We found no difference in the presence and distribution of clinically significant coronary stenoses in RA compared with the patients without RA, regardless of the CAD type (for having any significant stenosis in stable CAD OR 0.9, STEMI OR 0.8, and NSTACS OR 1.1), stratification by RA duration, sex, or burden of concomitant CV risk factors. Although RA may accelerate the development of clinical CAD events, the underlying angiographic characteristics are similar to those in patients without RA.
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- 2021
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46. Patients’ experiences of clinical trial participation involving a product remotely assessing study drug adherence
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Henriksson, Catrin, Olsson, Anneli, Andersen, Kasper, Arefalk, Gabriel, Erlinge, David, Hofmann, Robin, Ridderstråle, Wilhelm, Rutgersson, Annika, Oldgren, Jonas, and James, Stefan
- Abstract
The participation of patients in clinical trials is crucial for the development of healthcare. There are several challenges in the recruitment of trial participants with acute medical conditions. The registry-based randomized DAPA-MI clinical trial recruited patients during hospitalization for myocardial infarction and provided study drugs in bottles with smart caps that used wireless technology to transmit monitoring data. This interview study aimed to investigate patients’ experience of participation in a clinical trial and their attitude to the new bottle cap technology.
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- 2024
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47. Screening for Helicobacter pyloriinfection in patients with cardiovascular and gastrointestinal disease
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Wärme, Jonatan, Sundqvist, Martin O., James, Stefan, and Hofmann, Robin
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- 2024
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48. No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.
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Ragnarsson, Sigurdur, Janiec, Mikael, Modrau, Ivy Susanne, Dreifaldt, Mats, Ericsson, Anders, Holmgren, Anders, Hultkvist, Henrik, Jeppsson, Anders, Sartipy, Ulrik, Ternström, Lisa, Per Vikholm, M.D., de Souza, Domingos, James, Stefan, and Thelin, Stefan
- Abstract
The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the "no-touch" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303. [ABSTRACT FROM AUTHOR]
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- 2020
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49. Percutaneous Treatment and Outcomes of Small Coronary Vessels: A SCAAR Report.
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Silverio, Angelo, Buccheri, Sergio, Venetsanos, Dimitrios, Alfredsson, Joakim, Lagerqvist, Bo, Persson, Jonas, Witt, Nils, James, Stefan, and Sarno, Giovanna
- Abstract
The aim of this study was to investigate the outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) or newer-generation drug-eluting stents (n-DES). Notwithstanding the available evidence from a few randomized clinical trials and meta-analyses, the best device for PCI in patients with small-vessel coronary artery disease is not yet established. The study included all consecutive patients with de novo lesions in small coronary vessels undergoing PCI in Sweden from April 2009 to July 2017. A small coronary vessel was defined by a device diameter ≤2.5 mm. The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction. The study population included 14,788 patients: 1,154 treated with DCBs and 13,634 with n-DES. Overall, 35,541 PCIs were performed using 2,503 DCBs and 33,038 n-DES. The propensity score–adjusted regression analysis showed a significantly higher risk for restenosis in the DCB group compared with the n-DES group (adjusted hazard ratio [HR]: 2.027; 95% confidence interval [CI]: 1.537 to 2.674). Conversely, no difference in the risk for target lesion thrombosis (adjusted HR: 0.741; 95% CI: 0.412 to 1.331) was detected. The risk for all-cause death (adjusted HR: 1.178; 95% CI: 0.992 to 1.399) and myocardial infarction (adjusted HR: 1.251; 95% CI: 0.960 to 1.629) was comparable between groups. Because of the significantly higher risk for restenosis up to 3 years, this research suggests that DCBs are not an equally effective alternative to n-DES for percutaneous treatment of small coronary vessels. [ABSTRACT FROM AUTHOR]
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- 2020
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50. Effect of Oxygen Therapy on Cardiovascular Outcomes in Relation to Baseline Oxygen Saturation.
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James, Stefan K., Erlinge, David, Herlitz, Johan, Alfredsson, Joakim, Koul, Sasha, Fröbert, Ole, Kellerth, Thomas, Ravn-Fischer, Annica, Alström, Patrik, Östlund, Ollie, Jernberg, Tomas, Lindahl, Bertil, and Hofmann, Robin
- Abstract
The aim of this study was to determine the effect of supplemental oxygen in patients with myocardial infarction (MI) on the composite of all-cause death, rehospitalization with MI, or heart failure related to baseline oxygen saturation. A secondary objective was to investigate outcomes in patients developing hypoxemia. In the DETO2X-AMI (Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 l/min for 6 to 12 h or ambient air. The study population of 5,010 patients with confirmed MI was divided by baseline oxygen saturation into a low-normal (90% to 94%) and a high-normal (95% to 100%) cohort. Outcomes are reported within 1 year. To increase power, all follow-up time (between 1 and 4 years) was included post hoc, and interaction analyses were performed with oxygen saturation as a continuous covariate. The composite endpoint of all-cause death, rehospitalization with MI, or heart failure occurred significantly more often in patients in the low-normal cohort (17.3%) compared with those in the high-normal cohort (9.5%) (p < 0.001), and most often in patients developing hypoxemia (23.6%). Oxygen therapy compared with ambient air was not associated with improved outcomes regardless of baseline oxygen saturation (interaction p values: composite endpoint, p = 0.79; all-cause death, p = 0.33; rehospitalization with MI, p = 0.86; hospitalization for heart failure, p = 0.35). Irrespective of oxygen saturation at baseline, we found no clinically relevant beneficial effect of routine oxygen therapy in normoxemic patients with MI regarding cardiovascular outcomes. Low-normal baseline oxygen saturation or development of hypoxemia was identified as an independent marker of poor prognosis. (An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction; NCT01787110) [ABSTRACT FROM AUTHOR]
- Published
- 2020
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