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1,218 results on '"Lewis, Basil S."'

201. Antithrombotic therapy and major adverse limb events in patients with chronic lower extremity arterial disease: systematic review and meta-analysis from the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy in Collaboration with the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases

Author

Savarese, Gianluigi, primary, Reiner, Martin F, additional, Uijl, Alicia, additional, D’Amario, Domenico, additional, Agewall, Stefan, additional, Atar, Dan, additional, Baumgartner, Iris, additional, Borghi, Claudio, additional, De Carlo, Marco, additional, Drexel, Heinz, additional, Kaski, Juan Carlos, additional, Kjeldsen, Keld P, additional, Kucher, Nils, additional, Lund, Lars H, additional, Niessner, Alexander, additional, Semb, Anne Grete, additional, Schmidt, Thomas A, additional, Sulzgruber, Patrick, additional, Tamargo, Juan, additional, Vitale, Cristiana, additional, Wassmann, Sven, additional, Aboyans, Victor, additional, and Lewis, Basil S, additional

Published
2019
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203. Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial

Author

Guimarães, Patricia O., primary, Pokorney, Sean D., additional, Lopes, Renato D., additional, Wojdyla, Daniel M., additional, Gersh, Bernard J., additional, Giczewska, Anna, additional, Carnicelli, Anthony, additional, Lewis, Basil S., additional, Hanna, Michael, additional, Wallentin, Lars, additional, Vinereanu, Dragos, additional, Alexander, John H., additional, and Granger, Christopher B., additional

Published
2019
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204. The CSL112-2001 trial: Safety and tolerability of multiple doses of CSL112 (apolipoprotein A-I [human]), an intravenous formulation of plasma-derived apolipoprotein A-I, among subjects with moderate renal impairment after acute myocardial infarction

Author

Gibson, C. Michael, primary, Kerneis, Mathieu, additional, Yee, Megan K., additional, Daaboul, Yazan, additional, Korjian, Serge, additional, Mehr, Ali Poyan, additional, Tricoci, Pierluigi, additional, Alexander, John H., additional, Kastelein, John J.P., additional, Mehran, Roxana, additional, Bode, Christoph, additional, Lewis, Basil S., additional, Mehta, Ravindra, additional, Duffy, Danielle, additional, Feaster, John, additional, Halabi, Majdi, additional, Angiolillo, Dominick J., additional, Duerschmied, Daniel, additional, Ophuis, Ton Oude, additional, and Merkely, Bela, additional

Published
2019
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205. The role of pharmacogenomics in contemporary cardiovascular therapy: a position statement from the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy

Author

Magavern, Emma Forton, Kaski, Juan Carlos, Turner, Richard M, Drexel, Heinz, Janmohamed, Azara, Scourfield, Andrew, Burrage, Daniel, Floyd, Christopher N, Adeyeye, Elizabeth, Tamargo, Juan, Lewis, Basil S, Kjeldsen, Keld Per, Niessner, Alexander, Wassmann, Sven, Sulzgruber, Patrick, Borry, Pascal, Agewall, Stefan, Semb, Anne Grete, Savarese, Gianluigi, Pirmohamed, Munir, and Caulfield, Mark J

Abstract

There is a strong and ever-growing body of evidence regarding the use of pharmacogenomics to inform cardiovascular pharmacology. However, there is no common position taken by international cardiovascular societies to unite diverse availability, interpretation, and application of such data, nor is there recognition of the challenges of variation in clinical practice between countries within Europe. Aside from the considerable barriers to implementing pharmacogenomic testing and the complexities of clinically actioning results, there are differences in the availability of resources and expertise internationally within Europe. Diverse legal and ethical approaches to genomic testing and clinical therapeutic application also require serious thought. As direct-to-consumer genomic testing becomes more common, it can be anticipated that data may be brought in by patients themselves, which will require critical assessment by the clinical cardiovascular prescriber. In a modern, pluralistic and multi-ethnic Europe, self-identified race/ethnicity may not be concordant with genetically detected ancestry and thus may not accurately convey polymorphism prevalence. Given the broad relevance of pharmacogenomics to areas, such as thrombosis and coagulation, interventional cardiology, heart failure, arrhythmias, clinical trials, and policy/regulatory activity within cardiovascular medicine, as well as to genomic and pharmacology subspecialists, this position statement attempts to address these issues at a wide-ranging level.

Published
2022
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206. Challenges in cardiovascular pharmacogenomics implementation: a viewpoint from the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy

Author

Magavern, Emma F, Kaski, Juan Carlos, Turner, Richard M, Drexel, Heinz, Janmohamed, Azara, Scourfield, Andrew, Burrage, Daniel, Floyd, Christopher N, Adeyeye, Elizabeth, Tamargo, Juan, Lewis, Basil S, Kjeldsen, Keld Per, Niessner, Alexander, Wassmann, Sven, Sulzgruber, Patrick, Borry, Pascal, Agewall, Stefan, Semb, Anne Grete, Savarese, Gianluigi, Pirmohamed, Munir, and Caulfield, Mark J

Abstract

Pharmacogenomics promises to advance cardiovascular therapy, but there remain pragmatic barriers to implementation. These are particularly important to explore within Europe, as there are differences in the populations, availability of resources, and expertise, as well as in ethico-legal frameworks. Differences in healthcare delivery across Europe present a challenge, but also opportunities to collaborate on pharmacogenomics implementation. Clinical workforce upskilling is already in progress but will require substantial input. Digital infrastructure and clinical support tools are likely to prove crucial. It is important that widespread implementation serves to narrow rather than widen any existing gaps in health equality between populations. This viewpoint supplements the working group position paper on cardiovascular pharmacogenomics to address these important themes.

Published
2022
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211. Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

Author

Vinereanu, Dragos, Wang, Alice, Mulder, Hillary, Lopes, Renato D., Jansky, Petr, Lewis, Basil S., Gersh, Bernard J., Avezum, Alvaro, Hanna, Michael, Held, Claes, Wallentin, Lars, Granger, Clristopler B., Alexander, Jam H., Vinereanu, Dragos, Wang, Alice, Mulder, Hillary, Lopes, Renato D., Jansky, Petr, Lewis, Basil S., Gersh, Bernard J., Avezum, Alvaro, Hanna, Michael, Held, Claes, Wallentin, Lars, Granger, Clristopler B., and Alexander, Jam H.

Abstract

Objective: To assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. Methods: There were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model. Results: Patients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory. Conclusions; In anticoagulated pa

Published
2018
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212. Apixaban following acute coronary syndromes in patients with prior stroke : Insights from the APPRAISE-2 trial

Author

Sherwood, Matthew W, Lopes, Renato D, Sun, Jie Lena, Liaw, Danny, Harrington, Robert A, Wallentin, Lars, Laskowitz, Daniel T, James, Stefan K, Goodman, Shaun G, Darius, Harald, Lewis, Basil S, Gibson, C Michael, Pieper, Karen S, Alexander, John H, Sherwood, Matthew W, Lopes, Renato D, Sun, Jie Lena, Liaw, Danny, Harrington, Robert A, Wallentin, Lars, Laskowitz, Daniel T, James, Stefan K, Goodman, Shaun G, Darius, Harald, Lewis, Basil S, Gibson, C Michael, Pieper, Karen S, and Alexander, John H

Abstract

BACKGROUND AND PURPOSE: Patients with prior stroke are at greater risk for recurrent cardiovascular events post-acute coronary syndromes (ACS) and may have a different risk/benefit profile with antithrombotic therapy than patients without prior stroke. METHODS: We studied 7391 patients with ACS from APPRAISE-2, stratified by the presence or absence of prior stroke. Baseline characteristics and outcomes of cardiovascular death, myocardial infarction (MI), or stroke were compared between groups. Interactions between prior stroke, treatment assignment (apixaban vs placebo), and outcomes were tested before and after multivariable adjustment with Cox proportional hazards models. RESULTS: A total of 902 patients (12%) had prior stroke. Those with prior stroke were older (69 vs 67 years), had more hypertension (91% vs 77%), peripheral vascular disease (22% vs18%), and impaired renal function (38% vs 30%) but less diabetes (44% vs 48%) than those without prior stroke. Patients with prior stroke vs no prior stroke had higher unadjusted rates of cardiovascular death (4.8% vs 4.0%), MI (11.2% vs 7.1%), and ischemic stroke (3.2% vs 0.9%). Patients with prior stroke assigned to apixaban had similar rates of the composite of cardiovascular death, MI, or stroke compared with those assigned to placebo (HR 1.39; 95% CI 0.92-2.08). Patients without prior stroke assigned to apixaban had similar rates of cardiovascular death, MI, or ischemic stroke compared with those assigned to placebo (HR 0.87; 95% CI 0.73-1.04; P-interaction=.041). Median follow-up was 240 days. CONCLUSIONS: Patients with prior stroke are at higher risk for recurrent cardiovascular events post-ACS and had a differential risk/benefit profile with oral anticoagulation.

Published
2018
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213. Antithrombotic therapy use and clinical outcomes following thrombo-embolic events in patients with atrial fibrillation : insights from ARISTOTLE

Author

Goto, Shinya, Merrill, Peter, Wallentin, Lars, Wojdyla, Daniel M., Hanna, Michael, Avezum, Alvaro, Easton, J. Donald, Harjola, Veli-Pekka, Huber, Kurt, Lewis, Basil S., Parkhomenko, Alexander, Zhu, Jun, Granger, Christopher B., Lopes, Renato D., Alexander, John H., Goto, Shinya, Merrill, Peter, Wallentin, Lars, Wojdyla, Daniel M., Hanna, Michael, Avezum, Alvaro, Easton, J. Donald, Harjola, Veli-Pekka, Huber, Kurt, Lewis, Basil S., Parkhomenko, Alexander, Zhu, Jun, Granger, Christopher B., Lopes, Renato D., and Alexander, John H.

Abstract

Aims We investigated baseline characteristics, antithrombotic use, and clinical outcomes of patients with atrial fibrillation (AF) and a thrombo-embolic event in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study to better inform the care of these high-risk patients. Method and results Thrombo-embolic events were defined as stroke (ischaemic or unknown cause) or systemic embolism (SE). Clinical outcomes were estimated using the Kaplan-Meier method. All-cause mortality and International Society on Thrombosis and Haemostasis (ISTH) major bleeding after events were analysed using a Cox proportional hazards model with time-dependent covariates. Of 18 201 patients in ARISTOTLE, 365 experienced a thrombo-embolic event [337 strokes (ischaemic or unknown cause), 28 SE]; 46 (12.6%) of which were fatal. In the 30 days before and after a thrombo-embolic event, 11% and 37% of patients, respectively, were not taking an oral anticoagulant. During follow-up (median 1.8 years), 22 patients (7.1%/year) had a recurrent stroke, 97 (30.1%/year) died, and 10 (6.7%/year) had major bleeding. Compared with patients without a thrombo-embolic event, the short-and long-term adjusted hazards of death in patients with a thrombo-embolic event were high [<= 30 days: hazard ratio (HR) 54.3%, 95% confidence interval (95% CI) 41.4-71.3; >30 days: HR 3.5, 95% CI 2.5-4.8; both P<0.001]. The adjusted hazards of major bleeding were also high short-term (HR 10.37, 95% CI 3.87-27.78; P<0.001) but not long-term (HR 1.7, 95% CI: 0.77-3.88; P=0.18). Conclusions Thrombo-embolic events were rare but associated with high short-and long-term morbidity and mortality. Substantial numbers of patients are not receiving oral anticoagulattherapy before and, despite this risk, after a first thrombo-embolic event.

Published
2018
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214. Reasons for disparity in statin adherence rates between clinical trials and real-world observations:A review

Author

Vonbank, Alexander, Drexel, Heinz, Agewall, Stefan, Lewis, Basil S., Dopheide, Joern F., Kjeldsen, Keld, Ceconi, Claudio, Savarese, Gianluigi, Rosano, Giuseppe, Wassmann, Sven, Niessner, Alexander, Schmidt, Thomas Andersen, Saely, Christoph H., Baumgartner, Iris, Tamargo, Juan, Vonbank, Alexander, Drexel, Heinz, Agewall, Stefan, Lewis, Basil S., Dopheide, Joern F., Kjeldsen, Keld, Ceconi, Claudio, Savarese, Gianluigi, Rosano, Giuseppe, Wassmann, Sven, Niessner, Alexander, Schmidt, Thomas Andersen, Saely, Christoph H., Baumgartner, Iris, and Tamargo, Juan

Abstract

With statins, the reported rate of adverse events differs widely between randomized clinical trials (RCTs) and observations in clinical practice, the rates being 1–2% in RCTs vs. 10–20% in the so-called real world. One possible explanation is the claim that RCTs mostly use a run-in period with a statin. This would exclude intolerant patients from remaining in the trial and therefore favour a bias towards lower rates of intolerance. We here review data from RCTs with more than 1000 participants with and without a run-in period, which were included in the Cholesterol Treatment Trialists Collaboration. Two major conclusions arise: (i) the majority of RCTs did not have a test dose of a statin in the run-in phase. (ii) A test dose in the run-in phase was not associated with a significantly improved adherence rate within that trial when compared to trials without a test dose. Taken together, the RCTs of statins reviewed here do not suggest a bias towards an artificially higher adherence rate because of a run-in period with a test dose of the statin. Other possible explanations for the apparent disparity between RCTs and real-world observations are also included in this review albeit mostly not supported by scientific data.

Published
2018

215. Expert consensus document on the management of hyperkalaemia in patients with cardiovascular disease treated with renin angiotensin aldosterone system inhibitors:Coordinated by the Working Group on Cardiovascular Pharmacotherapy of the European Society of Cardiology

Author

Rosano, Giuseppe M.C., Tamargo, Juan, Kjeldsen, Keld P., Lainscak, Mitja, Agewall, Stefan, Anker, Stefan D., Ceconi, Claudio, Coats, Andrew J.S., Drexel, Heinz, Filippatos, Gerasimos, Kaski, Juan Carlos, Lund, Lars, Niessner, Alexander, Ponikowski, Piotr, Savarese, Gianluigi, Schmidt, Thomas A., Seferovic, Petar, Wassmann, Sven, Walther, Thomas, Lewis, Basil S., Rosano, Giuseppe M.C., Tamargo, Juan, Kjeldsen, Keld P., Lainscak, Mitja, Agewall, Stefan, Anker, Stefan D., Ceconi, Claudio, Coats, Andrew J.S., Drexel, Heinz, Filippatos, Gerasimos, Kaski, Juan Carlos, Lund, Lars, Niessner, Alexander, Ponikowski, Piotr, Savarese, Gianluigi, Schmidt, Thomas A., Seferovic, Petar, Wassmann, Sven, Walther, Thomas, and Lewis, Basil S.

Abstract

Renin angiotensin aldosterone system inhibitors/antagonists/blockers (RAASi) are a cornerstone in treatment of patients with cardiovascular diseases especially in those with heart failure (HF) due to their proven effect on surrogate and hard endpoints. Renin angiotensin aldosterone system inhibitors are also the basis in treatment of arterial hypertension, and they are furthermore indicated to reduce events and target organ damage in patients with diabetes and chronic kidney disease, where they have specific indication because of the evidence of benefit. Renin angiotensin aldosterone system inhibitor therapy, however, is associated with an increased risk of hyperkalaemia. Patients with chronic kidney disease and HF are at increased risk of hyperkalaemia and 50% of these patients experience two or more yearly recurrences. A substantial proportion of patients receiving RAASi therapy have their therapy down-titrated or more often discontinued even after a single episode of elevated potassium (K\+) level. Since RAASi therapy reduces mortality and morbidity in patients with cardiovascular disease steps should, when hyperkalaemia develops, be considered to lower K\+ level and enable patients to continue their RAASi therapy. The use of such measures are especially important in those patients with the most to gain from RAASi therapy.

Published
2018

216. Non-insulin antidiabetic pharmacotherapy in patients with established cardiovascular disease:a position paper of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy

Author

Niessner, Alexander, Tamargo, Juan, Koller, Lorenz, Saely, Christoph H., Schmidt, Thomas Andersen, Savarese, Gianluigi, Wassmann, Sven, Rosano, Giuseppe, Ceconi, Claudio, Torp-Pedersen, Christian, Kaski, Juan Carlos, Kjeldsen, Keld Per, Agewall, Stefan, Walther, Thomas, Drexel, Heinz, Lewis, Basil S., Niessner, Alexander, Tamargo, Juan, Koller, Lorenz, Saely, Christoph H., Schmidt, Thomas Andersen, Savarese, Gianluigi, Wassmann, Sven, Rosano, Giuseppe, Ceconi, Claudio, Torp-Pedersen, Christian, Kaski, Juan Carlos, Kjeldsen, Keld Per, Agewall, Stefan, Walther, Thomas, Drexel, Heinz, and Lewis, Basil S.

Published
2018

217. Usefulness of late potentials on the immediate postoperative signal-averaged electrocardiogram in predicting ventricular tachyarrhythmias early after isolated coronary artery bypass grafting

Author

Elami, Amir, Merin, Gideon, Flugelman, Moshe Y., Adar, Lyorit, Rudis, Ehud, Halon, David A., and Lewis, Basil S.

Subjects
Coronary artery bypass -- Complications, Ventricular tachycardia -- Diagnosis, Electrocardiography -- Evaluation, Health
Abstract

The present study was undertaken to determine the value of abnormal late ventricular potentials on signal-averaged electrocardiograms (ECG) in identifying patients at risk of developing ventricular tachycardia or ventricular fibrillation in the early postoperative period after coronary artery bypass grafting, Signal-averaged ECGs were recorded immediately after operation in 72 patients. Abnormal late potentials were defined as the presence of 2 or 3 of the following: (1) root-mean-square amplitude of the last 40 ms of the QRS 120 ms (in patients with conduction defects, only the first 2 criteria were used). Abnormal late ventricular potentials were present on the immediate postoperative signal-averaged ECG in 26 of the 72 patients (36%). Life-threatening ventricular tachyarrhythmias occurred in 6 patients. Late potentials were present in all 6 patients, but only in 20 of 66 (30%) who did not develop ventricular tachyarrhythmias (p

Published
1994

220. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)

Author

Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J, Borger, Michael A, Brotons, Carlos, Chew, Derek P, Gencer, Baris, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F, Windecker, Stephan, Patrono, Marco, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thomas, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathios, James, Stefan, Lewis, Basil S, Lip, Gregory y H, Piepoli, Massimo F, Richter, Dimitrios, Rosemann, Thomas, Sechtem, Udo, Steg, Ph Gabriel, Vrints, Christian, Luis Zamorano, Jose, Nutrition, obésité et risque thrombotique (NORT), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU)-Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J, Borger, Michael A, Brotons, Carlo, Chew, Derek P, Gencer, Bari, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F, Windecker, Stephan, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thoma, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathio, James, Stefan, Lewis, Basil S, Lip, Gregory Y H, Piepoli, Massimo F, Richter, Dimitrio, Rosemann, Thoma, Sechtem, Udo, Steg, Ph Gabriel, Vrints, Christian, Luis Zamorano, Jose, ACS - Amsterdam Cardiovascular Sciences, APH - Amsterdam Public Health, and Cardiology

Subjects
High-sensitivity troponin, Ticagrelor, Chest pain unit, medicine.medical_treatment, Atherothrombosis, Myocardial ischaemia, Recommendations, MESH: Risk Assessment, Early invasive strategy, Electrocardiography, Acute cardiac care, Acute coronary syndromes, Angioplasty, Anticoagulation, Apixaban, Aspirin, Beta-blockers, Bivalirudin, Bypass surgery, Cangrelor, Clopidogrel, Dabigatran, Diabetes, Enoxaparin, European society of cardiology, Fondaparinux, Glycoprotein IIb/IIIa inhibitors, Guidelines, Heparin, Nitrates, Non-ST-elevation myocardial infarction, Platelet inhibition, Prasugrel, Revascularization, Rhythm monitoring, Rivaroxaban, Statin, Stent, Unstable angina, Vorapaxar, Cardiology and Cardiovascular Medicine, ST segment, Myocardial infarction, 610 Medicine & health, ComputingMilieux_MISCELLANEOUS, MESH: Platelet Glycoprotein GPIIb-IIIa Complex, Platelet aggregation inhibitor, MESH: Percutaneous Coronary Intervention, MESH: Hemorrhage, medicine.medical_specialty, Acute coronary syndrome, Cardiotonic Agents, MESH: Algorithms, Hemorrhage, Platelet Glycoprotein GPIIb-IIIa Complex, MESH: Anticoagulants, Risk Assessment, Percutaneous Coronary Intervention, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Humans, Acute Coronary Syndrome, Physical Examination, Management of acute coronary syndrome, MESH: Humans, MESH: Cardiotonic Agents, Recommendation, medicine.disease, MESH: Acute Coronary Syndrome, Long-Term Care, MESH: Coronary Angiography, MESH: Non-ST Elevated Myocardial Infarction, Purinergic P2Y Receptor Antagonists, Human medicine, Biomarkers, Guideline, Diabete, Nitrate, Coronary Angiography, MESH: Angina Pectoris, MESH: Long-Term Care, Non-ST Elevated Myocardial Infarction, reproductive and urinary physiology, Atherothrombosi, MESH: Platelet Aggregation Inhibitors, embryonic structures, Cardiology, MESH: Purinergic P2Y Receptor Antagonists, biological phenomena, cell phenomena, and immunity, Algorithms, medicine.drug, Settore BIO/14 - FARMACOLOGIA, Glycoprotein IIb/IIIa inhibitor, European Society of Cardiology, Angina Pectoris, Diagnosis, Differential, MESH: Physical Examination, MESH: Diagnosis, Differential, Internal medicine, medicine, Beta-blocker, urogenital system, business.industry, Percutaneous coronary intervention, Anticoagulants, MESH: Electrocardiography, MESH: Biomarkers, business, Platelet Aggregation Inhibitors
Abstract

ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation : The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC).

Published
2015

221. Guía ESC 2015 sobre el tratamiento de los síndromes coronarios agudos en pacientes sin elevación persistente del segmento ST: Grupo de Trabajo de la Sociedad Europea de Cardiología (ESC) para el tratamiento de los síndromes coronarios agudos en pacientes sin elevación persistente del segmento ST

Author

Roffi, Marco, Patrono, Carlo, Collet, Jean Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J., Borger, Michael A., Brotons, Carlos, Chew, Derek P., Gencer, Baris, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F., Windecker, Stephan, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thomas, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick Smith, David, Huber, Kurt, Iliodromitis, Efstathios, James, Stefan, Lewis, Basil S., Lip, Gregory Y. H., Piepoli, Massimo F., Richter, Dimitrios, Rosemann, Thomas, Sechtem, Udo, Steg, P. h. Gabriel, Vrints, Christian, Zamorano, José Luis, Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J., Borger, Michael A., Brotons, Carlo, Chew, Derek P., Gencer, Bari, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F., Windecker, Stephan, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Mendieta Badimon, Lina Guiomar, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thoma, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathio, James, Stefan, Lewis, Basil S., Lip, Gregory Y.H., Piepoli, Massimo F., Richter, Dimitrio, Rosemann, Thoma, Sechtem, Udo, Steg, Ph. Gabriel, Vrints, Christian, and Zamorano, José Luis

Subjects
Cardiology and Cardiovascular Medicine
Abstract

N/A

Published
2015

222. Nitrate tolerance in heart failure: differential venous, pulmonary and systemic arterial effects

Author

Makhoul, Nabeel, Dakak, Nader, Flugelman, Moshe Y., Merdler, Amnon, Shefer, Arie, Schneeweiss, Adam, Halon, David A., and Lewis, Basil S.

Subjects
Drug tolerance -- Analysis, Nitroglycerin -- Health aspects, Congestive heart failure -- Drug therapy, Health
Abstract

The hemodynamic profile of tolerance to intravenous nitroglycerin was studied in 9 patients with New York Heart Association Class III to IV congestive heart failure. After rapid dosage build-up to the maximal tolerated dose (decrease in pulmonary wedge Pressure to 10 mm Hg or systolic blood pressure to 90 mm Hg), nitroglycerin (525 [+/-] 548 [mu]g/min) was administered at a constant continuous intravenous infusion for a total of 24 hours. The extent of nitrate tolerance at 24 hours was calculated as the percentage loss of the benefit achieved at time of peak effect of nitroglycerin. Tolerance had a different time course and magnitude in the venous, arterial and pulmonary circulations. At 24 hours, right atrial pressure and pulmonary vascular resistance returned to control values in most patients, while 40 to 50% of the effect on systemic vascular resistance, cardiac index and pulmonary wedge pressure was maintained. These findings emphasize the importance of precise definitions in studies relating to nitrate tolerance. (Am J Cardiol 1990;65:28J-31J), Congestive heart failure is the inability of the heart to pump blood, which leads to congestion of fluid within the lungs. It can be treated with nitrate drugs, which dilate blood vessels. However, nitrate treatment may result in drug tolerance or decreased effectiveness, which interferes with the beneficial effects of these agents in the treatment of congestive heart failure. The characteristics of tolerance, which developed during intravenous therapy with the nitrate agent nitroglycerin, were assessed in nine patients in advanced stages of congestive heart failure. The maximal tolerated dose of nitroglycerin was given, followed by continuous intravenous administration of the drug for 24 hours. Nitrate tolerance at 24 hours was determined as the percentage of loss of beneficial effect at the time of peak or maximal effect of nitroglycerin. After 24 hours, the pressure in the right atrium (upper chamber) of the heart and pulmonary vascular resistance, the pressure against blood flow in the lungs, returned to pre-treatment values. However, improvements in systemic vascular resistance, the pressure opposing blood flow in the peripheral circulation; cardiac index, a measure of amount of blood pumped by the heart; and pulmonary wedge pressure, a measure of pressures within the left ventricle and left atrium (chambers of the heart), were partially maintained after 24 hours. The results show the importance of specifically defining nitrate tolerance in studies examining this complication of nitrate therapy. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1990

223. Reasons for disparity in statin adherence rates between clinical trials and real-world observations: a review

Author

Vonbank, Alexander, primary, Drexel, Heinz, additional, Agewall, Stefan, additional, Lewis, Basil S, additional, Dopheide, Joern F, additional, Kjeldsen, Keld, additional, Ceconi, Claudio, additional, Savarese, Gianluigi, additional, Rosano, Giuseppe, additional, Wassmann, Sven, additional, Niessner, Alexander, additional, Schmidt, Thomas Andersen, additional, Saely, Christoph H, additional, Baumgartner, Iris, additional, and Tamargo, Juan, additional

Published
2018
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225. Expert consensus document on the management of hyperkalaemia in patients with cardiovascular disease treated with renin angiotensin aldosterone system inhibitors: coordinated by the Working Group on Cardiovascular Pharmacotherapy of the European Society of Cardiology

Author

Rosano, Giuseppe M C, primary, Tamargo, Juan, additional, Kjeldsen, Keld P, additional, Lainscak, Mitja, additional, Agewall, Stefan, additional, Anker, Stefan D, additional, Ceconi, Claudio, additional, Coats, Andrew J S, additional, Drexel, Heinz, additional, Filippatos, Gerasimos, additional, Kaski, Juan Carlos, additional, Lund, Lars, additional, Niessner, Alexander, additional, Ponikowski, Piotr, additional, Savarese, Gianluigi, additional, Schmidt, Thomas A, additional, Seferovic, Petar, additional, Wassmann, Sven, additional, Walther, Thomas, additional, and Lewis, Basil S, additional

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2018
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226. Antithrombotic therapy use and clinical outcomes following thrombo-embolic events in patients with atrial fibrillation: insights from ARISTOTLE

Author

Goto, Shinya, primary, Merrill, Peter, additional, Wallentin, Lars, additional, Wojdyla, Daniel M, additional, Hanna, Michael, additional, Avezum, Alvaro, additional, Easton, J Donald, additional, Harjola, Veli-Pekka, additional, Huber, Kurt, additional, Lewis, Basil S, additional, Parkhomenko, Alexander, additional, Zhu, Jun, additional, Granger, Christopher B, additional, Lopes, Renato D, additional, and Alexander, John H, additional

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2018
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227. Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

Author

Vinereanu, Dragos, primary, Wang, Alice, additional, Mulder, Hillary, additional, Lopes, Renato D, additional, Jansky, Petr, additional, Lewis, Basil S, additional, Gersh, Bernard J, additional, Avezum, Alvaro, additional, Hanna, Michael, additional, Held, Claes, additional, Wallentin, Lars, additional, Granger, Christopher B, additional, and Alexander, John H, additional

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2018
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228. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial

Author

Anand, Sonia S, primary, Bosch, Jackie, additional, Eikelboom, John W, additional, Connolly, Stuart J, additional, Diaz, Rafael, additional, Widimsky, Peter, additional, Aboyans, Victor, additional, Alings, Marco, additional, Kakkar, Ajay K, additional, Keltai, Katalin, additional, Maggioni, Aldo P, additional, Lewis, Basil S, additional, Störk, Stefan, additional, Zhu, Jun, additional, Lopez-Jaramillo, Patricio, additional, O'Donnell, Martin, additional, Commerford, Patrick J, additional, Vinereanu, Dragos, additional, Pogosova, Nana, additional, Ryden, Lars, additional, Fox, Keith A A, additional, Bhatt, Deepak L, additional, Misselwitz, Frank, additional, Varigos, John D, additional, Vanassche, Thomas, additional, Avezum, Alvaro A, additional, Chen, Edmond, additional, Branch, Kelley, additional, Leong, Darryl P, additional, Bangdiwala, Shrikant I, additional, Hart, Robert G, additional, Yusuf, Salim, additional, SALA, JORGELINA, additional, CARTASEGNA, LUIS, additional, VICO, MARISA, additional, HOMINAL, MIGUEL ANGEL, additional, HASBANI, EDUARDO, additional, CACCAVO, ALBERTO, additional, ZAIDMAN, CESAR, additional, VOGEL, DANIEL, additional, HRABAR, ADRIAN, additional, SCHYGIEL, PABLO OMAR, additional, CUNEO, CARLOS, additional, LUQUEZ, HUGO, additional, MACKINNON, IGNACIO J., additional, AHUAD GUERRERO, RODOLFO ANDRES, additional, COSTABEL, JUAN PABLO, additional, BARTOLACCI, INES PALMIRA, additional, MONTANA, OSCAR, additional, BARBIERI, MARIA, additional, GOMEZ VILAMAJO, OSCAR, additional, GARCIA DURAN, RUBEN OMAR, additional, SCHIAVI, LILIA BEATRIZ, additional, GARRIDO, MARCELO, additional, INGARAMO, ADRIAN, additional, BORDONAVA, ANSELMO PAULINO, additional, PELAGAGGE, MARIA JOSE, additional, NOVARETTO, LEONARDO, additional, ALBISU DI GENNERO, JUAN PABLO, additional, IBANEZ SAGGIA, LUZ MARIA, additional, ALVAREZ, MOIRA, additional, VITA, NESTOR ALEJANDRO, additional, MACIN, STELLA MARIS, additional, DRAN, RICARDO DARIO, additional, CARDONA, MARCELO, additional, GUZMAN, LUIS, additional, SARJANOVICH, RODOLFO JUAN, additional, CUADRADO, JESUS, additional, NANI, SEBASTIAN, additional, LITVAK BRUNO, MARCOS RAUL, additional, CHACON, CAROLINA, additional, MAFFEI, LAURA ELENA, additional, GRINFELD, DIEGO, additional, VENSENTINI, NATALIA, additional, MAJUL, CLAUDIO RODOLFO, additional, LUCIARDI, HECTOR LUCAS, additional, GONZALEZ COLASO, PATRICIA DEL CARMEN, additional, FERRE PACORA, FREDY ANTONI, additional, VAN DEN HEUVEL, PAUL, additional, VERHAMME, PETER, additional, ECTOR, BAVO, additional, DEBONNAIRE, PHILIPPE, additional, VAN DE BORNE, PHILIPPE, additional, LEROY, JEAN, additional, SCHROE, HERMAN, additional, VRANCKX, PASCAL, additional, ELEGEERT, IVAN, additional, HOFFER, ETIENNE, additional, DUJARDIN, KARL, additional, INDIO DO BRASIL, CLARISSE, additional, PRECOMA, DALTON, additional, ABRANTES, JOSE ANTONIO, additional, MANENTI, EULER, additional, REIS, GILMAR, additional, SARAIVA, JOSE, additional, MAIA, LILIA, additional, HERNANDES, MAURO, additional, ROSSI, PAULO, additional, ROSSI DOS SANTOS, FABIO, additional, ZIMMERMANN, SERGIO LUIZ, additional, RECH, RAFAEL, additional, ABIB JR, EDUARDO, additional, LEAES, PAULO, additional, BOTELHO, ROBERTO, additional, DUTRA, OSCAR, additional, SOUZA, WEIMAR, additional, BRAILE, MARIA, additional, IZUKAWA, NILO, additional, NICOLAU, JOSE CARLOS, additional, TANAJURA, LUIZ FERNANDO, additional, SERRANO JUNIOR, CARLOS VICENTE, additional, MINELLI, CESAR, additional, NASI, LUIZ ANTONIO, additional, OLIVEIRA, LIVIA, additional, DE CARVALHO CANTARELLI, MARCELO JOSE, additional, TYTUS, RICHARD, additional, PANDEY, SHEKHAR, additional, LONN, EVA, additional, CHA, JAMES, additional, VIZEL, SAUL, additional, BABAPULLE, MOHAN, additional, LAMY, ANDRE, additional, SAUNDERS, KEVIN, additional, BERLINGIERI, JOSEPH, additional, KIAII, BOB, additional, BHARGAVA, RAKESH, additional, MEHTA, PRAVINSAGAR, additional, HILL, LAURIE, additional, FELL, DAVID, additional, LAM, ANDY, additional, AL-QOOFI, FAISAL, additional, BROWN, CRAIG, additional, PETRELLA, ROBERT, additional, RICCI, JOSEPH A, additional, GLANZ, ANTHONY, additional, NOISEUX, NICOLAS, additional, BAINEY, KEVIN, additional, MERALI, FATIMA, additional, HEFFERNAN, MICHAEL, additional, DELLA SIEGA, ANTHONY, additional, DAGENAIS, GILLES R, additional, DAGENAIS, FRANCOIS, additional, BRULOTTE, STEEVE, additional, NGUYEN, MICHEL, additional, HARTLEIB, MICHAEL, additional, GUZMAN, RANDOLPH, additional, BOURGEOIS, RONALD, additional, RUPKA, DENNIS, additional, KHAYKIN, YAARIV, additional, GOSSELIN, GILBERT, additional, HUYNH, THAO, additional, PILON, CLAUDE, additional, CAMPEAU, JEAN, additional, PICHETTE, FRANCIS, additional, DIAZ, ARIEL, additional, JOHNSTON, JAMES, additional, SHUKLE, PRAVIN, additional, HIRSCH, GREGORY, additional, RHEAULT, PAUL, additional, CZARNECKI, WLODZIMIERZ, additional, ROY, ANNIE, additional, NAWAZ, SHAH, additional, FREMES, STEPHEN, additional, SHUKLA, DINKAR, additional, JANO, GABRIEL, additional, COBOS, JORGE LEONARDO, additional, CORBALAN, RAMON, additional, MEDINA, MARCELO, additional, NAHUELPAN, LEONARDO, additional, RAFFO, CARLOS, additional, PEREZ, LUIS, additional, POTTHOFF, SERGIO, additional, STOCKINS, BENJAMIN, additional, SEPULVEDA, PABLO, additional, PINCETTI, CHRISTIAN, additional, VEJAR, MARGARITA, additional, TIAN, HONGYAN, additional, WU, XUESI, additional, KE, YUANNAN, additional, JIA, KAIYING, additional, YIN, PENGFEI, additional, WANG, ZHAOHUI, additional, YU, LITIAN, additional, WU, SHULIN, additional, WU, ZONGQUI, additional, LIU, SHAO WEN, additional, BAI, XIAO JUAN, additional, ZHENG, YANG, additional, YANG, PING, additional, YANG, YUN MEI, additional, ZHANG, JIWEI, additional, GE, JUNBO, additional, CHEN, XIAO PING, additional, LI, JUNXIA, additional, HU, TAO HONG, additional, ZHANG, RUIYAN, additional, ZHENG, ZHE, additional, CHEN, XIN, additional, TAO, LIANG, additional, LI, JIANPING, additional, HUANG, WEIJIAN, additional, FU, GUOSHENG, additional, LI, CHUNJIAN, additional, DONG, YUGANG, additional, WANG, CHUNSHENG, additional, ZHOU, XINMIN, additional, KONG, YE, additional, SOTOMAYOR, ARISTIDES, additional, ACCINI MENDOZA, JOSE LUIS, additional, CASTILLO, HENRY, additional, URINA, MIGUEL, additional, AROCA, GUSTAVO, additional, PEREZ, MARITZA, additional, MOLINA DE SALAZAR, DORA INES, additional, SANCHEZ VALLEJO, GREGORIO, additional, FERNANDO, MANZUR J, additional, GARCIA, HENRY, additional, GARCIA, LUIS HERNANDO, additional, ARCOS, EDGAR, additional, GOMEZ, JUAN, additional, CUERVO MILLAN, FRANCISCO, additional, TRUJILLO DADA, FREDY ALBERTO, additional, VESGA, BORIS, additional, MORENO SILGADO, GUSTAVO ADOLFO, additional, ZIDKOVA, EVA, additional, LUBANDA, JEAN-CLAUDE, additional, KALETOVA, MARKETA, additional, KRYZA, RADIM, additional, MARCINEK, GABRIEL, additional, RICHTER, MAREK, additional, SPINAR, JINDRICH, additional, MATUSKA, JIRI, additional, TESAK, MARTIN, additional, MOTOVSKA, ZUZANA, additional, BRANNY, MARIAN, additional, MALY, JIRI, additional, MALY, MARTIN, additional, WIENDL, MARTIN, additional, FOLTYNOVA CAISOVA, LENKA, additional, SLABY, JOSEF, additional, VOJTISEK, PETR, additional, PIRK, JAN, additional, SPINAROVA, LENKA, additional, BENESOVA, MIROSLAVA, additional, CANADYOVA, JULIA, additional, HOMZA, MIROSLAV, additional, FLORIAN, JINDRICH, additional, POLASEK, ROSTISLAV, additional, COUFAL, ZDENEK, additional, SKALNIKOVA, VLADIMIRA, additional, BRAT, RADIM, additional, BRTKO, MIROSLAV, additional, JANSKY, PETR, additional, LINDNER, JAROSLAV, additional, MARCIAN, PAVEL, additional, STRAKA, ZBYNEK, additional, TRETINA, MARTIN, additional, DUARTE, YAN CARLOS, additional, POW CHON LONG, FREDDY, additional, SANCHEZ, MAYRA, additional, LOPEZ, JOSE, additional, PERUGACHI, CARMITA, additional, MARMOL, RICARDO, additional, TRUJILLO, FREDDY, additional, TERAN, PABLO, additional, TUOMILEHTO, JAAKKO, additional, TUOMILEHTO, HENRI, additional, TUOMINEN, MARJA-LEENA, additional, KANTOLA, ILKKA, additional, STEG, GABRIEL, additional, ABOYANS, VICTOR, additional, LECLERCQ, FLORENCE, additional, FERRARI, EMILE, additional, BOCCARA, FRANCK, additional, MESSAS, EMMANUEL, additional, MISMETTI, PATRICK, additional, SEVESTRE, MARIE ANTOINETTE, additional, CAYLA, GUILLAUME, additional, MOTREFF, PASCAL, additional, STOERK, STEFAN, additional, DUENGEN, HANS-DIRK, additional, STELLBRINK, CHRISTOPH, additional, GUEROCAK, OSMAN, additional, KADEL, CHRISTOPH, additional, BRAUN-DULLAEUS, RUEDIGER, additional, JESERICH, MICHAEL, additional, OPITZ, CHRISTIAN, additional, VOEHRINGER, HANS-FRIEDRICH, additional, APPEL, KARL-FRIEDRICH, additional, WINKELMANN, BERNHARD, additional, DORSEL, THOMAS, additional, NIKOL, SIGRID, additional, DARIUS, HARALD, additional, RANFT, JURGEN, additional, SCHELLONG, SEBASTIAN, additional, JUNGMAIR, WOLFGANG, additional, DAVIERWALA, PIROZE, additional, VORPAHL, MARC, additional, BAJNOK, LASZLO, additional, LASZLO, ZOLTAN, additional, NOORI, EBRAHIM, additional, VERESS, GABOR, additional, VERTES, ANDRAS, additional, ZSARY, ANDRAS, additional, KIS, ERNO, additional, KORANYI, LASZLO, additional, BAKAI, JUDIT, additional, BODA, ZOLTAN, additional, POOR, FERENC, additional, JARAI, ZOLTAN, additional, KEMENY, VENDEL, additional, BARTON, JOHN, additional, MCADAM, BRENDAN, additional, MURPHY, ANDREW, additional, CREAN, PETER, additional, MAHON, NIALL, additional, CURTIN, RONAN, additional, MACNEILL, BRIAIN, additional, DINNEEN, SEAN, additional, HALABI, MAJDI, additional, ZIMLICHMAN, REUVEN, additional, ZELTSER, DAVID, additional, TURGEMAN, YOAV, additional, KLAINMAN, ELIEZER, additional, LEWIS, BASIL, additional, KATZ, AMOS, additional, ATAR, SHAUL, additional, NIKOLSKY, EUGENIA, additional, BOSI, STEFANO, additional, NALDI, MONICA, additional, FAGGIANO, POMPILIO, additional, ROBBA, DEBORA, additional, MOS, LUCIO, additional, SINAGRA, GIANFRANCO, additional, COSMI, FRANCO, additional, OLTRONA VISCONTI, LUIGI, additional, CARMINE, DE MATTEIS, additional, DI PASQUALE, GIUSEPPE, additional, DI BIASE, MATTEO, additional, MANDORLA, SARA, additional, BERNARDINANGELI, MARINO, additional, PICCINNI, GIOVANNI CARLO, additional, GULIZIA, MICHELE MASSIMO, additional, GALVANI, MARCELLO, additional, VENTURI, FLAVIO, additional, MOROCUTTI, GIORGIO, additional, BALDIN, MARIA GRAZIA, additional, OLIVIERI, CARLO, additional, PERNA, GIAN PIERO, additional, CIRRINCIONE, VINCENZO, additional, KANNO, TAKAYASU, additional, DAIDA, HIROYUKI, additional, OZAKI, YUKIO, additional, MIYAMOTO, NAOMASA, additional, HIGASHIUE, SHINICHI, additional, DOMAE, HIROSHI, additional, HOSOKAWA, SHINOBU, additional, KOBAYASHI, HIROO, additional, KURAMOCHI, TAKEHIKO, additional, FUJII, KENSHI, additional, MIZUTOMI, KAZUAKI, additional, SAKU, KEIJIRO, additional, KIMURA, KAZUO, additional, HIGUCHI, YOSHIHARU, additional, ABE, MITSUNORI, additional, OKUDA, HARUHITO, additional, NODA, TOSHIYUKI, additional, MITA, TERUAKI, additional, HIRAYAMA, ATSUSHI, additional, ONAKA, HARUHIKO, additional, INOKO, MORIAKI, additional, HIROKAMI, MITSUGU, additional, OKUBO, MUNENORI, additional, AKATSUKA, YUTAKA, additional, IMAMAKI, MIZUHO, additional, KAMIYA, HARUO, additional, MANITA, MAMORU, additional, HIMI, TOSHIHARU, additional, UENO, HIDEKI, additional, HISAMATSU, YUJI, additional, AKO, JUNYA, additional, NISHINO, YASUHIRO, additional, KAWAKAMI, HIDEO, additional, YAMADA, YUTAKA, additional, KORETSUNE, YUKIHIRO, additional, YAMADA, TAKAHISA, additional, YOSHIDA, TETSURO, additional, SHIMOMURA, HIDEKI, additional, KINOSHITA, NORIYUKI, additional, TAKAHASHI, AKIHIKO, additional, YUSOFF, KHALID, additional, WAN AHMAD, WAN AZMAN, additional, ABU HASSAN, MUHAMMAD RADZI, additional, KASIM, SAZZLI, additional, ABDUL RAHIM, AIZAI AZAN, additional, MOHD ZAMRIN, DIMON, additional, MACHIDA, MASAHARU, additional, HIGASHINO, YORIHIKO, additional, UTSU, NORIAKI, additional, NAKANO, AKIHIKO, additional, NAKAMURA, SHIGERU, additional, HASHIMOTO, TETSUO, additional, ANDO, KENJI, additional, SAKAMOTO, TOMOHIRO, additional, PRINS, F.J., additional, LOK, DIRK, additional, MILHOUS, JOHANNES GERT-JAN, additional, VIERGEVER, ERIC, additional, WILLEMS, FRANK, additional, SWART, HENK, additional, ALINGS, MARCO, additional, BREEDVELD, ROB, additional, DE VRIES, KEES-JAN, additional, VAN DER BORGH, ROGER, additional, OEI, FANNY, additional, ZOET-NUGTEREN, STIENEKE, additional, KRAGTEN, HANS, additional, HERRMAN, JEAN PAUL, additional, VAN BERGEN, PAUL, additional, GOSSELINK, MARCEL, additional, HOEKSTRA, EDUARD, additional, ZEGERS, ERWIN, additional, RONNER, EELKO, additional, DEN HARTOG, FRANK, additional, BARTELS, GERARD, additional, NIEROP, PETER, additional, VAN DER ZWAAN, COEN, additional, VAN ECK, JACOB, additional, VAN GORSELEN, EDWIN, additional, GROENEMEIJER, BJORN, additional, HOOGSLAG, PIETER, additional, DE GROOT, MARC ROBERT, additional, LOYOLA, ALDRIN, additional, SULIT, DENNIS JOSE, additional, REY, NANNETTE, additional, ABOLA, MARIA TERESA, additional, MORALES, DANTE, additional, PALOMARES, ELLEN, additional, ABAT, MARC EVANS, additional, ROGELIO, GREGORIO, additional, CHUA, PHILIP, additional, DEL PILAR, JOSE CARLO, additional, ALCARAZ, JOHN DENNIS, additional, EBO, GERALDINE, additional, TIRADOR, LOUIE, additional, CRUZ, JOSEFINA, additional, ANONUEVO, JOHN, additional, PITARGUE, ARTHUR, additional, JANION, MARIANNA, additional, GUZIK, TOMASZ, additional, GAJOS, GRZEGORZ, additional, ZABOWKA, MACIEJ, additional, RYNKIEWICZ, ANDRZEJ, additional, BRONCEL, MARLENA, additional, SZUBA, ANDRZEJ, additional, CZARNECKA, DANUTA, additional, MAGA, PAWEL, additional, STRAZHESKO, IRINA, additional, VASYUK, YURY, additional, SIZOVA, ZHANNA, additional, POZDNYAKOV, YURY, additional, BARBARASH, OLGA, additional, VOEVODA, MIKHAIL, additional, POPONINA, TATIANA, additional, REPIN, ALEXEY, additional, OSIPOVA, IRINA, additional, EFREMUSHKINA, ANNA, additional, NOVIKOVA, NINA, additional, AVERKOV, OLEG, additional, ZATEYSHCHIKOV, DMITRY, additional, VERTKIN, ARKADIY, additional, AUSHEVA, AZA, additional, COMMERFORD, PATRICK, additional, SEEDAT, SAADIYA, additional, VAN ZYL, LOUIS, additional, ENGELBRECHT, JAN, additional, MAKOTOKO, ELLEN MAKONLI, additional, PRETORIUS, CATHARINA ELIZABETH, additional, MOHAMED, ZAID, additional, HORAK, ADRIAN, additional, MABIN, THOMAS, additional, KLUG, ERIC, additional, BAE, JANG-HO, additional, KIM, CHEOLHO, additional, KIM, CHONG-JIN, additional, KIM, DONG-SOO, additional, KIM, YONG JIN, additional, JOO, SEUNGJAE, additional, HA, JONG-WON, additional, PARK, CHUL SOO, additional, KIM, JANG YOUNG, additional, KIM, YOUNG-KWON, additional, JARNERT, CHRISTINA, additional, MOOE, THOMAS, additional, DELLBORG, MIKAEL, additional, TORSTENSSON, INGEMAR, additional, ALBERTSSON, PER, additional, JOHANSSON, LARS, additional, AL-KHALILI, FARIS, additional, ALMROTH, HENRIK, additional, ANDERSSON, TOMMY, additional, PANTEV, EMIL, additional, TENGMARK, BENGT-OLOV, additional, LIU, BO, additional, RASMANIS, GUNDARS, additional, WAHLGREN, CARL-MAGNUS, additional, MOCCETTI, TIZIANO, additional, PARKHOMENKO, ALEXANDER, additional, TSELUYKO, VIRA, additional, VOLKOV, VOLODYMYR, additional, KOVAL, OLENA, additional, KONONENKO, LYUDMYLA, additional, PROKHOROV, OLEKSANDR, additional, VDOVYCHENKO, VALERIY, additional, BAZYLEVYCH, ANDRIY, additional, RUDENKO, LEONID, additional, VIZIR, VADYM, additional, KARPENKO, OLEKSANDR, additional, MALYNOVSKY, YAROSLAV, additional, KOVAL, VALENTYNA, additional, STOROZHUK, BORYS, additional, COTTON, JAMES, additional, VENKATARAMAN, ASOK, additional, MORIARTY, ANDREW, additional, CONNOLLY, DEREK, additional, DAVEY, PATRICK, additional, SENIOR, ROXY, additional, BIRDI, INDERPAUL, additional, CALVERT, JOHN, additional, DONNELLY, PATRICK, additional, TREVELYAN, JASPER, additional, CARTER, JUSTIN, additional, PEACE, AARON, additional, AUSTIN, DAVID, additional, KUKREJA, NEVILLE, additional, HILTON, THOMAS, additional, SRIVASTAVA, SUNNY, additional, WALSH, RONALD, additional, FIELDS, RONALD, additional, HAKAS, JOSEPH, additional, PORTNAY, EDWARD, additional, GOGIA, HARINDER, additional, SALACATA, ABRAHAM, additional, HUNTER, JOHN J., additional, BACHARACH, J MICHAEL, additional, SHAMMAS, NICOLAS, additional, SURESH, DAMODHAR, additional, SCHNEIDER, RICKY, additional, GURBEL, PAUL, additional, BANERJEE, SUBHASH, additional, GRENA, PAUL, additional, BEDWELL, NOEL, additional, SLOAN, STEPHEN, additional, LUPOVITCH, STEVEN, additional, SONI, ANAND, additional, GIBSON, KATHLEEN, additional, SANGRIGOLI, RENEE, additional, MEHTA, RAJENDRA, additional, I-HSUAN TSAI, PETER, additional, GILLESPIE, EVE, additional, DEMPSEY, STEPHEN, additional, HAMROFF, GLENN, additional, BLACK, ROBERT, additional, LADER, ELLIS, additional, KOSTIS, JOHN B., additional, BITTNER, VERA, additional, MCGUINN, WILLIAM, additional, BRANCH, KELLEY, additional, MALHOTRA, VINAY, additional, MICHAELSON, STEPHEN, additional, VACANTE, MICHAEL, additional, MCCORMICK, MATTHEW, additional, ARIMIE, RALUCA, additional, CAMP, ALAN, additional, DAGHER, GEORGE, additional, KOSHY, N. MATHEW, additional, THEW, STEPHEN, additional, COSTELLO, FREDERICK, additional, HEIMAN, MARK, additional, CHILTON, ROBERT, additional, MORAN, MICHAEL, additional, ADLER, FREDRIC, additional, COMEROTA, ANTHONY, additional, SEIWERT, ANDREW, additional, FRENCH, WILLIAM, additional, SEROTA, HARVEY, additional, HARRISON, ROBERT, additional, BAKAEEN, FAISAL, additional, OMER, SHUAB, additional, CHANDRA, LOKESH, additional, WHELAN, ALAN, additional, BOYLE, ANDREW, additional, ROBERTS-THOMSON, PHILIP, additional, ROGERS, JAMES, additional, CARROLL, PATRICK, additional, COLQUHOUN, DAVID, additional, SHAW, JAMES, additional, BLOMBERY, PETER, additional, AMERENA, JOHN, additional, HII, CHRIS, additional, ROYSE, ALISTAIR, additional, SINGH, BHUWAN, additional, SELVANAYAGAM, JOSEPH, additional, JANSEN, SHIRLEY, additional, LO, WINGCHI, additional, HAMMETT, CHRISTOPHER, additional, POULTER, ROHAN, additional, NARASIMHAN, SESHASAYEE, additional, WIGGERS, HENRIK, additional, NIELSEN, HENRIK, additional, GISLASON, GUNNAR, additional, KOBER, LARS, additional, HOULIND, KIM, additional, BOENELYKKE SOERENSEN, VIBEKE, additional, DIXEN, ULRIK, additional, REFSGAARD, JENS, additional, ZEUTHEN, ELISABETH, additional, SOEGAARD, PETER, additional, HRANAI, MARIAN, additional, GASPAR, LUDOVIT, additional, PELLA, DANIEL, additional, HATALOVA, KATARINA, additional, DROZDAKOVA, ERIKA, additional, COMAN, IOAN, additional, DIMULESCU, DOINA, additional, VINEREANU, DRAGOS, additional, CINTEZA, MIRCEA, additional, SINESCU, CRINA, additional, ARSENESCU, CATALINA, additional, BENEDEK, IMRE, additional, BOBESCU, ELENA, additional, DOBREANU, DAN, additional, GAITA, DAN, additional, IANCU, ADRIAN, additional, ILIESIU, ADRIANA, additional, LIGHEZAN, DANIEL, additional, PETRESCU, LUCIAN, additional, PIRVU, OCTAVIAN, additional, TEODORESCU, IULIA, additional, TESLOIANU, DAN, additional, VINTILA, MARIUS MARCIAN, additional, and CHIONCEL, OVIDIU, additional

Published
2018
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229. Clinical Efficacy and Safety of Evolocumab in High-Risk Patients Receiving a Statin

Author

Giugliano, Robert P., primary, Keech, Anthony, additional, Murphy, Sabina A., additional, Huber, Kurt, additional, Tokgozoglu, S. Lale, additional, Lewis, Basil S., additional, Ferreira, Jorge, additional, Pineda, Armando Lira, additional, Somaratne, Ransi, additional, Sever, Peter S., additional, Pedersen, Terje R., additional, and Sabatine, Marc S., additional

Published
2017
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230. Non-insulin antidiabetic pharmacotherapy in patients with established cardiovascular disease: a position paper of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy

Author

Niessner, Alexander, primary, Tamargo, Juan, additional, Koller, Lorenz, additional, Saely, Christoph H, additional, Schmidt, Thomas Andersen, additional, Savarese, Gianluigi, additional, Wassmann, Sven, additional, Rosano, Giuseppe, additional, Ceconi, Claudio, additional, Torp-Pedersen, Christian, additional, Kaski, Juan Carlos, additional, Kjeldsen, Keld Per, additional, Agewall, Stefan, additional, Walther, Thomas, additional, Drexel, Heinz, additional, and Lewis, Basil S, additional

Published
2017
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231. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease : Insights From the ARISTOTLE Trial

Author

Hu, Peter T., Lopes, Renato D., Stevens, Susanna R., Wallentin, Lars, Thomas, Laine, Alexander, John H., Hanna, Michael, Lewis, Basil S., Verheugt, Freek W. A., Granger, Christopher B., Jones, W. Schuyler, Hu, Peter T., Lopes, Renato D., Stevens, Susanna R., Wallentin, Lars, Thomas, Laine, Alexander, John H., Hanna, Michael, Lewis, Basil S., Verheugt, Freek W. A., Granger, Christopher B., and Jones, W. Schuyler

Abstract

Background- We studied (1) the rates of stroke or systemic embolism and bleeding in patients with atrial fibrillation and peripheral artery disease (PAD) and (2) the efficacy and safety of apixaban versus warfarin in patients with atrial fibrillation with and without PAD. Methods and Results- The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial randomized 18 201 patients with atrial fibrillation to apixaban or warfarin for stroke/systemic embolism prevention; 884 (4.9%) patients had PAD at baseline. Patients with PAD had higher unadjusted rates of stroke and systemic embolism (hazard ratio [HR] 1.73, 95% CI 1.22-2.45; P=0.002) and major bleeding (HR 1.34, 95% CI 1.00-1.81; P=0.05), but after adjustment, no differences existed in rates of stroke and systemic embolism (HR 1.32, 95% CI 0.93-1.88; P=0.12) and major bleeding (HR 1.03, 95% CI 0.76-1.40; P=0.83) compared with patients without PAD. The risk of stroke or systemic embolism was similar in patients assigned to apixaban and warfarin with PAD (HR 0.63, 95% CI 0.32-1.25) and without PAD (HR 0.80, 95% CI 0.66-0.96; interaction P= 0.52). Patients with PAD did not have a statistically significant reduction in major or clinically relevant nonmajor bleeding with apixaban compared with warfarin (HR 1.05, 95% CI 0.69-1.58), whereas those without PAD had a statistically significant reduction (HR 0.65, 95% CI 0.58-0.73; interaction P=0.03). Conclusions- Patients with PAD in ARISTOTLE had a higher crude risk of stroke or systemic embolism compared with patients without PAD that was not present after adjustment. The benefits of apixaban versus warfarin for stroke and systemic embolism were similar in patients with and without PAD. These findings highlight the need to optimize the treatment of patients with atrial fibrillation and PAD.

Published
2017
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232. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial

Author

Sabatine, Marc S., Leiter, Lawrence A., Wiviott, Stephen D., Giugliano, Robert P., Deedwania, Prakash, De Ferrari, Gaetano M., Murphy, Sabina A., Kuder, Julia F., Gouni-Berthold, Ioanna, Lewis, Basil S., Handelsman, Yehuda, Pineda, Armando Lira, Honarpour, Narimon, Keech, Anthony C., Sever, Peter S., Pedersen, Terje R., Sabatine, Marc S., Leiter, Lawrence A., Wiviott, Stephen D., Giugliano, Robert P., Deedwania, Prakash, De Ferrari, Gaetano M., Murphy, Sabina A., Kuder, Julia F., Gouni-Berthold, Ioanna, Lewis, Basil S., Handelsman, Yehuda, Pineda, Armando Lira, Honarpour, Narimon, Keech, Anthony C., Sever, Peter S., and Pedersen, Terje R.

Abstract

Background The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes. Methods FOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2.2 years. In this prespecified analysis, we investigated the effect of evolocumab on cardiovascular events by diabetes status at baseline, defined on the basis of patient history, clinical events committee review of medical records, or baseline HbA(1c) of 6 u 5% (48 mmol/mol) or greater or fasting plasma glucose (FPG) of 7.0 mmol/L or greater. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospital admission for unstable angina, or coronary revascularisation. The key secondary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. We also assessed the effect of evolocumab on glycaemia, and on the risk of new-onset diabetes among patients without diabetes at baseline. HbA 1c was measured at baseline then every 24 weeks and FPG was measured at baseline, week 12, week 24, and every 24 weeks thereafter, and potential cases of new-onset diabetes were adjudicated centrally. In a post-hoc analysis, we also investigated the effects on glycaemia and diabetes risk in patients with prediabetes (HbA (c) 5.7-6.4% [39-46 mmol/mol] or FPG 5.6-6.9 mmol/L) at baseline. FOURIER is registered with ClinicalTrials. gov, number NCT01764633. Findings At study baseline, 11 031 patients (40%) had diabetes and 16 533 (60%) did not have diabetes (of whom 10 344 had prediabetes and 6189 had normoglycaemia). Evolocumab significantly reduced cardiovascular out

Published
2017

233. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial

Author

Eisen, Alon, Ruff, Christian T, Braunwald, Eugene, Hamershock, Rose A, Lewis, Basil S, Hassager, Christian, Chao, Tze-Fan, Le Heuzey, Jean Yves, Mercuri, Michele, Rutman, Howard, Antman, Elliott M, Giugliano, Robert P, Eisen, Alon, Ruff, Christian T, Braunwald, Eugene, Hamershock, Rose A, Lewis, Basil S, Hassager, Christian, Chao, Tze-Fan, Le Heuzey, Jean Yves, Mercuri, Michele, Rutman, Howard, Antman, Elliott M, and Giugliano, Robert P

Abstract

BACKGROUND: Digoxin is widely used in patients with atrial fibrillation despite the lack of randomized controlled trials. Observational studies report conflicting results regarding its association with mortality, perhaps because of residual confounding by the presence of heart failure (HF).METHODS AND RESULTS: In the ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trial, clinical outcomes of patients with atrial fibrillation with and without HF were examined by baseline digoxin use during a median follow-up of 2.8 years. HF was defined at baseline as prior or current clinical stage C or D HF. Of 21 105 patients enrolled, 6327 (30%) were treated with digoxin at baseline. Among patients without HF (n=8981), digoxin use (20%) was independently associated with sudden cardiac death (adjusted hazard ratio, 1.51; 95% CI, 1.10-2.08), with no significant interaction by age, sex, left ventricular ejection fraction, renal function, or concomitant medications (P>0.05 for each). Consistent results were observed using propensity matching (adjusted hazard ratio for sudden cardiac death, 1.90; 95% CI, 1.36-2.65). Among patients with HF (n=12 124), digoxin use (37%) was associated with an increase in all-cause death, cardiovascular death, sudden cardiac death, and death caused by HF/cardiogenic shock (P<0.01 for each), but not with noncardiovascular death, stroke/systemic embolism, or myocardial infarction.CONCLUSIONS: In this observational analysis of patients with atrial fibrillation without investigator-reported HF, digoxin use was significantly associated with sudden cardiac death. While residual confounding cannot be excluded, the association between digoxin use and worse clinical outcomes highlights the need to examine digoxin use, particularly when prescribed to control heart rate in patients with atrial fibrillation in a randomized trial.CLINICAL TRIAL R

Published
2017

234. Reversal strategies for non-Vitamin K antagonist oral anticoagulants:A critical appraisal of available evidence and recommendations for clinical management - A joint position paper of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy and European Society of Cardiology Working Group on Thrombosis

Author

Niessner, Alexander, Tamargo, Juan, Morais, João, Koller, Lorenz, Wassmann, Sven, Husted, Steen Elkjær, Torp-Pedersen, Christian, Kjeldsen, Keld, Lewis, Basil S., Drexel, Heinz, Kaski, Juan Carlos, Atar, Dan, Storey, Robert F., Lip, Gregory Y.H., Verheugt, Freek W.A., Agewall, Stefan, Niessner, Alexander, Tamargo, Juan, Morais, João, Koller, Lorenz, Wassmann, Sven, Husted, Steen Elkjær, Torp-Pedersen, Christian, Kjeldsen, Keld, Lewis, Basil S., Drexel, Heinz, Kaski, Juan Carlos, Atar, Dan, Storey, Robert F., Lip, Gregory Y.H., Verheugt, Freek W.A., and Agewall, Stefan

Published
2017

235. Comprehensive efforts to increase adherence to statin therapy

Author

Vonbank, Alexander, Agewall, Stefan, Kjeldsen, Keld Per, Lewis, Basil S., Torp-Pedersen, Christian, Ceconi, Claudio, Funck-Brentano, Christian, Kaski, Juan Carlos, Niessner, Alexander, Tamargo, Juan, Walther, Thomas, Wassmann, Sven, Rosano, Giuseppe, Schmidt, Harald, Saely, Christoph H., Drexel, Heinz, Vonbank, Alexander, Agewall, Stefan, Kjeldsen, Keld Per, Lewis, Basil S., Torp-Pedersen, Christian, Ceconi, Claudio, Funck-Brentano, Christian, Kaski, Juan Carlos, Niessner, Alexander, Tamargo, Juan, Walther, Thomas, Wassmann, Sven, Rosano, Giuseppe, Schmidt, Harald, Saely, Christoph H., and Drexel, Heinz

Abstract

There is compelling evidence that statin therapy improves cardiovascular morbidity and mortality. Unfortunately, statin adherence is far from optimal regarding initiation, execution and persistence of treatment over time.26 Poor adherence to statin therapy is associated with a significantly increased risk of cardiovascular events and mortality. Evidence-based steps to improve adherence are available and should be taken in order to improve patient outcomes. Reinforcing statin adherence appears to have at least as strong beneficial effects as introducing a new drug.

Published
2017

236. Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)

Author

Punthakee, Zubin, Gerstein, Hertzel C., Bosch Pagans, Jordi, Tyrwhitt, Jessica, Jung, Hyejung, Lee, Shun Fu, Lonn, Eva, Marsden, Tamara, McKelvie, Robert, McQueen, Matthew J., Morillo, Carlos, Yusuf, Shazzid, Dagenais, Gilles, Diaz, Rafael, Maggioni, Aldo P., Probstfield, Jeffrey, Ramachandran, Ambady, Riddle, Matthew C., Rydén, Lars, Badings, Erik, Birkeland, Kare, Cardona Munoz, Ernesto G., Commerford, Patrick, Davies, Melanie, Fodor, George J., Gomis, Ramon, Hanefeld, Markolf, Hildebrandt, Per, Kacerovsky Bielesz, Gertrud, Keltai, Matyas, Lanas, Fernando, Lewis, Basil S., Lopez-Jaramillo, Patricio, Marin Neto, Jose Antonio, Marre, Michel, Mendoza, Ivan, Pan, Chun yue, Pirags, Valdis, Rosenstock, Julio, Spinas, Giatgen A., Sreenan, Seamus, Syvänne, Mikko, Yale, Jean Francois, and ORIGIN Trial Investigators

Subjects
Omega-3, Fatty Acids, Insulin Glargine, Postintervention, Cardiovascular
Abstract

8 p., OBJECTIVE The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulin glargine on cardiovascular outcomes and cancers and reduced incident diabetes in high–cardiovascular risk adults with dysglycemia after 6.2 years of active treatment. Omega-3 fatty acids had neutral effects on cardiovascular outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured posttrial effects of these interventions during an additional 2.7 years. RESEARCH DESIGN AND METHODS Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated. RESULTS Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocated to omega-3 fatty acid supplements (2,368) versus placebo (2,403). Posttrial, small differences in median HbA1c persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50 mmol/mol], P = 0.025). From randomization to the end of posttrial follow-up, no differences were found between the glargine and standard care groups in myocardial infarction, stroke, or cardiovascular death (1,185 vs. 1,165 events; hazard ratio 1.01 [95% CI 0.94–1.10]; P = 0.72); myocardial infarction, stroke, cardiovascular death, revascularization, or hospitalization for heart failure (1,958 vs. 1,910 events; 1.03 [0.97–1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99 [0.88–1.12]; P = 0.91) or between omega-3 and placebo groups in cardiovascular death (688 vs. 700; 0.98 [0.88–1.09]; P = 0.68) or other outcomes. CONCLUSIONS During >6 years of treatment followed by >2.5 years of observation, insulin glargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect.

Published
2016

237. Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Author

Lonn, Eva M, Bosch, Jackie, López-Jaramillo, Patricio, Zhu, Jun, Liu, Lisheng, Pais, Prem, Diaz, Rafael, Xavier, Denis, Sliwa, Karen, Dans, Antonio, Avezum, Álvaro, Piegas, Leopoldo S, Keltai, Katalin, Keltai, Matyas, Chazova, Irina, Peters, Ron JG, Held, Claes, Yusoff, Khalid, Lewis, Basil S, Jansky, Petr, Parkhomenko, Alexander, Khunti, Kamlesh, Toff, William D, Reid, Christopher M, Varigos, John, Leiter, Lawrence A, Molina, Dora I, McKelvie, Robert, Pogue, Janice, Wilkinson, Joanne, Jung, Hyejung, Dagenais, Gilles, Department of Medicine, and Faculty of Health Sciences

Subjects
Male, Incidence, Tetrazoles, Blood Pressure, Kaplan-Meier Estimate, Middle Aged, Hydrochlorothiazide, candesartan, Double-Blind Method, Cardiovascular Diseases, Risk Factors, Hypertension, Humans, Benzimidazoles, Drug Therapy, Combination, Female, Hypotension, Antihypertensive Agents, Aged
Abstract

Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear. In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years. The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P=0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P=0.02 and P=0.009, respectively, for trend in the two outcomes). Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials.gov number, NCT00468923.)

Published
2016
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238. Premature permanent discontinuation of apixaban or warfarin in patients with atrial fibrillation

Author

Carnicelli, Anthony P, Al-Khatib, Sana M, Xavier, Denis, Dalgaard, Frederik, Merrill, Peter D, Wojdyla, Daniel M, Lewis, Basil S, Hanna, Michael, Alexander, John H, Lopes, Renato D, Wallentin, Lars, and Granger, Christopher B

Abstract

AimsThe ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial randomised patients with atrial fibrillation at risk of stroke to apixaban or warfarin. We sought to describe patients from ARISTOTLE who prematurely permanently discontinued study drug.Methods/ResultsWe performed a posthoc analysis of patients from ARISTOTLE who prematurely permanently discontinued study drug during the study or follow-up period. Discontinuation rates and reasons for discontinuation were described. Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation. A total of 4063/18 140 (22.4%) patients discontinued study drug at a median of 7.3 (2.2, 15.2) months after randomisation. Patients with discontinuation were more likely to be female and had a higher prevalence of cardiovascular disease, diabetes, renal impairment and anaemia. Premature permanent discontinuation was more common in those randomised to warfarin than apixaban (23.4% vs 21.4%; p=0.002). The most common reasons for discontinuation were patient request (46.1%) and adverse event (34.9%), with no significant difference between treatment groups. The cumulative incidence of clinical events ≤30 days after premature permanent discontinuation for all-cause death, thromboembolism, myocardial infarction, and major bleeding was 5.8%, 2.6%, 0.9%, and 3.0%, respectively. No significant difference was seen between treatment groups with respect to clinical outcomes after discontinuation.ConclusionPremature permanent discontinuation of study drug in ARISTOTLE was common, less frequent in patients receiving apixaban than warfarin and was followed by high 30-day rates of death, thromboembolism and major bleeding. Initiatives are needed to reduce discontinuation of oral anticoagulation.

Published
2021
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239. Rationale, Design and Baseline Characteristics of Participants in the C ardiovascular O utco m es for P eople Using A nticoagulation S trategie s (COMPASS) Trial

Author

Bosch, Jackie, primary, Eikelboom, John W., additional, Connolly, Stuart J., additional, Bruns, Nancy Cook, additional, Lanius, Vivian, additional, Yuan, Fei, additional, Misselwitz, Frank, additional, Chen, Edmond, additional, Diaz, Rafael, additional, Alings, Marco, additional, Lonn, Eva M., additional, Widimsky, Petr, additional, Hori, Masatsugu, additional, Avezum, Alvaro, additional, Piegas, Leopoldo S., additional, Bhatt, Deepak L., additional, Branch, Kelley R.H., additional, Probstfield, Jeffrey L., additional, Liang, Yan, additional, Liu, Lisheng, additional, Zhu, Jun, additional, Maggioni, Aldo P., additional, Lopez-Jaramillo, Patricio, additional, O'Donnell, Martin, additional, Fox, Keith A.A., additional, Kakkar, Ajay, additional, Parkhomenko, Alexander N., additional, Ertl, Georg, additional, Störk, Stefan, additional, Keltai, Katalin, additional, Keltai, Matyas, additional, Ryden, Lars, additional, Dagenais, Gilles R., additional, Pogosova, Nana, additional, Dans, Antonio L., additional, Lanas, Fernando, additional, Commerford, Patrick J., additional, Torp-Pedersen, Christian, additional, Guzik, Tomasz J., additional, Verhamme, Peter B., additional, Vinereanu, Dragos, additional, Kim, Jae-Hyung, additional, Ha, Jong-Won, additional, Tonkin, Andrew M., additional, Varigos, John D., additional, Lewis, Basil S., additional, Felix, Camilo, additional, Yusoff, Khalid, additional, Steg, Philippe Gabriel, additional, Aboyans, Victor, additional, Metsarinne, Kaj P., additional, Anand, Sonia S., additional, Hart, Robert G., additional, Lamy, Andre, additional, Moayyedi, Paul, additional, Leong, Darryl P., additional, Sharma, Mukul, additional, and Yusuf, Salim, additional

Published
2017
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240. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF‐TIMI 48 Trial

Author

Eisen, Alon, primary, Ruff, Christian T., additional, Braunwald, Eugene, additional, Hamershock, Rose A., additional, Lewis, Basil S., additional, Hassager, Christian, additional, Chao, Tze‐Fan, additional, Le Heuzey, Jean Yves, additional, Mercuri, Michele, additional, Rutman, Howard, additional, Antman, Elliott M., additional, and Giugliano, Robert P., additional

Published
2017
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241. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease: Insights From the ARISTOTLE Trial

Author

Hu, Peter T., primary, Lopes, Renato D., additional, Stevens, Susanna R., additional, Wallentin, Lars, additional, Thomas, Laine, additional, Alexander, John H., additional, Hanna, Michael, additional, Lewis, Basil S., additional, Verheugt, Freek W. A., additional, Granger, Christopher B., additional, and Jones, W. Schuyler, additional

Published
2017
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242. Comprehensive efforts to increase adherence to statin therapy

Author

Vonbank, Alexander, primary, Agewall, Stefan, additional, Kjeldsen, Keld Per, additional, Lewis, Basil S., additional, Torp-Pedersen, Christian, additional, Ceconi, Claudio, additional, Funck-Brentano, Christian, additional, Kaski, Juan Carlos, additional, Niessner, Alexander, additional, Tamargo, Juan, additional, Walther, Thomas, additional, Wassmann, Sven, additional, Rosano, Giuseppe, additional, Schmidt, Harald, additional, Saely, Christoph H., additional, and Drexel, Heinz, additional

Published
2017
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243. On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)

Author

Blazing, Michael A., primary, Giugliano, Robert P., additional, de Lemos, James A., additional, Cannon, Christopher P., additional, Tonkin, Andrew, additional, Ballantyne, Christie M., additional, Lewis, Basil S., additional, Musliner, Thomas A., additional, Tershakovec, Andrew M., additional, Lokhnygina, Yuliya, additional, White, Jennifer A., additional, Reist, Craig, additional, McCagg, Amy, additional, and Braunwald, Eugene, additional

Published
2016
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244. The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid and diabetes trials.

Author

Drexel, Heinz, Rosano, Giuseppe M C, Lewis, Basil S, Huber, Kurt, Vonbank, Alexander, Dopheide, Jörn F, Mader, Arthur, Niessner, Alexander, Savarese, Gianluigi, Wassmann, Sven, and Agewall, Stefan

Abstract

Randomized clinical trials (RCTs) are important and the Gold Standard for drugs in modern cardiovascular (CV) therapy. The cornerstone of RCTs is the recording of hard clinical endpoints instead of surrogates. It is important to select an appropriate endpoint. Efficacy endpoints must be clinically relevant and can be hierarchically divided. A very interesting innovation in endpoint acquisition is the total event paradigm.

Published
2020
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245. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention

Author

Windecker, Stephan, Lopes, Renato D., Massaro, Tyler, Jones-Burton, Charlotte, Granger, Christopher B., Aronson, Ronald, Heizer, Gretchen, Goodman, Shaun G., Darius, Harald, Jones, W. Schuyler, Aschermann, Michael, Brieger, David, Cura, Fernando, Engstrøm, Thomas, Fridrich, Viliam, Halvorsen, Sigrun, Huber, Kurt, Kang, Hyun-Jae, Leiva-Pons, Jose L., Lewis, Basil S., Malaga, German, Meneveau, Nicolas, Merkely, Bela, Milicic, Davor, Morais, João, Potpara, Tatjana S., Raev, Dimitar, Sabaté, Manel, de Waha-Thiele, Suzanne, Welsh, Robert C., Xavier, Denis, Mehran, Roxana, and Alexander, John H.

Abstract

Supplemental Digital Content is available in the text.

Published
2019
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247. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial.

Author

Franchi, Francesco, James, Stefan K., Lakic, Tatevik Ghukasyan, Budaj, Andrzej J., Cornel, Jan H., Katus, Hugo A., Keltai, Matyas, Kontny, Frederic, Lewis, Basil S., Storey, Robert F., Himmelmann, Anders, Wallentin, Lars, Angiolillo, Dominick J., Ghukasyan Lakic, Tatevik, and PLATO Investigators

Published
2019
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248. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation : Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC).

Author

Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J, Borger, Michael A, Brotons, Carlos, Chew, Derek P, Gencer, Baris, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F, Windecker, Stephan, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thomas, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathios, James, Stefan, Lewis, Basil S, Lip, Gregory Y H, Piepoli, Massimo F, Richter, Dimitrios, Rosemann, Thomas, Sechtem, Udo, Steg, Ph Gabriel, Vrints, Christian, Luis Zamorano, Jose, Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J, Borger, Michael A, Brotons, Carlos, Chew, Derek P, Gencer, Baris, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F, Windecker, Stephan, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thomas, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathios, James, Stefan, Lewis, Basil S, Lip, Gregory Y H, Piepoli, Massimo F, Richter, Dimitrios, Rosemann, Thomas, Sechtem, Udo, Steg, Ph Gabriel, Vrints, Christian, and Luis Zamorano, Jose

Published
2016
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249. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease

Author

Yusuf, Salim, Lonn, Eva, Pais, Prem, Bosch, Jackie, Lopez-Jaramillo, Patricio, Zhu, Jun, Xavier, Denis, Avezum, Alvaro, Leiter, Lawrence A., Piegas, Leopoldo S., Parkhomenko, Alexander, Keltai, Matyas, Keltai, Katalin, Sliwa, Karen, Chazova, Irina, Peters, Ron J. G., Held, Claes, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Accini, Jose L., McKelvie, Robert, Pogue, Janice, Jung, Hyejung, Liu, Lisheng, Diaz, Rafael, Dans, Antonio, Dagenais, Gilles, Yusuf, Salim, Lonn, Eva, Pais, Prem, Bosch, Jackie, Lopez-Jaramillo, Patricio, Zhu, Jun, Xavier, Denis, Avezum, Alvaro, Leiter, Lawrence A., Piegas, Leopoldo S., Parkhomenko, Alexander, Keltai, Matyas, Keltai, Katalin, Sliwa, Karen, Chazova, Irina, Peters, Ron J. G., Held, Claes, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Accini, Jose L., McKelvie, Robert, Pogue, Janice, Jung, Hyejung, Liu, Lisheng, Diaz, Rafael, Dans, Antonio, and Dagenais, Gilles

Abstract

BACKGROUND Elevated blood pressure and elevated low-density lipoprotein (LDL) cholesterol increase the risk of cardiovascular disease. Lowering both should reduce the risk of cardiovascular events substantially. METHODS In a trial with 2-by-2 factorial design, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to rosuvastatin (10 mg per day) or placebo and to candesartan (16 mg per day) plus hydrochlorothiazide (12.5 mg per day) or placebo. In the analyses reported here, we compared the 3180 participants assigned to combined therapy (with rosuvastatin and the two antihypertensive agents) with the 3168 participants assigned to dual placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included heart failure, cardiac arrest, or revascularization. The median follow-up was 5.6 years. RESULTS The decrease in the LDL cholesterol level was 33.7 mg per deciliter (0.87 mmol per liter) greater in the combined-therapy group than in the dual-placebo group, and the decrease in systolic blood pressure was 6.2 mm Hg greater with combined therapy than with dual placebo. The first coprimary outcome occurred in 113 participants (3.6%) in the combined-therapy group and in 157 (5.0%) in the dual-placebo group (hazard ratio, 0.71; 95% confidence interval [CI], 0.56 to 0.90; P=0.005). The second coprimary outcome occurred in 136 participants (4.3%) and 187 participants (5.9%), respectively (hazard ratio, 0.72; 95% CI, 0.57 to 0.89; P=0.003). Muscle weakness and dizziness were more common in the combined-therapy group than in the dual-placebo group, but the overall rate of discontinuation of the trial regimen was similar in the two groups. CONCLUSIONS The combination of rosuvastatin (10 mg per day), candesartan (16 mg per day), and hydrochlorothiazide (12.5 mg per day) was associated with a significantly

Published
2016
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250. Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Author

Lonn, Eva M., Bosch, Jackie, Lopez-Jaramillo, Patricio, Zhu, Jun, Liu, Lisheng, Pais, Prem, Diaz, Rafael, Xavier, Denis, Sliwa, Karen, Dans, Antonio, Avezum, Alvaro, Piegas, Leopoldo S., Keltai, Katalin, Keltai, Matyas, Chazova, Irina, Peters, Ron J. G., Held, Claes, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Parkhomenko, Alexander, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Leiter, Lawrence A., Molina, Dora I., McKelvie, Robert, Pogue, Janice, Wilkinson, Joanne, Jung, Hyejung, Dagenais, Gilles, Yusuf, Salim, Lonn, Eva M., Bosch, Jackie, Lopez-Jaramillo, Patricio, Zhu, Jun, Liu, Lisheng, Pais, Prem, Diaz, Rafael, Xavier, Denis, Sliwa, Karen, Dans, Antonio, Avezum, Alvaro, Piegas, Leopoldo S., Keltai, Katalin, Keltai, Matyas, Chazova, Irina, Peters, Ron J. G., Held, Claes, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Parkhomenko, Alexander, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Leiter, Lawrence A., Molina, Dora I., McKelvie, Robert, Pogue, Janice, Wilkinson, Joanne, Jung, Hyejung, Dagenais, Gilles, and Yusuf, Salim

Abstract

BACKGROUND Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear. METHODS In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years. RESULTS The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P = 0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P = 0.02 and P = 0.009, respectively, for trend in the two outcomes). CONCLUSIONS Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascul

Published
2016
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