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3. Non-vitamin K oral anticoagulants for secondary stroke prevention in patients with atrial fibrillation

Author

Diener, Hans-Christoph, Hankey, Graeme J, Easton, J Donald, Lip, Gregory YH, Hart, Robert G, and Caso, Valeria

Subjects
Nutrition, Brain Disorders, Clinical Research, Prevention, Stroke, Hematology, Blood, Cardiovascular, Good Health and Well Being, Non-vitamin K oral anticoagulants, Atrial fibrillation, TIA, Secondary stroke prevention, Warfarin, Embolic stroke of undetermined source, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology
Abstract

The aims of this article are to review the evidence regarding the use of non-vitamin K oral anticoagulants (NOACs) for secondary stroke prevention as compared to vitamin K antagonists in patients with atrial fibrillation (AF) and in patients with embolic strokes of uncertain source (ESUS), and when to initiate or resume anticoagulation after an ischaemic stroke or intracranial haemorrhage. Four large trials compared NOACs with warfarin in patients with AF. In our meta-analyses, the rate of all stroke or systemic embolism (SE) was 4.94% with NOACs vs. 5.73% with warfarin. Among the patients with AF and previous transient ischaemic attack or ischaemic stroke, the rate of haemorrhagic stroke was halved with a NOAC vs. warfarin, and the rate of major bleeding was 5.7% with a NOAC vs. 6.4% with warfarin. There was no significant difference in mortality. In a trial comparing apixaban with aspirin in patients with AF, the rate of stroke or SE was 2.4% at 1 year with apixaban vs. 9.2% at 1 year with aspirin and the rates of major bleeding were 4.1% with apixaban vs. 2.9% with aspirin. Data from registries confirmed the results from the randomized trials. Initiation or resumption of anticoagulation after ischaemic stroke or cerebral haemorrhage depends on the size and severity of stroke and the risk of recurrent bleeding. Two large trials tested the hypothesis that NOACs are more effective than 100 mg aspirin in patients with ESUS. Neither trial showed a significant benefit of the NOAC over aspirin. In the meta-analysis, the rate all stroke or SE was 4.94% with NOACs vs. 5.73% with warfarin and the rate of haemorrhagic stroke was halved with a NOAC. The four NOACs had broadly similar efficacy for the major outcomes in secondary stroke prevention.

Published
2020

4. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group.

Author

Barkun, Alan N, Almadi, Majid, Kuipers, Ernst J, Laine, Loren, Sung, Joseph, Tse, Frances, Leontiadis, Grigorios I, Abraham, Neena S, Calvet, Xavier, Chan, Francis KL, Douketis, James, Enns, Robert, Gralnek, Ian M, Jairath, Vipul, Jensen, Dennis, Lau, James, Lip, Gregory YH, Loffroy, Romaric, Maluf-Filho, Fauze, Meltzer, Andrew C, Reddy, Nageshwar, Saltzman, John R, Marshall, John K, and Bardou, Marc

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Digestive Diseases, Hematology, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cardiovascular, Blood Transfusion, Cardiovascular Diseases, Endoscopy, Gastrointestinal, Gastrointestinal Hemorrhage, Hemodynamics, Hemostatic Techniques, Humans, Peptic Ulcer, Proton Pump Inhibitors, Risk Assessment, Secondary Prevention, Medical and Health Sciences, General & Internal Medicine, Clinical sciences
Abstract

DescriptionThis update of the 2010 International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding (UGIB) refines previous important statements and presents new clinically relevant recommendations.MethodsAn international multidisciplinary group of experts developed the recommendations. Data sources included evidence summarized in previous recommendations, as well as systematic reviews and trials identified from a series of literature searches of several electronic bibliographic databases from inception to April 2018. Using an iterative process, group members formulated key questions. Two methodologists prepared evidence profiles and assessed quality (certainty) of evidence relevant to the key questions according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Group members reviewed the evidence profiles and, using a consensus process, voted on recommendations and determined the strength of recommendations as strong or conditional.RecommendationsPreendoscopic management: The group suggests using a Glasgow Blatchford score of 1 or less to identify patients at very low risk for rebleeding, who may not require hospitalization. In patients without cardiovascular disease, the suggested hemoglobin threshold for blood transfusion is less than 80 g/L, with a higher threshold for those with cardiovascular disease. Endoscopic management: The group suggests that patients with acute UGIB undergo endoscopy within 24 hours of presentation. Thermocoagulation and sclerosant injection are recommended, and clips are suggested, for endoscopic therapy in patients with high-risk stigmata. Use of TC-325 (hemostatic powder) was suggested as temporizing therapy, but not as sole treatment, in patients with actively bleeding ulcers. Pharmacologic management: The group recommends that patients with bleeding ulcers with high-risk stigmata who have had successful endoscopic therapy receive high-dose proton-pump inhibitor (PPI) therapy (intravenous loading dose followed by continuous infusion) for 3 days. For these high-risk patients, continued oral PPI therapy is suggested twice daily through 14 days, then once daily for a total duration that depends on the nature of the bleeding lesion. Secondary prophylaxis: The group suggests PPI therapy for patients with previous ulcer bleeding who require antiplatelet or anticoagulant therapy for cardiovascular prophylaxis.

Published
2019

5. Cognitive Decline Over Time in Patients With Systolic Heart Failure Insights From WARCEF

Author

Lee, Tetz C, Qian, Min, Liu, Yutong, Graham, Susan, Mann, Douglas L, Nakanishi, Koki, Teerlink, John R, Lip, Gregory YH, Freudenberger, Ronald S, Sacco, Ralph L, Mohr, Jay P, Labovitz, Arthur J, Ponikowski, Piotr, Lok, Dirk J, Matsumoto, Kenji, Estol, Conrado, Anker, Stefan D, Pullicino, Patrick M, Buchsbaum, Richard, Levin, Bruce, Thompson, John LP, Homma, Shunichi, Di Tullio, Marco R, and Investigators, WARCEF

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Clinical Research, Cardiovascular, Brain Disorders, Aged, Anticoagulants, Aspirin, Cognitive Dysfunction, Female, Fibrinolytic Agents, Heart Failure, Systolic, Humans, Male, Middle Aged, Retrospective Studies, Stroke Volume, Time Factors, Warfarin, cognitive function, comorbidities, dementia, longitudinal analysis, Mini-Mental State Examination, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThis study sought to characterize cognitive decline (CD) over time and its predictors in patients with systolic heart failure (HF).BackgroundDespite the high prevalence of CD and its impact on mortality, predictors of CD in HF have not been established.MethodsThis study investigated CD in the WARCEF (Warfarin versus Aspirin in Reduced Ejection Fraction) trial, which performed yearly Mini-Mental State Examinations (MMSE) (higher scores indicate better cognitive function; e.g., normal score: 24 or higher). A longitudinal time-varying analysis was performed among pertinent covariates, including baseline MMSE and MMSE scores during follow-up, analyzed both as a continuous variable and a 2-point decrease. To account for a loss to follow-up, data at the baseline and at the 12-month visit were analyzed separately (sensitivity analysis).ResultsA total of 1,846 patients were included. In linear regression, MMSE decrease was independently associated with higher baseline MMSE score (p

Published
2019

7. Continuous infusion versus bolus injection of loop diuretics for acute heart failure

Author

Rasoul, Debar, additional, Zhang, Juqian, additional, Farnell, Ebony, additional, Tsangarides, Andreas A, additional, Chong, Shiau Chin, additional, Fernando, Ranga, additional, Zhou, Can, additional, Ihsan, Mahnoor, additional, Ahmed, Sarah, additional, Lwin, Tin S, additional, Bateman, Joanne, additional, Hill, Ruaraidh A, additional, Lip, Gregory YH, additional, and Sankaranarayanan, Rajiv, additional

Published
2024
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10. Non-Vitamin K Antagonist Oral Anticoagulants

Author

Shantsila, Eduard and Lip, Gregory YH

Subjects
Hematology, Surgery, Cardiology, bic Book Industry Communication::M Medicine, bic Book Industry Communication::M Medicine::MN Surgery, bic Book Industry Communication::T Technology, engineering, agriculture::TC Biochemical engineering
Abstract

Hematology; Surgery; Cardiology

Published
2016
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11. Association between mortality and implantable cardioverter‐defibrillators by aetiology of heart failure: a propensity‐matched analysis of the WARCEF trial

Author

Lee, Tetz C, Qian, Min, Mu, Lan, Di Tullio, Marco R, Graham, Susan, Mann, Douglas L, Nakanishi, Koki, Teerlink, John R, Lip, Gregory YH, Freudenberger, Ronald S, Sacco, Ralph L, Mohr, Jay P, Labovitz, Arthur J, Ponikowski, Piotr, Lok, Dirk J, Estol, Conrado, Anker, Stefan D, Pullicino, Patrick M, Buchsbaum, Richard, Levin, Bruce, Thompson, John LP, Homma, Shunichi, Ye, Siqin, and Investigators, for the WARCEF

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Clinical Research, Cardiovascular, Aged, Anticoagulants, Aspirin, Cardiomyopathies, Cause of Death, Defibrillators, Implantable, Echocardiography, Female, Follow-Up Studies, Heart Failure, Heart Ventricles, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Propensity Score, Radionuclide Ventriculography, Retrospective Studies, Risk Factors, Stroke Volume, Survival Rate, United States, Ventricular Function, Left, Warfarin, Heart failure with reduced ejection fraction, Implantable cardioverter-defibrillator, Non-ischaemic cardiomyopathy, Propensity score matching, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

AimsThere is debate on whether the beneficial effect of implantable cardioverter-defibrillators (ICDs) is attenuated in patients with non-ischaemic cardiomyopathy (NICM). We assess whether any ICD benefit differs between patients with NICM and those with ischaemic cardiomyopathy (ICM), using data from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial.Methods and resultsWe performed a post hoc analysis using WARCEF (N = 2293; ICM, n = 991 vs. NICM, n = 1302), where participants received optimal medical treatment. We developed stratified propensity scores for having an ICD at baseline using 41 demographic and clinical variables and created 1:2 propensity-matched cohorts separately for ICM patients with ICD (N = 223 with ICD; N = 446 matched) and NICM patients (N = 195 with ICD; N = 390 matched). We constructed a Cox proportional hazards model to assess the effect of ICD status on mortality for patients with ICM and those with NICM and tested the interaction between ICD status and aetiology of heart failure. During mean follow-up of 3.5 ± 1.8 years, 527 patients died. The presence of ICD was associated with a lower risk of all-cause death among those with ICM (hazard ratio: 0.640; 95% confidence interval: 0.448 to 0.915; P = 0.015) but not among those with NICM (hazard ratio: 0.984; 95% confidence interval: 0.641 to 1.509; P = 0.941). There was weak evidence of interaction between ICD status and the aetiology of heart failure (P = 0.131).ConclusionsThe presence of ICD is associated with a survival benefit in patients with ICM but not in those with NICM.

Published
2019

12. Left atrial volume and cardiovascular outcomes in systolic heart failure: effect of antithrombotic treatment

Author

Di Tullio, Marco R, Qian, Min, Thompson, John LP, Labovitz, Arthur J, Mann, Douglas L, Sacco, Ralph L, Pullicino, Patrick M, Freudenberger, Ronald S, Teerlink, John R, Graham, Susan, Lip, Gregory YH, Levin, Bruce, Mohr, Jay P, Buchsbaum, Richard, Estol, Conrado J, Lok, Dirk J, Ponikowski, Piotr, Anker, Stefan D, Homma, Shunichi, and Investigators, for the WARCEF

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Heart Disease - Coronary Heart Disease, Patient Safety, Clinical Trials and Supportive Activities, Hematology, Heart Disease, Clinical Research, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Stroke, Anticoagulants, Argentina, Aspirin, Canada, Cardiac Volume, Dose-Response Relationship, Drug, Echocardiography, Female, Heart Atria, Heart Failure, Systolic, Humans, Incidence, Male, Middle Aged, Platelet Aggregation Inhibitors, Stroke Volume, Survival Rate, Thromboembolism, Treatment Outcome, United States, Warfarin, Heart failure, Left atrium, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

AimsLeft atrium (LA) dilation is associated with adverse cardiovascular (CV) outcomes. Blood stasis, thrombus formation and atrial fibrillation may occur, especially in heart failure (HF) patients. It is not known whether preventive antithrombotic treatment may decrease the incidence of CV events in HF patients with LA enlargement. We investigated the relationship between LA enlargement and CV outcomes in HF patients and the effect of different antithrombotic treatments.Methods and resultsTwo-dimensional echocardiography with LA volume index (LAVi) measurement was performed in 1148 patients with systolic HF from the Warfarin versus Aspirin in Reduced Ejection Fraction (WARCEF) trial. Patients were randomized to warfarin or aspirin and followed for 3.4 ± 1.7 years. While the primary aim of the trial was a composite of ischaemic stroke, death, and intracerebral haemorrhage, the present report focuses on the individual CV events, whose incidence was compared across different LAVi and treatment subgroups. After adjustment for demographics and clinical covariates, moderate or severe LA enlargement was significantly associated with total death (hazard ratio 1.6 and 2.7, respectively), CV death (HR 1.7 and 3.3), and HF hospitalization (HR 2.3 and 2.6) but not myocardial infarction (HR 1.0 and 1.4) or ischaemic stroke (1.1 and 1.5). The increased risk was observed in both patients treated with warfarin or aspirin. In warfarin-treated patients, a time in therapeutic range >60% was associated with lower event rates, and an interaction between LAVi and time in therapeutic range was observed for death (P = 0.034).ConclusionsIn patients with systolic HF, moderate or severe LA enlargement is associated with death and HF hospitalization despite treatment with antithrombotic medications. The possibility that achieving a more consistent therapeutic level of anticoagulation may decrease the risk of death requires further investigation.

Published
2018

15. Heart Failure Severity and Quality of Warfarin Anticoagulation Control (From the WARCEF Trial)

Author

Lee, Tetz C, Qian, Min, Lip, Gregory YH, Di Tullio, Marco R, Graham, Susan, Mann, Douglas L, Nakanishi, Koki, Teerlink, John R, Freudenberger, Ronald S, Sacco, Ralph L, Mohr, JP, Labovitz, Arthur J, Ponikowski, Piotr, Lok, Dirk J, Estol, Conrado, Anker, Stefan D, Pullicino, Patrick M, Buchsbaum, Richard, Levin, Bruce, Thompson, John LP, Homma, Shunichi, Ye, Siqin, and Investigators, The WARCEF

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Cardiovascular, Hematology, Clinical Research, Anticoagulants, Aspirin, Atrial Fibrillation, Double-Blind Method, Female, Heart Failure, Humans, Male, Middle Aged, Quality of Life, Severity of Illness Index, Stroke Volume, Thromboembolism, Treatment Outcome, Warfarin, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

Previous studies in patients with atrial fibrillation showed that a history of heart failure (HF) could negatively impact anticoagulation quality, as measured by the average time in therapeutic range (TTR). Whether additional markers of HF severity are associated with TTR has not been investigated thoroughly. We aimed to examine the potential role of HF severity in the quality of warfarin control in patients with HF with reduced ejection fraction. Data from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction Trial were used to investigate the association between TTR and HF severity. Multivariable logistic regression models were used to examine the association of markers of HF severity, including New York Heart Association (NYHA) class, Minnesota Living with HF (MLWHF) score, and frequency of HF hospitalization, with TTR ≥70% (high TTR). We included 1,067 participants (high TTR, N = 413; low TTR, N = 654) in the analysis. In unadjusted analysis, patients with a high TTR were older and less likely to have had strokes or receive other antiplatelet agents. Those patients also had lower NYHA class, better MLWHF scores, greater 6-minute walk distance, and lower frequency of HF hospitalizations. Multivariable analysis showed that NYHA class III and/or IV (Odds ratio [OR] 0.68 [95% confidence intervals [CIs] 0.49 to 0.94]), each 10-point increase in MLWHF score (i.e., worse health-related quality of life) (OR 0.92 [0.86 to 0.99]), and higher number of HF hospitalization per year (OR0.45 [0.30 to 0.67]) were associated with decreased likelihood of having high TTR. In HF patients with systolic dysfunction, NYHA class III and/or IV, poor health-related quality of life, and a higher rate of HF hospitalization were independently associated with suboptimal quality of warfarin anticoagulation control. These results affirm the need to assess the new approaches, such as direct oral anticoagulants, to prevent thromboembolism in this patient population.

Published
2018

21. Aspirin Does Not Increase Heart Failure Events in Heart Failure Patients From the WARCEF Trial

Author

Teerlink, John R, Qian, Min, Bello, Natalie A, Freudenberger, Ronald S, Levin, Bruce, Di Tullio, Marco R, Graham, Susan, Mann, Douglas L, Sacco, Ralph L, Mohr, JP, Lip, Gregory YH, Labovitz, Arthur J, Lee, Seitetz C, Ponikowski, Piotr, Lok, Dirk J, Anker, Stefan D, Thompson, John LP, Homma, Shunichi, and Investigators, WARCEF

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Clinical Research, Clinical Trials and Supportive Activities, Cardiovascular, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Anticoagulants, Aspirin, Cyclooxygenase Inhibitors, Double-Blind Method, Female, Heart Failure, Hospitalization, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Stroke Volume, Warfarin, aspirin, heart failure, hospitalization, survival, warfarin, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThe aim of this study was to determine whether aspirin increases heart failure (HF) hospitalization or death in patients with HF with reduced ejection fraction receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).BackgroundBecause of its cyclooxygenase inhibiting properties, aspirin has been postulated to increase HF events in patients treated with ACE inhibitors or ARBs. However, no large randomized trial has addressed the clinical relevance of this issue.MethodsWe compared aspirin and warfarin for HF events (hospitalization, death, or both) in the 2,305 patients enrolled in the WARCEF (Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction) trial (98.6% on ACE inhibitor or ARB treatment), using conventional Cox models for time to first event (489 events). In addition, to examine multiple HF hospitalizations, we used 2 extended Cox models, a conditional model and a total time marginal model, in time to recurrent event analyses (1,078 events).ResultsAfter adjustment for baseline covariates, aspirin- and warfarin-treated patients did not differ in time to first HF event (adjusted hazard ratio: 0.87; 95% confidence interval: 0.72 to 1.04; p = 0.117) or first hospitalization alone (adjusted hazard ratio: 0.88; 95% confidence interval: 0.73 to 1.06; p = 0.168). The extended Cox models also found no significant differences in all HF events or in HF hospitalizations alone after adjustment for covariates.ConclusionsAmong patients with HF with reduced ejection fraction in the WARCEF trial, there was no significant difference in risk of HF events between the aspirin and warfarin-treated patients. (Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction trial [WARCEF]; NCT00041938).

Published
2017

22. Resting Heart Rate and Ischemic Stroke in Patients with Heart Failure

Author

Nakanishi, Koki, Di Tullio, Marco R, Qian, Min, Thompson, John LP, Labovitz, Arthur J, Mann, Douglas L, Sacco, Ralph L, Pullicino, Patrick M, Freudenberger, Ronald S, Teerlink, John R, Graham, Susan, Lip, Gregory YH, Levin, Bruce, Mohr, Jay P, Buchsbaum, Richard, Estol, Conrado J, Lok, Dirk J, Ponikowski, Piotr, Anker, Stefan D, and Homma, Shunichi

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Brain Disorders, Clinical Research, Prevention, Cardiovascular, Stroke, Good Health and Well Being, Adrenergic beta-Antagonists, Aged, Anticoagulants, Brain Ischemia, Electrocardiography, Female, Fibrinolytic Agents, Heart Failure, Heart Rate, Humans, Incidence, Kaplan-Meier Estimate, Linear Models, Male, Middle Aged, Multivariate Analysis, Platelet Aggregation Inhibitors, Prognosis, Proportional Hazards Models, Rest, Risk Factors, Time Factors, Beta-blocker, Heart failure, Ischemic stroke, Resting heart rate, Sinus rhythm, Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial, WARCEF Investigators, Clinical Sciences, Neurosciences, Neurology & Neurosurgery, Clinical sciences
Abstract

BackgroundAlthough high resting heart rate (RHR) is known to be associated with an increased risk of mortality and hospital admission in patients with heart failure, the relationship between RHR and ischemic stroke remains unclear. This study is aimed at investigating the relationship between RHR and ischemic stroke in patients with heart failure in sinus rhythm.MethodsWe examined 2,060 patients with systolic heart failure in sinus rhythm from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial. RHR was determined from baseline electrocardiogram, and was examined as both a continuous variable and a categorical variable using quartiles. Ischemic strokes were identified during follow-up and adjudicated by physician review.ResultsDuring 3.5 ± 1.8 years of follow-up, 77 patients (5.3% from Kaplan-Meier [KM] curve) experienced an ischemic stroke. The highest incidence of ischemic stroke (21/503 [KM 6.9%]) was observed in the lowest RHR quartile (RHR 79 beats/min (p = 0.693). Multivariable Cox proportional hazards analysis revealed that RHR was significantly associated with ischemic stroke (hazard ratio per unit decrease: 1.07, 95% CI 1.02-1.13, when RHR

Published
2017

23. International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF): Rationale, Design, and Initial Descriptives.

Author

Hsu, Jonathan C, Akao, Masaharu, Abe, Mitsuru, Anderson, Karen L, Avezum, Alvaro, Glusenkamp, Nathan, Kohsaka, Shun, Lane, Deirdre A, Lip, Gregory YH, Ma, Chang-Sheng, Masoudi, Frederick A, Potpara, Tatjana S, Siong, Teo Wee, Turakhia, Mintu P, Tse, Hung-Fat, Rumsfeld, John S, and Maddox, Thomas M

Subjects
Humans, Atrial Fibrillation, Myocardial Revascularization, Registries, Research Design, International Cooperation, Disease Management, atrial fibrillation, clinical registries, global health, quality of care and outcomes, Cardiorespiratory Medicine and Haematology
Published
2016

24. CHA2DS2‐VASc score and adverse outcomes in patients with heart failure with reduced ejection fraction and sinus rhythm

Author

Ye, Siqin, Qian, Min, Zhao, Bo, Buchsbaum, Richard, Sacco, Ralph L, Levin, Bruce, Di Tullio, Marco R, Mann, Douglas L, Pullicino, Patrick M, Freudenberger, Ronald S, Teerlink, John R, Mohr, JP, Graham, Susan, Labovitz, Arthur J, Estol, Conrado J, Lok, Dirk J, Ponikowski, Piotr, Anker, Stefan D, Lip, Gregory YH, Thompson, John LP, Homma, Shunichi, and Investigators, on behalf of the WARCEF

Subjects
Clinical Research, Brain Disorders, Patient Safety, Stroke, Cardiovascular, Aged, Anticoagulants, Aspirin, Double-Blind Method, Female, Heart Failure, Heart Rate, Humans, Male, Middle Aged, Prognosis, Randomized Controlled Trials as Topic, Stroke Volume, Systole, Warfarin, Heart failure, Sinus rhythm, Bleeding, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology
Abstract

AimsThe aim of this study was to determine whether the CHA2 DS2 -VASc score can predict adverse outcomes such as death, ischaemic stroke, and major haemorrhage, in patients with systolic heart failure in sinus rhythm.Methods and resultsCHA2 DS2 -VASc scores were calculated for 1101 patients randomized to warfarin and 1123 patients randomized to aspirin. Adverse outcomes were defined as death or ischaemic stroke, death alone, ischaemic stroke alone, and major haemorrhage. Using proportional hazards models, we found that each 1-point increase in the CHA2 DS2 -VASc score was associated with increased hazard of death or ischaemic stroke events [hazard ratio (HR) for the warfarin arm = 1.21, 95% confidence interval (CI) 1.13-1.30, P < 0.001; for aspirin, HR = 1.20, 95% CI 1.11-1.29, P < 0.001]. Similar increased hazards for higher CHA2 DS2 -VASc scores were observed for death alone, ischaemic stroke alone, and major haemorrhage. Overall performance of the CHA2 DS2 -VASc score was assessed using c-statistics for full models containing the risk score, treatment assignment, and score-treatment interaction, with the c-statistics for the full models ranging from 0.57 for death to 0.68 for major haemorrhage.ConclusionsThe CHA2 DS2 -VASc score predicted adverse outcomes in patients with systolic heart failure in sinus rhythm, with modest prediction accuracy.

Published
2016

25. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab

Author

Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., Schwartz, Gregory G., Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Szarek, Michael, White, Harvey D., Zeiher, Andreas M., Tricoci, Pierluigi, Roe, Matthew T., Mahaffey, Kenneth W., Edelberg, Jay M., Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Pordy, Robert, Sasiela, William J., Tamby, Jean-François, Diaz, Rafael, Aylward, Philip E, Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Lopes, Renato D., Gotcheva, Nina N, Goodman, Shaun G., Prieto, Juan-Carlos, Yong, Huo, López-Jaramillo, Patricio, Pećin, Ivan, Reiner, Zeljko, Ostadal, Petr, Poulsen, Steen Hvitfeldt, Viigimaa, Margus, Nieminen, Markku S, Danchin, Nicolas, Chumburidze, Vakhtang, Marx, Nikolaus, Liberopoulos, Evangelos, Carlos, Pablo, Valdovinos, Montenegro, Tse, Hung-Fat, Kiss, Robert Gabor, Xavier, Denis, Zahger, Doron, Valgimigli, Marco, Kimura, Takeshi, Kim, Hyo Soo, Kim, Sang-Hyun, Erglis, Andrejs, Laucevicius, Aleksandras, Kedev, Sasko, Yusoff, Khalid, Ramos López, Gabriel Arturo, Alings, Marco, White, Harvey D., Halvorsen, Sigrun, Correa Flores, Roger M, Sy, Rody G., Budaj, Andrzej, Morais, Joao, Dorobantu, Maria, Karpov, Yuri, Ristic, Arsen D., Chua, Terrance, Murin, Jan, Fras, Zlatko, Dalby, Anthony J, Tuñón, José, de Silva, H. Asita, Hagström, Emil, Landmesser, Ulf, Müller, Christian, Chiang, Chern-En, Sritara, Piyamitr, Guneri, Sema, Parkhomenko, Alexander, Ray, Kausik K., Moriarty, Patrick M., Roe, Matthew T., Vogel, Robert, Chaitman, Bernard, Kelsey, Sheryl F., Olsson, Anders G., Rouleau, Jean-Lucien, Simoons, Maarten L., Alexander, Karen, Meloni, Chiara, Rosenson, Robert, Sijbrands, Eric J.G., Tricoci, Pierluigi, Alexander, John H., Armaganijan, Luciana, Bagai, Akshay, Bahit, Maria Cecilia, Brennan, J. Matthew, Clifton, Shaun, DeVore, Adam D., Deloatch, Shalonda, Dickey, Sheila, Dombrowski, Keith, Ducrocq, Grégory, Eapen, Zubin, Endsley, Patricia, Eppinger, Arleen, Harrison, Robert W., Hess, Connie Ng, Hlatky, Mark A., Jordan, Joseph Dedrick, Knowles, Joshua W., Kolls, Bradley J., Kong, David F., Leonardi, Sergio, Lillis, Linda, Lopes, Renato D., Maron, David J., Mahaffey, Kenneth W., Marcus, Jill, Mathews, Robin, Mehta, Rajendra H., Mentz, Robert J., Moreira, Humberto Graner, Patel, Chetan B., Pereira, Sabrina Bernardez, Perkins, Lynn, Povsic, Thomas J., Puymirat, Etienne, Roe, Matthew T., Jones, William Schuyler, Shah, Bimal R., Sherwood, Matthew W., Stringfellow, Kenya, Sujjavanich, Darin, Toma, Mustafa, Trotter, Charlene, van Diepen, Sean F.P., Wilson, Matthew D., Tze-Kay Yan, Andrew, Schiavi, Lilia B, Garrido, Marcelo, Alvarisqueta, Andrés F, Sassone, Sonia A, Bordonava, Anselmo P, Alves De Lima, Alberto E, Schmidberg, Jorge M, Duronto, Ernesto A, Caruso, Orlando C, Novaretto, 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Anthony J, Reuter, Helmuth, Moodley, Rajendran, Vida, Manuel, Fillat, Angel R. Cequier, Peris, Vicente Bodí, Jimenez, Francisco Fuentes, Marín, Francisco, Cruz Fernández, Jose M, Hidalgo Urbano, Rafael Jesus, Gil-Extremera, Blas, Toledo, Pablo, Worner Diz, Fernando, Garcia-Dorado, David, Iñiguez, Andres, Gonzalez-Juanatey, Jose R, Portales, Javier Fernandez, Murillo, Fernando Civeira, Pericas, Laia Matas, Zamorano, Jose Luis, De Mora Martin, Manuel, Cortada, Jordi Bruguera, Alonso Martin, Joaquin J, Serrano Antolin, Jose Maria, De Berrazueta Fernández, José R, Vázquez de Prada, José Antonio, Díaz Fernández, Jose Francisco, García Lledó, José Alberto, Cosín Sales, Juan, Rodriguez, Javier Botas, Tragant, Gabriel Gusi, Benedicto, Amparo, Gonzalez-Juanatey, Carlos, Camprubí Potau, Mercedes, Perez, Ignacio Plaza, De La Tassa, César Morís, Rincon, Pablo Loma-Osorio, Recena, Javier Balaguer, Escudier, Juan M, Payeras, Antonio Coca, Orcajo, Norberto Alonso, Constantine, Godwin, Haniffa, Ruvaiz, Tissera, Nirmali, Amarasekera, Stanley, Ponnamperuma, Chandrike, Fernando, Nimali, Fernando, Kaputella, Jayawardena, Jayanthimala, Wijeyasingam, Santharaj, Ranasinghe, Gotabhaya, Ekanayaka, Ruvan, Mendis, Sepalika, Senaratne, Vajira, Mayurathan, Gnanamoorthy, Rajapaksha, Ajantha, Sirisena, Thilak, Herath, Jagath I, Amarasena, Naomali, Berglund, Stefan, Rasmanis, Gundars, Hagström, Emil, Vedin, Ola, Witt, Nils, Mourtzinis, Georgios, Nicol, Peter, Hansen, Ole, Romeo, Stefano, Jensen, Steen Agergaard, Torstensson, Ingemar, Ahremark, Ulf, Sundelin, Torbjörn, Moccetti, Tiziano, Müller, Christian, Mach, Francois, Binde, Ronald, Landmesser, Ulf, Gämperli, Oliver, Chiang, Chern-En, Tsai, Wei- Chuan, Ueng, Kwo-Chang, Lai, Wen-Ter, Liu, Ming-En, Hwang, Juey- Jen, Yin, Wei-Hsian, Hsieh, I-Chang, Hsieh, Ming-Jer, Hsiang Lin, Wei, Kuo, Jen-Yuan, Huang, Tsuei-Yuan, Fang, Chih-Yuan, Kaewsuwanna, Pinij, Soonfuang, Wasant, Jintapakorn, Woravut, Sukonthasarn, Apichard, Sritara, Piyamitr, Wongpraparut, Nattawut, Sastravaha, Krisada, Sansanayudh, Nakarin, Kehasukcharoen, Wirash, Piyayotai, Dilok, Chotnoparatpat, Paiboon, Camsari, Ahmet, Kultursay, Hakan, Guneri, Sema, Mutlu, Bulent, Ersanli, Murat, Demirtas, Mustafa, Kirma, Cevat, Ural, Ertan, Koldas, Lale, Karpenko, Oleksandr, Prokhorov, Alexander, Vakaluyk, Ihor, Myshanych, Halyna, Reshotko, Dmytro, Batushkin, Valeriy, Rudenko, Leonid, Kovalskyi, Ihor, Kushnir, Mykola, Tseluyko, Vira, Mostovoy, Yuriy, Stanislavchuk, Mykola, Kyiak, Yulian, Karpenko, Yuriy, Malynovsky, Yaroslav, Klantsa, Andriy, Kutniy, Oles, Amosova, Ekaterina, Tashchuk, Viktor, Leshchuk, Oleh, Parkhomenko, Alexander, Rishko, Mykola, Kopytsya, Mykola, Yagensky, Andriy, Vatutin, Mykola, Bagriy, Andriy, Barna, Olga M, Ushakov, Olexiy, Dzyak, Georgiy, Goloborodko, Borys, Rudenko, Anatolii, Zheleznyy, Volodymyr, Trevelyan, Jasper, Zaman, Azfar, Lee, Kaeng, Moriarty, Andrew, Aggarwal, Rajesh K, Clifford, Piers, Wong, Yuk- Ki, Iqbal, Syed MR, Subkovas, Eduardas, Braganza, Denise, Sarkar, David, Storey, Robert, Griffiths, Huw, Mcclure, Sam, Muthusamy, Rangasamy, Smith, Simon, Kurian, John, Levy, Terry, Barr, Craig, Kadr, Honer, Gerber, Robert, Simaitis, Audrius, Soran, Handrean, Brodison, Adrian, Ayaz, Mohammad, Cheema, Muhammad, Oliver, Richard, Thackray, Simon, Mudawi, Telal, Rahma, Gohar, Sultan, Ayyaz, Reynolds, Timothy, Sharman, David, Spriging, david, Butler, Rob, Wilkinson, Peter, Lip, Gregory YH, Ossei-Gerning, Nicholas, Vardi, Gil, Baldari, Duccio, Brabham, David, Treasure II, Charles, Dahl, Charles, Palmer, Bruce, Wiseman, Alan, Khan, Abul, Puri, Sanjeev, Mohart, Ann Elizabeth, Ince, Carlos, Flores, Enrique, Wright, Scott, Cheng, Shi-Chi, Rosenberg, Michael, Rogers, William, Kosinski, Edward, Forgosh, Les, Waltman, Jonathan, Shoukfeh, Mohammad, Dagher, Georges, Cambier, Patrick, Lieber, Ira, Kumar, Priya, East, Cara, Krichmar, Perry, Hasan, Mian, White, Lindsey, Knickelbine, Thomas, Haldis, Thomas, Gillespie, Eve, Amidon, Thomas, Suh, David, Arif, Imran, Abdallah, mouhamad, Akhter, Faiq, Carlson, Eric, D’Urso, Michael, El- Ahdab, Fadi, Nelson, William, Moriarty, Katie, Harris, Barry, Cohen, Steven, Carter, Luther, Doty, Daniel, Sabatino, Kenneth, Haddad, Tariq, Rao, Sunder, Mulkay, Angel, Jovin, Ion, Klancke, Kim, Malhotra, Vinay, Devarapalli, Sai K, Koren, Michael, Chandna, Harish, Dodds, George, Goraya, Tauqir, Bengston, James, Janik, Matthew, Moran, Joseph, Sumner, Andrew, Kobayashi, John, Davis, William, Yazdani, Shahram, Pasquini, John, Thakkar, Maitreya, Vedere, Amarnath, Leimbach, Wayne, Rider, James, fenton, Sarah, Singh, Narendra, Shah, Anil V, Moriarty, Patrick M., Janosik, Denise, Pepine, Carl, Berman, Brett, Gelormini, Joseph, Daniels, Christopher, Richard, Kerensky, Keating, Friederike, Kondo, Nicholas I, Shetty, Sanjay, Levite, Howard, Waider, Winfried, Takata, Theodore, Abu-Fadel, Mazen, Shah, Vipul, Aggarwal, Rahul, Kumar, Anil, Hattler, Brack, Do, Rose, Link, Chad, Bortnick, Anna, Kinzfogl, George, Ghitis, Arnold, Larry, John, Teufel, Edward, Kuhlman, Peter, Mclaurin, Brent, Zhang, Wenwu, Thew, Stephen, Abbas, Jalal, White, Matthew, Islam, Othman, Subherwal, Sumeet, Ranadive, Nandkishore, Vakili, Babak, Gring, Christian, Henderson, David, Schuchard, Timothy, Farhat, Naim, Kline, Geoffrey, Mahal, Sharan, Whitaker, Jack, Speirs, Shawn, Andersen, Rolf, Daboul, Nizar, Horwitz, Phillip, Zahr, Firas, Ponce, George, Jafar, Zubair, Mcgarvey, Joseph, Panchal, Vipul, Voyce, Stephen, Blok, Thomas, Sheldon, William, Azizad, Masoud M, Schmalfuss, Carsten, Picone, Mark, Pederson, Robert, Herzog, William, Friedman, Keith, Lindsey, Jason, Timothy, Eichenlaub, Leonard, Parilak, Lepor, Norman, El Shahawy, Mahfouz, Weintraub, Howard, Irimpen, Anand, Alonso, Alvaro, May, Wade, Christopher, Daniels, Galski, Thomas, Chu, Alan, Mody, Freny, Ramin, Ebrahimi, Hodes, Zachary, Rossi, Joseph, Rose, Gregory, Fairlamb, James, Lambert, Charles, Raisinghani, Ajit, Abbate, Antonio, Vetrovec, George, King, Marilyn, Carey, Charles, Gerber, Jaime, Younis, Liwa, Park, Hyeun (Tom), Vidovich, Mladen, Knutson, Thomas, Friedman, Dennis, Chaleff, Fred, Loussararian, Arthur, Rozeman, Phillip, Kimmelstiel, Carey, Kuvin, Jeffrey, Silver, Kevin, Foster, Malcolm, Tonnessen, Glen, Espinoza, Andrey, Amlani, Mohamadali, Wali, Andreas, Malozzi, Christopher, Jong, Geert T, Massey, Clara, Wattanakit, Keattiyoat, O’Donnell, Philip J., Singal, Dinesh, Jaffrani, Naseem, Banuru, Sridhar, Fisher, Daniel, Xenakis, Mark, Perlmutter, Neal, Bhagwat, Ravi, Strader, James, Blonder, Ronald, Akyea-Djamson, Ayim, Labroo, Ajay, Lee, Kwan, Marais, H. John, Claxton, Edmund, Weiss, Robert, Kathryn, Rohr, Berk, Martin, Rossi, Peter, Joshi, Parag, Khera, Amit, Khaira, Ajit S, Kumkumian, Greg, Lupovitch, Steven, Purow, Joshua, Welka, Stephen, Hoffman, David, Fischer, Stuart, Soroka, Eugene, Eagerton, Donald, Pancholy, Samir, Ray, Michael, Erenrich, Norman, Farrar, Michael, Pollock, Stewart, French, William J, Diamantis, Steve, Guy, Douglas, Gimple, Lawrence, Neustel, Mark, Schwartz, Steven, Pereira, Edward, Albert, Seals, Spriggs, Douglas, Strain, Janet, Mittal, Suneet, Vo, Anthony, Chane, Majed, Hall, Jason, Vijay, Nampalli, Lotun, Kapildeo, Lester, F. Martin, Nahhas, Ahed, Pope, Theodore, Nager, Paul, Vohra, Rakesh, Sharma, Mukesh, Bashir, Riyaz, Ahmed, Hinan, Berlowitz, Michael, Fishberg, Robert, Barrucco, Robert, Yang, Eric, Radin, Michael, Sporn, Daniel, Stapleton, Dwight, Eisenberg, Steven, Landzberg, Joel, Mcgough, Martin, Turk, Samir, Schwartz, Michael, Sundram, P. Sandy, Jain, Diwakar, Zainea, Mark, Bayron, Carlos, Karlsberg, Ronald, Dohad, Suhail, Lui, Henry, Keen, William, Westerhausen, Donald, Khurana, Sandeep, Agarwal, Himanshu, Birchem, Jessica, Penny, William, Chang, Mark, Murphy, Sherrill, Henry, John, Schifferdecker, Branislav, Gilbert, John M, Chalavarya, Gopal, Eaton, Charles, Schmedtje, John F, Christenson, Stuart, Dotani, Imran, Denham, Douglas, Macdonell, Alexander, Gibson, Paul, Rahman, Aref, Al Joundi, Tammam, Assi, Nizar, Conrad, Gary, Kotha, Purushotham, Love, Michael, Giesler, Gregory, Rubenstein, Howard, Gamil, Dawood, Akright, Laura, Krawczyk, Justine, Cobler, Joanne, Wells, Terry, Welker, James, Foster, Robert, Gilmore, Richard, Anderson, Jay, Jacoby, Douglas, Harris, Bill, Gardner, Geraldine, Dandillaya, Ramprasad, Vora, Kishor, Kostis, John, Hunter, John, Laxson, David, Ball, Eric, Anderson, Jay, Wells, Terry, Vora, Kishor, Ball, Eric, Welker, James, Lopes, Renato D., Egydio, Flavia, Kawakami, Anelise, Oliveira, Janaina, Goodman, Shaun G., Wozniak, Julianna, Matthews, Alexander, Ratky, Caroline, Valiris, Janine, Berdan, Lisa, Hepditch, Anita, Quintero, Kirby, Roe, Matthew T., Rorick, Tyrus, Westbrook, Melissa, Danchin, Nicolas, Bezault, Madeleine, Drouet, Elodie, Simon, Tabassome, White, Harvey D., Alsweiler, Caroline, Sinnaeve, Peter, Luyten, Anne, Aylward, Philip E, Butters, Julie, Griffith, Liddy, Shaw, Michelle, Hagström, Emil, Grunberg, Lena, Szarek, Michael, Islam, Shahidul, Brégeault, Marie-France, Bougon, Nathalie, Faustino, Douglas, Fontecave, Sylvie, Murphy, Judith, Tamby, Jean- Francois, Verrier, Melanie, Agnetti, Veronique, Andersen, Dorthe, Badreddine, Emmy, Bekkouche, Mhamed, Bouancheau, Cecile, Brigui, Imane, Brocklehurst, Maddy, Cianciarulo, Joseph, Devaul, Dawn, Domokos, Szilvia, Gache, Cecile, Gobillot, Caroline, Guillou, Severine, Healy, Jan, Heath, Megan, Jaiwal, Gayatri, Javierre, Carine, Labeirie, Julien, Monier, Myriam, Morales, Ulises, Mrabti, Asmaa, Mthombeni, Bicky, Okan, Betim, Smith, Lucile, Sheller, Jennifer, Sopena, Sebastien, Pellan, Valerie, Benbernou, Fadela, Bengrait, Nafissa, Lamoureux, Maud, Kralova, Katarina, Scemama, Michel, Bejuit, Raphael, Coulange, Anthony, Berthou, Christelle, Repincay, Jérôme, Lorenzato, Christelle, Etienne, Alexis, Gouet, Valerie, Lecorps, Guillaume, Loizeau, Virginie, Normand, Mickael, Ourliac, Anne, Rondel, Christelle, Adamo, Antony, Beltran, Pascale, Barraud, Pauline, Dubois-Gache, Helene, Halle, Benjamin, Metwally, Lamia, Mourgues, Maxime, Sotty, Marc, Vincendet, Marion, Cotruta, Raluca, Chengyue, Zhu, Fournie-Lloret, Dominique, Morrello, Christine, Perthuis, Aurelie, Picault, Patrick, Zobouyan, Isabelle, Colhoun, Helen M., Dempsey, Michael A., and McClanahan, Mark A.

Published
2022
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26. Clinical trial evaluation: the EDOSURE clinical trial program.

Author

Griffin, Michael and Lip, Gregory YH

Abstract

EDOSURE is a trial program of the direct oral anticoagulant drug edoxaban, comprising ten randomized clinical trials of which eight are currently published. They evaluate the use of edoxaban in the treatment of nonvalvular atrial fibrillation and acute venous thromboembolism, including in special circumstances such as patients undergoing cardiac procedures, cancer-associated venous thromboembolism, and elderly patients whose bleeding risk precludes conventional anticoagulation strategies. As a result of the collective evidence generated by EDOSURE, edoxaban is now recommended as a treatment option by numerous international guidelines. This review summarizes the context, rationale, and key findings of the studies. EDOSURE is a collection of clinical trials of the medication edoxaban – a blood thinner used to treat or prevent clotting. It encompasses ten trials, eight of which are complete and two are ongoing. Edoxaban's main uses are in patients with atrial fibrillation, or venous clots (e.g., deep vein thrombosis). Trials of blood thinners need to assess the balance of effectiveness (how well the drug treats or prevents clotting) against risk (causing bleeding). These trials collectively demonstrate first that edoxaban is an effective treatment in these conditions and is at least as safe as traditional options like warfarin. Second, in patients with atrial fibrillation who are undergoing procedures like cardiac stenting or ablations, edoxaban is as effective as the previous standard treatments. Finally, in higher-risk populations, such as frail and/or elderly patients, edoxaban can represent a relatively safe option at lower doses. This article is a review of the individual trials, their important findings, and potential limiting factors. Article highlights EDOSURE is an ongoing clinical trial program of edoxaban – a direct oral anticoagulant. In its entirety, it provides an evidence base for edoxaban use in a variety of clinical scenarios, both for nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). Engage-TIMI-48 (2013) found edoxaban (at two different doses – 30 and 60 mg OD) noninferior to warfarin for the prevention of stroke in patients with NVAF. Edoxaban was safer with regard to bleeding events. Hokusai-VTE (2013) assessed edoxaban use in acute VTE. Edoxaban was again noninferior for efficacy (prevention of recurrent VTE), and superior in terms of safety (major or clinically relevant nonmajor bleeding). Ensure AF (2016) found that for NVAF patients undergoing direct current cardioversion, both edoxaban and warfarin represent safe anticoagulant strategies, with very low rates of iatrogenic stroke. However, the study was underpowered for the demonstration of noninferiority. ELIMINATE-AF (2019) assessed NVAF patients undergoing catheter ablation, with the primary efficacy outcome Similarly to Ensure-AF, rates of stroke and bleeding were very low in both warfarin and vitamin K antagonist arms, precluding noninferiority calculations. The authors concluded, however, both are viable options in this patient group. ENTRUST-AF-PCI (2019) examined NVAF patients undergoing percutaneous coronary intervention (PCI), comparing dual therapy with edoxaban + P2Y12 inhibitor, versus triple therapy with warfarin + P2Y12 inhibitor + aspirin. The edoxaban regime was noninferior for efficacy (a composite outcome including stent thrombosis alongside major adverse cardiovascular events), and trended toward superiority for safety (major bleeding). ENVISAGE-TAVI AF (2021) investigated edoxaban use after successful transcatheter aortic valve implantation (TAVI) in patients with concomitant AF. The comparator was a vitamin K antagonist (predominantly warfarin). While noninferiority was reached for efficacy, the main finding from this study was a 40% higher risk of bleeding in the edoxaban arm, a potentially surprising contrast to the other trials discussed in this review. One possible explanation for this difference is the older, frailer population undergoing TAVI compared with the other study cohorts. Hokusai VTE-Cancer (2017) challenged the idea that heparin-derived anticoagulants were the gold standard in cancer-associated VTE. In this study, edoxaban, met noninferiority thresholds for efficacy and safety compared with dalteparin and trended toward a lower rate of recurrent VTE. There was, however, a signal for increased gastrointestinal bleeding in patients with gastrointestinal malignancies. ELDERCARE-AF (2020) was an innovative trial of low-dose edoxaban (15 mg OD) in frail elderly patients who were considered too high risk for traditional anticoagulant medications. Compared with placebo, edoxaban was associated with a 66% reduction in stroke or systemic embolism, at the cost of an increased rate of bleeding, though the latter did not reach statistical significance. STABLED and ENRICH-AF are ongoing trials. STABLED is assessing the effect of catheter ablation on stroke risk, in AF patients who are taking edoxaban. ENRICH-AF is investigating edoxaban versus aspirin use in AF patients with recent intracranial hemorrhage and high predicted stroke risk. Together – these trials support the use of edoxaban for NVAF and VTE across a broad range of specific clinical scenarios. Its bleeding risk profile is generally favorable compared with warfarin, except possibly in older frailer patients. [ABSTRACT FROM AUTHOR]

Published
2024
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28. Left Ventricular Ejection Fraction and Risk of Stroke and Cardiac Events in Heart Failure

Author

Di Tullio, Marco R, Qian, Min, Thompson, John LP, Labovitz, Arthur J, Mann, Douglas L, Sacco, Ralph L, Pullicino, Patrick M, Freudenberger, Ronald S, Teerlink, John R, Graham, Susan, Lip, Gregory YH, Levin, Bruce, Mohr, JP, Buchsbaum, Richard, Estol, Conrado J, Lok, Dirk J, Ponikowski, Piotr, Anker, Stefan D, and Homma, Shunichi

Subjects
Epidemiology, Biomedical and Clinical Sciences, Health Sciences, Brain Disorders, Cardiovascular, Stroke, Heart Disease, Clinical Research, Clinical Trials and Supportive Activities, Good Health and Well Being, Aged, Aspirin, Cardiovascular Diseases, Cerebral Hemorrhage, Female, Heart Failure, Humans, Incidence, Male, Middle Aged, Risk Factors, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Warfarin, aspirin, echocardiography, heart failure, heart ventricles, stroke, warfarin, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurosciences, Neurology & Neurosurgery, Clinical sciences, Allied health and rehabilitation science
Abstract

Background and purposeIn heart failure (HF), left ventricular ejection fraction (LVEF) is inversely associated with mortality and cardiovascular outcomes. Its relationship with stroke is controversial, as is the effect of antithrombotic treatment. We studied the relationship of LVEF with stroke and cardiovascular events in patients with HF and the effect of different antithrombotic treatments.MethodsIn the Warfarin Versus Aspirin in Reduced Ejection Fraction (WARCEF) trial, 2305 patients with systolic HF (LVEF≤35%) and sinus rhythm were randomized to warfarin or aspirin and followed for 3.5±1.8 years. Although no differences between treatments were observed on primary outcome (death, stroke, or intracerebral hemorrhage), warfarin decreased the stroke risk. The present report compares the incidence of stroke and cardiovascular events across different LVEF and treatment subgroups.ResultsBaseline LVEF was inversely and linearly associated with primary outcome, mortality and its components (sudden and cardiovascular death), and HF hospitalization, but not myocardial infarction. A relationship with stroke was only observed for LVEF of

Published
2016

29. Effects of Quercetin on Blood Pressure: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Author

Serban, Maria‐Corina, Sahebkar, Amirhossein, Zanchetti, Alberto, Mikhailidis, Dimitri P, Howard, George, Antal, Diana, Andrica, Florina, Ahmed, Ali, Aronow, Wilbert S, Muntner, Paul, Lip, Gregory YH, Graham, Ian, Wong, Nathan, Rysz, Jacek, Banach, Maciej, and Group, for the Lipid and Blood Pressure Meta‐analysis Collaboration

Subjects
Prevention, Nutrition, Complementary and Integrative Health, Cardiovascular, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antioxidants, Blood Pressure, Humans, Quercetin, Randomized Controlled Trials as Topic, blood pressure, flavonoids, high blood pressure, hypertension, lipids, meta-analysis, nutrition, quercetin, Lipid and Blood Pressure Meta‐analysis Collaboration (LBPMC) Group, meta‐analysis, Cardiorespiratory Medicine and Haematology
Abstract

Quercetin, the most abundant dietary flavonol, has antioxidant effects in cardiovascular disease, but the evidence regarding its effects on blood pressure (BP) has not been conclusive. We assessed the impact of quercetin on BP through a systematic review and meta-analysis of available randomized controlled trials. We searched PUBMED, Cochrane Library, Scopus, and EMBASE up to January 31, 2015 to identify placebo-controlled randomized controlled trials investigating the effect of quercetin on BP. Meta-analysis was performed using either a fixed-effects or random-effect model according to I(2) statistic. Effect size was expressed as weighted mean difference (WMD) and 95% CI. Overall, the impact of quercetin on BP was reported in 7 trials comprising 9 treatment arms (587 patients). The results of the meta-analysis showed significant reductions both in systolic BP (WMD: -3.04 mm Hg, 95% CI: -5.75, -0.33, P=0.028) and diastolic BP (WMD: -2.63 mm Hg, 95% CI: -3.26, -2.01, P500 mg/day. Further studies are necessary to investigate the clinical relevance of these results and the possibility of quercetin application as an add-on to antihypertensive therapy.

Published
2016

31. Bleeding Risk and Antithrombotic Strategy in Patients With Sinus Rhythm and Heart Failure With Reduced Ejection Fraction Treated With Warfarin or Aspirin

Author

Ye, Siqin, Cheng, Bin, Lip, Gregory YH, Buchsbaum, Richard, Sacco, Ralph L, Levin, Bruce, Di Tullio, Marco R, Qian, Min, Mann, Douglas L, Pullicino, Patrick M, Freudenberger, Ronald S, Teerlink, John R, Mohr, JP, Graham, Susan, Labovitz, Arthur J, Estol, Conrado J, Lok, Dirk J, Ponikowski, Piotr, Anker, Stefan D, Thompson, John LP, Homma, Shunichi, and Investigators, WARCEF

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Hematology, Clinical Research, Heart Disease, Cardiovascular, Stroke, Prevention, Brain Disorders, Aged, Anticoagulants, Aspirin, Female, Heart Failure, Hemorrhage, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Proportional Hazards Models, Risk Assessment, Stroke Volume, Ventricular Dysfunction, Left, Warfarin, WARCEF Investigators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

We sought to assess the performance of existing bleeding risk scores, such as the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HAS-BLED) score or the Outpatient Bleeding Risk Index (OBRI), in patients with heart failure with reduced ejection fraction (HFrEF) in sinus rhythm (SR) treated with warfarin or aspirin. We calculated HAS-BLED and OBRI risk scores for 2,305 patients with HFrEF in SR enrolled in the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial. Proportional hazards models were used to test whether each score predicted major bleeding, and comparison of different risk scores was performed using Harell C-statistic and net reclassification improvement index. For the warfarin arm, both scores predicted bleeding risk, with OBRI having significantly greater C-statistic (0.72 vs 0.61; p = 0.03) compared to HAS-BLED, although the net reclassification improvement for comparing OBRI to HAS-BLED was not significant (0.32, 95% confidence interval [CI] -0.18 to 0.37). Performance of the OBRI and HAS-BLED risk scores was similar for the aspirin arm. For participants with OBRI scores of 0 to 1, warfarin compared with aspirin reduced ischemic stroke (hazard ratio [HR] 0.51, 95% CI 0.26 to 0.98, p = 0.042) without significantly increasing major bleeding (HR 1.24, 95% CI 0.66 to 2.30, p = 0.51). For those with OBRI score of ≥2, there was a trend for reduced ischemic stroke with warfarin compared to aspirin (HR 0.56, 95% CI 0.27 to 1.15, p = 0.12), but major bleeding was increased (HR 4.04, 95% CI 1.99 to 8.22, p

Published
2015

32. Quality of Anticoagulation Control in Preventing Adverse Events in Patients With Heart Failure in Sinus Rhythm

Author

Homma, Shunichi, Thompson, John LP, Qian, Min, Ye, Siqin, Di Tullio, Marco R, Lip, Gregory YH, Mann, Douglas L, Sacco, Ralph L, Levin, Bruce, Pullicino, Patrick M, Freudenberger, Ronald S, Teerlink, John R, Graham, Susan, Mohr, JP, Labovitz, Arthur J, Buchsbaum, Richard, Estol, Conrado J, Lok, Dirk J, Ponikowski, Piotr, and Anker, Stefan D

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Research, Heart Disease, Clinical Trials and Supportive Activities, Hematology, Cardiovascular, Stroke, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Anticoagulants, Aspirin, Brain Ischemia, Cerebral Hemorrhage, Chi-Square Distribution, Double-Blind Method, Drug Monitoring, Female, Heart Failure, Heart Rate, Humans, Male, Middle Aged, Multivariate Analysis, Platelet Aggregation Inhibitors, Predictive Value of Tests, Proportional Hazards Models, Risk Factors, Stroke Volume, Time Factors, Treatment Outcome, Ventricular Function, Left, Warfarin, anticoagulant, heart failure, hemorrhage, stroke, WARCEF Investigators, Biochemistry and Cell Biology, Cardiorespiratory Medicine and Haematology, Medical Physiology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Medical physiology
Abstract

BackgroundThe aim of this study is to examine the relationship between time in the therapeutic range (TTR) and clinical outcomes in heart failure patients in sinus rhythm treated with warfarin.Methods and resultsWe used data from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial to assess the relationship of TTR with the WARCEF primary outcome (ischemic stroke, intracerebral hemorrhage, or death), with death alone, ischemic stroke alone, major hemorrhage alone, and net clinical benefit (primary outcome and major hemorrhage combined). Multivariable Cox models were used to examine how the event risk changed with TTR and to compare the high TTR, low TTR, and aspirin-treated patients, with TTR being treated as a time-dependent covariate. A total of 2217 patients were included in the analyses; among whom 1067 were randomized to warfarin and 1150 were randomized to aspirin. The median (interquartile range) follow-up duration was 3.6 (2.0-5.0) years. Mean (±SD) age was 61±11.3 years, with 80% being men. The mean (±SD) TTR was 57% (±28.5%). Increasing TTR was significantly associated with reduction in primary outcome (adjusted P

Published
2015

33. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial

Author

Schwartz, Gregory G., Steg, Ph. Gabriel, Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Szarek, Michael, White, Harvey D., Zeiher, Andreas M., Tricoci, Pierluigi, Roe, Matthew T., Mahaffey, Kenneth W., Edelberg, Jay M., Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Pordy, Robert, Sasiela, William J., Tamby, Jean-François, Aylward, Philip E., Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Lopes, Renato D., Gotcheva, Nina N., Prieto, Juan-Carlos, Yong, Huo, López-Jaramillo, Patricio, Pećin, Ivan, Reiner, Zeljko, Ostadal, Petr, Viigimaa, Margus, Nieminen, Markku S., Chumburidze, Vakhtang, Marx, Nikolaus, Danchin, Nicolas, Liberopoulos, Evangelos, Montenegro Valdovinos, Pablo Carlos, Tse, Hung-Fat, Kiss, Robert Gabor, Xavier, Denis, Zahger, Doron, Valgimigli, Marco, Kimura, Takeshi, Kim, Hyo Soo, Kim, Sang-Hyun, Erglis, Andrejs, Laucevicius, Aleksandras, Kedev, Sasko, Yusoff, Khalid, Ramos López, Gabriel Arturo, Alings, Marco, Halvorsen, Sigrun, Correa Flores, Roger M., Budaj, Andrzej, Morais, Joao, Dorobantu, Maria, Karpov, Yuri, Ristic, Arsen D., Chua, Terrance, Murin, Jan, Fras, Zlatko, Dalby, Anthony J., Tuñón, José, de Silva, H. 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William, Jr, Friedman, Keith, Lindsey, Jason, Nowins, Rosemary, Timothy, Eichenlaub, Leonard, Parilak, Lepor, Norman, El Shahawy, Mahfouz, Weintraub, Howard, Irimpen, Anand, Alonso, Alvaro, May, Wade, Christopher, Daniels, Galski, Thomas, Chu, Alan, Mody, Freny, Ramin, Ebrahimi, Hodes, Zachary, Rossi, Joseph, Rose, Gregory, Fairlamb, James, Lambert, Charles, Jr, Raisinghani, Ajit, Abbate, Antonio, Vetrovec, George, King, Marilyn, Carey, Charles, Gerber, Jaime, Younis, Liwa, Park, Hyeun (Tom), Vidovich, Mladen, Knutson, Thomas, Friedman, Dennis, Chaleff, Fred, Loussararian, Arthur, Rozeman, Phillip, Kimmelstiel, Carey, Kuvin, Jeffrey, Silver, Kevin, Foster, Malcolm, Tonnessen, Glen, Espinoza, Andrey, Amlani, Mohamadali, Wali, Andreas, Malozzi, Christopher, Jong, Geert T, Massey, Clara, Wattanakit, Keattiyoat, O'Donnell, Philip J., Singal, Dinesh, Jaffrani, Naseem, Banuru, Sridhar, Fisher, Daniel, Xenakis, Mark, Perlmutter, Neal, Bhagwat, Ravi, Strader, James, Jr, Blonder, Ronald, 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John, Claxton, Edmund, Jr, Weiss, Robert, Kathryn, Rohr, Berk, Martin, Rossi, Peter, Joshi, Parag, Khera, Amit, Khaira, Ajit S, Kumkumian, Greg, Lupovitch, Steven, Purow, Joshua, Welka, Stephen, Hoffman, David, Fischer, Stuart, Soroka, Eugene, Eagerton, Donald, Pancholy, Samir, Ray, Michael, Erenrich, Norman, Farrar, Michael, Pollock, Stewart, French, William J, Diamantis, Steve, Guy, Douglas, Gimple, Lawrence, Neustel, Mark, Schwartz, Steven, Pereira, Edward, Albert, Seals, Spriggs, Douglas, Strain, Janet, Mittal, Suneet, Vo, Anthony, Chane, Majed, Hall, Jason, Vijay, Nampalli, Lotun, Kapildeo, Lester, F. Martin, Nahhas, Ahed, Pope, Theodore, Nager, Paul, Vohra, Rakesh, Sharma, Mukesh, Bashir, Riyaz, Ahmed, Hinan, Berlowitz, Michael, Fishberg, Robert, Barrucco, Robert, Yang, Eric, Radin, Michael, Sporn, Daniel, Stapleton, Dwight, Eisenberg, Steven, Landzberg, Joel, Mcgough, Martin, Turk, Samir, Schwartz, Michael, Sundram, P. 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Published
2019
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46. Conclusions

Author

Shantsila, Eduard, Lip, Gregory YH, Shantsila, Eduard, and Lip, Gregory YH

Published
2016
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49. Recurrent Stroke in the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial

Author

Pullicino, Patrick M, Qian, Min, Sacco, Ralph L, Freudenberger, Ron, Graham, Susan, Teerlink, John R, Mann, Douglas, Di Tullio, Marco R, Ponikowski, Piotr, Lok, Dirk J, Anker, Stefan D, Lip, Gregory YH, Estol, Conrado J, Levin, Bruce, Mohr, Jay P, Thompson, John LP, and Homma, Shunichi

Subjects
Stroke, Heart Disease, Cardiovascular, Clinical Research, Brain Disorders, Aged, Anticoagulants, Aspirin, Female, Fibrinolytic Agents, Heart Failure, Humans, Male, Middle Aged, Recurrence, Stroke Volume, Warfarin, Heart failure, Ejection fraction, WARCEF Investigators, Clinical Sciences, Neurosciences, Neurology & Neurosurgery
Abstract

Background and purposeWARCEF randomized 2,305 patients in sinus rhythm with ejection fraction (EF) ≤ 35% to warfarin (INR 2.0-3.5) or aspirin 325 mg. Warfarin reduced the incident ischemic stroke (IIS) hazard rate by 48% over aspirin in a secondary analysis. The IIS rate in heart failure (HF) is too low to warrant routine anticoagulation but epidemiologic studies show that prior stroke increases the stroke risk in HF. In this study, we explore IIS rates in WARCEF patients with and without baseline stroke to look for risk factors for IIS and determine if a subgroup with an IIS rate high enough to give a clinically relevant stroke risk reduction can be identified.MethodsWe compared potential stroke risk factors between patients with baseline stroke and those without using the exact conditional score test for Poisson variables. We looked for risk factors for IIS, by comparing IIS rates between different risk factors. For EF we tried cut-off points of 10, 15 and 20%. The cut-off point 15% was used as it was the highest EF that was associated with a significant increase in IIS rate. IIS and EF strata were balanced as to warfarin/aspirin assignment by the stratified randomized design. A multiple Poisson regression examined the simultaneous effects of all risk factors on IIS rate. IIS rates per hundred patient years (/100 PY) were calculated in patient groups with significant risk factors. Missing values were assigned the modal value.ResultsTwenty of 248 (8.1%) patients with baseline stroke and 64 of 2,048 (3.1%) without had IIS. IIS rate in patients with baseline stroke (2.37/100 PY) was greater than patients without (0.89/100 PY) (rate ratio 2.68, p < 0.001). Fourteen of 219 (6.4%) patients with ejection fraction (EF)

Published
2014

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