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3. Efficacy and Safety of Non–Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation

Author

Patel, Siddharth M., Braunwald, Eugene, Steffel, Jan, Boriani, Giuseppe, Palazzolo, Michael G., Antman, Elliott M., Bohula, Erin A., Carnicelli, Anthony P., Connolly, Stuart J., Eikelboom, John W., Gencer, Baris, Granger, Christopher B., Morrow, David A., Patel, Manesh R., Wallentin, Lars, Ruff, Christian T., and Giugliano, Robert P.

Published
2024
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4. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

Author

Jones, W Schuyler, Mulder, Hillary, Wruck, Lisa M, Pencina, Michael J, Kripalani, Sunil, Muñoz, Daniel, Crenshaw, David L, Effron, Mark B, Re, Richard N, Gupta, Kamal, Anderson, R David, Pepine, Carl J, Handberg, Eileen M, Manning, Brittney R, Jain, Sandeep K, Girotra, Saket, Riley, Danielle, DeWalt, Darren A, Whittle, Jeff, Goldberg, Ythan H, Roger, Veronique L, Hess, Rachel, Benziger, Catherine P, Farrehi, Peter, Zhou, Li, Ford, Daniel E, Haynes, Kevin, VanWormer, Jeffrey J, Knowlton, Kirk U, Kraschnewski, Jennifer L, Polonsky, Tamar S, Fintel, Dan J, Ahmad, Faraz S, McClay, James C, Campbell, James R, Bell, Douglas S, Fonarow, Gregg C, Bradley, Steven M, Paranjape, Anuradha, Roe, Matthew T, Robertson, Holly R, Curtis, Lesley H, Sharlow, Amber G, Berdan, Lisa G, Hammill, Bradley G, Harris, Debra F, Qualls, Laura G, Marquis-Gravel, Guillaume, Modrow, Madelaine F, Marcus, Gregory M, Carton, Thomas W, Nauman, Elizabeth, Waitman, Lemuel R, Kho, Abel N, Shenkman, Elizabeth A, McTigue, Kathleen M, Kaushal, Rainu, Masoudi, Frederick A, Antman, Elliott M, Davidson, Desiree R, Edgley, Kevin, Merritt, James G, Brown, Linda S, Zemon, Doris N, McCormick, Thomas E, Alikhaani, Jacqueline D, Gregoire, Kenneth C, Rothman, Russell L, Harrington, Robert A, and Hernandez, Adrian F

Subjects
Clinical Trials and Supportive Activities, Heart Disease - Coronary Heart Disease, Cardiovascular, Patient Safety, Comparative Effectiveness Research, Clinical Research, Heart Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Aspirin, Atherosclerosis, Cardiovascular Diseases, Female, Hemorrhage, Hospitalization, Humans, Male, Medication Adherence, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke, ADAPTABLE Team, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.MethodsUsing an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.ResultsA total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).ConclusionsIn this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Published
2021

9. Abstract 14750: Performance of a Polygenic Risk Score for Coronary Artery Disease Across the Spectrum of ASCVD: An Analysis of 60k Patients From 6 TIMI Randomized Trials

Author

Zimerman, Andre, Kamanu, Frederick, Melloni, Giorgio, Roselli, Carolina, Antman, Elliott M, Bhatt, Deepak, Bonaca, Marc P, Cannon, Christopher P, Giugliano, Robert, OʼDonoghue, Michelle, Scirica, Benjamin, Wiviott, Stephen D, Braunwald, Eugene, Ellinor, Patrick T, Sabatine, Marc S, Ruff, Christian, and Marston, Nicholas A

Published
2023
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10. Sodium and Health: Old Myths and a Controversy Based on Denial

Author

Cappuccio, Francesco P., Campbell, Norm R. C., He, Feng J., Jacobson, Michael F., MacGregor, Graham A., Antman, Elliott, Appel, Lawrence J., Arcand, JoAnne, Blanco-Metzler, Adriana, Cook, Nancy R., Guichon, Juliet R., L’Abbè, Mary R., Lackland, Daniel T., Lang, Tim, McLean, Rachael M., Miglinas, Marius, Mitchell, Ian, Sacks, Frank M., Sever, Peter S., Stampfer, Meir, Strazzullo, Pasquale, Sunman, Wayne, Webster, Jacqui, Whelton, Paul K., and Willett, Walter

Published
2022
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16. NIH Centers for Accelerated Innovations Program: principles, practices, successes and challenges

Author

Antman, Elliott M, Di Corleto, Paul E, Freeman, Mason W, Ganz, Tomas, Golan, David E, Kitterman, Roger, Loscalzo, Joseph, Low, Mark, McKenna, Erin, O'Connor, Alan C, Palazzolo, Michael, Parrish, John, Reizes, Ofer, Ross, Robert S, Vaughan, Cheryl, Vince, D Geoffrey, and Watts, Lesley

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Health Sciences, Clinical Research, Diffusion of Innovation, National Cancer Institute (U.S.), Program Development, United States, NIH Centers for Accelerated Innovations, Medical and Health Sciences, Pharmacology & Pharmacy, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Commercializing innovations in academic environments is notoriously challenging. Here, we describe the progress of the NIH Centers for Accelerated Innovations program — initiated in 2013 to address these challenges — which we believe could help set a new standard for the early-stage commercialization of biomedical innovations in academic environments.

Published
2017

17. Abstract 12228: Development of a Novel Polygenic Risk Score to Predict Risk of Aortic Stenosis Events

Author

Small, Aeron M, Melloni, Giorgio, Kamanu, Frederick, Roselli, Carolina, Bergmark, Brian A, Bonaca, Marc P, Odonoghue, Michelle L, Giugliano, Robert, Scirica, Benjamin M, Bhatt, Deepak L, Antman, Elliott M, Raz, Itamar, Peloso, Gina, WILSON, PETER, Odonnell, Christopher J, Natarajan, Pradeep, Braunwald, Eugene, Lubitz, Steven A, Ellinor, Patrick T, Ruff, Christian T, Sabatine, Marc S, and Marston, Nicholas F

Published
2022
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18. Comprehensive characterization of protein–protein interactions perturbed by disease mutations

Author

Cheng, Feixiong, Zhao, Junfei, Wang, Yang, Lu, Weiqiang, Liu, Zehui, Zhou, Yadi, Martin, William R., Wang, Ruisheng, Huang, Jin, Hao, Tong, Yue, Hong, Ma, Jing, Hou, Yuan, Castrillon, Jessica A., Fang, Jiansong, Lathia, Justin D., Keri, Ruth A., Lightstone, Felice C., Antman, Elliott Marshall, Rabadan, Raul, Hill, David E., Eng, Charis, Vidal, Marc, and Loscalzo, Joseph

Published
2021
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19. Application of the Win Ratio Method in the ENGAGE AF-TIMI 48 Trial Comparing Edoxaban With Warfarin in Patients With Atrial Fibrillation.

Author

Bergmark, Brian A., Park, Jeong-Gun, Hamershock, Rose A., Melloni, Giorgio E. M., De Caterina, Raffaele, Antman, Elliott M., Ruff, Christian T., Rutman, Howard, Mercuri, Michele F., Lanz, Hans-Joachim, Braunwald, Eugene, and Giugliano, Robert P.

Abstract

BACKGROUND: Cardiovascular trials often use a composite end point and a time-to-first event model. We sought to compare edoxaban versus warfarin using the win ratio, which offers data complementary to time-to-first event analysis, emphasizing the most severe clinical events. METHODS: ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind, randomized trial in which patients with atrial fibrillation were assigned 1:1:1 to a higher dose edoxaban regimen (60/30 mg daily), a lower dose edoxaban regimen (30/15 mg daily), or warfarin. In an exploratory analysis, we analyzed the trial outcomes using an unmatched win ratio approach. The win ratio for each edoxaban regimen was the total number of edoxaban wins divided by the number of warfarin wins for the following ranked clinical outcomes: 1: death; 2: hemorrhagic stroke; 3: ischemic stroke/systemic embolic event/epidural or subdural bleeding; 4: noncerebral International Society on Thrombosis and Haemostasis major bleeding; and 5: cardiovascular hospitalization. RESULTS: 21 105 patients were randomized to higher dose edoxaban regimen (N=7035), lower dose edoxaban regimen (N=7034), or warfarin (N=7046), yielding >49 million pairs for each treatment comparison. The median age was 72 years, 38% were women, and 59% had prior vitamin K antagonist use. The win ratio was 1.11 (95% CI, 1.05-1.18) for higher dose edoxaban regimen versus warfarin and 1.11 (95% CI, 1.05-1.18) for lower dose edoxaban regimen versus warfarin. The favorable impacts of edoxaban on death (34% of wins) and cardiovascular hospitalization (41% of wins) were the major contributors to the win ratio. Results consistently favored edoxaban in subgroups based on creatine clearance and dose reduction at baseline, with heightened benefit among those without prior vitamin K antagonist use. CONCLUSIONS: In a win ratio analysis of the ENGAGE AF-TIMI 48 trial, both dose regimens of edoxaban were superior to warfarin for the net clinical outcome incorporating ischemic and bleeding events. As the win ratio emphasizes the most severe clinical events, this analysis supports the superiority of edoxaban over warfarin in patients with atrial fibrillation. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Novel Polygenic Risk Score and Established Clinical Risk Factors for Risk Estimation of Aortic Stenosis

Author

Small, Aeron M., primary, Melloni, Giorgio E. M., additional, Kamanu, Frederick K., additional, Bergmark, Brian A., additional, Bonaca, Marc P., additional, O’Donoghue, Michelle L., additional, Giugliano, Robert P., additional, Scirica, Benjamin M., additional, Bhatt, Deepak, additional, Antman, Elliott M., additional, Raz, Itamar, additional, Wiviott, Stephen D., additional, Truong, Buu, additional, Wilson, Peter W. F., additional, Cho, Kelly, additional, O’Donnell, Christopher J., additional, Braunwald, Eugene, additional, Lubitz, Steve A., additional, Ellinor, Patrick, additional, Peloso, Gina M., additional, Ruff, Christian T., additional, Sabatine, Marc S., additional, Natarajan, Pradeep, additional, and Marston, Nicholas A., additional

Published
2024
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28. Clinical Application of a Novel Genetic Risk Score for Ischemic Stroke in Patients With Cardiometabolic Disease

Author

Marston, Nicholas A., Patel, Parth N., Kamanu, Frederick K., Nordio, Francesco, Melloni, Giorgio M., Roselli, Carolina, Gurmu, Yared, Weng, Lu-Chen, Bonaca, Marc P., Giugliano, Robert P., Scirica, Benjamin M., O’Donoghue, Michelle L., Cannon, Christopher P., Anderson, Christopher D., Bhatt, Deepak L., Gabriel Steg, Philippe, Cohen, Marc, Storey, Robert F., Sever, Peter, Keech, Anthony C., Raz, Itamar, Mosenzon, Ofri, Antman, Elliott M., Braunwald, Eugene, Ellinor, Patrick T., Lubitz, Steven A., Sabatine, Marc S., and Ruff, Christian T.

Published
2021
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31. AP-453071-2 SYNCHRONOUS AND ASYNCHRONOUS ATRIAL FIBRILLATION EDUCATION DIRECTED BY ALLIED PROFESSIONALS FOR IMPROVED PATIENT CARE

Author

Shea, Julie B., primary, Tedrow, Usha B., additional, Zei, Paul C., additional, Tadros, Thomas M., additional, Antman, Elliott, additional, Piazza, Gregory, additional, Fanikos, John, additional, Kapur, Sunil, additional, Romero, Jorge, additional, Steiger, Nathaniel, additional, Antonellis, Megan, additional, Rousseau, Lauren A., additional, Blake, Jayne S., additional, Sauer, William H., additional, and Koplan, Bruce A., additional

Published
2023
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43. Privacy-aware multi-institutional time-to-event studies

Author

Späth, Julian, primary, Matschinske, Julian, additional, Kamanu, Frederick K., additional, Murphy, Sabina A., additional, Zolotareva, Olga, additional, Bakhtiari, Mohammad, additional, Antman, Elliott M., additional, Loscalzo, Joseph, additional, Brauneck, Alissa, additional, Schmalhorst, Louisa, additional, Buchholtz, Gabriele, additional, and Baumbach, Jan, additional

Published
2022
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46. Discharge Aspirin Dose and Clinical Outcomes in Patients With Acute Coronary Syndromes Treated With Prasugrel Versus Clopidogrel: An Analysis From the TRITON–TIMI 38 Study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel–Thrombolysis In Myocardial Infarction 38)

Author

Kohli, Payal, Udell, Jacob A., Murphy, Sabina A., Cannon, Christopher P., Antman, Elliott M., Braunwald, Eugene, and Wiviott, Stephen D.

Published
2014
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49. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS

Author

Valgimigli, Marco, Bueno, Héctor, Byrne, Robert A., Collet, Jean-Philippe, Costa, Francesco, Jeppsson, Anders, Jüni, Peter, Kastrati, Adnan, Kolh, Philippe, Mauri, Laura, Montalescot, Gilles, Neumann, Franz-Josef, Petricevic, Mate, Roffi, Marco, Steg, Philippe Gabriel, Windecker, Stephan, Zamorano, Jose Luis, Levine, Glenn N., Badimon, Lina, Vranckx, Pascal, Agewall, Stefan, Andreotti, Felicita, Antman, Elliott, Barbato, Emanuele, Bassand, Jean-Pierre, Bugiardini, Raffaele, Cikirikcioglu, Mustafa, Cuisset, Thomas, De Bonis, Michele, Delgado, Victora, Fitzsimons, Donna, Gaemperli, Oliver, Galiè, Nazzareno, Gilard, Martine, Hamm, Christian W, Ibanez, Borja, Iung, Bernard, James, Stefan, Knuuti, Juhani, Landmesser, Ulf, Leclercq, Christophe, Lettino, Maddalena, Lip, Gregory, Piepoli, Massimo Francesco, Pierard, Luc, Schwerzmann, Markus, Sechtem, Udo, Simpson, Iain A, Uva, Miguel Sousa, Stabile, Eugenio, Storey, Robert F, Tendera, Michal, Van de Werf, Frans, Verheugt, Freek, and Aboyans, Victor

Published
2018
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