Abstract | BACKGROUND: DESIGN: COMBINE AF incorporates de-identified individual patient data from 77,282 patients with atrial fibrillation at risk for stroke randomized to NOAC, warfarin, or aspirin from 5 pivotal randomized controlled trials. All patients randomized in the constituent trials are included. Variables common to ≥3 of the constituent trials are included in the master database. Individual trial data sets from the 4 coordinating centers were combined at the Duke Clinical Research Institute. The final database will be securely shared with the 4 academic coordinating centers. The combined master database will be used to perform statistical analyses aimed at better understanding underlying risk factors and outcomes in patients with atrial fibrillation treated with oral anticoagulants, with a special focus on patient subgroups and uncommon outcomes. The initial analysis from COMBINE AF will be a network meta-analysis investigating the relative efficacy and safety of pooled higher-dose NOACs versus pooled lower-dose NOACs versus warfarin with respect to multiple time-to-event efficacy and safety outcomes. COMBINE AF is registered with PROSPERO (CRD42020178771). CONCLUSION: In conclusion, COMBINE AF provides a rich and robust database consisting of individual patient data and will offer opportunities to investigate oral anticoagulants across many patient subgroups. Data sharing and collaboration across academic institutions and investigators will serve as overarching themes.
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Authors | Anthony P Carnicelli, Hwanhee Hong, Robert P Giugliano, Stuart J Connolly, John Eikelboom, Manesh R Patel, Lars Wallentin, David A Morrow, Daniel Wojdyla, Kaiyuan Hua, Stefan H Hohnloser, Jonas Oldgren, Christian T Ruff, Jonathan P Piccini, Renato D Lopes, John H Alexander, Christopher B Granger, COMBINE AF Investigators |
Journal | American heart journal
(Am Heart J)
Vol. 233
Pg. 48-58
(03 2021)
ISSN: 1097-6744 [Electronic] United States |
PMID | 33296688
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 Elsevier Inc. All rights reserved. |
Chemical References |
- Anticoagulants
- Warfarin
- Aspirin
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Topics |
- Academic Medical Centers
- Aged
- Anticoagulants
(therapeutic use)
- Aspirin
(therapeutic use)
- Atrial Fibrillation
(complications)
- Computer Security
- Databases, Factual
- Embolism
(prevention & control)
- Female
- Humans
- Information Dissemination
- Male
- Multicenter Studies as Topic
(statistics & numerical data)
- Network Meta-Analysis
- Randomized Controlled Trials as Topic
(statistics & numerical data)
- Stroke
(prevention & control)
- Warfarin
(therapeutic use)
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