Author + information
- Received June 9, 2015
- Revision received August 25, 2015
- Accepted August 27, 2015
- Published online December 28, 2015.
- Matthew J. Price, MD∗∗ (, )
- Vivek Y. Reddy, MD†,
- Miguel Valderrábano, MD‡,
- Jonathan L. Halperin, MD†,
- Douglas N. Gibson, MD∗,
- Nicole Gordon, BSEE§,
- Kenneth C. Huber, MD‖ and
- David R. Holmes Jr., MD¶
- ∗Scripps Clinic, La Jolla, California
- †Mount Sinai School of Medicine, New York, New York
- ‡Methodist Hospital, Houston, Texas
- §Boston Scientific, Marlborough, Massachusetts
- ‖St. Luke’s Hospital, Kansas City, Missouri
- ¶Mayo Clinic, Rochester, Minnesota
- ↵∗Reprint requests and correspondence:
Dr. Matthew J. Price, 10666 North Torrey Pines Road, Mail Drop S1056, La Jolla, California 92037.
Objectives The purpose of this study was to compare the relative risk of major bleeding with left atrial appendage (LAA) closure compared with long-term warfarin therapy.
Background LAA closure is an alternative approach to chronic oral anticoagulation for the prevention of thromboembolism in patients with atrial fibrillation (AF).
Methods We conducted a pooled, patient-level analysis of the 2 randomized clinical trials that compared WATCHMAN (Boston Scientific, Natick, Massachusetts) LAA closure with long-term warfarin therapy in AF.
Results A total of 1,114 patients were included, with a median follow-up of 3.1 years. The overall rate of major bleeding from randomization to the end of follow-up was similar between treatment groups (3.5 events vs. 3.6 events per 100 patient-years; rate ratio [RR]: 0.96; 95% confidence interval [CI]: 0.66 to 1.40; p = 0.84). LAA closure significantly reduced bleeding >7 days post-randomization (1.8 events vs. 3.6 events per 100 patient-years; RR: 0.49; 95% CI: 0.32 to 0.75; p = 0.001), with the difference emerging 6 months after randomization (1.0 events vs. 3.5 events per 100 patient-years; RR: 0.28; 95% CI: 0.16 to 0.49; p < 0.001), when patients assigned to LAA closure were able to discontinue adjunctive oral anticoagulation and antiplatelet therapy. The reduction in bleeding with LAA closure was directionally consistent across all patient subgroups.
Conclusions There was no difference in the overall rate of major bleeding in patients assigned to LAA closure compared with extended warfarin therapy over 3 years of follow-up. However, LAA closure significantly reduced bleeding beyond the procedural period, particularly once adjunctive pharmacotherapy was discontinued. The favorable effect of LAA closure on long-term bleeding should be considered when selecting a stroke prevention strategy for patients with nonvalvular AF. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL]; NCT01182441)
This study was supported by Boston Scientific. Dr. Price has received consulting and proctoring fees from Boston Scientific, St. Jude, and W.L. Gore & Company. Dr. Reddy has received research grant support and consultant fees from Boston Scientific, St. Jude Medical, and Coherex. Dr. Valderrábano is supported by National Institutes of Health/National Heart, Lung, and Blood Institute R21HL097305 and R01 HL115003; has received consulting and speaking honoraria and research support from Boston Scientific, St. Jude Medical, and Medtronic; has received consulting and proctoring honoraria from SentreHeart; and has served as a consultant for Biosense-Webster. Dr. Halperin has served as a consultant for Boston Scientific, Medtronic, Biotronik, Johnson & Johnson, Boehringer Ingelheim, Daiichi Sankyo, Pfizer, Bayer Healthcare, and Janssen. Dr. Gibson has received speaker and proctoring fees from SentreHeart and Boston Scientific. Ms. Gordon is an employee of Boston Scientific. Dr. Huber has served as a consultant for Boston Scientific. Dr. Holmes has received research grant support from Boston Scientific; and the LAA closure technology has been licensed to Boston Scientific, and both Mayo Clinic and Dr. Holmes have contractual rights to receive future royalties from this license.
- Received June 9, 2015.
- Revision received August 25, 2015.
- Accepted August 27, 2015.
- 2015 American College of Cardiology Foundation