Author + information
- Received December 21, 2018
- Revision received March 6, 2019
- Accepted April 3, 2019
- Published online June 3, 2019.
- Lars Søndergaard, MD, DMSca,∗ (, )
- Yam-Hong Wong, MBBSa,b,
- Vivek Y. Reddy, MDc,
- Lucas V.A. Boersma, MD, PhDd,
- Martin W. Bergmann, MD, PhDe,
- Shephal Doshi, MDf,
- Saibal Kar, MDg,
- Horst Sievert, MDh,
- Scott Wehrenberg, MSi,
- Kenneth Stein, MDi and
- David R. Holmes Jr., MDj
- aRigshospitalet, University of Copenhagen, Copenhagen, Denmark
- bMedicine and Geriatric Department, Tuen Mun Hospital, Hong Kong, China
- cIcahn School of Medicine at Mount Sinai, New York, New York
- dSt. Antonius Hospital, Nieuwegein, the Netherlands
- eCardiologicum Hamburg, Hamburg, Germany
- fProvidence St. John’s Health Center, Santa Monica, California
- gCedars-Sinai Medical Center, Los Angeles, California
- hCardioVascular Center Frankfurt, Frankfurt am Main, Germany
- iBoston Scientific, Minneapolis, Minnesota
- jMayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Lars Søndergaard, Rigshospitalet, Section 2011, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Objectives In this propensity-matched analysis of post–left atrial appendage closure antithrombotic therapy, the safety and effectiveness of oral anticoagulation (OAC) and antiplatelet therapy (APT) were compared.
Background Left atrial appendage closure with the WATCHMAN device is an alternative to OAC in patients with nonvalvular atrial fibrillation, who are at high bleeding risk. Initial trials included 45 days of post-implantation OAC, but registry data suggest that APT may suffice.
Methods Patients from the PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), CAP (Continued Access to PROTECT-AF), CAP2 (Continued Access to PREVAIL), ASAP (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology), and EWOLUTION (Registry on WATCHMAN Outcomes in Real-Life Utilization) trials receiving either OAC or APT post-implantation were matched and compared for nonprocedural bleeding and stroke or systemic thromboembolism over 6 months following implantation. Each patient on APT was matched with 2 patients on OAC, with propensity scores derived from age, sex, congestive heart failure, hypertension, diabetes, prior transient ischemic attack or stroke, peripheral vascular disease, left ventricular ejection fraction, renal impairment, and different atrial fibrillation subtypes.
Results The cohort on OAC (n = 1,018; 95% receiving warfarin and 5% receiving nonwarfarin OAC) was prescribed 45-day OAC post-implantation (92% also received single APT), followed by 6-month single or dual APT. The cohort on APT (n = 509; 91% receiving dual APT and 9% receiving single APT) received APT for variable durations. Six-month freedom from nonprocedural major bleeding was similar (OAC, 95.7%; APT, 95.5%; p = 0.775) despite more early bleeds with OAC. Freedom from thromboembolism beyond 7 days was similar between groups (OAC, 98.8%; APT, 99.4%; p = 0.089). However, device-related thrombosis was more frequent with APT (OAC, 1.4%; APT, 3.1%; p = 0.018).
Conclusions After left atrial appendage closure with the WATCHMAN, although device-related thrombosis was more common with APT, both APT and OAC strategies resulted in similar safety and efficacy endpoints.
- antiplatelet therapy
- antithrombotic therapy
- atrial fibrillation
- direct oral anticoagulation
- left atrial appendage closure
- oral anticoagulation
Dr. Søndergaard has received consulting fees and institutional research grants from Boston Scientific. Dr. Reddy has received consulting fees and research grants from Boston Scientific, Coherex, SentreHEART, and St. Jude Medical; has conflicts with other companies not related to this manuscript; and his wife is employed by Boston Scientific but has no connection with Mount Sinai Hospital and receives no direct financial benefit from any LAAC procedures performed at Mount Sinai. Dr. Boersma has received personal fees from Boston Scientific and Medtronic outside the submitted work. Dr. Bergmann has received personal fees from Boston Scientific, St. Jude Medical, Biosense Webster, and Johnson & Johnson outside the submitted work. Dr. Doshi has received consulting fees and research grants from Boston Scientific, St. Jude Medical, Coherex, and SentreHEART; and is the national principal investigator of CAP2 (Continued Access to PREVAIL). Dr. Kar has received research grants from Boston Scientific, St. Jude Medical, and Abbott Vascular; is a member of the advisory board for LAAC; is the national principal investigator of CAP (Continued Access to PROTECT-AF) and CAP2; and has served as a proctor for Boston Scientific. Dr. Kar also has received honorarium from Abbott Vascular, Boston Scientific, Medtronic, and W.L. Gore. Dr. Seivert has received personal fees from Abbott, Aptus, Atrium, Biosense Webster, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Comed, Contego, Covidien, CSI, CVRx, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Guided Delivery Systems, Hemoteq, InSeal Medical, InspireMD, Kona Medical, Lumen Biomedical, Lifetech, Lutonix, Maya Medical, Medtronic, Occlutech, pfm Medical, Recor, Trireme, Trivascular, Valtech, Vascular Dynamics, Venus Medical, Veryan, and Vessix outside the submitted work; and holds stock options in Cardiokinetix, Access Closure, Coherex, and SMT outside the submitted work. Mr. Wehrenberg is an employee and a shareholder at Boston Scientific. Dr. Stein is an employee and a shareholder at Boston Scientific. Dr. Holmes, Jr. and the Mayo Clinic have financial interests in technology related to this research. That technology has been licensed to Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 21, 2018.
- Revision received March 6, 2019.
- Accepted April 3, 2019.
- 2019 American College of Cardiology Foundation
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