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. 2023 Nov 27;16(22):2708-2718.
doi: 10.1016/j.jcin.2023.08.013. Epub 2023 Nov 8.

DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis

Megan Coylewright  1 , David R Holmes Jr  2 , Samir R Kapadia  3 , Jonathan C Hsu  4 , Douglas N Gibson  5 , James V Freeman  6 , Robert W Yeh  7 , Jonathan P Piccini  8 , Matthew J Price  5 , Dominic J Allocco  9 , Devi G Nair  10
Affiliations

DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis

Megan Coylewright et al. JACC Cardiovasc Interv. .

Abstract

Background: Left atrial appendage occlusion (LAAO) is an approved alternative for stroke prevention in atrial fibrillation for patients with an "appropriate rationale" to avoid long-term oral anticoagulation (OAC). Many patients undergoing LAAO are at high risk of bleeding.

Objectives: This study sought to investigate whether dual antiplatelet therapy (DAPT) is a safe alternative to OAC (direct oral anticoagulation [DOAC] or warfarin) with aspirin after LAAO.

Methods: Using National Cardiovascular Data Registry LAAO registry data, patients undergoing Watchman FLX (Boston Scientific) implantation (August 5, 2020-September 30, 2021) were included in 1:1 propensity-matched analyses comparing discharge medication regimens (DAPT, DOAC/aspirin, or warfarin/aspirin). A composite endpoint (death, stroke, major bleeding, and systemic embolism), its components, and device-related thrombus between discharge and 45 days were evaluated.

Results: In 49,968 patients implanted with the Watchman FLX during the study period, the mean age was 77 years, and 40% were women. Postimplant DOAC/aspirin was prescribed in 24,497 patients, warfarin/aspirin in 3,913, and DAPT in 4,155. DAPT patients had more comorbid conditions than patients receiving OAC/aspirin. After propensity score matching, the 45-day composite endpoint rates were similar among the groups (DAPT = 3.44% vs DOAC/aspirin: 4.06%; P = 0.13 and DAPT = 3.23% vs warfarin/aspirin: 3.08%; P = 0.75). Death, stroke, and device-related thrombus were also similar; major bleeding was slightly increased in DOAC/aspirin patients (DAPT = 2.48% vs DOAC/aspirin = 3.25%; P = 0.04 and DAPT = 2.25% vs warfarin/aspirin = 2.22%; P = 0.93).

Conclusions: In a large registry, DAPT had a similar safety profile compared with current Food and Drug Administration-approved postimplant drug regimens of OAC with aspirin following LAAO with the Watchman FLX. Shared decision making for nonpharmacologic stroke prevention should include a discussion of postprocedure medical therapy options.

Keywords: anticoagulation; antiplatelet; bleeding; left atrial appendage occlusion; stroke.

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Conflict of interest statement

Funding Support and Author Disclosures This analysis was supported by Boston Scientific Corporation. The views expressed here represent those of the authors and do not necessarily represent the official views of the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Coylewrite has received honoraria from Edwards LifeSciences, Medtronic, Boston Scientific, and Occlutech. Dr Hsu has received honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol Myers Squibb, Pfizer, Sanofi, Zoll Medical, iRhythm, Acutus Medical, Galvanize Therapeutics, and Biosense Webster; has received research grants from Biotronik and Biosense Webster; and has equity interest in Vektor Medical. Dr Freeman has received research funding from the National Institutes of Health/National Heart, Lung, and Blood Institute and the American College of Cardiology National Cardiovascular Data Registry; has received consulting/advisory board fees from Medtronic, Boston Scientific, Biosense Webster, and PaceMate; and has equity in PaceMate. Dr Yeh has received research funding and consulting fees from Abbott Vascular, Boston Scientific, and Medtronic; and has received research funding from Bard, Cook, and Philips. Dr Piccini is supported by R01AG074185 from the National Institutes of Aging; has received grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips; and serves as a consultant to Abbott, Abbvie, ARCA biopharma, Bayer, Boston Scientific, Bristol Myers Squibb (Myokardia), Element Science, Itamar Medical, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, ReCor, Sanofi, Philips, and Up-to-Date. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria from W.L. Gore, Baylis Medical, Biotronik, and Philips; has received consulting honoraria and speaker fees from Medtronic; has received consulting honoraria from Biosense Webster and Shockwave; and has equity in Indian Wells, Inc. Dr Allocco is a full-time employee and stockholder of Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.. Study flow diagram
Abbreviations: DAPT = dual antiplatelet therapy, DOAC = direct oral anticoagulant
Central illustration.
Central illustration.. Study overview and findings.
Propensity-matched (1:1) outcomes at 45 days post-implant in patients discharged on DAPT (blue) vs DOAC/aspirin (green) and warfarin/aspirin (orange) treated with WATCHMAN FLX. Abbreviations: DAPT = dual antiplatelet therapy, DOAC = direct oral anticoagulant
See this image and copyright information in PMC

Comment in

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