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Randomized Controlled Trial
. 2023 Oct:264:123-132.
doi: 10.1016/j.ahj.2023.05.022. Epub 2023 Jun 4.

Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation

Saibal Kar  1 , Shephal K Doshi  2 , Mohamad Alkhouli  3 , A John Camm  4 , Megan Coylewright  5 , Michael C Gibson  6 , Christopher B Granger  7 , Mahmut E Gurol  8 , Kenneth Huber  9 , Moussa Mansour  10 , Devi G Nair  11 , Andrea Natale  12 , Stuart J Pocock  13 , Vivek R Reddy  14 , Walid Saliba  15 , Thomas Christen  16 , Dominic J Allocco  16 , Kenneth A Ellenbogen  17 , Martin B Leon  18
Affiliations
Free article
Randomized Controlled Trial

Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation

Saibal Kar et al. Am Heart J. 2023 Oct.
Free article

Abstract

Background: Percutaneous left atrial appendage (LAA) closure (LAAC) was developed as a nonpharmacologic alternative to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) who are at an increased risk for stroke or systemic embolism. The Watchman device permanently seals off the LAA to prevent thrombi from escaping into the circulation. Previous randomized trials have established the safety and efficacy of LAAC compared to warfarin. However, direct OACs (DOACs) have become the preferred pharmacologic strategy for stroke prevention in patients with AF, and there is limited data comparing Watchman FLX to DOACs in a broad AF patient population. CHAMPION-AF is designed to prospectively determine whether LAAC with Watchman FLX is a reasonable first-line alternative to DOACs in patients with AF who are indicated for OAC therapy.

Study design: A total of 3,000 patients with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women) were randomized to Watchman FLX or DOAC in a 1:1 allocation at 142 global clinical sites. Patients in the device arm were to be treated with DOAC and aspirin, DOAC alone, or DAPT for at least 3 months postimplant followed by aspirin or P2Y12 inhibitor for 1-year. Control patients were required to take an approved DOAC for the duration of the trial. Clinical follow-up visits are scheduled at 3- and 12-months, and then annually through 5 years; LAA imaging is required at 4 months in the device group. Two primary end points will be evaluated at 3 years: (1) composite of stroke (ischemic/hemorrhagic), cardiovascular death, and systemic embolism compared for noninferiority, and (2) nonprocedural bleeding (International Society on Thrombosis and Haemostasis [ISTH] major and clinically relevant nonmajor bleeding) tested for superiority in the device arm against DOACs. The third primary noninferiority end point is the composite of ischemic stroke and systemic embolism at 5 years. Secondary end points include 3- and 5-year rates of (1) ISTH-defined major bleeding and (2) the composite of cardiovascular death, all stroke, systemic embolism, and nonprocedural ISTH bleeding.

Conclusions: This study will prospectively evaluate whether LAAC with the Watchman FLX device is a reasonable alternative to DOACs in patients with AF.

Clinical trial registration: NCT04394546.

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Conflict of interest statement

Disclosures Dr Kar is a consultant to BSC, Abbott Vascular, Medtronic, LAMINAR, V-wave, Intershunt Highlife, co-principal investigator of the CHAMPION AF and REPAIR-MR studies and a steering committee member for the Triluminate and RELIEVE HF trials. Dr Doshi serves as a consultant to BSC, Biosense Webster, Abbott Vascular, Conformal and is co-principal investigator of the CHAMPION AF study. Dr Alkhouli is on the advisory board for BSC and received institutional research grant from BSC. Dr Camm received personal fees from Anthos, Menarini, Bayer, Daiichi Sankyo, Pfizer, Abbott and BSC. Dr Coylewright received research funding from BSC and Edwards Life Sciences and is a consultant for BSC, Edwards Life Sciences, Occlutech and Medtronic. Dr Gibson received research grant support payable to his institution and consulting fees from J&J, BMS, Diachi Sankyo, CeleCor and Merck. Dr Granger receives consulting fees from Abbvie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer Corporation, Boehringer Ingelheim, BSC, Bristol Myers Squibb, Cardionomics, CeleCor Therapeutics, Janssen Pharmaceutical, Medscape, LLC, Medtronic, Inc., Merck, Nation Institutes of Health, Novo Nordisk, Novartis Pharmaceutical Company, PLX Pharma, Pfizer, Philips, REATA and NephroSynergy. He has an equity in Tenac.io. and salary funded by Duke grants sponsored by Boehinger Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, FDA, Janssen Pharmaceuticals, Novartis Pharmaceutical Company, Pfizer, and Philips. Dr Gurol received research funding from NIH and the hospital he is affiliated to received research funding from AVID, Pfizer and BSC. Dr Huber is on the Watchman Advisory Board. Dr Mansour is a consultant: for BSC. Dr Nair is an advisory board member and consultant for, and received research grant support from Biosense Webster, BSC, Abbott and Medtronic. Dr Natale is a consultant for Abbott, Baylis, Biosense Webster, BSC, Biotronik and Medtronic. Dr Pocock is a consultant for BSC. Dr Reddy serves as a consultant to, and has received grant support from, BSC. He reports additional disclosures unrelated to this manuscript: Consultant for and has equity in Ablacon, Acutus Medical, Affera, Medtronic, Apama Medical, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD, Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; Consultant for AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; Equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Saliba is on the advisory board for BSC. Dr Christen and Allocco are full-time employees with an equity interest in BSC. Dr Ellenbogen received research support/lecture fees/honorarium and is a consultant for BSC. Dr Leon received clinical research grants to Columbia University from Abiomed-J&J, Abbott, BSC, Edwards and Medtronic.

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