enrollment have been excluded from previous large clinical studies, 4,5 so in many cases, the complete U.S. Food and Drug Administration (FDA)-approved postprocedural treatment protocols studied in pivotal trials of WATCHMAN are rarely adhered to and are adjusted for individual patients. 6 Findings from a large cohort study and metaanalysis on the safety and efficacy of postprocedural antithrombotic therapy at discharge are available, but few reports of long-term outcomes have been published. 7,8 The safety and efficacy of various antithrombotic regimens have been reported in small trials in other Western countries but these may result in an overdose in smaller-stature Japanese patients especially. 9 LAAC may become more widely used in Japan, and there is, therefore, a need for appropriate antithrombotic therapy for the Japanese population. 10 The aim of the present study was to discuss the safety and efficacy of reduced-dose postoperative antithrombotic therapy, especially in patients with HBR.
Cardioembolic stroke is the most common adverse event in patients with atrial fibrillation (AF). Oral anticoagulants (OAC) are the gold standard for preventing stroke and systemic embolism, but some patients have contraindications to OAC therapy due to a high bleeding risk (HBR). In September 2019, the WATCHMAN TM left atrial appendage closure (LAAC) device (Boston Scientific, St. Paul, MN, USA) was commercially introduced in Japan as an alternative to anticoagulation therapy. In Japan, LAAC is approved for patients with nonvalvular AF (NVAF), long-term OAC use, and HBR (HAS-BLED score ≥3, a history of Bleeding Academic Research Consortium [BARC] type 3 bleeding, requiring dual antiplatelet therapy [DAPT] for ≥1 year, multiple episodes of falls requiring interventions, or a history of cerebral amyloid angiopathy). 1-3 However, anticoagulation therapy is required after the procedure to prevent device-related thrombosis (DRT), and the use of antithrombotic drugs after WATCHMAN implantation in patients with HBR is controversial. Patients with previous stroke/transient ischemic attack within 90 days of
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