Key result
Post-LAAC SAPT yields protocol modification rates similar to low-dose DOAC with no observed strokes.
Why the study?
The standard postprocedural regimen after LAAC for NVAF involves oral anticoagulation plus an antiplatelet agent followed by dual antiplatelet therapy, but modification is frequently required in clinical practice due to bleeding concerns. The safety and efficacy of monotherapy strategies and their protocol modification rates needed evaluation.
Does post-LAAC monotherapy with either single antiplatelet therapy or low-dose DOAC result in low rates of antithrombotic protocol modification within 6 months in high-risk Japanese patients with non-valvular atrial fibrillation?
Does post-LAAC monotherapy with either single antiplatelet therapy or low-dose DOAC result in low rates of antithrombotic protocol modification within 6 months in high-risk Japanese patients with non-valvular atrial fibrillation?
Both single antiplatelet therapy and low-dose DOAC monotherapy strategies appear safe and effective during the first 6 months after WATCHMAN FLX Pro left atrial appendage closure, with low rates of protocol modification (6.7% and 4.3%) and no strokes or systemic embolisms.
Monotherapy post-LAAC shows low modification rates without strokes; leaves open confirmation in randomized trials before practice change.
Background Percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) is approved in Japan. The standard postprocedural regimen consists of oral anticoagulation plus an antiplatelet agent for the first 45 days, followed by dual antiplatelet therapy up to 6 months. However, in real-world clinical practice, modification of antithrombotic therapy is frequently required due to bleeding concerns. Aim To evaluate the safety and efficacy of two monotherapy strategies after LAAC in Japanese patients with NVAF, with a particular focus on modification of the antithrombotic protocol during follow-up. Methods The Safety and Efficacy of Two Monotherapies after LAAC in Patients with NVAF (SAPT-LAA) study is a prospective, investigator-initiated, multicenter, interventional, non-randomized study. We planned to enroll NVAF patients eligible for WATCHMAN FLX Pro implantation according to the Japanese Circulation Society guidelines. After device implantation, patients received either single antiplatelet therapy (SAPT) or low-dose direct oral anticoagulant (DOAC) for 3 months, followed by SAPT alone for an additional 3 months. For this analysis, the primary endpoint was modification of the antithrombotic protocol within 6 months after LAAC. Device-related thrombus (DRT) was assessed using cardiac computed tomography or transesophageal echocardiography at 45 days and 6 months. Results A total of 106 patients were enrolled (SAPT group: 60; DOAC group: 46). The mean age was 76.1 ± 5.5 years, and 38 (36%) were women. Non-paroxysmal AF was present in 57 (54%) patients. The mean CHA2DS2-VASc score was 4.7 ± 1.3, and the mean HAS-BLED score was 3.0 ± 0.3, indicating a cohort with high thromboembolic and bleeding risks. No procedural major complications occurred. One patient in the DOAC group and one patient in the SAPT group died of heart failure, both considered unrelated to the procedure. Excluding these two patients, 6-month follow-up was completed in all remaining patients. In the SAPT group, antithrombotic protocol modification occurred in four patients (6.7%). Two patients developed asymptomatic pulmonary embolism, one developed left atrial thrombus, and one developed right atrial thrombus; in all four cases, DOAC therapy was initiated. In the DOAC group, protocol modification occurred in two patients (4.3%). One patient developed asymptomatic pulmonary embolism and required dose escalation from a reduced to a standard DOAC dose. Another patient developed device-related thrombus and was switched to an alternative DOAC. During follow-up, no stroke,or systemic embolism were observed. Conclusions This sub-analysis of the SAPT-LAA study suggests that both monotherapy strategies appear safe and effective during early follow-up after LAAC. Although antithrombotic protocol modification was required in a small proportion of patients in both groups due to thrombotic events, no stroke, or systemic embolism was observed.
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Kondo et al. (2026) studied Non-valvular atrial fibrillation undergoing percutaneous left atrial appendage closure (n=106). Single antiplatelet therapy (SAPT) for 6 months post-LAAC vs. Low-dose direct oral anticoagulant (DOAC) for 3 months followed by SAPT alone for 3 months was evaluated on Modification of the antithrombotic protocol within 6 months after left atrial appendage closure. Single antiplatelet therapy vs low-dose DOAC after WATCHMAN FLX Pro LAAC required antithrombotic protocol modification in 6.7% vs 4.3% of patients within 6 months, with no strokes observed.
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