P4565Rivaroxaban treatment strategies reduce not only the first bleeding event, but all (including multiple) bleeding events: A PIONEER Substudy

Transcatheter left atrial appendage (LAA) closure is an alternative strategy for stroke prevention in atrial fibrillation (AF) patients. However, the absence of definite consensus concerning appropriate antithrombotic regimens after implantation in patients with high bleeding risk or that cannot receive anticoagulation remains an issue. The aim of this study was to evaluate clinical outcomes in these patients using the two main LAA closure systems and their different antithrombotic strategies in clinical practice. Methods and results: A total of 377 consecutive patients (229 males, 74.88.9 years old, CHA2DS2-VASc score 4.51.4, HASBLED score 3.71.0) with AF received LAA closure from 2012 to 2016 in 7 French centers. Successful implantation rate was 96.0%, whereas 15 patients were not implanted due to anatomical reason, complication related to transseptal catheterization or LAA thrombus during procedure. There were 245 Watchman devices (68%) and 115 ACP devices (32%) implanted. Two patients received successful LAA closure by Coherex Wavecrest device. At discharge, 36% received a single anti platelet therapy (APT), 21% received dual APT, 29% received oral anticoagulation (OAC) and no APT, 6% received OAC plus APT and 8% received no antithrombotic therapy. There were no significant differences between patients treated with the 5 types of antithrombotic strategies for age (p=0.85), CHA2DS2-VASc (p=0.96), HAS-BLED (p=0.15) and history of previous bleeding (p=0.25). Compared to patients treated with the Watchman device, those treated with the ACP device were older (75.88.7 vs 74.49.2, p=0.02) had slightly higher CHA2DS2-VASc score 4.81.2 vs 4.41.5, p=0.001) and HAS-BLED score (3.91.0 vs 3.71.1, p=0.049) and were more likely to be treated with no antithrombotic therapy at discharge (19% vs 3%, p<0.0001) and less frequently treated with oral anticoagulation (22% vs 41%, p=0.0005). Mean follow up was 1111 months during which 75 major cardiovascular events (22 thrombi on device, 10 ischemic strokes, 18 major hemorrhages and 25 deaths) were recorded in 69 patients. Patients treated with ACP had a higher risk of major cardiovascular events (HR 1.95, 95% CI, p=1.19-3.19, p=0.008). This result was similar after adjustment on age, sex, CHA2DS2-VASc score, HAS-BLED score and treatment at discharge (adjusted HR 1.87, 95% CI 1.09-3.21, p=0.023). Age was the only other independent predictor of event (HR 1.03-95% CI 1.00-1.07, p=0.045). None of the several antithrombotic strategies was significantly associated with a different risk of cardiovascular event.