Dr. Ahmet Karaduman

POPular PAUSE TAVI - Continuation or interruption of oral anticoagulation during TAVI

Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2407794

Background: Approximately one-third of patients undergoing transcatheter aortic-valve implantation (TAVI) require oral anticoagulation due to concomitant conditions, primarily atrial fibrillation. Interrupting oral anticoagulation during TAVI might reduce bleeding risk, whereas continuing it could lower the risk of thromboembolism.

Methods: This was an international, open-label, randomized, noninferiority trial involving patients on oral anticoagulants scheduled for TAVI. Participants were randomly assigned in a 1:1 ratio to either continue or interrupt oral anticoagulation around the time of the procedure. The primary outcome was a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days post-TAVI.

Results: In the modified intention-to-treat population, 858 patients were analyzed: 431 in the continuation group and 427 in the interruption group. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group versus 63 patients (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% CI, -3.1 to 6.6; P=0.18 for noninferiority). Thromboembolic events were reported in 38 patients (8.8%) in the continuation group compared to 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding events were more common in the continuation group, occurring in 134 patients (31.1%) compared to 91 patients (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).

Conclusions: Among patients undergoing TAVI who require oral anticoagulation, continuing anticoagulation periprocedurally was not found to be noninferior to interrupting anticoagulation regarding the composite incidence of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days.

Interpretations:
The trial demonstrated that periprocedural continuation of oral anticoagulation in TAVI patients was not noninferior to its interruption in preventing a composite of adverse cardiovascular events and major bleeding. While the risk of thromboembolic events was similar between groups, the continuation strategy was associated with a higher incidence of bleeding. These findings suggest that interrupting oral anticoagulation may be a safer strategy to minimize bleeding risks without significantly increasing thromboembolic complications in this population