Key Points:
- Many patients who undergo transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation. However, there is uncertainty over the safety and efficacy of continuing anticoagulation versus holding periprocedural anticoagulation during TAVI.
- In this international, international, open-label, randomized, noninferiority trial clinical trial, 869 patients undergoing TAVI who were also receiving long-term anticoagulants were randomized to either continuation strategy or interruption strategy of their anticoagulation.
- Continuation of anticoagulation was found to be non-inferior to interruption of anticoagulation for composite outcomes of death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.
Despite advances over the years, thromboembolic and bleeding complications remain frequent in patients undergoing transcatheter aortic-valve implantation (TAVI). To complicate matters, it is estimated that up to one-third of patients undergoing TAVI have a concomitant indication for oral anticoagulation. The optimal management of such patients undergoing TAVI remains unknown with providers weighing the decreased risk of bleeding with interruption strategies while increasing the risk of thromboembolic events.
The Periprocedural Continuation versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) trial was an international, investigator-initiated, open-label, randomized clinical trial performed in 22 European sites. The study randomized 869 patients who were planning to undergo TAVI and were receiving long-term oral anticoagulants. Patients were randomized to either continue anticoagulation throughout the periprocedural period or stop anticoagulation following a high-bleeding-risk procedure (i.e: stop anticoagulation 48 hours prior to TAVI without a heparin bridge). The primary outcome was composite death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.
The results of the trial were presented as a late breaking clinical trial at the European Society of Cardiology Congress on August 31, 2024 with a simultaneous publication in the New England Journal of Medicine. Among the 858 patients (431 continuation arm; 427 interruption arm) included for modified intention-to-treat analysis, the average age was 81 years, 35% were women, and the average CHA2DS2-VASc score was 4.5. No patients were lost to follow-up and over 90% adherence to protocol in both arms. A primary-outcome event occurred in 71 patients (16.5%) in the continuation arm and 63 patients (14.8%) in the interruption group (95% confidence interval -3.1 to 6.6, P = 0.18 for noninferiority). Safety outcomes which included freedom from death from any cause; stroke from any cause; VARC-3 type 2, 3, or 4 bleeding; major vascular, access-related, or cardiac structural complications; acute kidney injury stage 3 or 4; moderate or severe aortic regurgitation; new permanent pacemaker owing to procedure-related conduction abnormalities and surgery or intervention related to the device) occurred in 291 patients (67.5%) in the continupation group and in 299 (70.0%) in the interruption group (95% confidence interval -8.7 to 3.7).
Limitations of the trial include open-label design, pragmatic design which did not include neurologic examination or neuroimaging, and finally, powered to show non-inferiority for composite bleeding and thromboembolic events, not separately.
In their simultaneous publication, the investigators concluded that “periprocedural continuation was not found to be noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular com- plications, or major bleeding within 30 days.”