By Jeffrey Zimmet, MD, PhD
Synopsis: In this investigator-initiated, open-label trial, continuing oral anticoagulation leading up to a transcatheter aortic valve replacement procedure led to more bleeding and no reduction in thromboembolic events compared with interrupting anticoagulation.
Source: van Ginkel DJ, Bor WL, Dubois CLF, et al. Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: Rationale and design of the POPular PAUSE TAVI trial. EuroIntervention. 2023;19(9):766-771.
Nearly one-third of patients presenting for transcatheter aortic valve replacement (TAVR) have an indication for long-term oral anticoagulation, with atrial fibrillation representing the most common reason. The standard approach is to interrupt the anticoagulant peri-procedurally. Prior observational studies have suggested that the risk of thromboembolism, especially stroke, may be attenuated by continuing the anticoagulant without interruption.
The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) trial was an investigator-initiated trial designed to determine the optimal strategy for managing peri-procedural oral anticoagulation in these patients. The study was funded by the Netherlands Organization for Health Research and Development and was carried out at 22 European sites. Patients with an absolute indication to continue anticoagulation without interruption (for example, patients with mechanical valves, intracardiac thrombus, or recent venous thromboembolism) were excluded.
A total of 858 patients were enrolled in the trial. The mean age was 81 years and 35% were female. Atrial fibrillation was the indication for oral anticoagulation in 95% of patients and the average CHA2DS2-VASc score was 4.5. Enrolled patients were randomized in a 1:1 ratio to continue anticoagulation or to stop anticoagulation at least 48 hours before the TAVR procedure. The primary endpoint was a composite of cardiovascular mortality, stroke, myocardial infarction, major vascular complications, and major bleeding within 30 days of the procedure. Secondary endpoints included all thromboembolic events, cerebrovascular events, and bleeding complications.
At the planned 30-day follow-up, the primary composite endpoint occurred in 16.5% of patients in the continued oral anticoagulant (OAC) group and in 14.8% of the interrupted OAC group (risk difference, 1.7%; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). The noninferiority margin of 4% was not met. Among the secondary endpoints, bleeding was significantly more common among patients who did not interrupt anticoagulation. Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 patients (21.3%) in the interruption group, giving an absolute risk difference of 9.8 percentage points. Rates of stroke or transient ischemic attack (TIA) were nearly identical between the two groups (6.5% vs. 6.3%), and all thromboembolic events likewise were not significantly different.
The investigators in this trial were not able to state that peri-procedural continuation of anticoagulation was noninferior to interruption. Specifically, they reported a higher incidence of major bleeding and major vascular complications in the continued oral anticoagulation group, with no apparent benefit in thromboembolic events.
Commentary
In summary, POPular PAUSE TAVI is the first randomized clinical trial to assess the safety and efficacy of periprocedural continuation vs. interruption of OAC in patients undergoing TAVR.
This is an example of a study that asks a simple, answerable question and comes up with straightforward and immediately actionable results.
Interrupting anticoagulation has been considered the standard approach in TAVR, especially given large-bore arterial access and the very real risk of major bleeding. However, the significant risk of stroke and other thromboembolic complications in every case series of TAVR raised the possibility that there might be a tradeoff between bleeding and cerebrovascular risks. This is analogous to the practice in atrial fibrillation ablation, where some data have shown that peri-procedural continuation of anticoagulation may reduce cerebral events. However, in the case of TAVR, this trial shows no apparent benefit with a strong suggestion of harm. Interruption of oral anticoagulation remains the clear standard of care for these procedures.
Jeffrey Zimmet is Associate Professor of Medicine, University of California, San Francisco; Director, Cardiac Catheterization Laboratory, San Francisco VA Medical Center.
In this investigator-initiated, open-label trial, continuing oral anticoagulation leading up to a transcatheter aortic valve replacement procedure led to more bleeding and no reduction in thromboembolic events compared with interrupting anticoagulation.
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