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LONDON -- It was best that people interrupt their oral anticoagulation (OAC) therapy around the time they get transcatheter aortic valve replacement (TAVR, also TAVI), the POPular PAUSE TAVI trial found.

The question of periprocedural anticoagulation, most frequently encountered in patients with atrial fibrillation (Afib), got a clear answer as the trial's primary outcome -- a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVR -- 16.5% for those continuing OAC vs 14.8% for those who paused OAC (P=0.18 for noninferiority).

Whether patients were on a direct OAC (DOAC) or a vitamin K antagonist, the strategy of keeping anticoagulation going close to TAVR was associated with more bleeding (31.1% vs 21.3% of patients) -- driven by excess minor bleeds -- without a reduction in thromboembolic events (8.8% vs 8.2%).

"The first randomized trial on periprocedural oral anticoagulation in patients undergoing TAVI provides evidence for interruption of oral anticoagulation," Dirk Jan van Ginkel, MD, of St. Antonius Hospital in Nieuwegein, the Netherlands, told the audience during the annual meeting of the European Society of Cardiology (ESC).

The full study manuscript was simultaneously published in the .

"Despite the effort to simplify the periprocedural approach to TAVI, the increase in bleeding complications that we observed may outweigh the convenience of continuing oral anticoagulation throughout the periprocedural period," van Ginkel and colleagues wrote.

"However, our trial was not designed to assess the benefit of continued oral anticoagulation with respect to thromboembolic events. Continued oral anticoagulation may be important especially in patients with a high CHA₂DS₂-VASc score or a history of stroke, who might be at increased risk for thromboembolic events because of their underlying vascular or cerebrovascular disease; the risk-benefit ratio may differ as compared with that in the general population of patients undergoing TAVI," the investigators cautioned.

Indeed, their trial excluded people with a mechanical heart valve, recent venous thromboembolism, among other groups.

Even so, POPular PAUSE TAVI "finally denies" the observational TAVR studies that had suggested no increased risk of bleeding or vascular complications with continuing OAC, according to ESC session discussant Gilles Montalescot, MD, PhD, of Pitié-Salpêtrière Hospital in Paris.

The trial thus supports existing warnings against continuing OAC -- and should be implemented in the guidelines, Montalescot suggested. "Patients anticoagulated for Afib and scheduled for a TAVI procedure should have their anticoagulant stopped without [low-molecular-weight heparin] bridging," he urged.

Montalescot urged more research on how to better prevent bleeding from TAVR.

For the present report, van Ginkel and colleagues chose an open-label design and intended it to be powered for noninferiority.

POPular PAUSE TAVI was performed at 22 centers in Europe and included people with symptomatic severe aortic stenosis who were planned for transfemoral or transsubclavian TAVR and on long-term OAC.

Participants were randomized to either continue or interrupt their OAC at a median 7 days before TAVR. Continuation meant that people stayed on OAC including on the day of TAVR, whereas interruption of OAC followed guidelines for a high-bleeding risk procedure (OAC was restarted as soon as deemed safe after TAVR, a median 1 day later).

The modified intention-to-treat population had 858 people (mean age 81, one-third women). Nearly 95% had Afib as the indication for OAC. The mean CHA₂DS₂-VASc score was 4.5. Over 80% of people were on a DOAC, about 30% of them on a reduced dose.

People using concomitant antiplatelet therapy reached 12.5%, namely due to percutaneous coronary intervention. Antiplatelet users were a group that had disproportionately more bleeds after TAVR, van Ginkel explained.

TAVR was done with cerebral embolic protection devices in 9.9% of cases. The trial lacked routine neuroimaging to assess silent cerebral ischemia, however, van Ginkel said.

He also cautioned that the open-label study design left room for reporting and ascertainment biases.

POPular PAUSE TAVI nevertheless had the strength of over-90% adherence to study protocol in both study arms.

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