RCT provides support for interrupting oral anticoagulation during TAVI instead of continuing

This summary is based on the presentation of Dirk Jan van Ginkel, MD (Nieuwegein, the Netherlands) at the ESC Congress 2024 - POPular PAUSE TAVI - Continuation or interruption of oral anticoagulation during TAVI?

Introduction and methods

About one-third of patients undergoing TAVI have an indication for oral anticoagulation (OAC) because of concomitant disease, mainly AF. Although clinical guidelines recommend interrupting OAC for a few days in patients undergoing interventions with a high bleeding risk, observational studies have shown continuation of OAC during TAVI was associated with a lower risk of stroke and no increased risk of bleeding.

The POPular PAUSE TAVI (Periprocedural Continuation versus Interruption of Oral Anticoagulant Drugs during Transcatheter Aortic Valve Implantation) trial was an international, open-label, noninferiority, phase 4 RCT conducted at 22 European sites. In this trial, 858 patients on long-term oral anticoagulants who were scheduled to undergo TAVI were randomized to periprocedural continuation or interruption of OAC. In 94.9% of the patients, the indication for long-term OAC was AF.

The primary endpoint was a composite outcome of CV death, all-cause stroke, MI, major vascular complications, or major bleeding within 30 days after TAVI. Secondary endpoints (assessed at discharge and 30 days) included procedure-related individual components of the primary endpoint, procedure-related bleeding complications, and procedure-related thromboembolic complications.

Main results

• The primary endpoint occurred in 71 patients (16.5%) in group assigned to the continued OAC strategy (n=431) and 63 patients (14.8%) in the group with interrupted OAC (n=427) (risk difference: 1.7 percentage points; 95%CI: −3.1 to 6.6; P=0.18 for noninferiority).
• The frequency of thromboembolic events was 8.8% in the continuation group and 8.2% in the interruption group (risk difference: 0.6 percentage points; 95%CI: −3.1 to 4.4).
• The rate of bleeding events was 31.1% in the continuation group and 21.3% in the interruption group (risk difference: 9.8 percentage points; 95%CI: 3.9–15.6). These were mostly minor bleedings (21.6% vs. 12.9%; risk difference: 8.7 percentage points; 95%CI: 3.7–13.7), but there was also a numerical, albeit not statistically significant, difference in major bleedings (11.1% vs. 8.9%; risk difference: 2.2 percentage points; 95%CI: −1.8 to 6.3).

Conclusion

In patients with an indication for long-term OAC because of concomitant disease, mainly AF, continuing OAC during TAVI had no advantage over interrupting this treatment with respect to the incidence of the primary endpoint (i.e., composite outcome of CV death, stroke, MI, major vascular complications, or major bleeding at 30 days). The frequency of thromboembolic events did not differ between the 2 strategies, but the bleeding rate was higher when OAC was continued. According to Dirk Jan van Ginkel, “this trial provides the first randomized data that support interruption of OAC in patients undergoing TAVI.”

 - Our reporting is based on the information provided at the ESC Congress 2024 -

The findings of this study were simultaneously published in N Engl J Med.