Hot Line: Oral anticoagulants should be paused before TAVI
01 Sep 2024
As discussed yesterday by Doctor Dirk Jan van Ginkel (St Antonius Hospital - Nieuwegein, Netherlands), the optimal strategy for periprocedural anticoagulation management is not well studied in patients undergoing transcatheter aortic valve implantation (TAVI): “Whether oral anticoagulants (OAC) should be interrupted in patients with a long-term indication, such as those with atrial fibrillation (AF), was uncertain. Observational evidence suggests that continuation may decrease the risk of thromboembolic events and does not increase the risk of bleeding. We conducted the POPular PAUSE TAVI trial to investigate continuing vs. interrupting OAC.”
This was an open-label, investigator-initiated, non-inferiority trial in patients on OAC with planned TAVI, which excluded those who were at high risk for thromboembolism for whom OAC interruption was not an option. Participants were randomised to continue OAC or to stop OAC at least 48 hours before TAVI. The primary endpoint was a composite of CV mortality, stroke of any cause, myocardial infarction, major vascular complications and major bleeding within 30 days after TAVI.
In total, 858 patients were randomised who had a mean age of 81 years, with 34.5% women. The mean CHA2DS2-VASC score was 4.5. Over 80% were taking direct oral anticoagulants (81.9%), with the rest taking vitamin K antagonists (18.1%).
The primary endpoint occurred in 16.5% of patients with continued OAC and 14.8% with interrupted OAC (risk difference 1.7%; 95% CI −3.1 to 6.6; p=0.18 for non-inferiority).
The non-inferiority margin (4% for the absolute between-group difference) was not met and therefore the investigators were not able to state that continuation was non-inferior to interruption.
Any bleeding occurred in 31.1% of patients in the continued group and 21.3% in the interrupted group (risk difference 9.8; 95% CI 3.9 to 15.6). There was no difference in thromboembolic events with continued vs. interrupted OAC (8.8% vs. 8.2%; risk difference 0.6; 95% CI −3.1 to 4.4).
“We now have evidence from a randomised trial that continuing OAC provides no apparent benefit in terms of thromboembolic events. Given the higher incidence of bleeding, our data support interrupting OAC in patients undergoing TAVI,” concluded Professor Jur ten Berg, the trial’s Principal Investigator.
