Patients undergoing transcatheter aortic valve implantation (TAVI) do not benefit from the continuation of oral anticoagulation compared to those whose anticoagulants were interrupted before the procedure, new research has shown.
This was among the findings of the POPular PAUSE TAVI trial, an open-label, investigator-initiated, non-inferiority trial in patients receiving oral anticoagulation undergoing TAVI, comparing the two anticoagulation strategies. Results of the trial were presented at the 2024 European Society of Cardiology (ESC) congress (30 August–2 September, London, UK) and published in the New England Journal of Medicine.
At ESC 2024, Dirk-Jan van Ginkel (St Antonius Hospital, Nieuwegein, The Netherlands), on behalf of the POPular PAUSE TAVI investigators, reported that the trial’s primary endpoint—a composite of cardiovascular mortality, stroke, myocardial infarction (MI), major vascular complications and major bleeding—occurred at 30 days in 16.5% of patients who continued oral anticoagulation during TAVI, compared to 14.8% of patients whose oral anticoagulation regime was interrupted.
The risk difference of 1.7% between the two strategies in favour of the interruption group meant that the trial’s non-inferiority margin was not met, hence POPular PAUSE TAVI investigators suggest that their data support the interruption of oral anticoagulation during TAVI.
“The current population undergoing TAVI is different than, for example, the PCI [percutaneous coronary intervention] population,” Van Ginkel said. “These patients are generally older, they have more comorbidities, for example, renal disease, peripheral arterial disease, and cerebrovascular disease. Also, larger catheters are needed to perform TAVI.”
“When such patients using oral anticoagulation undergo a high bleeding risk procedure, such as TAVI, general guidelines on perioperative anticoagulation management recommend interrupting oral anticoagulation for a couple of days,” he noted. Whilst this has been assessed in some observational studies, which have shown a potential decrease in the risk of stroke, without an increase in bleeding when oral anticoagulation was continued, there have been no randomised trials to compare the two strategies in patients undergoing TAVI.
Taking place in 22 European centres, POPular PAUSE TAVI saw 858 patients randomised 1:1 either to continue or stop oral anticoagulation at least 48 hours before their TAVI procedure. The mean age was 81 years and 34.5% were women, 81.9% were taking direct oral anticoagulants, with 18.1% taking vitamin k antagonists.
Secondary endpoints, including cardiovascular mortality, risk of thromboembolic events and ischaemic stroke were comparable between the groups, Van Ginkel noted, but bleeding events occurred in 31.1% of patients in the continuation group and 21.3% in the interrupted group.
“There was no advantage of continuing oral anticoagulation compared with interruption in patients undergoing TAVI with a need for anticoagulation and there was more bleeding in the continuation group,” he said. “Therefore, we think that this trial provides the first randomised data which support interruption of anticoagulation in patients undergoing TAVI.”
The findings of the trial should prompt a change in guidelines, discussant Gilles Montalescot (Pitié-Salpêtrière Hospital, Paris, France) said following the presentation of the results at ESC 2024.
“Patients anticoagulated for atrial fibrillation and scheduled for TAVI procedures should have their anticoagulants stopped without low molecular-weight heparin bridging,” Montalescot said. “This recommendation should be taken by the ESC guidelines, because so far we have no recommendations at the ESC level for this situation.”
