LONDON — Continuing oral anticoagulant drugs rather than briefly stopping them during transcatheter aortic valve implantation (TAVI) failed to provide any benefits and, in fact, increased the risk for bleeding, report trial investigators.
The randomized controlled POPular PAUSE TAVI trial presented at the European Society of Cardiology Congress showed that patients randomly assigned to continuous anticoagulant therapy were 1.7 percentage points more likely to experience cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding in the 30 days after TAVI than those assigned to interrupted anticoagulant therapy.
“This is the first randomized trial that provides evidence for interruption of oral anticoagulation,” said investigator Dirk Jan van Ginkel, MD, from the St. Antonius Hospital in Nieuwegein, the Netherlands.
The researchers assessed the best approach for patients taking anticoagulant therapy for atrial fibrillation or other indications who were in need of valve replacement for aortic stenosis, a population that accounts for one third of all patients undergoing TAVI.
The POPular PAUSE TAVI trial
Some guidelines recommend stopping anticoagulants for a brief period before and after TAVI because of a known risk for bleeding with the procedure.
But observational studies have suggested that continuing anticoagulants could decrease the risk for stroke and other TAVI-associated thrombotic events.
TAVI has become a common alternative to surgical valve replacement since it was introduced in 2002, and its use has expanded from patients who cannot undergo surgery to those at high risk and, recently, to those at lower risk.
The size of the new trial — 858 patients — provided the statistical power needed to show whether continuing anticoagulants was at least not inferior to interrupting them. But it showed that continuation was, in fact, inferior in terms of the combined outcomes.
When the combined outcomes were broken down, the researchers found no reduction in thromboembolic events in those who continued anticoagulation therapy. However, they did find an increase in bleeding, the vast majority of which was related to the procedure.
Mitigating Between Bleeding and Thrombosis Risk
Van Ginkel cautioned that almost all patients in the trial underwent TAVI performed using the transfemoral approach, but he pointed out that there may be different results with other approaches.
The question of managing anticoagulation when there are risks for bleeding and thrombosis has arisen in the context of other procedures, said Gilles Montalescot, MD, PhD, from the Pitié-Salpêtrière University Hospital in Paris, who was not involved with the trial.
Montalescot gave the example of pacemaker implantation. “There is no ambiguity in the excess bleeding risk with continuation” of anticoagulants, he pointed out. “This denies the observational data and supports the current caution in some guidelines.”
More questions about other possible strategies have arisen from the POPular PAUSE TAVI trial, in which anticoagulants were paused for various periods, depending on the specific drug being used.
Montalescot wondered whether a limited interruption of 24 hours would be enough. He also said that the bleeding complications of TAVI need to be better prevented, given that almost all bleeding events are related to the procedure.
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