Continuing oral anticoagulant drugs rather than briefly stopping them during transcatheter aortic valve implantation (TAVI) failed to provide any benefits and even increased the risk for bleeding, the authors of a trial presented at the European Society of Cardiology Congres have found.

 

The randomised controlled POPular PAUSE TAVI trial showed that patients randomly assigned to continuous anticoagulant therapy were 1.7% 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.

 

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.

 

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.