Apixaban appears safe for most TAVR patients, but questions remain
Apixaban is not superior to traditional treatment methods after transcatheter aortic valve replacement (TAVR), according to new data presented at ACC.21, the American College of Cardiology’s 70th annual scientific session.
Researchers have previously found that apixaban, a non-vitamin K antagonist oral anticoagulant, can provide significant value when treating some subsets of patients with atrial fibrillation. The team behind the ATLANTIS trial aimed to learn if apixaban might make a similar impact on TAVR patients, comparing its safety and effectiveness to more traditional treatment options such as vitamin K antagonists (VKAs) or aspirin.
The analysis included more than 1,500 patients who underwent a successful TAVR procedure from 2016 to 2019 in one of four different countries. Approximately one in three patients required anticoagulation therapy for a reason other than the procedure; half of those patients were treated with apixaban, and the other half were treated with warfarin, a VKA. Among patients who did not require anticoagulation, half were treated with apixaban, and the other half were treated with antiplatelet medication such as aspirin.
Overall, after one year, there was no significant difference in the composite endpoint of all-cause mortality, stroke, heart attack, valve thrombosis, pulmonary or systemic embolism, deep vein thrombosis or major bleeding events. While one of those outcomes were reported in 18.4% of patients taking apixaban, they occurred in 20.1% of patients who were taking either warfarin or antiplatelet medication. This may technically be an improvement, but the difference between the two groups was still not statistically significant.
Perhaps the single biggest takeaway from the team’s work is that apixaban did appear to help limit blood clots in TAVR patients—but certain patients who did not require anticoagulation experienced heightened rates of non-cardiovascular mortality.
“Our results do not suggest we can routinely use apixaban as the default antithrombotic treatment after successful TAVR,” lead author Jean-Philippe Collet, MD, a professor of medicine and interventional cardiologist at Groupe Hospitalier Pitié-Salpêtrière in Paris, said in a statement. “Although the safety of apixaban is the same as standard care and it better prevents valve thrombosis, we observed an unexplained signal on non-cardiovascular mortality among patients who do not need oral anticoagulation. In patients with an indication for oral anticoagulation, apixaban compares favorably with VKA on all endpoints and remains easier to use.”
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.