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Apixaban was not superior to standard of care antithrombotic treatment for preventing thrombotic or bleeding events after successful transcatheter aortic valve replacement, regardless of indication for oral anticoagulation.
The randomized, open-label ATLANTIS trial enrolled 1,510 patients at 50 centers across France, Germany, Italy and Spain who underwent successful TAVR from 2016 to 2019. Patients were stratified by need for oral anticoagulation. About one-third of patients required anticoagulation for a reason other than the TAVR procedure. Patients with an indication for oral anticoagulation were randomly assigned to twice-daily apixaban (Eliquis, Bristol Myers Squibb/Pfizer) 5 mg or a vitamin K antagonist and patients with no indication for oral anticoagulation were assigned twice-daily apixaban or single or dual antiplatelet therapy when needed for a coronary indication.
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In the intent-to-treat analysis, apixaban was not superior to standard care for the primary endpoint, which was a composite of all-cause death, transient ischemic attack/stroke, MI, valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism or major bleeding at 1 year (HR = 0.92; 95% CI, 0.73-1.16), including in patients with an indication for oral anticoagulation other than TAVR (HR = 0.88; 95% CI, 0.66-1.17) and for patients without an indication for oral anticoagulation (HR = 1.02; 95% CI, 0.68-1.51; P value for interaction = .57), according to results presented by Jean-Philippe Collet, MD, professor of medicine and interventional cardiologist at Groupe Hospitalier Pitie-Salpetriere in Paris, during the American College of Cardiology Scientific Session.
In a post hoc sensitivity analysis of the primary endpoint without valve thrombosis, apixaban also was not superior to standard care (HR = 1.12; 95% CI, 0.88-1.44) regardless of whether the patient had an indication for oral anticoagulation.
The standard care group had a higher incidence of bioprosthetic thrombosis (4.7% vs. 1.1%; HR = 0.23; 95% CI, 0.11-0.5) and deep vein thrombosis or pulmonary embolism (1.5% vs. 0.1%; HR = 0.09; 95% CI, 0.1-0.72).
Results showed no difference in the primary safety endpoint of life-threatening, disabling or major bleeding with apixaban vs. standard care (8.5% vs. 8.5%; HR = 1.02; 95% CI, 0.72-1.44).
When the researchers looked only at patients with an indication for oral anticoagulation, there was no difference with respect to the primary outcome, secondary efficacy outcome, safety outcomes or valve thrombosis.
Jean-Philippe Collet
“This shows that, given the ease of use of apixaban, this may be a good target for this patient [population] with an indication for oral anticoagulation other than [TAVR] itself,” he said.
When the researchers looked only at those without an indication for oral anticoagulation, there was a numerically higher number of primary outcome events in the standard care group vs. the apixaban group, but more secondary efficacy outcomes in the apixaban group. He said this was not driven by an increase in MI or stroke, but more CV deaths in the apixaban group (2.66% vs. 0.96%; HR = 2.99; 95% CI, 1.07-8.35). Most of the CV deaths were related to sepsis or end-stage renal failure as previously shown in the GALILEO study, he said.
“Our results do not suggest we can routinely use apixaban as the default antithrombotic treatment after successful TAVR. Although the safety of apixaban is the same as standard care and it better prevents valve thrombosis, we observed an unexplained signal on noncardiovascular mortality among patients who do not need oral anticoagulation. In patients with an indication for oral anticoagulation, apixaban compares favorably with vitamin K antagonists on all endpoints and remains easier to use,” Collet said in a press release.
Michael J. Mack
During a discussion of the trial, Michael J. Mack, MD, cardiothoracic surgeon at Baylor Scott & White Health, said ATLANTIS “was a very well-done study in an area that is a significant clinical conundrum in terms of management of patients after TAVR.
“We can summarize the field right now by saying that valve thrombosis is common afterward. It’s a dynamic process that some patients develop by 30 days and resolve by a year. Other patients develop it after 30 days. It does not seem to be associated with clinical events, and there’s no evidence, now that we have [ATLANTIS], that anything other than aspirin is beneficial to these patients,” Mack said.