ATLANTIS

The goal of the trial was to assess the efficacy and safety of Apixaban 5 mg BID compared with standard of care (antiplatelet therapy [APT] or oral anticoagulant [OAC]) among patients undergoing transcatheter aortic valve replacement commonly known as (TAVR). In this study 1500 patients of mean age of 82 years, with 53% having a Self-expanding valve; 47% with balloon-expandable valve and 3% with valve-in-valve were included. The trial was divided into 2 layers, in one stratum Apixaban was compared to standard Vitamin K Antagonist requiring Oral Anti-Coagulant therapy and in other stratum Apixaban was compared to standard Antiplatelet therapy (Single or Dual) not requiring an Anti-Coagulant therapy. The results after a median follow up of 1 year showed that The composite primary endpoint of time to death, stroke, myocardial infarction (MI), systemic emboli, intracardiac or valve thrombosis, deep vein thrombosis/pulmonary embolism, or major bleeding between Apixaban and standard of care with Vitamin K Antagonist or DAPT/SAPT was not statistically significant. Similar results were also seen with Primary safety outcomes. In the secondary outcome of all-cause mortality, death, MI and stroke was higher in the Apixaban group The major bleeding events were more in Apixaban compared to standard of care Non-cardiovascular death was higher with Apixaban in patients that did not require anti-coagulation therapy. The venous thromboembolism was significantly lower in the Apixaban treatment arm compared to standard of care, this was also confirmed with subset 4D-CT imaging analysis The results of this trial indicate that apixaban is not superior to the standard of care among patients undergoing TAVR. Valve leaflet thrombosis was lower with apixaban compared with Anti-Platelet Therapy, but this did not translate into an improvement in clinical outcomes. In fact, among patients without an indication for OAC, apixaban use resulted in higher noncardiovascular mortality compared with APT use. Results are similar to the GALILEO trial with low-dose rivaroxaban. These data do, however, support the use of apixaban instead of VKA if needed among patients requiring long-term OAC. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.