#ACC21: Pfizer, Bristol Myers' Eliquis flops in post-heart surgery patients, spurring an 'unexplained signal' in certain deaths
Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.
Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.
The Pfizer and Bristol Myers Squibb-partnered drug did show some numerical benefit in preventing clots around the site of the TAVR without an increased risk of bleeding but couldn’t hit its outcomes marks. Meanwhile, the results in patients who otherwise were not prone to clotting were a troubling sign for researchers in the ATLANTIS study, although they couldn’t determine exactly how or whether Eliquis was tied to those non-CV deaths.
“Our results do not suggest we can routinely use (Eliquis) as the default antithrombotic treatment after successful TAVR,” said lead author Jean-Philippe Collet in a statement. “Although the safety of (Eliquis) 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 who are prone to excess bleeding on non-vitamin K antagonists like Eliquis, researchers said the drug could emerge as the treatment of choice post-TAVR. Either way, the unexplained deaths are worthy of further analysis, they said. Researchers also posited the results could simply be a “play of chance,” Collet said.
The study was conducted by the Allies in Cardiovascular Trials Initiatives and Organized Networks (ACTION) Group and sought to test Eliquis against standard-of-care VKAs or aspirin. The study enrolled 1,510 patients at 50 centers in four countries who underwent a successful TAVR procedure between 2016-19.
One year after the surgery, the study found no significant difference in the primary endpoint, a composite of all cause death, stroke, heart attack, valve thrombosis, pulmonary or systemic embolism, deep vein thrombosis or major bleeding between Eliquis and SOC. About 18% of patients on Eliquis posted one of those events compared with 20.1% on SOC standard care. There were also numerically higher numbers of secondary endpoints including death, stroke, heart attack or systemic embolism in the Eliquis group compared with control.
The investigator-sponsored ATLANTIS study was a follow-up on J&J’s GALILEO trial testing blood thinner Xarelto in patients after a TAVR. That study was stopped early due to excessive bleeding in the Xarelto arm. Researchers on ATLANTIS said deaths in non-blood thinner indicated patients were similar to findings in GALILEO without the increased risk of bleeding.