Pfizer and Bristol Myers Squibb's Eliquis Fails to Demonstrate Benefit in High-Risk Patients Following Valve Replacement Surgery

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Recently, overseas media reported that Eliquis, the non-warfarin anticoagulant developed by Pfizer and Bristol-Myers Squibb, has become the most prescribed medication in its class on the market, even surpassing warfarin's long-standing dominance. However, a study has shown that Eliquis failed to demonstrate clinical benefits in difficult-to-treat patients following valve replacement surgery, while also raising a concerning safety signal.

Eliquis failed to demonstrate superiority over standard of care in preventing serious clinical outcomes following transcatheter aortic valve replacement (TAVR), and was associated with an "unexplained signal" in a subset of patients with higher non-CV mortality who did not require blood thinners outside of the procedure.

This study was conducted by the Cardiovascular Trial Initiative and Organizational Network (ACTION) group to compare Eliquis with standard-of-care vitamin K antagonists (VKAs) or aspirin. The study enrolled 1,510 patients from 50 centers across 4 countries who successfully underwent transcatheter aortic valve replacement (TAVR) between 2016 and 2019.

At one year postoperatively, the study found no significant difference between Eliquis and standard of care (SoC) regarding the primary endpoint (comprising all-cause mortality, stroke, myocardial infarction, valve thrombosis, pulmonary or systemic embolism, deep vein thrombosis, or major bleeding). Approximately 18% of patients in the Eliquis group experienced such events, compared with 20.1% in the SoC group. However, the proportion of patients reaching the secondary endpoint comprising death, stroke, myocardial infarction, or systemic embolism was higher in the Eliquis group than in the control group.

Eliquis, co-developed by Pfizer and Bristol-Myers Squibb, did demonstrate certain data-supported benefits in preventing blood clots around the TAVR site without increasing the risk of bleeding, but failed to meet its primary endpoint. Meanwhile, for patients not prone to clotting, although it cannot be definitively determined how or whether Eliquis is associated with those non-CV deaths, this remains a concerning signal for researchers.

Researchers stated that, regardless, these unexplained deaths warrant further analysis, and these results may simply be “due to chance.”

Jean-Philippe Collet, MD, lead author of the study, said in a statement: "Our results do not support the routine use of Eliquis as the default antithrombotic therapy after TAVR. Although Eliquis demonstrated a safety profile comparable to standard therapy and was more effective at preventing valve thrombosis, we observed an unexplained signal of non-cardiovascular death in patients who do not require oral anticoagulation."

Source: Pfizer, Bristol Myers' Eliquis flops in post-heart surgery patients, spurring an 'unexplained signal' in certain deaths