Bayer’s inhibitor reduces risk of bleeding, but needs more clinical evidence for best treatment in patients with non-valvular atrial fibrillation



Bayer logo, image: Bayer

According to a Phase IIIb study of Bayer AG’s PIONEER AF-PCI, two different treatment strategies with its oral Factor Xa inhibitor Xarelto (rivaroxaban) both significantly reduced the risk of bleeding compared to a vitamin K antagonist (VKA) treatment strategy in patients with non-valvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) with stent placement.

Specifically, rivaroxaban 15 mg once daily in combination with single antiplatelet therapy significantly reduced the rate of clinically significant bleeding by 41 per cent (relative risk reduction; equivalent to 9.9 per cent absolute risk reduction) compared to VKA plus dual antiplatelet therapy (DAPT) through 12 months of randomised therapy in these patients. Rivaroxaban 2.5 mg twice daily in combination with DAPT reduced the rate of clinically significant bleeding compared to VKA + DAPT by 37 per cent (relative risk reduction; equivalent to 8.7 per cent absolute risk reduction) through 12 months of randomised therapy, which was also statistically significant. Similar rates for the exploratory efficacy endpoint (cardiovascular death, MI, stroke, and stent thrombosis) were observed; however, the study was not powered for statistical significance on efficacy.

Bayer presented the results from PIONEER AF-PCI – the first randomised trial of a non-vitamin K antagonist oral anticoagulant (NOAC) in this patient population – on Monday as a Late-Breaking Clinical Trial at American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, LA, USA and published simultaneously in The New England Journal of Medicine. Furthermore, a supporting sub-analysis of PIONEER AF-PCI showing significantly fewer rates of all-cause mortality or recurrent hospitalisation due to adverse events for patients taking rivaroxaban plus antiplatelet therapy compared to those on VKA plus antiplatelet therapy was also simultaneously published in Circulation.

“Patients with non-valvular AF who undergo PCI are at increased risk of blood clots, which can trigger severe consequences including stroke, myocardial infarction and stent thrombosis. In order to reduce the risk of these, patients are currently being treated with a combination therapy that increases their risk of bleeding,” said C. Michael Gibson, M.S., M.D., Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center in Boston, USA and the Principal Investigator of the PIONEER AF-PCI study. “Now, the PIONEER AF-PCI study demonstrated that statistically one bleeding event could be prevented if 11 patients were treated with the 15 mg once-daily rivaroxaban treatment strategy, thus offering physicians essential guidance to make more informed treatment decisions for this patient population in the future.”

“PIONEER AF-PCI answers an important medical question because it is potentially relevant for the 20-45% of AF patients that also have coronary artery disease and are at risk of having to have a PCI. The actual rate of PCI procedures in AF patients is approximately 1% per year,” said Dr Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Bayer Chief Medical Officer.

Bayer said in its news release that despite this, there was a lack of clinical evidence to guide best possible treatment strategies in these patients. Current Guidelines and consensus / position papers recommend a combination of antiplatelet and anticoagulant therapies for the initial phase after PCI in patients with AF – a treatment approach that has been associated with an increased risk of bleeding, including intracranial bleeding, Bayer has said.

In addition, PIONEER AF-PCI adds to the extensive investigation of rivaroxaban, which, by the time of its completion, Bayer expects to include more than 275,000 patients in both clinical trials and real-world settings.

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