Rivaroxaban reduces bleeding risk after PCI in patients with atrial fibrillation
medwireNews: Use of rivaroxaban moderates the bleeding risk associated with oral anticoagulation plus antiplatelet treatment after percutaneous coronary intervention (PCI) in patients with atrial fibrillation, indicate results of the phase III PIONEER AF-PCI trial.
Clinically significant bleeding over 12 months occurred in 16.8% of 696 patients in the low-dose rivaroxaban group and in 18.0% of 706 in the very-low-dose rivaroxaban group, compared with 26.7% of 697 patients receiving standard therapy including warfarin, giving hazard ratios for the rivaroxaban groups versus controls of 0.59 and 0.63, respectively.
Furthermore, patients receiving low- and very-low-dose rivaroxaban had lower rates of bleeding requiring medical attention compared with the standard therapy group, with corresponding rates of 14.6%, 15.8%, and 22.6%.
The results of the PIONEER AF-PCI randomized open-label trial were presented by lead investigator C Michael Gibson (Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA) at the American Heart Association Scientific Sessions 2016 meeting, held in New Orleans, Louisiana, USA, with simultaneous publication in The New England Journal of Medicine.
Commenting on the study, discussant Philippe Steg (Université Paris Diderot, France) said that there is a need to clarify the optimal treatment regimen “in terms of choice of agents, dose, and duration” to prevent stroke and stent thrombosis in patients with atrial fibrillation and acute coronary syndrome.
He added that “PIONEER AF-PCI is one of very few prospective randomized trials to address the issue.”
Participants in the low-dose group received rivaroxaban 15 mg once daily plus a P2Y12 inhibitor for 12 months, those in the very-low-dose group received rivaroxaban 2.5 mg twice daily plus dual antiplatelet therapy (DAPT) for 1, 6, or 12 months according to individual need, and those in the standard therapy group were given warfarin once daily plus DAPT for 1, 6, or 12 months.
Triple therapy of a vitamin K antagonist plus DAPT with a P2Y12 inhibitor and aspirin is a “common guideline-supported practice,” write Gibson and colleagues.
“However, this approach may result in excessive major bleeding,” they add.
Gibson said that the rivaroxaban-containing treatment regimens “reduced the risk of clinically significant bleeding as compared with standard of care,” and “yielded comparable efficacy with broad confidence intervals.”
Major adverse cardiovascular events – a composite of death from cardiovascular causes, myocardial infarction, or stroke – occurred in 6.5% of patients in the low-dose rivaroxaban group, 5.6% in the very-low-dose rivaroxaban group, and 6.0% in the standard therapy group.
The authors explain that although the efficacy of the three treatment strategies appeared to be similar, efficacy was a secondary endpoint and the trial “was not powered to definitively establish either superiority or noninferiority.”
They also caution that while the very-low-dose regimen of rivaroxaban 2.5 mg twice daily with DAPT is indicated for the prevention of cardiovascular events in patients with an acute coronary syndrome in Europe and other settings, the low dose of 15 mg once daily “is not currently approved for the management of an acute coronary syndrome or atrial fibrillation.”
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