Among patients with atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stenting, a rivaroxaban-based strategy reduces the risk of clinically significant bleeding compared with warfarin-based treatment. This finding is from the first randomized trial to address the issue of the best treatment strategy for patients with both AF and PCI with stenting.
The trial results were simultaneously published online in the New England Journal of Medicine and presented by C. Michael Gibson, MD, of the Beth Israel Deaconess Medical Center, at the Scientific Sessions of the American Heart Association held November 12 to 16, 2016, in New Orleans, LA. Eric D. Peterson, MD, of Duke, was also involved in the study.
Although combination therapy with aspirin and a P2Y12 inhibitor is not as effective as warfarin for patients with AF, the combination of aspirin and a P2Y12 inhibitor is more effective than warfarin for patients with coronary stents. Triple therapy—warfarin plus dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor and aspirin—has been used for patients with both AF and PCI with stenting, but this therapy has been associated with a risk of major bleeding.
The Study Exploring Two Strategies of Rivaroxaban and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention (PIONEER AF-PCI) was an open-label, multicenter, controlled, randomized trial in which 2,124 patients with AF who had undergone PCI with stenting were randomly assigned to 1 of 3 groups:
- Group 1: Low-dose rivaroxaban 15 mg once daily plus a P2Y12 inhibitor (clopidogrel, ticagrelor, or prasugrel) for 12 months
- Group 2: Very-low-dose rivaroxaban 2.5 mg twice daily plus DAPT for 1, 6, or 12 months
- Group 3: Standard therapy with dose-adjusted warfarin once daily plus DAPT for 1, 6, or 12 months
Gibson explained that physicians could choose the duration of therapy as well as the drug before randomization. The primary outcome was clinically significant bleeding according to Thrombolysis In Myocardial Infarction (TIMI) criteria.
The rates of significant bleeding were lower among patients assigned to group 1 or 2 compared with those in group 3. Specifically, clinically significant bleeding occurred in 16.8% of study patients in group 1 compared with 18.0% in group 2 and 26.7% in group 3 (hazard ratio [HR] 0.59, P < .001 for group 1 vs group 3; HR 0.63, P < .001 for group 2 vs group 3). The results were the same across several subgroups.
In addition to TIMI criteria to define bleeding events, the International Society on Thrombosis and Haemostasis, Global Use of Strategies to Open Occluded Coronary Arteries, and Bleeding Academic Research Consortium scales were used for prespecified secondary analyses.
“The take-home message is that it doesn’t matter how you define bleeding—the results were similar,” said Gibson.
With regard to secondary outcomes, the rates of cardiovascular-related death, myocardial infarction, and stroke were similar for all 3 groups (6.5% for group 1 vs 5.6% for group 2 vs 6.0% for group 3). Rates of all-cause mortality and rehospitalization were lower with a rivaroxaban-based strategy compared with warfarin plus DAPT (34.1% for group 1 vs 31.2% for group 2 vs 41.5% for group 3).
Although the efficacy rates were similar, Gibson explained that the results were inconclusive because of broad confidence intervals.
Source: Gibson CM, Mehran R, Bode C, et al. An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted VKA in subjects with AF who undergo PCI (PIONEER AF-PCI). Presented at: American Heart Association Scientific Sessions 2016; November 12-16, 2016; New Orleans, LA. Abstract LBCT.02.