In patients with atrial fibrillation undergoing coronary angioplasty with stents, standard anticoagulation with vitamin K antagonists plus dual antiplatelet therapy with a P2Y12 inhibitor and aspirin reduces the risk of stent thrombosis and stroke, but increases the risk of bleeding.

The effectiveness and safety of anticoagulation with rivaroxaban plus one or two antiplatelet agents are uncertain.

This study enrolled 2124 participants with nonvalvular atrial fibrillation undergoing coronary angioplasty with stenting, who were randomized to three groups (in a 1:1:1 ratio):

• low-dose rivaroxaban (15 mg once daily) plus a P2Y12 inhibitor for a year (Group 1),
• very-low-dose rivaroxaban (2.5 mg twice daily) plus dual antiplatelet therapy for 1, 6, or 12 months (Group 2), or
• standard therapy with a vitamin K antagonist plus dual antiplatelet therapy for 1, 6, and 12 months (Group 3).

The primary safety outcome was clinically significant bleeding (a composite of major bleeding and minor bleeding according to Thrombolysis in Myocardial Infarction [TIMI] criteria or any bleeding requiring medical attention).

The rates of significant bleeding were lower in the two groups receiving rivaroxaban when compared with the group receiving vitamin K antagonists:

Group 1: 16.8%

Group 2: 18.0%

Group 3: 26.7%

(Hazard ratio [HR] for Group 1 vs. Group 3: 0.59; 95% confidence interval [CI]: 0.47 to 0.76; p <0.001; HR for Group 2 vs. Group 3: 0.63; 95% CI: 0.50 to 0.80; p <0.001)

The rates of death from cardiovascular causes, acute myocardial infarction, and stroke were similar among the three groups:

Group 1: 6.5%

Group 2: 5.6%

Group 3: 6%

(p values for all comparisons were nonsignificant).

Conclusion

In participants with atrial fibrillation undergoing coronary angioplasty, the administration of either low-dose rivaroxaban plus a P2Y12 inhibitor for 12 months or very-low-dose rivaroxaban plus dual antiplatelet therapy for 1, 6, or 12 months was associated with a lower rate of clinically significant bleeding when compared with standard therapy with a vitamin K antagonist plus dual antiplatelet therapy.

Original title: Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. PIONEER AF-PCI Clinical Trials

Reference: C. Michael Gibson et al. N Engl J Med. 2016 Nov 14. [Epub ahead of print].

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