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PIONEER AF-PCI

Gibson et al reports the results of the PIONEER AF-PCI trial. This trial was a randomized clinical trial of three antiplatelet/anticoagulation regimens for patients with atrial fibrillation undergoing coronary stent implantation. The treatment groups:

  • rivaroxaban 15 mg per day + clopidogrel/ticagrelor/prasugrel [1,6,12 months pre-specified durations]
  • rivaroxaban 2.5 mg bd + low dose aspirin + clopidogrel/ticagrelor/prasugrel [DAPT 1,6,12 months pre-specified durations]
  • vitamin K antagonist (INR 2-3) + clopidogrel/ticagrelor/prasugrel [1,6,12 months pre-specified durations]

The safety end-points were lower with rivaroxaban. The efficacy end-points were similar but the authors advise caution in regard to the confidence of no type I error.

Abstract

BACKGROUND

In patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) with placement of stents, standard anticoagulation with a vitamin K antagonist plus dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor and aspirin reduces the risk of thrombosis and stroke but increases the risk of bleeding. The effectiveness and safety of anticoagulation with rivaroxaban plus either one or two antiplatelet agents are uncertain.

METHODS

We randomly assigned 2124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting to receive, in a 1:1:1 ratio, low-dose rivaroxaban (15 mg once daily) plus a P2Y12 inhibitor for 12 months (group 1), very-low-dose rivaroxaban (2.5 mg twice daily) plus DAPT for 1, 6, or 12 months (group 2), or standard therapy
with a dose-adjusted vitamin K antagonist (once daily) plus DAPT for 1, 6, or 12 months (group 3). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to Thrombolysis in
Myocardial Infarction [TIMI] criteria or bleeding requiring medical attention).

RESULTS

The rates of clinically significant bleeding were lower in the two groups receiving rivaroxaban than in the group receiving standard therapy (16.8% in group 1, 18.0% in group 2, and 26.7% in group 3; hazard ratio for group 1 vs. group 3, 0.59; 95% confidence interval [CI], 0.47 to 0.76; P<0.001; hazard ratio 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, myocardial infarction, or stroke were similar in the three groups (Kaplan– Meier estimates, 6.5% in group 1, 5.6% in group 2, and 6.0% in group 3; P values
for all comparisons were nonsignificant).

CONCLUSIONS

In participants with atrial fibrillation undergoing PCI with placement of stents, the administration of either low-dose rivaroxaban plus a P2Y12 inhibitor for 12 months or very-low-dose rivaroxaban plus DAPT for 1, 6, or 12 months was associated with a lower rate of clinically significant bleeding than was standard therapy with a vitamin
K antagonist plus DAPT for 1, 6, or 12 months. The three groups had similar efficacy rates, although the observed broad confidence intervals diminish the surety of any conclusions regarding efficacy.

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Substudy

A substudy of re-hospitalization is very interesting. Graphics from this substudy follow:

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  1. phoenixcardiology
    November 15, 2016 at 11:26 am

    There is a typographical error. I should have put type II error. I will correct when I can.

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