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November 14, 2016New England Journal of Medicine1,592 citationsOpen Access

Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI

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CGC. Michael GibsonRMRoxana MehranCBChristoph Bode

Structured PICO

Does low-dose or very-low-dose rivaroxaban reduce clinically significant bleeding compared to standard vitamin K antagonist therapy in participants with atrial fibrillation undergoing PCI with stent placement?

P
Population
Participants with atrial fibrillation undergoing PCI with placement of stents
I
Intervention
Low-dose rivaroxaban plus a P2Y12 inhibitor for 12 months OR very-low-dose rivaroxaban plus DAPT for 1, 6, or 12 months
C
Comparator
Standard therapy with a vitamin K antagonist plus DAPT for 1, 6, or 12 months
O
Outcome
Clinically significant bleedingsafety

In patients with atrial fibrillation undergoing PCI, rivaroxaban-based antithrombotic regimens reduce clinically significant bleeding compared to standard vitamin K antagonist plus DAPT.

Limitations

  • Broad confidence intervals diminish the surety of any conclusions regarding efficacy

Abstract

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. (Funded by Janssen Scientific Affairs and Bayer Pharmaceuticals; PIONEER AF-PCI ClinicalTrials.gov number, NCT01830543 .).

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Cite This Study

Gibson et al. (2016) studied this question.

synapsesocial.com/papers/69d5707d75589c71d767dc79https://doi.org/10.1056/nejmoa1611594
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  5. 5An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI)2014 · 173 citations