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Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI
C Michael Gibson1, Roxana Mehran1, Christoph Bode1
1From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (C.M.G., S.K., Y.D.); the Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M., J.H.); Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg (C.B.), and Bayer Pharmaceuticals, Leverkusen (M.E.) - both in Germany; Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam (F.W.V.); Janssen Pharmaceuticals, Titusville (P.W., M.B., J.I., P.B.), and the Division of Cardiology, Newark Beth Israel Medical Center, Newark (M.C.) - both in New Jersey; University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (G.Y.H.L.); Aarhus University Hospital, Medical Department, Hospital Unit West, Herning, Denmark (S.H.); Duke Clinical Research Institute, Durham, NC (E.D.P.); and the Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh (K.A.F.).
Insights
Rivaroxaban-based anticoagulation significantly reduced bleeding in atrial fibrillation patients after PCI compared to standard therapy. Efficacy rates were similar across all treatment groups, offering a safer alternative for thrombosis prevention.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Standard anticoagulation (Vitamin K antagonist + DAPT) for atrial fibrillation patients undergoing PCI reduces thrombosis but increases bleeding risk.
- The safety and efficacy of rivaroxaban combined with antiplatelet agents in this patient population remain uncertain.
Purpose of the Study:
- To compare the safety and efficacy of two rivaroxaban-based anticoagulation strategies against standard therapy in patients with atrial fibrillation undergoing PCI with stenting.
Main Methods:
- A randomized trial involving 2124 participants with nonvalvular atrial fibrillation post-PCI.
- Three groups were assigned: low-dose rivaroxaban + P2Y12 inhibitor, very-low-dose rivaroxaban + DAPT, or standard therapy (VKA + DAPT).
- The primary safety outcome was clinically significant bleeding.
Main Results:
- Rivaroxaban groups showed significantly lower rates of clinically significant bleeding compared to the standard therapy group (16.8% and 18.0% vs. 26.7%).
- Rates of death from cardiovascular causes, myocardial infarction, or stroke were comparable across all three groups.
- Hazard ratios for bleeding favored rivaroxaban regimens (HR 0.59 for low-dose, 0.63 for very-low-dose vs. standard therapy).
Conclusions:
- Rivaroxaban-based anticoagulation (low-dose or very-low-dose) is associated with reduced bleeding compared to standard VKA therapy in atrial fibrillation patients post-PCI.
- Efficacy rates were similar across groups, though broad confidence intervals warrant caution in interpreting efficacy conclusions.
- The PIONEER AF-PCI trial suggests a potentially safer anticoagulation approach for this high-risk patient group.
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. (Funded by Janssen Scientific Affairs and Bayer Pharmaceuticals; PIONEER AF-PCI ClinicalTrials.gov number, NCT01830543 .).
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