Abstract | BACKGROUND: 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 .).
|
Authors | C Michael Gibson, Roxana Mehran, Christoph Bode, Jonathan Halperin, Freek W Verheugt, Peter Wildgoose, Mary Birmingham, Juliana Ianus, Paul Burton, Martin van Eickels, Serge Korjian, Yazan Daaboul, Gregory Y H Lip, Marc Cohen, Steen Husted, Eric D Peterson, Keith A Fox |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 375
Issue 25
Pg. 2423-2434
(12 22 2016)
ISSN: 1533-4406 [Electronic] United States |
PMID | 27959713
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Vitamin K
- Rivaroxaban
|
Topics |
- Aged
- Atrial Fibrillation
(drug therapy, therapy)
- Cardiovascular Diseases
(epidemiology, mortality)
- Confidence Intervals
- Drug Therapy, Combination
- Factor Xa Inhibitors
(administration & dosage, adverse effects)
- Female
- Hemorrhage
(chemically induced, prevention & control)
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Percutaneous Coronary Intervention
- Platelet Aggregation Inhibitors
(adverse effects, therapeutic use)
- Purinergic P2Y Receptor Antagonists
(adverse effects, therapeutic use)
- Rivaroxaban
(administration & dosage, adverse effects)
- Stents
- Vitamin K
(antagonists & inhibitors)
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|