Prevention of bleeding in patients with atrial fibrillation undergoing PCI
Open accessAbstract
BACKGROUND: 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: 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: 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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RCTs comparing TAT with DAT in patients with AF and ACS or post-PCI had limited sample size with few patients with diabetes (28-37% across RCTs).
“limited sample size with few patients with diabetes (28-37% across RCTs; Supplementary data online, Table S14).”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [341]
These RCTs had relatively short follow-up (6-14 months).
“relatively short follow-up (6-14 months)”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [341]
These RCTs are underpowered to assess both the efficacy of DAT and the safety of major bleeding of TAT in patients with diabetes.
“Thus, these RCTs are underpowered to assess both the efficacy of DAT and the safety of major bleeding of TAT in patients with diabetes.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [341]
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- Authors
- Gibson, C. M., Mehran, R., Bode, C., Halperin, J., Verheugt, F. W., Wildgoose, P., Birmingham, M., Ianus, J., Burton, P., van Eickels, M., Korjian, S., Daaboul, Y., Lip, G. Y. H., Cohen, M., Husted, S., Peterson, E. D., & Fox, K. A.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Newark Beth Israel Medical Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-12-22
- Volume
- 375
- Issue
- 25
- Pages
- 2423-2434
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2556417520
- Cited by
- 1,590
- References
- 13
- Citations by year
- 2026: 82 · 2025: 85 · 2024: 90 · 2023: 110 · 2022: 137 · 2021: 187 · 2020: 243 · 2019: 243 · 2018: 236 · 2017: 163 · 2016: 10
- FWCI
- 179.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Funders
- Eli Lilly and Company
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Regeneron Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- atrial fibrillation, percutaneous coronary intervention, rivaroxaban, direct oral anticoagulants, dual antiplatelet therapy, vitamin K antagonists, bleeding risk, major bleeding, stroke prevention, myocardial infarction, cardiovascular mortality
- MeSH terms
- Rivaroxaban, Aged, Atrial Fibrillation, Cardiovascular Diseases, Drug Therapy, Combination, Female, Hemorrhage, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Vitamin K, Stents, Confidence Intervals, Kaplan-Meier Estimate, Purinergic P2Y Receptor Antagonists, Percutaneous Coronary Intervention, Factor Xa Inhibitors
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