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Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation
- Source :
- Cannon, C P, Bhatt, D L, Oldgren, J, Lip, G Y H, Ellis, S G, Maeng, M, Merkely, B, Manassie, J, Januzzi, J L, Ten Berg, J M, Steg, P G, Hohnloser, S H & RE-DUAL PCI Steering Committee and Investigators 2017, ' Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation ', The New England Journal of Medicine, vol. 377, no. 16, pp. 1513-1524 . https://doi.org/10.1056/NEJMoa1708454
- Publication Year :
- 2017
- Publisher :
- Baim Institute for Clinical Research, USA; Brigham and Women’s Hospital, Heart and Vascular Center, USA; Harvard Medical School, USA, 2017.
-
Abstract
- BACKGROUND: Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding.METHODS: In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also tested for the noninferiority of dual therapy with dabigatran (both doses combined) to triple therapy with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization.RESULTS: The incidence of the primary end point was 15.4% in the 110-mg dual-therapy group as compared with 26.9% in the triple-therapy group (hazard ratio, 0.52; 95% confidence interval [CI], 0.42 to 0.63; PCONCLUSIONS: Among patients with atrial fibrillation who had undergone PCI, the risk of bleeding was lower among those who received dual therapy with dabigatran and a P2Y12 inhibitor than among those who received triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events. (Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864 .).
- Subjects :
- Male
Ticagrelor
Adenosine
Platelet Aggregation Inhibitors/therapeutic use
030204 cardiovascular system & hematology
0302 clinical medicine
Hemorrhage/chemically induced
Atrial Fibrillation
Medicine
Cardiac and Cardiovascular Systems
030212 general & internal medicine
Stroke
risk
Kardiologi
Incidence
Research Support, Non-U.S. Gov't
General Medicine
Middle Aged
Clopidogrel
Dabigatran
Multicenter Study
Drug Therapy, Combination/adverse effects
Randomized Controlled Trial
Purinergic P2Y Receptor Antagonists/adverse effects
Cardiology
Platelet aggregation inhibitor
Drug Therapy, Combination
Female
Anticoagulants/adverse effects
Cardiology and Cardiovascular Medicine
medicine.drug
Risk
medicine.medical_specialty
Ticlopidine
Hemorrhage
Warfarin/adverse effects
Ticlopidine/analogs & derivatives
03 medical and health sciences
Percutaneous Coronary Intervention
Internal medicine
Adenosine/adverse effects
Journal Article
Humans
cardiovascular diseases
Dabigatran/adverse effects
Aged
clopidogrel
Aspirin
business.industry
Atrial Fibrillation/drug therapy
percutaneous coronary intervention
Warfarin
Anticoagulants
ta3121
medicine.disease
Conventional PCI
Aspirin/therapeutic use
Purinergic P2Y Receptor Antagonists
incidence
business
Platelet Aggregation Inhibitors
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Cannon, C P, Bhatt, D L, Oldgren, J, Lip, G Y H, Ellis, S G, Maeng, M, Merkely, B, Manassie, J, Januzzi, J L, Ten Berg, J M, Steg, P G, Hohnloser, S H & RE-DUAL PCI Steering Committee and Investigators 2017, ' Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation ', The New England Journal of Medicine, vol. 377, no. 16, pp. 1513-1524 . https://doi.org/10.1056/NEJMoa1708454
- Accession number :
- edsair.doi.dedup.....e13931000e1ba7b7512f50c0dfddb1d3