Abstract | BACKGROUND: HYPOTHESIS: The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males. METHODS: The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event ( stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint. RESULTS: A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively). CONCLUSIONS:
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Authors | David S Eccleston, Joseph M Kim, Jurien M Ten Berg, P Gabriel Steg, Deepak L Bhatt, Stefan H Hohnloser, Anne de Veer, Matias Nordaby, Corinna Miede, Takeshi Kimura, Gregory Y H Lip, Jonas Oldgren, Christopher P Cannon |
Journal | Clinical cardiology
(Clin Cardiol)
Vol. 44
Issue 7
Pg. 1002-1010
(Jul 2021)
ISSN: 1932-8737 [Electronic] United States |
PMID | 34042199
(Publication Type: Journal Article)
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Copyright | © 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC. |
Chemical References |
- Anticoagulants
- Fibrinolytic Agents
- Platelet Aggregation Inhibitors
- Warfarin
- Dabigatran
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Topics |
- Anticoagulants
(adverse effects)
- Atrial Fibrillation
(complications, diagnosis, drug therapy)
- Coronary Artery Disease
(drug therapy)
- Dabigatran
(adverse effects)
- Drug Therapy, Combination
- Female
- Fibrinolytic Agents
(adverse effects)
- Humans
- Male
- Percutaneous Coronary Intervention
(adverse effects)
- Platelet Aggregation Inhibitors
(adverse effects)
- Warfarin
(adverse effects)
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