Key result
Dabigatran dual therapy reduced the risk of major or clinically relevant non-major bleeding events compared to warfarin triple therapy regardless of baseline proton pump inhibitor use.
Why the study?
To evaluate whether PPI use allows safe use of warfarin triple therapy or offers additional bleeding reduction when combined with dabigatran dual therapy in AF patients post-PCI.
Does dabigatran dual therapy reduce bleeding compared to warfarin triple therapy in patients with atrial fibrillation post-percutaneous coronary intervention, regardless of baseline proton pump inhibitor use?
RCT (n=2,678)
1:1:1 or 1:1
Yes
Does dabigatran dual therapy reduce bleeding compared to warfarin triple therapy in patients with atrial fibrillation post-percutaneous coronary intervention, regardless of baseline proton pump inhibitor use?
Hazard Ratio: 0.64 (95% CI 0.48–0.85)
Absolute Event Rate: 16.2% vs 26%
p-value: p=interaction p=0.3476
Dabigatran dual therapy reduces bleeding risk compared to warfarin triple therapy in patients with atrial fibrillation undergoing PCI, and this safety benefit is maintained regardless of baseline proton pump inhibitor use.
BACKGROUND AND OBJECTIVE: In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy? METHODS: The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor. RESULTS: Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy). CONCLUSIONS: Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS. GOV UNIQUE IDENTIFIER: NCT02164864.
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Nicolau et al. (2020) conducted an RCT in Atrial Fibrillation post-Percutaneous Coronary Intervention (n=2,678). Dabigatran dual therapy (with clopidogrel or ticagrelor) vs. Warfarin triple therapy (with clopidogrel or ticagrelor and aspirin) was evaluated on ISTH major bleeding event or clinically relevant non-major bleeding event in patients using a proton pump inhibitor at baseline (Dabigatran 110 mg vs Warfarin) (HR 0.64, 95% CI 0.48-0.85, p=interaction p=0.3476). Dabigatran dual therapy reduced the risk of major or clinically relevant non-major bleeding events compared to warfarin triple therapy regardless of baseline proton pump inhibitor use.
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