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Oldgren J, Steg PG, Hohnloser SH, et al. Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial. Eur Heart J. 2019 Feb 21. pii: 5359476. doi: 10.1093/eurheartj/ehz059. (Original) PMID: 30793734
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Internal Medicine
Family Medicine (FM)/General Practice (GP)
General Internal Medicine-Primary Care(US)
Hemostasis and Thrombosis

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AIMS: After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment.

METHODS AND RESULTS: In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63) for 110 mg and 0.67 (0.50-0.90) for 150 mg]; elective PCI [0.57 (0.43-0.76) for 110 mg and 0.76 (0.56-1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28-0.76) for 110 mg and 0.59 (0.34-1.04) for 150 mg]; or clopidogrel [0.51 (0.41-0.64) for 110 mg and 0.73 (0.58-0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.

CONCLUSION: The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.

Comments from Clinical Raters
As this is a prespecified subgroup analysis, no formal conclusions can be drawn; yet it is interesting to think about the net benefit for both Dabigatran doses. Again, likewise RE-LY study, it seems that the net benefit favors Dabigatran 150 mg. This study may help cardiologists to limit the use the lower dose: not much benefit in terms of bleeding, but possibly more ischemic/thrombotic events.
Family Medicine (FM)/General Practice (GP)
As a GP, I find this analysis is somewhat out of my scope. Interestingly, the focus has completely shifted from thrombosis to bleeding, even so that a clear hind of increased in-stent thrombosis with dual treatment with Dabigatran 110 mg, the most feared among thrombosis after PCI. Moreover, the RCT is underpowered to adequately answer important questions regarding subgroups and end-points such as in stent thrombosis. Therefore, it is not very useful for clinical practice, in my opinion.
General Internal Medicine-Primary Care(US)
This industrially sponsored study of dabigitran versus warfarin as therapy with clopdigral and ASA showed less bleeding and, while underpowered, perhaps the same stroke MI and death risk. In my opinion, the discussion was biased and promoted the use of diabigitran.
Hemostasis and Thrombosis
The most physiological therapy against thrombosis is LMWH. Therefore, new medications should be compared with LMWH. Dabigatran without monitoring its activity in an ultra-specific F10a/F2a generation Assay is too risky!
Hemostasis and Thrombosis
Most practitioners will be satisfied with the usefulness of this article.

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