SOLACI | Latin American Society of Interventional Cardiology

The discussion about the best anti-thrombotic strategy for patients with atrial fibrillation undergoing PCI seemed never-ending until the RE-DUAL PCI trial was published in the New England Journal of Medicine (NEJM). This study has arrived to simplify the tough choice between the risk of a thrombotic event vs. the risk of bleeding with a simpler scheme, without giving up efficacy and gaining in safety.

2725 patients with atrial fibrillation undergoing PCI were randomized to a triple scheme with warfarin + a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (between 1 and 3 months) vs. a dual scheme with dabigatran (110 mg or 150 mg twice a day) plus a P2Y12 inhibitor (clopidogrel or ticagrelor), without aspirin.

Outside the United States, elderly patients (≥80 years of age, or ≥70 years of age in Japan) received 110-mg dabigatran twice a day.

Primary end point was major bleeding or clinically relevant minor bleeding at 14 month mean follow up. The study also tested non inferiority as regards thrombotic events (acute myocardial infarction, stroke or systemic embolism), death or unplanned revascularization.

The incidence of primary end point was 15.4% for 110 mg for the dual scheme vs. 26.9% for the triple scheme (HR, 0.52; CI 95%, 0.42 to 0.63; p<0.001 for non inferiority and p<0.001 for superiority). The dual antithrombotic therapy with 150 mg dabigatran had 20.2% event rate, compared to 25.7% of the triple scheme, which did not include elderly patients outside the US (HR, 0.72; CI 95%, 0.58 to 0.88; p<0.001 for non inferiority).

The combined efficacy end point was 13.7% for the dual scheme vs. 13.4% for the triple scheme (p=0.005 for non inferiority).

Adverse events rate was similar between both groups.

Conclusion

In patients with atrial fibrillation that must be anticoagulated also undergoing PCI, dual therapy with dabigatran plus a P2Y12 inhibitor was significantly safer than the triple scheme with warfarin, P2Y12 inhibitor and aspirin. Regarding thrombotic events, both strategies resulted similar.

Editorial Comment

The lower rate of bleeding is on the same line as the one observed in the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulant Therapy). However, it seems amplified in this population, with higher risk of bleeding, where aspirin was discontinued at randomization.

The RE-DUAL PCI is the largest randomized trial to validate the WOEST trial (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting), with enough statistical power to be considered definitive.

Título original: Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation.

Referencia: Christopher P. Cannon et al. N Engl J Med. 2017 Oct 19;377(16):1513-1524.