Long-term safety and efficacy of dual therapy with oral anticoagulation and clopidogrel in patients with atrial fibrillation treated with drug-eluting stents.

BACKGROUND: The optimal antithrombotic treatment for patients on oral anticoagulants (OAC) undergoing percutaneous coronary intervention (PCI) is controversial. We analyzed the safety and efficacy of dual therapy with OAC plus clopidogrel in atrial fibrillation (AF) patients receiving drug-eluting stents (DES). METHODS AND
RESULTS: In this retrospective analysis, all AF patients treated with dual therapy were retrospectively identified. Efficacy endpoints included cardiac death, myocardial infarction (MI), stent thrombosis (ST) and cerebrovascular stroke at follow-up, while safety was assessed by bleeding events defined by the Bleeding Academic Research Consortium (BARC). Between January 2008 and August 2010, 221 patients with high-risk AF received a DES and a dual therapy with OAC and clopidogrel. At a mean follow-up of 19 months, bleeding complications occurred in 22 patients (10 %), more than half of them (n = 12) were related to the index PCI. We observed 11 cardiac deaths (4.9 %), 9 MIs (4.1 %), 3 definite (1.4 %) and no probable ST at follow-up. All definite ST occurred after cessation of clopidogrel at 8, 22, and 30 months after PCI in patients not adequately anticoagulated. Eight patients (3.6 %) had an ischemic stroke, five of which after temporary or permanent cessation of OAC.
CONCLUSION: The data generated from this large single-center experience in AF patients treated with DES revealed that dual therapy with OAC plus clopidogrel for 6-12 months followed by monotherapy with OAC appears both safe and effective at long-term follow-up. However, after clopidogrel cessation, maintaining therapeutic anticoagulation with an INR >2 is essential to prevent both thrombotic and embolic events.