Background: The safety of combination treatment with new oral anticoagulants (NOACs) and clopidogrel remains an issue of debate. We investigated the association of such combination therapy with major hemorrhagic complications in a real-world cohort of elderly atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI) with stenting.
Methods: We used a 40% random sample Medicare denominator file and corresponding inpatient, outpatient (2003-2013) and prescription (2006-2013) claims to conduct a cohort study of AF patients receiving cardiac stents, between 2006 and 2013. Cox models were employed to investigate the association of combination therapy (oral anticoagulant and an antiplatelet medication) with major hemorrhagic complications.
Results: We identified 182,242 AF patients undergoing stenting (average age 73.8 years, 51.3% female). Mean follow up was 36.8 months. Current combination therapy including a NOAC was associated with an increased risk of intracranial hemorrhage (ICH) (HR 3.21; 95% CI 1.59-6.47), upper gastrointestinal hemorrhage (HR 2.77; 95% CI 2.21-3.49), other significant hemorrhage (HR 2.87; 95% CI 2.27-3.62), or any hemorrhage (HR 2.73; 95% CI 2.31-3.21) in comparison to clopidogrel alone. The corresponding effect for combination treatment with warfarin was smaller (HR 2.05; 95% CI 1.97-2.13 for all hemorrhages).
Conclusions: In a cohort of elderly AF patients undergoing PCI and stenting we identified an association of combination treatment with NOACs and antiplatelets with an increased risk of major hemorrhagic complications, in comparison to antiplatelets alone. This effect was larger than the corresponding risk associated with combination treatment including warfarin.