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Combination warfarin, aspirin, clopidogrel linked to higher risk for bleeding after AF

Hansen ML. Arch Intern Med. 2010;170:1433-1441.

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Combination warfarin and clopidogrel, as well as warfarin, aspirin and clopidogrel, for treatment after atrial fibrillation was associated with a more than threefold increased risk for fatal and nonfatal bleeding compared with warfarin alone, according to data from a Danish cohort study.

Researchers obtained data from nationwide registries for 82,854 patients aged 30 years or older who were hospitalized for AF between 1997 and 2006. All of the patients included in the study had at least one prescription for warfarin, aspirin or clopidogrel filled after being discharged from the hospital. Using Cox proportional hazard models, the researchers estimated the risk for fatal and nonfatal bleeding associated with the combination therapies.

Mean follow-up was 3.3 years, during which time 11.4% of patients had nonfatal or fatal bleeding. Combination clopidogrel and warfarin therapy and combination clopidogrel, warfarin and aspirin therapy had the highest incidence rates for bleeding (13.9% per year for dual therapy and 15.7% per year for triple therapy). Using warfarin monotherapy as a reference, the researchers reported that the HR for warfarin and clopidogrel combined was 3.08 (95% CI, 2.32-3.91) and for triple therapy was 3.70 (95% CI, 2.89-4.76). The HR for aspirin alone was 0.93 (95% CI, 0.88-0.98), for clopidogrel alone was 1.06 (95% CI, 0.87-1.29), for aspirin and clopidogrel combined was 1.66 (95% CI, 1.34-2.04) and for warfarin and aspirin combined was 1.83 (95% CI, 1.72-1.96). The risk for death was higher among patients with a nonfatal bleeding episode (HR=2.45; 95% CI, 2.37-2.57), and combination therapy was not associated with improvement in the risk for ischemic stroke.

“These results stress that appropriate selection of patients for these therapies is important and that physicians should consider the expected benefits and risks carefully before prescribing combination therapy,” the researchers wrote.

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