Clinical InvestigationsFactors affecting bleeding risk during anticoagulant therapy in patients with atrial fibrillation: Observations from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study
Section snippets
Methods
Four thousand sixty patients were randomized in the AFFIRM trial and their clinical characteristics have been previously reported.15., 16. The average length of follow-up was 3.5 years (range 0 to 5.9 years). The primary end point was total mortality, analyzed by intention-to-treat. Secondary end points included composites of total mortality, disabling intracranial bleeding (subdural and/or subarachnoid hemorrhage, intraparenchymal hemorrhage), stroke (embolus, thrombosis, hemorrhage),
Results
Baseline characteristics for patients with and those without major bleeding events are summarized in Table I. Patients with major bleeding events were older and more likely to have a history of congestive heart failure, diabetes, or hepatic or renal disease.
Numbers and actuarial rates of major bleeding events are shown in Table II. Two hundred sixty patients (9.2%) had at least one major bleeding event. Of these, 136 had been randomized to the rate-control group and 124 to the rhythm-control
Discussion
Randomized clinical trials have shown that anticoagulation with warfarin results in a 60% to 70% reduction in the risk of stroke and systemic thromboembolism during AF.4., 5., 6., 7., 8., 9., 10. The efficacy of warfarin is even higher if an on-therapy, rather than an intention-to-treat analysis, is used.16 Because chronic anticoagulation also raises the risk of bleeding complications, current guidelines recommend warfarin only for those patients with AF in whom the risk for thromboembolic
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The AFFIRM investigators and their affiliations are listed in Ref. [13].