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Vitamin K antagonist (VKA) therapy is associated with the known risk of bleeding. Before starting VKA therapy, the benefits of anticoagulation are weighed against the risks, namely the risk of major bleeding. There are patient characteristics associated with a higher risk of bleeding on VKA therapy, such as age over 75 years, a previous history of bleeding and comorbid disease states, such as hypertension, cerebrovascular disease or a history of stroke, renal insufficiency, and malignancy.1 Over 50% of individuals with atrial fibrillation (AF) are over 75 years of age, and with increasing age the risk of stroke with AF increases, as well as the risk of major bleeding events.1,2 Due to the concerns with bleeding, very few studies in AF have included patients over the age of 80 years, a group likely to derive a significant benefit from VKA therapy.2

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Poli and colleagues performed a prospective, observational study in very old patients taking VKA therapy to evaluate the quality and safety of anticoagulation therapy. Very old patients, defined as over 80 years of age, starting VKA therapy for either thromboprophylaxis of AF or venous thromboembolism (VTE) were managed by specialized anticoagulation centers. Major bleeding was defined as fatal, intracranial, ocular causing blindness, articular, or retroperitoneal bleeding; when surgery or an invasive procedure was required to stop bleeding; transfusion of more than 2 units of blood; or when the hemoglobin decreased by more than 2g/dL. All patients were maintained at an INR goal of 2.0 to 3.0 and were seen every 2 to 4 weeks. There were 4093 patients followed for 2.35 ± 2.1 year with 73.7% taking VKA therapy for AF. The median age of the patients at the beginning of the study was 84 years; 77.5% lived with their family, 2.9% had a history of major bleeding, and 4.2% has a history of 2 or more falls. Patients with AF had more cardiovascular risk factors and VTE patients had more cancer.3

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The time in therapeutic range was 62% with 11% above and 24% below the therapeutic range. There was no difference in the time in therapeutic range between patients with or without a bleeding event. There were 179 major bleeds for a rate of 1.87 per 100 patient-years, with 53 intracranial (0.55 per 100 patient-years) and 26 fatal bleeds (0.27 per 100 patient-years). The mean age at the time of a bleeding event was 85 years, the average time to a major bleed was 14.2 months, and the median INR was 2.5 with 82.1% bleeding when within the therapeutic range. There was a 2.4-times greater risk of bleeding within 3 months of starting VKA therapy (3.87 vs. 1.63 bleeds per 100 patient-years). In univariate analysis, a higher risk of bleeding was found in men (relative risk, RR 1.4), patients ≥ 85 years (RR 1.3), and patients receiving therapy for VTE (RR 1.4). Other factors associated with a higher risk of bleeding included hypertension (RR 1.4), history of bleeding (RR 5.41), renal failure (serum creatinine ≥ 1.5 m/dL, ...

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