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Extended Therapy After Unprovoked VTE: Bleeding Risk Is High
Current guidelines recommend continuing anticoagulation indefinitely after a first unprovoked proximal deep venous thrombosis or pulmonary embolism, except in patients with high risk for bleeding (Chest 2021 Aug 2; [e-pub]; Blood Adv 2020; 4:4693). Investigators culled data from 14 randomized clinical trials and 13 prospective cohort studies (nearly 10,000 total patients) to determine the incidence of major bleeding in patients with a first unprovoked venous thromboembolism (VTE) who were treated for at least 6 additional months after initial anticoagulation for 3 to 6 months.
Annual rates of major bleeding among patients who received warfarin or direct-acting oral anticoagulants (DOACs) were 1.7% and 1.1%, respectively. Bleeding rates were significantly higher in subgroups with the following characteristics:
- Older (age, ≥65): incident rate ratios, 1.8 and 2.9 for warfarin and DOACs, respectively
- Creatinine clearance <50 mL/minute: IRRs, 2.8 and 3.7, respectively
- History of bleeding: IRRs, 3.5 and 18.8, respectively
- Concomitant use of antiplatelet therapy: IRRs, 2.9 and 17.2, respectively
- Hemoglobin levels <10g/dL: IRRs, 6.5 and 17.4, respectively
Case-fatality rates (i.e., risk for death among patients who developed major bleeds) were 8.3% for warfarin patients and 9.7% for DOAC patients.
Comment
This report suggests that major bleeding (which has a case-fatality rate 2 to 3 times the case-fatality rate of recurrent VTE) from extended VTE therapy might portend worse outcomes for patients than would recurrent VTE if therapy is not continued after the initial 3 to 6 months. Although the annual rate of recurrent VTE is higher than the rate of major bleeding by at least several percentage points, the potentially greater morbidity and mortality associated with major bleeding might negate the importance of that difference. This danger is especially evident among patients with the listed risk factors, regardless of whether they receive warfarin or DOACs. Surprisingly, DOACs might lead to higher risk than warfarin in some patient subgroups. Clinicians should engage in shared decision making with patients prior to consideration of extended VTE therapy.
Citation(s)
Author:
Khan F et al.
Title:
Long-term risk for major bleeding during extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta-analysis.
Source:
Ann Intern Med
2021
Sep
14; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Daniel D. Dressler, MD, MSc, MHM, FACP