Key result
In patients with VTE, DOACs were associated with a lower risk of major bleeding compared with LMWH or VKA therapy, regardless of statin use.
Why the study?
To evaluate the impact of coadministering statins with direct oral anticoagulants on the risk of major bleeding events in patients with venous thromboembolism.
Does long-term anticoagulation with DOACs reduce the risk of major bleeding compared to LMWH or VKAs in patients with VTE, regardless of concurrent statin use?
Cohort (n=73,659)
Yes
Does long-term anticoagulation with DOACs reduce the risk of major bleeding compared to LMWH or VKAs in patients with VTE, regardless of concurrent statin use?
In patients with VTE, DOACs are associated with a lower risk of major bleeding compared to LMWH or VKAs, and this safety benefit persists regardless of concurrent statin therapy.
Answers are grounded in this paper and cite their sources.
DOACs associated with lower major bleeding risk than LMWH/VKAs in statin users with VTE; extends observational safety data but leaves practice implications open pending RCTs.
OBJECTIVE: To evaluate the impact of coadministering statins with direct oral anticoagulants (DOACs) on the risk of major bleeding events in patients with venous thromboembolism (VTE). DESIGN: Observational cohort analysis based on a multicentre international registry. SETTING: Data were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries. PARTICIPANTS: A total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins. METHODS: Multivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use. RESULTS: From October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76). CONCLUSIONS: In patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.
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Giorno et al. (2024) conducted a cohort in Venous thromboembolism (n=73,659). DOACs vs. LMWH or VKA therapy was evaluated on Major bleeding events (adjusted HR 0.59, 95% CI 0.48 to 0.74). In patients with VTE, DOACs were associated with a lower risk of major bleeding compared with LMWH or VKA therapy, regardless of statin use.
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