Safety and effectiveness of dabigatran in routine clinical practice: The RE-COVERY DVT/PE study

Goldhaber, Samuel Z. and Ageno, Walter and Casella, Ivan B. and Chee, Kok Han and Schellong, Sebastian and Singer, Daniel E. and Voccia, Isabelle and Tang, Wenbo and Schulman, Sam (2022) Safety and effectiveness of dabigatran in routine clinical practice: The RE-COVERY DVT/PE study. Journal of Thrombosis And Thrombolysis, 53 (2). pp. 399-409. ISSN 0929-5305, DOI

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RE-COVERY DVT/PE is a two-phase, international, observational study of anticoagulant therapy in patients with deep vein thrombosis and/or pulmonary embolism (DVT/PE). The objective of the second phase was to compare the safety and effectiveness of dabigatran versus a vitamin K antagonist (VKA) over 1 year of follow-up. Primary safety and effectiveness outcomes were major or clinically relevant nonmajor bleeding events (MBE/CRNMBEs) and symptomatic recurrent venous thromboembolism (VTE) (including deaths related to recurrent VTE). To minimize bias due to unbalanced patient characteristics, only patients in an overlapping range of estimated propensity scores were included (analytic set), and propensity score weighting was applied to compare outcomes. Outcome analysis used an as-treated approach, censoring patients after they stopped or switched their initial anticoagulant. Overall, 3009 patients enrolled from 2016 to 2018 were eligible: 60% were diagnosed with DVT alone, 21% with PE alone, and 19% with DVT plus PE. The analytic set consisted of 2969 patients. The incidence rate in %/year (95% confidence interval CI]) of MBE/CRNMBEs was 2.63 (1.79-3.74) with dabigatran versus 4.48 (3.23-6.06) with warfarin; hazard ratio 0.63 (95% CI 0.32-1.25). For symptomatic recurrent nonfatal or fatal VTE the incidence rate was 1.53 (0.91-2.42) with dabigatran versus 2.01 (1.21-3.14) with VKAs; hazard ratio 0.78 (95% CI 0.30-2.02). In conclusion, we found lower annualized rates of MBE/CRNMBEs with dabigatran than VKA, although the difference was not statistically significant. Annualized rates of symptomatic VTE or related mortality were similar with dabigatran and VKA. These observational results with 1 year of follow-up reflect those of the randomized clinical trials. GRAPHICS] .

Item Type: Article
Funders: Boehringer Ingelheim
Uncontrolled Keywords: Anticoagulation; Dabigatran etexilate; Real-world clinical outcomes; Venous thromboembolism
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 26 Apr 2022 04:06
Last Modified: 26 Apr 2022 04:06

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