دورية أكاديمية
Safety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE study.
| العنوان: | Safety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE study. |
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| المؤلفون: | Goldhaber SZ; Cardiovascular Division, Brigham and Women's Hospital and Hardvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. sgoldhaber@partners.org., Ageno W; University of Insubria, Varese, Italy., Casella IB; Surgery Department, Clinics Hospital, University of São Paulo, São Paulo, Brazil., Chee KH; University of Malaya, Kuala Lumpur, Malaysia., Schellong S; Stadtisches Klinikum Dresden, Dresden, Germany., Singer DE; Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA., Voccia I; Boehringer Ingelheim Canada, Burlington, ON, Canada., Tang W; Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA., Schulman S; Thrombosis and Atherosclerosis Research Institute and McMaster University, Hamilton, ON, Canada.; Department of Obstetrics and Gynecology, The I.M. Sechenov First Moscow State Medical University, Moscow, Russia. |
| المصدر: | Journal of thrombosis and thrombolysis [J Thromb Thrombolysis] 2022 Feb; Vol. 53 (2), pp. 399-409. Date of Electronic Publication: 2021 Aug 28. |
| نوع المنشور: | Journal Article; Observational Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Kluwer Academic Publishers Country of Publication: Netherlands NLM ID: 9502018 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-742X (Electronic) Linking ISSN: 09295305 NLM ISO Abbreviation: J Thromb Thrombolysis Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Dordrecht ; Norwell, MA] : Kluwer Academic Publishers, c1994- |
| مواضيع طبية MeSH: | Pulmonary Embolism*/diagnosis , Venous Thromboembolism*/diagnosis, Anticoagulants/adverse effects ; Dabigatran/adverse effects ; Humans ; Warfarin/adverse effects |
| مستخلص: | 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. Trial registration: ClinicalTrials.gov identifier NCT02596230, first registered November 4, 2015. (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.) |
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| فهرسة مساهمة: | Keywords: Anticoagulation; Dabigatran etexilate; Real-world clinical outcomes; Venous thromboembolism |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02596230 |
| المشرفين على المادة: | 0 (Anticoagulants) 5Q7ZVV76EI (Warfarin) I0VM4M70GC (Dabigatran) |
| تواريخ الأحداث: | Date Created: 20210828 Date Completed: 20220406 Latest Revision: 20220406 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1007/s11239-021-02463-x |
| PMID: | 34453675 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1573-742X |
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| DOI: | 10.1007/s11239-021-02463-x |