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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP-
dc.contributor.authorGOLDHABER, Samuel Z.-
dc.contributor.authorAGENO, Walter-
dc.contributor.authorCASELLA, Ivan B.-
dc.contributor.authorCHEE, Kok Han-
dc.contributor.authorSCHELLONG, Sebastian-
dc.contributor.authorSINGER, Daniel E.-
dc.contributor.authorVOCCIA, Isabelle-
dc.contributor.authorTANG, Wenbo-
dc.contributor.authorSCHULMAN, Sam-
dc.identifier.citationJOURNAL OF THROMBOSIS AND THROMBOLYSIS, v.53, n.2, p.399-409, 2022-
dc.description.abstractRE-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] .eng
dc.description.sponsorshipBoehringer IngelheimBoehringer Ingelheim-
dc.relation.ispartofJournal of Thrombosis and Thrombolysis-
dc.subjectDabigatran etexilateeng
dc.subjectReal-world clinical outcomeseng
dc.subjectVenous thromboembolismeng
dc.subject.otheracute venous thromboembolismeng
dc.titleSafety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE studyeng
dc.rights.holderCopyright SPRINGEReng
dc.subject.wosCardiac & Cardiovascular Systemseng
dc.subject.wosPeripheral Vascular Diseaseeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng, Samuel Z.:Brigham & Womens Hosp, Cardiovasc Div, 75 Francis St, Boston, MA 02115 USA; Hardvard Med Sch, 75 Francis St, Boston, MA 02115 USA-, Walter:Univ Insubria, Varese, Italy-, Kok Han:Univ Malaya, Kuala Lumpur, Malaysia-, Sebastian:Stadt Klinikum Dresden, Dresden, Germany-, Daniel E.:Massachusetts Gen Hosp, Boston, MA 02114 USA; Harvard Med Sch, Boston, MA 02115 USA-, Isabelle:Boehringer Ingelheim Canada, Burlington, ON, Canada-, Wenbo:Boehringer Ingelheim Pharmaceut Inc, 90 E Ridge POB 368, Ridgefield, CT 06877 USA-, Sam:Thrombosis & Atherosclerosis Res Inst, Hamilton, ON, Canada; McMaster Univ, Hamilton, ON, Canada; IM Sechenov First Moscow State Med Univ, Dept Obstet & Gynecol, Moscow, Russia-
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Artigos e Materiais de Revistas Científicas - HC/ICHC
Instituto Central - HC/ICHC

Artigos e Materiais de Revistas Científicas - LIM/02
LIM/02 - Laboratório de Anatomia Médico-Cirúrgica

Artigos e Materiais de Revistas Científicas - ODS/03
ODS/03 - Saúde e bem-estar

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