Please use this identifier to cite or link to this item: https://observatorio.fm.usp.br/handle/OPI/46210
Full metadata record
DC FieldValueLanguage
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.date.accessioned2022-04-19T13:07:07Z-
dc.date.available2022-04-19T13:07:07Z-
dc.date.issued2022-
dc.identifier.citationJOURNAL OF THROMBOSIS AND THROMBOLYSIS, v.53, n.2, p.399-409, 2022-
dc.identifier.issn0929-5305-
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/46210-
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.language.isoeng-
dc.publisherSPRINGEReng
dc.relation.ispartofJournal of Thrombosis and Thrombolysis-
dc.rightsrestrictedAccesseng
dc.subjectAnticoagulationeng
dc.subjectDabigatran etexilateeng
dc.subjectReal-world clinical outcomeseng
dc.subjectVenous thromboembolismeng
dc.subject.otheracute venous thromboembolismeng
dc.subject.otheratrial-fibrillationeng
dc.subject.otherwarfarineng
dc.subject.othermanagementeng
dc.subject.otheranticoagulantseng
dc.subject.otherdefinitioneng
dc.subject.otherqualityeng
dc.subject.othertherapyeng
dc.subject.otherprofileeng
dc.subject.otherdiseaseeng
dc.titleSafety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE studyeng
dc.typearticleeng
dc.rights.holderCopyright SPRINGEReng
dc.identifier.doi10.1007/s11239-021-02463-x-
dc.identifier.pmid34453675-
dc.subject.wosCardiac & Cardiovascular Systemseng
dc.subject.wosHematologyeng
dc.subject.wosPeripheral Vascular Diseaseeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
hcfmusp.author.externalGOLDHABER, Samuel Z.:Brigham & Womens Hosp, Cardiovasc Div, 75 Francis St, Boston, MA 02115 USA; Hardvard Med Sch, 75 Francis St, Boston, MA 02115 USA-
hcfmusp.author.externalAGENO, Walter:Univ Insubria, Varese, Italy-
hcfmusp.author.externalCHEE, Kok Han:Univ Malaya, Kuala Lumpur, Malaysia-
hcfmusp.author.externalSCHELLONG, Sebastian:Stadt Klinikum Dresden, Dresden, Germany-
hcfmusp.author.externalSINGER, Daniel E.:Massachusetts Gen Hosp, Boston, MA 02114 USA; Harvard Med Sch, Boston, MA 02115 USA-
hcfmusp.author.externalVOCCIA, Isabelle:Boehringer Ingelheim Canada, Burlington, ON, Canada-
hcfmusp.author.externalTANG, Wenbo:Boehringer Ingelheim Pharmaceut Inc, 90 E Ridge POB 368, Ridgefield, CT 06877 USA-
hcfmusp.author.externalSCHULMAN, 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-
hcfmusp.description.beginpage399-
hcfmusp.description.endpage409-
hcfmusp.description.issue2-
hcfmusp.description.volume53-
hcfmusp.origemWOS-
hcfmusp.origem.idWOS:000690699000001-
hcfmusp.origem.id2-s2.0-85113759636-
hcfmusp.publisher.cityDORDRECHTeng
hcfmusp.publisher.countryNETHERLANDSeng
hcfmusp.relation.referenceAgeno W, 2017, THROMB HAEMOSTASIS, V117, P415, DOI 10.1160/TH16-07-0566eng
hcfmusp.relation.referenceAgeno W, 2016, LANCET HAEMATOL, V3, pE12, DOI 10.1016/S2352-3026(15)00257-4eng
hcfmusp.relation.referenceAmin, 2014, CIRC-CARDIOVASC QUAL, V7eng
hcfmusp.relation.reference[Anonymous], 2020, PRADAXA US FDA PRESCeng
hcfmusp.relation.referenceBauersachs R, 2017, THROMB RES, V157, P181, DOI 10.1016/j.thromres.2017.07.029eng
hcfmusp.relation.referenceBeyer-Westendorf J, 2015, THROMB HAEMOSTASIS, V113, P231, DOI 10.1160/TH14-06-0484eng
hcfmusp.relation.referenceColeman CI, 2018, THROMB RES, V168, P31, DOI 10.1016/j.thromres.2018.05.031eng
hcfmusp.relation.referenceColeman CI, 2018, J THROMB THROMBOLYS, V46, P339, DOI 10.1007/s11239-018-1695-1eng
hcfmusp.relation.referenceCook LM, 2007, J THROMB HAEMOST, V5, P937, DOI 10.1111/j.1538-7836.2007.02507.xeng
hcfmusp.relation.referenceErkens PMG, 2012, PLOS ONE, V7, DOI 10.1371/journal.pone.0042269eng
hcfmusp.relation.referenceGallagher AM, 2012, CLIN APPL THROMB-HEM, V18, P370, DOI 10.1177/1076029611426139eng
hcfmusp.relation.referenceGoldhaber SZ, 2020, AM J MED, V133, P936, DOI 10.1016/j.amjmed.2020.03.036eng
hcfmusp.relation.referenceHakem H, 2018, J PAK MED ASSOC, V68, P1339eng
hcfmusp.relation.referenceKaatz S, 2015, J THROMB HAEMOST, V13, P2119, DOI 10.1111/jth.13140eng
hcfmusp.relation.referenceKearon C, 2016, CHEST, V149, P315, DOI 10.1016/j.chest.2015.11.026eng
hcfmusp.relation.referenceLi F, 2018, J AM STAT ASSOC, V113, P390, DOI 10.1080/01621459.2016.1260466eng
hcfmusp.relation.referenceLip GYH, 2011, EUROPACE, V13, P723, DOI 10.1093/europace/eur126eng
hcfmusp.relation.referenceLopez-Jimenez L, 2006, HAEMATOLOGICA, V91, P1046eng
hcfmusp.relation.referenceRoetker NS, 2018, THROMB HAEMOSTASIS, V118, P1637, DOI 10.1055/s-0038-1668521eng
hcfmusp.relation.referenceROSENDAAL FR, 1993, THROMB HAEMOSTASIS, V69, P236eng
hcfmusp.relation.referenceSchellong SM, 2019, THROMB HAEMOSTASIS, V119, P1675, DOI 10.1055/s-0039-1693461eng
hcfmusp.relation.referenceSchulman S, 2005, J THROMB HAEMOST, V3, P692, DOI 10.1111/j.1538-7836.2005.01204.xeng
hcfmusp.relation.referenceSchulman S, 2014, CIRCULATION, V129, P764, DOI 10.1161/CIRCULATIONAHA.113.004450eng
hcfmusp.relation.referenceSchulman S, 2011, ANN INTERN MED, V155, P653, DOI 10.7326/0003-4819-155-10-201111150-00003eng
hcfmusp.relation.referenceSchulman S, 2009, NEW ENGL J MED, V361, P2342, DOI 10.1056/NEJMoa0906598eng
hcfmusp.relation.referenceWeycker D, 2018, THROMB HAEMOSTASIS, V118, P1951, DOI 10.1055/s-0038-1673689eng
dc.description.indexMEDLINEeng
dc.identifier.eissn1573-742X-
hcfmusp.citation.scopus0-
hcfmusp.scopus.lastupdate2022-08-11-
Appears in Collections:

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


Files in This Item:
File Description SizeFormat 
art_GOLDHABER_Safety_and_effectiveness_of_dabigatran_in_routine_clinical_2022.PDF
  Restricted Access
publishedVersion (English)886.07 kBAdobe PDFView/Open Request a copy

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.