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Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial

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dc.contributor.author김영진-
dc.contributor.author서영주-
dc.contributor.author서지원-
dc.contributor.author신동호-
dc.contributor.author심지영-
dc.contributor.author이삭-
dc.contributor.author이승현-
dc.contributor.author이찬주-
dc.contributor.author하종원-
dc.contributor.author홍그루-
dc.date.accessioned2023-03-27T02:56:06Z-
dc.date.available2023-03-27T02:56:06Z-
dc.date.issued2023-01-
dc.identifier.issn0022-5223-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/193748-
dc.description.abstractObjective: Early warfarin anticoagulation is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair. It is unclear whether non-vitamin K antagonist oral anticoagulants can be a full alternative to warfarin. This study aimed to compare efficacy and safety of edoxaban with warfarin in patients early after surgical bioprosthetic valve implantation or valve repair. Methods: The Explore the Efficacy and Safety of Edoxaban in Patients after Heart Valve Repair or Bioprosthetic Valve Replacement study was a prospective, randomized (1:1), open-label, clinical trial conducted from December 2017 to September 2019. Patients were randomly assigned to receive edoxaban (60 mg or 30 mg once daily) or warfarin for the first 3 months after surgical bioprosthetic valve implantation or valve repair. The primary efficacy outcome was a composite of death, clinical thromboembolic events, or asymptomatic intracardiac thrombosis. The primary safety outcome was the occurrence of major bleeding. Results: Of 220 participants, 218 (109 per group) were included in the modified intention-to-treat analysis. The primary efficacy outcome occurred in 4 patients (3.7%) taking warfarin and none taking edoxaban (risk difference, -0.0367; 95% confidence interval, -0.0720 to -0.0014; P < .001 for noninferiority). The primary safety outcome occurred in 1 patient (0.9%) taking warfarin and 3 patients (2.8%) taking edoxaban (risk difference, 0.0183; 95% confidence interval, -0.0172 to 0.0539; P = .013 for noninferiority). Conclusions: Edoxaban is noninferior to warfarin for preventing thromboembolism and is potentially comparable for risk of major bleeding during the first 3 months after surgical bioprosthetic valve implantation or valve repair.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherMosby-
dc.relation.isPartOfJOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAnticoagulants / adverse effects-
dc.subject.MESHAtrial Fibrillation* / drug therapy-
dc.subject.MESHHemorrhage / chemically induced-
dc.subject.MESHHumans-
dc.subject.MESHProspective Studies-
dc.subject.MESHStroke* / prevention & control-
dc.subject.MESHThromboembolism* / etiology-
dc.subject.MESHThromboembolism* / prevention & control-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHWarfarin / adverse effects-
dc.titleEfficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Radiology (영상의학교실)-
dc.contributor.googleauthorChi Young Shim-
dc.contributor.googleauthorJiwon Seo-
dc.contributor.googleauthorYoung Jin Kim-
dc.contributor.googleauthorSeung Hyun Lee-
dc.contributor.googleauthorRaffaele De Caterina-
dc.contributor.googleauthorSak Lee-
dc.contributor.googleauthorGeu-Ru Hong-
dc.contributor.googleauthorExplore the Efficacy and Safety of Edoxaban in Patients after Heart Valve Repair or Bioprosthetic Valve Replacement (ENAVLE) study group-
dc.identifier.doi10.1016/j.jtcvs.2021.01.127-
dc.contributor.localIdA00727-
dc.contributor.localIdA01892-
dc.contributor.localIdA01913-
dc.contributor.localIdA02097-
dc.contributor.localIdA02213-
dc.contributor.localIdA02807-
dc.contributor.localIdA02935-
dc.contributor.localIdA03238-
dc.contributor.localIdA04257-
dc.contributor.localIdA04386-
dc.relation.journalcodeJ01906-
dc.identifier.eissn1097-685X-
dc.identifier.pmid33726903-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0022522321002282-
dc.subject.keywordNOACs-
dc.subject.keywordefficacy-
dc.subject.keywordnon-vitamin K antagonist oral anticoagulants-
dc.subject.keywordoral anticoagulants-
dc.subject.keywordsafety-
dc.subject.keywordvalve surgery-
dc.subject.keywordwarfarin-
dc.contributor.alternativeNameKim, Young Jin-
dc.contributor.affiliatedAuthor김영진-
dc.contributor.affiliatedAuthor서영주-
dc.contributor.affiliatedAuthor서지원-
dc.contributor.affiliatedAuthor신동호-
dc.contributor.affiliatedAuthor심지영-
dc.contributor.affiliatedAuthor이삭-
dc.contributor.affiliatedAuthor이승현-
dc.contributor.affiliatedAuthor이찬주-
dc.contributor.affiliatedAuthor하종원-
dc.contributor.affiliatedAuthor홍그루-
dc.citation.volume165-
dc.citation.number1-
dc.citation.startPage58-
dc.citation.endPage67.e4-
dc.identifier.bibliographicCitationJOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, Vol.165(1) : 58-67.e4, 2023-01-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Thoracic and Cardiovascular Surgery (흉부외과학교실) > 1. Journal Papers

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