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Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial
- Source :
- The Journal of Thoracic and Cardiovascular Surgery. 165:58-67.e4
- Publication Year :
- 2023
- Publisher :
- Elsevier BV, 2023.
-
Abstract
- Objective 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 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.
- Subjects :
- Pulmonary and Respiratory Medicine
medicine.medical_specialty
medicine.drug_class
medicine.medical_treatment
030204 cardiovascular system & hematology
Asymptomatic
law.invention
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
law
Edoxaban
medicine
business.industry
Warfarin
Absolute risk reduction
Vitamin K antagonist
Surgery
Clinical trial
030228 respiratory system
chemistry
Heart valve repair
medicine.symptom
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 00225223
- Volume :
- 165
- Database :
- OpenAIRE
- Journal :
- The Journal of Thoracic and Cardiovascular Surgery
- Accession number :
- edsair.doi...........36cf5995244a805769cb9a4b4010b42c