March 30, 2020
Edoxaban Compared to Warfarin After Surgical Bioprosthetic Valve Implantation or Valve Repair
March 30, 2020—Geu-Ru Hong, MD, and colleagues from Yonsei University College of Medicine in Seoul, South Korea, conducted a randomized clinical trial to compare the efficacy and safety of edoxaban and warfarin in the first 3 months after surgical bioprosthetic valve implantation or valve repair.
The background of the study is that early postoperative anticoagulation with warfarin is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair. Although direct oral anticoagulant can be used as an alternative to warfarin in this population, there has been no randomized clinical trial.
The data were revealed as a Featured Clinical Research presentation at the virtual conference of the American College of Cardiology’s Annual Scientific Session Together with the World Congress of Cardiology (ACC.20/WCC).
As summarized in the ACC.20/WCC abstract, the investigators randomly assigned 220 patients to receive either edoxaban (60 mg or 30 mg once daily) or warfarin (INR 2–3) after surgical bioprosthetic valve implantation or valve repair. The primary efficacy outcome was a composite of clinical thromboembolic events in the 3-month follow-up period and intracardiac thrombus in four-dimensional CT or echocardiography, which were performed 3 months after randomization. The primary safety outcome was a major bleeding episode.
The investigators reported that the primary efficacy outcome occurred in five patients (4.7%; one thromboembolic event and four intracardiac thrombus) in the warfarin group (n = 107) but did not occur in the edoxaban group (n = 102) (risk difference: –0.047; P < .001 for noninferiority). Major bleeding occurred in one patient (0.9%) in the warfarin group and in two patients (2%) in the edoxaban group (risk difference: 0.011; P = .002 for noninferiority).
Edoxaban is noninferior to warfarin in preventing thromboembolism and occurrence of major bleeding in the first 3 months after surgical bioprosthetic valve implantation or valve repair, concluded the investigator in the ACC.20/WCC presentation.