Edoxaban noninferior to warfarin for thromboembolism, bleeding early after surgical valve implantation or repair
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In patients who underwent surgical bioprosthetic valve implantation or repair, early postoperative anticoagulation with edoxaban was noninferior to warfarin for preventing thromboembolism and major bleeding during the first 3 months after the procedure, according to results of the ENAVLE trial presented at the virtual American College of Cardiology Scientific Session.
“Our findings suggest edoxaban might be an alternative to warfarin in patients early after successful surgical bioprosthetic valve implantation or valve repair,” Geu-Ru Hong, MD, PhD, professor in the division of cardiology at Yonsei University College of Medicine in Seoul, South Korea, said during the presentation.
Researchers analyzed data from patients aged 20 to 85 years who had successful surgical bioprosthetic valve implantation or repair to the aortic valve, mitral valve or both valves from December 2017 to September 2019.
Between 5 and 9 days after surgery, patients were assigned warfarin (n = 109; mean age, 68 years; 57% men) or edoxaban (Savaysa, Daiichi Sankyo; n = 109; mean age, 67 years; 48% men) for 3 months. The edoxaban dose was 60 mg or 30 mg once daily and the warfarin dose was adjusted to maintain an INR between 2 and 3.
The primary efficacy outcome was death, asymptomatic intracardiac thrombosis and clinical thromboembolic events, which was defined as MI, stroke, pulmonary embolism, symptomatic valve thrombosis, noncentral nervous system systemic embolism or deep vein thrombosis. In an intention-to-treat analysis, the primary efficacy outcome occurred in 0% of the edoxaban group vs. 3.67% of the warfarin group (risk difference, 0.0367; 95% CI, 0.072 to 0.0014; P for noninferiority < .001).
Major bleeding based on International Society on Thrombosis and Haemostasis criteria, the primary safety outcome, occurred in 2.75% of the edoxaban group vs. 0.92% of the warfarin group (risk difference = 0.0183; 95% CI, 0.0172 to 0.0539; P for noninferiority = .013).
“I want to congratulate [the researchers] on completing a randomized trial on this subject,” Daniel H. Steinberg, MD, FACC, Edna M. Sutton Endowed Chair in Structural Heart Disease and professor in the department of medicine at Medical University of South Carolina in Charleston, said during the discussion. “This is an area where there’s little real data to help guide therapy following surgical valve replacement.” – by Darlene Dobkowski
Reference:
Hong G-R, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).
Disclosures: The study was supported by a research grant from Daiichi Sankyo. Hong reports no relevant financial disclosures. Steinberg reports he received consultant fees/honoraria from Boston Scientific, Medtronic and Terumo Interventional Systems and research support from Abbott Laboratories, Edwards Lifesciences and Medtronic.