13 #AHA24 ScientificSessions.org Trial shows edoxaban reduces risk of stroke or systemic embolism early after bioprosthetic valve replacement Edoxaban, a direct oral anticoagulant (DOAC), was a safe and efficacious alternative anticoagulant therapy to warfarin early after bioprosthetic valve replacement, according to Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: the ENBALV trial. In the investigator-initiated phase 3, open label, multicenter trial, 410 patients undergoing bioprosthetic valve replacement were randomized 1:1 to edoxaban 60 mg or 30 mg daily adjusted by renal function, body weight and concomitant use of P-glycoprotein, or warfarin, with dose-adjusted monitoring prothrombin time test with an INR over a follow-up of 12 weeks after surgery; 389 patients were included in final analysis. The primary endpoint, a composite of stroke or systemic embolism at 12 weeks after surgery, occurred in 0.5% (n=1) in the edoxaban group and 1.5% (n=3) in the warfarin group (risk difference -1.03, 95% CI, -4.34 to 1.95). Major bleeding was numerically higher in the edoxaban group (4.1% versus 1.0%, risk difference 3.07; 95% CI, -0.67 to 7.27), but no fatal bleeding or intracranial hemorrhage was observed. In the warfarin group, one fatal intracranial hemorrhage was observed. Izumi Current guidelines recommend anticoagulant therapy with vitamin K antagonists within three to six months after bioprosthetic valve replacement to prevent thromboembolic events. “In an aging society, bioprosthetic valve replacement surgeries are increasing. Although DOACs are widely used for nonvalvular atrial fibrillation, they are not approved for early anticoagulation therapy after bioprosthetic valve replacement, including patients with sinus rhythm,” said Chisato Izumi, MD, the study’s principal investigator and a cardiologist at the National Cerebral and Cardiovascular Center in Osaka, Japan. “But our results suggest edoxaban, as an alternative anticoagulant therapy for 12 weeks after bioprosthetic valve replacement, may have clinical advantages for patients and medical staff, because patients’ conditions are largely variable during that time and edoxaban can be used with constant dose without the need for routinely monitoring anticoagulation activity. And compared to warfarin, edoxaban also has a low risk of interaction with other drugs and food, thus it is an appealing option for many patients.” Spironolactone may reduce heart failure but did not reduce primary outcomes in patients after acute myocardial infarction Aldosterone antagonism has been shown to reduce mortality in patients with chronic heart failure with reduced ejection fraction and in patients after myocardial infarction with overt heart failure and reduced ejection fraction. It plays a key role in reducing infarct size post-myocardial infarction and the development of heart failure. As a routine strategy, could spironolactone, an aldosterone antagonist, improve outcomes in patients with myocardial infarction but without heart failure? That was the question asked in The CLEAR SYNERGY (OASIS 9) Trial: A 2x2 Factorial Randomized Controlled Trial of Colchicine versus placebo and Spironolactone versus placebo in patients with myocardial infarction: The results of the spironolactone factorial. The placebo-controlled factorial design trial randomized 7,062 patients with ST-elevation myocardial infarction or large nonST-elevation myocardial infarction from 104 sites in 14 countries throughout North America, Europe, Egypt, Nepal and Australia to spironolactone 25 mg bid or placebo with enrollment between February 2018 and November 2022. Median follow-up was three years and a maximum of five years. Mean age was 60.6 years; 18% had diabetes and 9% had prior myocardial infarction. The co-primary outcomes for spironolactone were total composite events of cardiovascular death or new or worsening heart failure, and time-to-first occurrence of the composite of cardiovascular death, recurrent myocardial infarction, stroke or new or worsening heart failure. Overall, spironolactone postMI did not provide a statistically significant benefit for either primary endpoint, but a hypothesisgenerating on-treatment analysis indicated a significant benefit for both primary outcomes. New or worsening heart failure declined from 2.4% to 1.6%, representing a 30% overall heart failure relative risk reduction. Jolly “Treating patients with myocardial infarction with spironolactone was not shown to be beneficial in this trial, but our data reinforces what we already know: that spironolactone does prevent recurrent heart failure and could benefit the highest risk patients, those with myocardial infarction and heart failure,” said Sanjit Jolly, MD, the first author of the study and a scientist at the Population Health Research Institute, a joint institute of McMaster University and Hamilton Health Sciences. Jolly noted that spironolactone has been used to treat congestive heart failure for more than 20 years. “It is underprescribed for patients with myocardial infarction and congestive heart failure because newer agents are now available, but you should still consider it for these high-risk patients,” he said. The study was simultaneously published in the New England Journal of Medicine. Claiming CE credit for #AHA24 #AHA24 attendees can receive up to 24.75 Continuing Education credits. CE credit claiming is limited to participation during the event Nov. 15-18, 2024. Complete the credit claim process within 30 days to avoid credit expirations. Log in a. Go to education.heart.org. b. Enter your username and password and sign in. c. Click on your name in the upper right-hand corner and select My Library. Claim credit a. Click Start Survey to complete conference evaluation. b. Click Claim CE. c. Complete information and save. d. Your certificate is located in ‘My Account’ under ‘CE Details.’ Need assistance? For customer support, call 1-877-340-9899 (Monday-Friday between 8 a.m.-6 p.m. CST) or email education.help@email. education.heart.org.
RkJQdWJsaXNoZXIy MjI2NjI=