Study on Effects of Continuing vs. Stopping Statins Around Surgical Aortic Valve Replacement in Patients Over 60

What this Trial Is About

Researchers are evaluating the effects of continuing versus stopping statin treatment around the time of surgical aortic valve replacement SAVR to study its impact on postoperative atrial fibrillation POAF and cardiac protection. This study focuses on patients undergoing elective SAVR with a bioprosthesis who have been using statins for at least 7 days in the last 3 months. The trial aims to determine if stopping statins from 7 to 14 days before surgery until 30 days after affects early POAF risk and other complications such as infection, mortality, myocardial infarction, stroke, and rehospitalization. Participants are randomly assigned to either continue their prior statin therapy or discontinue it starting 7 to 14 days before surgery until 30 days postoperatively. During the hospital stay, patients receive continuous ECG monitoring and blood tests for cardiac markers at specified intervals. Measurements include transthoracic echocardiography, fluid balance records, and documentation of various medications and interventions. After discharge, study medication continues for 30 days, and a follow-up phone call assesses any symptoms of atrial fibrillation. Throughout the study, patients undergo thorough evaluations including baseline assessments, blood sampling, and imaging before and after surgery. Researchers monitor POAF occurrence up to 30 days postoperatively and record outcomes such as duration of atrial fibrillation, mortality rates, myocardial injury, stroke, and hospital stay length. Safety is monitored by continuous ECG and laboratory tests during hospitalization, with follow-up extending to one year for intermediate outcomes. Participants may leave the study anytime without consequences, and all data are collected with informed consent.

Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins