Statin Recapture Therapy before Coronary Artery Bypass Grafting Trial: Rationale and study design of a multicenter, randomized, double-blinded controlled clinical trial

Introduction Patients undergoing coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiac and cerebrovascular events (MACCEs). Recent clinical evidence shows that cardioprotection in patients receiving a chronic statin treatment can be "recaptured" by a high-dose statin therapy given shortly before an ischemia-reperfusion sequence. Evaluation of this novel therapeutic approach in the setting of CABG seems promising because myocardial ischemia-reperfusion injury plays a pivotal role in poor clinical outcomes that may be improved by a simple preoperative statin recapture treatment. Methods The investigator-initiated StaRT-CABG trial is a multicenter, randomized, double-blinded, 2-parallel group controlled clinical study in 2,630 patients. The trial aims to evaluate whether a high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (primary composite outcome: all-cause mortality, nonfatal myocardial infarction, and cerebrovascular events). Consenting patients who are on chronic statin therapy before surgery will be randomized to receive either oral statin reloading therapy or matching placebo 12 and 2 hours before CABG. Key secondary end points include enzymatic myocardial injury; new-onset atrial fibrillation; length of stay in the intensive care unit and hospital; need for repeat coronary revascularization at 30 days; and, finally, all-cause mortality at 12 months after surgery. Implications The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach to optimize the care for patients with coronary artery disease undergoing CABG.