Abstract
ABSTRACTNovel therapies capable of reducing myocardial infarct (MI) size when administered prior to reperfusion are required to prevent the onset of heart failure in ST‐segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). Experimental animal studies have demonstrated that mineralocorticoid receptor antagonist (MRA) therapy administered prior to reperfusion can reduce MI size, and MRA therapy prevents adverse left ventricular (LV) remodeling in post‐MI patients with LV impairment. With these 2 benefits in mind, we hypothesize that initiating MRA therapy prior to PPCI, followed by 3 months of oral MRA therapy, will reduce MI size and prevent adverse LV remodeling in STEMI patients. The MINIMISE‐STEMI trial is a prospective, randomized, double‐blind, placebo‐controlled trial that will recruit 150 STEMI patients from four centers in the United Kingdom. Patients will be randomized to receive either an intravenous bolus of MRA therapy (potassium canrenoate 200 mg) or matching placebo prior to PPCI, followed by oral spironolactone 50 mg once daily or matching placebo for 3 months. A cardiac magnetic resonance imaging scan will be performed within 1 week of PPCI and repeated at 3 months to assess MI size and LV remodeling. Enzymatic MI size will be estimated by the 48‐hour area‐under‐the‐curve serum cardiac enzymes. The primary endpoint of the study will be MI size on the 3‐month cardiac magnetic resonance imaging scan. The MINIMISE STEMI trial will investigate whether early MRA therapy, initiated prior to reperfusion, can reduce MI size and prevent adverse post‐MI LV remodeling.
Highlights
Coronary artery disease is one of the leading causes of death and disability worldwide,[1] resulting in an estimated 7.3 million deaths per year.[2]
For patients presenting with an acute segment elevation myocardial infarction (STEMI), the most effective therapy for limiting myocardial infarct (MI) size, preserving left ventricular (LV) function, and reducing the onset of heart failure (HF) is timely reperfusion using primary percutaneous coronary intervention (PPCI).[5,6,7,8]
Overall Study Design The MINIMISE-STEMI trial is a proof-of-concept randomized clinical trial designed to investigate whether mineralocorticoid receptor antagonist (MRA) therapy initiated prior to reperfusion and continued for 3 months can reduce MI size and prevent adverse LV remodeling at 3 months in STEMI patients treated by PPCI
Summary
Coronary artery disease is one of the leading causes of death and disability worldwide,[1] resulting in an estimated 7.3 million deaths per year.[2] Despite major advances in the field of interventional cardiology, the mortality of ST-segment elevation myocardial infarction (STEMI) remains high; inhospital mortality is approximately 5% to 6%, increasing to 7% to 18% at 1 year.[3] In a large US registry consisting of 606 500 patients with acute myocardial infarction, heart failure (HF) was identified in 20.4% of individuals at admission, with a further 8.6% developing HF during the hospitalization itself.[4] The onset of HF post-STEMI is closely related to the final myocardial infarct (MI) size. For patients presenting with an acute STEMI, the most effective therapy for limiting MI size, preserving left ventricular (LV) function, and reducing the onset of HF is timely reperfusion using primary percutaneous coronary intervention (PPCI).[5,6,7,8].
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