Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease
Lead SponsorUniversity of Roma La Sapienza
Indication/ConditionCoronary Artery Disease Acute Coronary Syndrome
This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.
For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.
For patients randomised to this arm, adherence to the National Cholesterol Education Program, Adult Treatment Panel III guidelines was required. In particular, in these patients,atorvastatin was started at the initial dosage of 20 mg/day immediately after randomisation. Subsequently, atorvastatin dosage was titrated in order to attain low-density lipoprotein cholesterol (LDL-C) levels <100 mg/dL (2.5 mmol/L).
Inclusion Criteria: non-ST-segment elevation acute myocardial infarction. coronary angiography within 48 hours from admission. angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI). Exclusion Criteria: ST-segment elevation acute myocardial infarction, clinical history of heart failure left ventricular ejection fraction <35%, any form of severe valvular dysfunction, previous implantation or indication to implant a cardioverter-defibrillator during the index admission, any increase in liver enzymes, history of any liver or muscle disease, renal failure with serum creatinine >2.5 mg/dL (221 mmol/L), need for continued use of intravenous medications to relieve anginal symptoms, presence of any major comorbidity with life expectancy <24 months.