High versus low dose statin therapy in Indian patients with acute ST-segment elevation myocardial infarction undergoing thrombolysis.

OBJECTIVES: This study sought to compare high dose versus low dose statin therapy in Indian patients with ST-segment elevation myocardial infarction (STEMI) undergoing thrombolysis.

BACKGROUND: Randomized trials have demonstrated that statin treatment reduced major adverse cardiac events (MACEs) in patients with stable angina pectoris and acute coronary syndrome. However, randomized studies of statin therapy in Indian patients with STEMI are scarce.

METHODS: Of 1859 patients with acute STEMI, 1027 eligible patients were randomized to 80-mg (n=512) or 10-mg (n=515) atorvastatin. Primary end point was 30-day incidence of MACE (death from any cause, myocardial infarction, NSTE-ACS requiring readmission, ischemia driven revascularization, and stroke). Secondary end points included individual components of primary end point and ST-segment resolution at 90min after thrombolysis.

RESULTS: Two groups did not differ in primary endpoints of MACEs (8.79% in high dose vs 9.32% in low dose atorvastatin group, OR=0.938, 95% CI=0.612-1.436, P=0.764). With 80mg atorvastatin, there was insignificant reduction in rate of reinfarction, revascularization and death. Stroke and readmission for NSTE-ACS increased in 80mg atrovastatin group, but was not statistically significant. ST-segment resolution was significantly higher in 80-mg atorvastatin arm (45.90% vs. 37.67%; p=0.008). Myalgia was more in 80mg statin group (18.06% vs 7.57%, p=0.0001).

CONCLUSIONS: High-dose atorvastatin did not show significant difference of MACEs in STEMI patients undergoing thrombolysis but showed significant improvement in immediate coronary flow depicted by ST-segment resolution. This benefit of high dose statin is to be weighed against greater myalgia, drug discontinuation and cost in Indian patients.