Abstract 4158: HMG-CoA Reductase Inhibitors for Prevention of Cardiac Events Following Percutaneous Coronary Intervention (PCI) in Japanese Patients with Acute or Chronic Ischemic Heart Disease; a Randomized Controlled Trial
Background Randomized trials have established statins as an agent for secondary and/or primary prevention of coronary artery disease. It has been unclear if lipid lowering therapy with statins is effective in preventing cardiovascular events in population with relatively lower mortality and morbidity of ischemic heart disease and also with lower cholesterol level such as Japanese. There are no evidences about statins if they also suppress cardiovascular events after PCI even in the era of coronary stents.
Methods and Results To evaluate the effects of statins after PCI on subsequent cardiovascular events, a prospective, randomized, open, blinded-endpoint trial conducted from February 2002 to September 2004 at 55 medical centers in Japan. A total of 1,019 patients whose serum total cholesterol levels (mg/dl) ranged 180 to 240 and who have undergone PCI was enrolled and randomly assigned to receive any available statins or no statin within 96 hours after PCI. After exclusion of violation of entry criteria and loss due to acute phase complications, 985 cases (486 in the statin and 499 in non-statin groups) were followed for up to 2 years. The primary endpoint was a composite of cardiovascular death, nonfatal acute myocardial infarction, unstable angina, congestive heart failure and stroke. Indications of PCI were stable angina in 54%, ST-elevation acute coronary syndrome in 41% and non ST-elevation acute coronary syndrome in 5%. Coronary stents were used in 84% of all cases. Primary end point events occurred in 6.2% in the statin and 11.2% in non-statin groups (p=0.0194 by log-rank test). Of all primary endpoint events, unstable angina was significantly suppressed by statin treatment (p=0.003 by log-rank test). In the non-statin group, target lesion or target vessel revascularization was done in 2.2-fold cases as compared to the statin group, on the other hand, bypass surgery or PCI for new lesion was done in 3.2-fold suggesting that statin could be more effective to suppress progression of new lesions than that of restenosis.
Conclusions For Japanese normocholesterolemic patients with ischemic heart disease treated with PCI, lipid-lowering therapy with statins reduces cardiovascular events, in particular unstable angina due to new lesions as well as restenosis.