Efficacy and safety of serial atorvastatin load in Chinese patients undergoing elective percutaneous coronary intervention: results of the ISCAP (Intensive Statin Therapy for Chinese Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention) randomized controlled trial

Although several studies have suggested that intensive statin pretreatment could reduce the incidence of procedure-related myocardial infarction in western population, the data on the effect in Asian patients have been still limited. The aim of the study was to investigate the efficacy and safety of intensive atorvastatin load in Chinese patients undergoing elective PCI. A total of 1202 patients with stable angina or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) scheduled to undergo PCI received either intensive statin treatment (80 mg atorvastatin daily x 2 days before PCI and 40 mg daily x 30 days after PCI) or usual care. The primary endpoint was incidence of major adverse cardiac events (cardiac death, myocardial infarction, or unexpected target vessel revascularization) within 30 days after PCI. Safety endpoints include the incidence of contrast induced nephropathy (CIN), ALT/AST >3 upper limit of normal (ULN), CK >5 ULN. The incidence of 30-day MACE did not significantly differ between the intensive group and control group (19.4 vs 18.3%, P = 0.63). Multivariate analysis revealed age (OR = 1.024, 95% CI 1.003-1.045, P = 0.023) and total stent length as an independent predictor of 30-day MACE (OR = 1.012, 95% CI 1.007-1.018, P < 0.0001). The incidence of CIN was comparable between intensive group and control group (4.09 vs 4.39%, P = 0.795). No significant differences were observed in other safety profile at all follow-ups between treatment groups. The ISCAP trial demonstrated that serial intensive atorvastatin therapy did not improve the clinical outcome with similar safety profile comparing with usual care among Chinese patients undergoing elective PCI.