1018-53 Pravastatin Prevents Restenosis After PTCA of High Grade Stenotic Lesions — Results of SHIPS (SHIga Pravastatin Study)

The Shiga Pravastatin Study (SHIPS) is a 5 center randomized, double blind placebo controlled trial to test whether pravastatin, 10 mg twice daily begun at least 10 days prior to elective PTCA in patients with total cholesterol (T-Chol) hess than 280 mg/dl can decrease restenosis. The endpoint is a between group comparison of frequency of restenosis defined as a more than 50% loss of gain at PTCA site at 3 months follow-up by automated quantitative coronary arteriography. 179 lesions (85 pravastatin. 94 placebo) in 124 patients (62 pravastatin. 62 placebo) were randomized. The two groups were comparable for baseline clinical and angiographic characteristics. T-Chol decreased from 204 to 172 mg/dl in pravastatin group (P l 0.001), but not in placebo (201 vs 202 mg/dl). Although restenosis rate was not different in the two groups (29.4% in pravastatin vs 39.4% in placebo. P = 0.16) as a whole, it was reduced to about 1/5 (8.B%) in pravastatin group compared to 44.B% in placebo (P = 0.0011) when the analysis was restricted to high grade lesions (≥ 75% diameter stenosis by automated analysis. which is equivalent to ≥90% stenosis by visual analysis; 34 lesions in pravastatin, 29 lesions in placebo). The effect of pravastatin in prevention of restenosis in high grade lesions was equally seen both in the groups with baseline T-Chol of above (10.5 vs 45.5%, P = 0.029) and below 200 mg/dl (6.7 vs 44.4%. P = 0.015). Conclusion Pravastatin prevents restenosis after PTCA of high grade lesions irrespective of baseline T-Chol level.