Coronary artery disease
Pravastatin reduces restenosis two years after percutaneous transluminal coronary angioplasty (REGRESS Trial)

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Abstract

The Regression Growth Evaluation Statin Study (REGRESS) is a placebo-controlled multicenter study designed to assess the effect of 2-year treatment with pravastatin on the progression and regression of angiographically documented coronary artery disease. One of the secondary end points was the occurrence of 2-year restenosis in the percutaneous transluminal coronary angioplasty (PTCA) block. We randomly assigned eligible patients to receive pravastatin 40 mg once daily or placebo. The end point was the percent diameter stenosis of the target lesion at 24 months, as assessed by (semi)quantitative coronary angiography. Two hundred twenty-one patients underwent scheduled PTCA, which was considered successful in 201 patients. One hundred seventy-eight patients underwent angiographic restudy (89%). The patients in the pravastatin group (n = 109) and placebo group (n = 112) were similar at baseline. Percent diameter stenosis before angioplasty was 78 ± 14% (mean ± SD) in the pravastatin group and 80 ± 14% in the placebo group (p = 0.46). At follow-up, the percent diameter stenosis was 32 ± 23% in the pravastatin group and 45 ± 29% in the placebo group (p <0.001). Clinical restenosis was significantly lower in the pravastatin group (7%) compared with the placebo group (29%) (p <0.001). Risk reduction for all events was 58%. We conclude that treatment with pravastatin reduces 2-year clinical and angiographic restenosis.

Section snippets

Study design and subjects

REGRESS6 was a prospective, double-blind, placebo-controlled, multicenter study designed to assess the effect of 2 years of treatment with pravastatin, on progression and regression of angiographically documented coronary atherosclerosis, in men with baseline cholesterol levels between 4 and 8 mmol/L (150 to 310 mg/dl). Inclusion and exclusion criteria have been described previously.6 In short, 18- to 70-year-old men with angiographically documented coronary artery disease (≥ coronary diameter

Patients

The study population consisted of 201 patients (100 patients in the pravastatin group and 101 patients in the placebo group). During follow-up, 2 patients died (placebo group) and 6 PTCA arteriograms were lost. Fourteen patients had no follow-up arteriogram due to patient refusal, and 1 patient was excluded because the initial diameter stenosis was <50%. Eight patients of the group who refused follow-up arteriography (4 in each treatment group) had early interventions during the follow-up

Discussion

This REGRESS substudy investigated the efficacy of pravastatin therapy in reducing angiographic and clinical restenosis 24 months after PTCA. Both restenosis parameters demonstrated a significant difference among the treatment groups in favor of the pravastatin group.

Angiographic restenosis is the nonacute luminal renarrowing observed after coronary angioplasty expressed in relative values (e.g., percent stenosis) or absolute values (e.g., minimum lumen diameter). Statistically, the data may be

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The REGRESS trial was supported by Bristol-Myers Squibb Co, Princeton, New Jersey, and was conducted under the auspices of the Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, The Netherlands. Manuscript received January 12, 2000; revised manuscript received and accepted April 14, 2000.

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