Coronary artery diseasePravastatin reduces restenosis two years after percutaneous transluminal coronary angioplasty (REGRESS Trial)☆
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.