CORONARY ANGIOGRAPHIC CHANGES WITH LOVASTATIN THERAPY - THE MONITOREDATHEROSCLEROSIS REGRESSION STUDY (MARS)

Objective: To assess the effects of lipid-lowering therapy with lovast atin on coronary angiographic findings in patients with coronary arter y disease and to compare the findings with those of two lipid-lowering angiographic trials using similar end points. Design: Randomized, dou ble-blind, placebo-controlled, multicenter coronary angiographic trial . Setting: Community- and university-based cardiac catheterization lab oratories.Participants: A total of 270 patients, 37 to 67 years old, w ith total cholesterol ranging from 4.92 to 7.64 mmol/L (190 to 295 mg/ dL) and angiographically defined coronary artery disease. Intervention : A cholesterol-lowering diet and either lovastatin, 80 mg/day, or pla cebo. Outcome: Per-patient change in percent diameter stenosis as dete rmined by quantitative coronary angiography (primary end point). Globa l change score, based on the consensus of blinded expert readers regar ding angiographic change (secondary endpoint). Results: Lovastatin low ered total cholesterol level by 32%, low-density lipoprotein cholester ol by 38%, and the apolipoprotein B by 26% and raised the high-density lipoprotein cholesterol by 8.5% (P < 0.001). Average percent diameter stenosis increased 2.2% in placebo recipients and 1.6% in lovastatin recipients (P > 0.20). For lesions 50% or greater, average percent dia meter stenosis increased 0.9% in placebo recipients and decreased 4.1% in lovastatin recipients (P = 0.005). The mean global change score wa s +0.9 (indicating progression) in the placebo group and +0.4 in the l ovastatin group (P = 0.002); 13 placebo recipients and 28 lovastatin r ecipients had global change scores indicating regression (P < 0.02). C onclusion: Treatment with lovastatin plus diet slows the rate of progr ession and increases the frequency of regression in coronary artery le sions (by global change score), especially in more severe lesions (by quantitative angiography). This is the third lipid-lowering trial to s how a benefit using the global change score, an end point predictive o f clinical coronary events. Differences between two of these trials, u sing quantitative coronary angiographic end points, may have theoretic al bearing on the mechanisms by which lipid-lowering therapy operates at the level of the arterial wall.