Context.— The Lifestyle Heart Trial demonstrated that intensive lifestyle changes may lead to regression of coronary atherosclerosis after 1 year.

Objectives.— To determine the feasibility of patients to sustain intensive lifestyle changes for a total of 5 years and the effects of these lifestyle changes (without lipid-lowering drugs) on coronary heart disease.

Design.— Randomized controlled trial conducted from 1986 to 1992 using a randomized invitational design.

Patients.— Forty-eight patients with moderate to severe coronary heart disease were randomized to an intensive lifestyle change group or to a usual-care control group, and 35 completed the 5-year follow-up quantitative coronary arteriography.

Setting.— Two tertiary care university medical centers.

Intervention.— Intensive lifestyle changes (10% fat whole foods vegetarian diet, aerobic exercise, stress management training, smoking cessation, group psychosocial support) for 5 years.

Main Outcome Measures.— Adherence to intensive lifestyle changes, changes in coronary artery percent diameter stenosis, and cardiac events.

Results.— Experimental group patients (20 [71%] of 28 patients completed 5-year follow-up) made and maintained comprehensive lifestyle changes for 5 years, whereas control group patients (15 [75%] of 20 patients completed 5-year follow-up) made more moderate changes. In the experimental group, the average percent diameter stenosis at baseline decreased 1.75 absolute percentage points after 1 year (a 4.5% relative improvement) and by 3.1 absolute percentage points after 5 years (a 7.9% relative improvement). In contrast, the average percent diameter stenosis in the control group increased by 2.3 percentage points after 1 year (a 5.4% relative worsening) and by 11.8 percentage points after 5 years (a 27.7% relative worsening) (P=.001 between groups. Twenty-five cardiac events occurred in 28 experimental group patients vs 45 events in 20 control group patients during the 5-year follow-up (risk ratio for any event for the control group, 2.47 [95% confidence interval, 1.48-4.20]).

Conclusions.— More regression of coronary atherosclerosis occurred after 5 years than after 1 year in the experimental group. In contrast, in the control group, coronary atherosclerosis continued to progress and more than twice as many cardiac events occurred.

The Lifestyle Heart Trial was the first randomized clinical trial to investigate whether ambulatory patients could be motivated to make and sustain comprehensive lifestyle changes and, if so, whether the progression of coronary atherosclerosis could be stopped or reversed without using lipid-lowering drugs as measured by computer-assisted quantitative coronary arteriography. This study derived from earlier studies that used noninvasive measures.1,2

After 1 year, we found that experimental group participants were able to make and maintain intensive lifestyle changes and had a 37.2% reduction in low-density lipoprotein (LDL) cholesterol levels and a 91% reduction in the frequency of anginal episodes.3 Average percent diameter stenosis regressed from 40.0% at baseline to 37.8% 1 year later, a change that was correlated with the degree of lifestyle change. In contrast, patients in the usual-care control group made more moderate changes in lifestyle, reduced LDL cholesterol levels by 6%, and had a 165% increase in the frequency of reported anginal episodes. Average percent diameter stenosis progressed from 42.7% to 46.1%.

Given these encouraging findings, we extended the study for an additional 4 years to determine (1) the feasibility of patients sustaining intensive changes in diet and lifestyle for a much longer time, and (2) the effects of these changes on risk factors, coronary atherosclerosis, myocardial perfusion, and cardiac events after 4 additional years.

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