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.