Context.-The Lifestyle Heart Trial demonstrated that intensive lifestyle ch
anges may lead to regression of coronary atherosclerosis after 1 year.
Objectives.-To determine the feasibility of patients to sustain intensive l
ifestyle 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 ran
domized invitational design.
Patients.-Forty-eight patients with moderate to severe coronary heart disea
se were randomized to an intensive lifestyle change group or to a usual-car
e control group, and 35 completed the 5-year follow-up quantitative coronar
y arteriography,
Setting.-Two tertiary care university medical centers.
Intervention.-Intensive lifestyle changes (10% fat whole foods vegetarian d
iet, 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 Ei-
year follow-up) made and maintained comprehensive lifestyle changes for 5 y
ears, whereas control group patients (15 [75%] of 20 patients completed 5-y
ear follow-up) made more moderate changes. In the experimental group, the a
verage percent diameter stenosis at baseline decreased 1.75 absolute percen
tage 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 pe
rcentage points after 5 years (a 27.7% relative worsening) (P=.001 between
groups. Twenty-five cardiac events occurred in 28 experimental group patien
ts vs 45 events in 20 control group patients during the 5-year follow-up (r
isk ratio for any event for the control group, 2.47 [95% confidence interva
l, 1.48-4.20]).
Conclusions.-More regression of coronary atherosclerosis occurred after 5 y
ears than after 1 year in the experimental group. In contrast, in the contr
ol group, coronary atherosclerosis continued to progress and more than twic
e as many cardiac events occurred.