Lifestyle Heart Trial - Long-term study - LHT long term follow up

Description:

The Lifestyle Heart Trial demonstrated that intensive lifestyle changes may lead to regression of coronary atherosclerosis after 1 year. This study sought to determine the feasibility of patients to sustain intensive lifestyle changes for 5 years and the effects of these lifestyle changes on coronary heart disease.

Hypothesis:

Intensive lifestyle changes would result in regression of coronary atherosclerosis after 5 years.

Study Design

Study Design:

Patients Screened: 193
Patients Enrolled: 48
Mean Follow Up: 5 years

Patient Populations:

35-75 years of age No other life-threatening illnesses No myocardial infarction during the preceding 6 weeks No history of receiving streptokinase or alteplase; Not currently receiving lipid-lowering drugs; One-, two-, or three-vessel coronary artery disease on angiography; Left ventricular ejection fraction >25%; Not scheduled to have coronary artery bypass grafting.

Primary Endpoints:

Percent diameter stenosis

Secondary Endpoints:

Program adherence Risk factor changes (weight loss, cholesterol levels, triglycerides, apolipoprotein A-I, and blood pressure) Frequency and duration of angina Cardiac events (myocardial infarction, coronary angioplasty, coronary artery bypass surgery, cardiac-related hospitalizations, and cardiac-related deaths)

Drug/Procedures Used:

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

Principal Findings:

In the experimental group, the average percent stenosis decreased from 40.7% at baseline to 38.5% at 1 year to 37.3% at 5 years (a 7.9% relative improvement). In the control group, the percent stenosis increased from 41.3% to 42.3% at 1 year to 51.9% at 5 years (a 27.7% relative worsening) (between-group differences, p=0.001 at 5 years). Patients in the experimental group sustained a weight loss of 5.8 kg (12.8 lbs) at 5 years; weight in the control group did not change significantly from baseline. LDL levels were decreased at 5 years by 20% below baseline in the experimental group and 19.3% in the control group. HDL levels and blood pressure did not differ between the 2 groups. Reported frequency of angina at 5 years decreased 72% in the experimental group and 36% in the control group. Cardiac events occurred significantly more frequently in the control group compared with the experimental group during the 5-year follow-up (risk ratio for any event for the control group=2.47, 95% C.I. 1.48-4.20).

Interpretation:

More regression of coronary atherosclerosis occurred after 5 years in the experimental group, while in the control group, coronary atherosclerosis progression continued and more than twice as many cardiac events occurred. Long-term adherence to intensive lifestyle changes remained notably high among these patients. The LDL reductions seen at 5 years are comparable with those achieved with lipid-lowering drugs in an ambulatory population. Despite the promising results, the study was relatively small (n=48) and generalizability is thus limited.

References:

JAMA 1998;280:2001-2007. 5 year results Lancet 1990;336:129-133. 1 year results

Keywords: Odds Ratio, Coronary Artery Disease, Myocardial Infarction, Life Style, Follow-Up Studies, Diet, Vegetarian, Weight Loss, Exercise, Lipids, Constriction, Pathologic, Streptokinase, Coronary Angiography, Stroke Volume, Tissue Plasminogen Activator, Coronary Artery Bypass, Smoking Cessation


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