Main Outcome Measures. In the experimental group, the average percent diameter stenosis at baseline decreased 1. In contrast, the average percent diameter stenosis in the control group increased by 2. 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. In contrast, in the control group, coronary atherosclerosis continued to progress and more than twice as many cardiac events occurred.
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Main Outcome Measures. In the experimental group, the average percent diameter stenosis at baseline decreased 1. In contrast, the average percent diameter stenosis in the control group increased by 2. 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.
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. After 1 year, we found that experimental group participants were able to make and maintain intensive lifestyle changes and had a Average percent diameter stenosis progressed from 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.
The design, recruitment, and study population were previously described. We identified patients as potentially eligible for our study who agreed to undergo quantitative coronary angiography. Following angiography, 93 patients remained eligible and were randomly assigned to experimental or control groups using a randomized invitational design to minimize crossover, ethical concerns, nocebo effects, and dropout.
Of these 93 patients who were eligible, 53 were randomly assigned to the experimental group and 40 to the usual-care control group. To detect possible selection biases, we collected data on age, marital status, reported angina, history of myocardial infarction, height, weight, number of diseased lesions, and stenosis severity for all patients who were randomized into the study but refused to participate.
We did not exclude any experimental group patients who volunteered even if we doubted their ability to adhere to the lifestyle program. All patients who volunteered were followed up using the intention-to-treat principle. After 1 year, 7 patients did not provide angiographic data, and the reasons for loss to follow-up have been reported. Two of these patients whose angiographic data were not usable after 1 year agreed to undergo quantitative coronary arteriography after 5 years; these results are included in the baseline to 5-year comparisons.
Four experimental and 4 control patients who had an angiogram at 1 year did not have a third angiogram after 5 years. Three of these 4 patients in the experimental group refused a third angiogram patients only volunteered for a 1-year study that was subsequently extended , and 1 died between years 1 and 4; of the 4 control group patients who did not undergo a third angiogram, 1 died, 2 underwent revascularization of the arterial lesions under study, and 1 developed Parkinson disease and became too ill to be safely tested.
Cine arteriograms made in San Francisco, Calif, were sent to the University of Texas Medical School, Houston, for blinded quantitative analyses as previously described in detail. All results, except lesion changes at 1 year 18 experimental and 15 control subjects and cardiac events after 5 years all 28 experimental and 20 control subjects , are based on the total of 35 patients 20 experimental and 15 control subjects who had both baseline and 5-year angiograms.
Of the remaining lesions, 14 were lost to the 4-year follow-up, as follows: in the experimental group, 2 lesions were excluded due to technical failure during the angiogram and 2 had views that did not match; in the control group, views did not match for 3 lesions, 3 lesions were excluded due to technical failure, 1 was excluded due to angioplasty, and 3 were excluded due to coronary artery bypass surgery.
Of the lesions available for analysis at 4 years, were from the experimental group and 77 were from the control group. The 1-year original study and the 4-year extension were approved by the committees on human research at California Pacific Medical Center and University of California, San Francisco, and each patient signed a written consent form after being fully informed of the study requirements.
Patients completed a 3-day diet diary at baseline and after 1 and 5 years to assess nutrient intake and dietary adherence. Also, patients were asked to complete a questionnaire reporting the frequency and duration of exercise and of each stress management technique. Information from these sources was quantified into continuous scores using an a priori determined formula.
The adherence measure was a continuous score reflecting daily intake of cholesterol in milligrams , fat in grams , frequency and duration of exercise, frequency and duration of stress management techniques, and smoking. A score of 1. The technicians responsible for performing all medical tests were blinded to patient group assignment. Also, different personnel implemented the lifestyle intervention, conducted the tests, and computed statistical analyses, although the dietitian was made aware of the nutrient analysis to monitor patients' safety and adherence.
Quantitative coronary arteriograms were blindly analyzed without knowledge of group assignment. Only 1 patient in the experimental group was actively smoking at baseline, and she quit at entry. Control group patients were asked to follow the advice of their personal physicians regarding lifestyle changes. We decided a priori to use percent diameter stenosis as the primary dependent variable.
Statistical methods to compare the 2 groups were previously described. Statistical significances of group differences were obtained for baseline levels, 1-year changes, and 5-year changes using F tests. Change scores were used for the baseline to 1-year and baseline to 5-year follow-up periods, and analysis of baseline levels, 1-year changes, and 5-year changes were done separately. Relative rates for cardiac events were analyzed and tested by Poisson regression using exact tests Stata 5.
Analyses across the 35 volunteers at baseline for whom 4-year lesion data were available showed no significant differences between the experimental group and the control group in demographic characteristics, history of myocardial infarction, angioplasty, bypass surgery, lesion number, lesion stenosis, dietary fat or cholesterol intake, exercise and stress management practice, blood pressure, exercise capacity, and psychosocial measures Table 1 , Table 2 , Table 3.
More women were randomly assigned to the control group 4 than to the experimental group 1 ; this fact accounted for half the weight difference 10 kg between the 2 groups and most of the height difference 6 cm. Experimental group patients had a slightly larger body mass index measured as the weight in kilograms divided by the square of the height in meters The lower body mass index in the control group may be due to the larger number of women in the control group.
In the experimental group, adherence to all aspects of the program was excellent during the first year and good after 5 years, whereas control group patients maintained more moderate changes during the 5 years consistent with conventional guidelines Table 2. The percentage of daily energy calories provided by fruits, vegetables, whole grains, soy, other legumes, nonfat dairy, and alcohol was comparable at 1 year and at 5 years.
Since patients volunteered originally only for a 1-year study, there was a significant decrease in meeting attendance after 1 year for 4 of the patients. Walking was the recommended form of exercise, but some patients jogged or did more strenuous exercise. Patients in the experimental group lost In the control group, LDL cholesterol levels decreased by 1.
None of the experimental group patients took lipid-lowering drugs during the 5 years of the study. Fourteen patients in the experimental group and 11 patients in the control group took aspirin during the study. Triglycerides did not change significantly in either group.
High-density lipoprotein levels and blood pressure did not differ between the 2 groups. The decrease in angina in the control group after 5 years was in large part because 3 of the 5 patients who reported an increase in anginal episodes from baseline to 1 year underwent coronary angioplasty between years 1 and 5. Because of this reduction in angina in control group patients who underwent revascularization, the between-group differences were no longer significant after 5 years Table 5.
At baseline, there were no significant differences between the experimental and control groups in any measure of lesion severity Table 3. Figure 2 shows the experimental group changes in percent diameter stenosis from baseline to 5 years according to tertiles of adherence to the lifestyle intervention. Of interest is that this relationship was not related to age or disease severity.
There was no significant relationship between adherence and lesion changes in the control group, perhaps because many of these patients began taking lipid-lowering drugs, which may have confounded the ability to detect a possible relationship. Indeed, we found significant correlations between changes in lipid levels LDL and total cholesterol and changes in lesions in both groups.
These correlations remained significant when examining either the lipid values at 5 years or the change in lipid values from baseline to 5 years. As a secondary analysis, we examined the results in control group patients who began taking lipid-lowering drugs during the study. Percent diameter stenosis progressed from In the control patients who did not take lipid-lowering drugs the disease progressed from No experimental group patients took lipid-lowering drugs during the study.
In other words, those who gained weight were more likely to show progression of atherosclerosis. Data on cardiac events were obtained from all 48 patients. Cardiac events included myocardial infarction, coronary angioplasty, coronary artery bypass surgery, cardiac-related hospitalizations, and cardiac-related deaths. At 5 years, there were more cardiac events in the control group 45 events for 20 patients, or 2.
The primary end point of this study, chosen a priori, was percent diameter stenosis. On average, there was more reduction continued improvement after 5 years than after 1 year in experimental group patients who were asked to make intensive lifestyle changes. In contrast, control group patients showed much more progression continued worsening in average percent diameter stenosis after 5 years than after 1 year, even though more than half of the control group patients were prescribed lipid-lowering medications during the course of the study.
Although the sample size was relative small, 12 these differences were statistically significant at both 1 year and 5 years. These findings support the feasibility of intensive lifestyle changes in delaying, stopping, or reversing the progression of coronary artery disease in ambulatory patients over prolonged periods.
We found more than twice as many cardiac events per patient in the control group than in the experimental group. These findings are consistent with other clinical trials showing that even small changes in percent diameter stenosis are often accompanied by marked reductions in cardiac events. Although there was some reduction in adherence to the intensive lifestyle intervention between years 1 and 5 in the experimental group, long-term adherence remained remarkably high in this sample of self-selected patients.
The level of lifestyle change, even at 5 years, is greater than in any other published study of ambulatory populations. These results are especially encouraging because these patients initially volunteered to participate for only 1 year when they entered the study. High-density lipoprotein levels decreased and triglycerides increased in experimental group patients overall, although the ratio of LDL to HDL was improved.
Recent reports assert that this phenomenon, which is often seen in very low-fat diets, may be harmful. Low HDL cholesterol levels due to reduced fat intake are the result of a decreased transport rate rather than the increased catabolism that is responsible for most cases of low HDL cholesterol levels in persons consuming a typical Western diet.
Our data provide evidence using quantitative coronary arteriography in this population that diet-induced lowering of HDL cholesterol does not confer the same risk of atherosclerosis as do low HDL cholesterol levels in Americans consuming a high-fat diet. The experimental group's marked reduction in frequency, severity, and duration of angina after 1 year was sustained at similar levels after 5 years.
This long-term reduction in angina is comparable with that achieved following coronary artery bypass surgery or angioplasty and helps to maintain long-term adherence.
When we began this study, we believed that the younger patients with milder disease would be more likely to show regression, but we did not find this to be true.
Instead, we found that the primary determinant of change in percent diameter stenosis in the experimental group was neither age nor disease severity but adherence to the recommended changes in diet and lifestyle. This relationship of adherence to percent diameter stenosis in the experimental group was found after 1 year 3 and also after 5 years in a dose-response relationship. Coronary artery minimum diameter remained stable in the experimental group but markedly narrowed in the control group during the 5 years of the study.
These data are consistent with other studies indicating that moderate changes in diet and lifestyle may not be sufficient to stop the progression of coronary atherosclerosis unless combined with lipid-lowering drugs.
After 5 years, the normal diameter the segment of least narrowing proximal to the minimum diameter decreased slightly in the experimental group but widened slightly in the control group. A slight decrease in normal diameter, at least up to a point, may improve myocardial perfusion by streamlining flow—decreasing the forward flow losses that occur when going from a larger to a sharply reduced lumen diameter.
These theoretical considerations are consistent with the substantially increased myocardial perfusion in the experimental group and decreased myocardial perfusion in the control group that we measured using cardiac positron emission tomography scans. More recently, an important study by Esselstyn et al 29 reported that a similar diet plus lipid-lowering drugs in 11 patients caused regression of 11 lesions and stabilization in the remaining 14 lesions after 5.
Although there was no control group, those who were adherent to the diet reported substantially fewer cardiac events than those who were not adherent.
Like all clinical trials, our study has limitations. Although the study participants were a diverse group, they may not be representative of the general population of patients with coronary heart disease.
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