Original Article
Mortality over a Period of 10 Years in Patients with Peripheral Arterial Disease
N Engl J Med 1992; 326:381-386February 6, 1992
- Abstract
- Abstract
Background.
Previous investigators have observed a doubling of the mortality rate among patients with intermittent claudication, and we have reported a fourfold increase in the overall mortality rate among subjects with large-vessel peripheral arterial disease, as diagnosed by noninvasive testing. In this study, we investigated the association of large-vessel peripheral arterial disease with rates of mortality from all cardiovascular diseases and from coronary heart disease.
Methods.
We examined 565 men and women (average age, 66 years) for the presence of large-vessel peripheral arterial disease by means of two noninvasive techniques — measurement of segmental blood pressure and determination of flow velocity by Doppler ultrasound. We identified 67 subjects with the disease (11.9 percent), whom we followed prospectively for 10 years.
Results.
Twenty-one of the 34 men (61.8 percent) and 11 of the 33 women (33.3 percent) with large-vessel peripheral arterial disease died during follow-up, as compared with 31 of the 183 men (16.9 percent) and 26 of the 225 women (11.6 percent) without evidence of peripheral arterial disease. After multivariate adjustment for age, sex, and other risk factors for cardiovascular disease, the relative risk of dying among subjects with large-vessel peripheral arterial disease as compared with those with no evidence of such disease was 3.1 (95 percent confidence interval, 1.9 to 4.9) for deaths from all causes, 5.9 (95 percent confidence interval, 3.0 to 11.4) for all deaths from cardiovascular disease, and 6.6 (95 percent confidence interval, 2.9 to 14.9) for deaths from coronary heart disease. The relative risk of death from causes other than cardiovascular disease was not significantly increased among the subjects with large-vessel peripheral arterial disease. After the exclusion of subjects who had a history of cardiovascular disease at base line, the relative risks among those with large-vessel peripheral arterial disease remained significantly elevated. Additional analyses revealed a 15-fold increase in rates of mortality due to cardiovascular disease and coronary heart disease among subjects with large-vessel peripheral arterial disease that was both severe and symptomatic.
Conclusions.
Patients with large-vessel peripheral arterial disease have a high risk of death from cardiovascular causes. (N Engl J Med 1992;326:381–6.)
Media in This Article
Figure 1
Kaplan–Meier Survival Curves Based on Mortality from All Causes among Normal Subjects and Subjects with Symptomatic or Asymptomatic Large-Vessel Peripheral Arterial Disease (LV-PAD).Figure 2
Kaplan–Meier Survival Curves Based on Mortality from All Causes among Normal Subjects and Subjects with Symptomatic or Asymptomatic Large-Vessel Peripheral Arterial Disease (LV-PAD), after the Exclusion of Subjects with Evidence of Cardiovascular Disease at Base Line.Article Activity
- Article
WE have previously reported an association between large-vessel peripheral arterial disease diagnosed with the noninvasive techniques of segmental blood-pressure measurement and determination of flow velocity by ultrasonography and the rate of mortality from all causes during the subsequent four years.1 In these analyses, large-vessel peripheral arterial disease was strongly related to the mortality rate, with a relative risk of death of 4.5 for patients with such disease; this association was independent of other risk factors for cardiovascular disease and of the presence of cardiovascular disease at base line. In that study, however, it was not possible to evaluate the rates of mortality from specific causes because of the small number of deaths in each category.
We have now followed this population for 10 years, and we report here our finding of an association of large-vessel peripheral arterial disease with mortality due to coronary heart disease, cardiovascular disease, and all causes. In addition, we report these associations in subgroups of subjects defined according to the severity of their symptoms and the anatomical location of the disease.
Methods
The study population initially comprised 624 men and women who were residents of a predominantly white, upper-middle-class community in southern California. The subjects were initially studied under a Lipid Research Clinics protocol involving two examinations, visit 1 and visit 2.2 A total of 4535 subjects 40 to 80 years of age came to the clinic for the first visit, and 1435 subjects for the second visit. Half the visit 2 subjects (n = 710) were chosen as a 15 percent random sample of the subjects who had come for visit 1, and the other half because they had hyperlipidemia, defined as a serum cholesterol level at or above the 90th percentile for age and sex, a serum triglyceride level at or above the 95th percentile, or the use of lipid-lowering medications. The present study evaluated a subgroup of the visit 2 subjects who were similar to the rest of the subjects in that group in terms of age, sex, and the percentage who had hyperlipidemia (47.9 percent).3 After a full explanation of the protocol, informed consent was obtained from all the study subjects.
Fifty-nine subjects, or 9.5 percent of the 624 who were eligible, were excluded from these analyses because of missing data or unreliable results on noninvasive testing. The excluded subjects were similar to the remainder of the study population with respect to subsequent mortality from all causes, cardiovascular disease, and coronary heart disease. Thus, 565 subjects (256 men and 309 women) remained to be studied; at base line they ranged in age from 38 to 82 years (average, 66). (An additional 90 subjects were later excluded from analysis because they had isolated small-vessel peripheral arterial disease rather than large-vessel peripheral arterial disease.)
Definition of Intermittent Claudication
Claudication was assessed by the Rose questionnaire4 and was defined as calf pain present on exercise but not at rest that was relieved within 10 minutes by rest. We also defined "possible" claudication as calf pain present on exercise but not at rest that otherwise did not fully meet the Rose criteria. Subjects who had leg pain at rest and those who had pain on exercise that did not include calf pain were not classified as having claudication.
Noninvasive Testing
Two noninvasive measures of perfusion in the lower extremities (segmental blood pressure and flow velocity) were used in diagnosing large-vessel peripheral arterial disease.3
The ratios of systolic blood pressure in the arm to systolic pressure at five different levels in the leg (at the upper thigh, above the knee, below the knee, above the ankle, and in the toe) were determined by the sphygmomanometric technique, with a mercury-in-Silastic gauge for the toe.5 6 7 Wide cuffs (15.5 cm) were used to obtain the three most proximal pressures and a 13.0-cm cuff for the pressure above the ankle. With these cuffs, the normal blood-pressure ratio (mean ±SD) is 1.0±0.15. Only blood-pressure ratios of 0.8 or less correlate well with angiographic evidence of the presence of arterial disease in the lower extremities.8
The Doppler effect produced by back-scattered ultrasound from red cells in motion was used to measure flow velocity in the femoral and posterior tibial arteries. Femoral peak forward flows ≤20 cm per second and posterior tibial peak forward flows ≤10 cm per second are considered to be abnormal when accompanied by delayed pulse decays or reduced deceleration, determined on the basis of angiographic comparison.9 A high degree of reproducibility has been established for these flow velocities in both arteries.9
Identification of Large-Vessel Peripheral Arterial Disease
Large-vessel peripheral arterial disease was diagnosed when either abnormal segment-to-arm blood-pressure ratios or abnormal flow velocities were found. Details of these criteria have been published elsewhere.1 , 3 We further subdivided the subjects with large-vessel peripheral arterial disease into two groups: those with moderate disease, defined by the presence of either abnormal blood-pressure ratios or abnormal flow velocities, and those with severe disease, defined by the presence of both abnormal blood-pressure ratios and abnormal flow velocities. Although these tests measure dynamic aspects of perfusion rather than the degree of anatomical obstruction, their results have been shown to be very highly correlated with large-vessel peripheral arterial disease of moderate or greater severity as determined angiographically.5 6 7 8 9
In various analyses, the subjects were classified as having large-vessel peripheral arterial disease that was either moderate or severe; as having either symptomatic claudication according to the Rose criteria (or "possible" claudication) or no symptoms; as having either unilateral or bilateral disease; and according to the anatomical location of the disease.
The subjects were asked whether they had ever had surgery for poor circulation to the extremities, other than for varicose veins, and if so, the nature and location of the surgery. Those with a documented history of surgery for large-vessel peripheral arterial disease underwent noninvasive testing along with the other subjects. Because surgery can improve blood flow substantially, for these analyses the subjects who had had such surgery (n = 6) were considered to have had severe, symptomatic disease.
Covariates
At base line the subjects completed a questionnaire that included information on their age and their cigarette-smoking habits. Their weight (in kilograms) and height (in meters) were measured, and the body-mass index (the weight in kilograms divided by the square of the height in meters) was calculated. Blood pressure was measured, while the subjects were seated, with a standard sphygmomanometer. The serum levels of high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol and triglycerides were measured with standardized methods from the Lipid Research Clinics program.10 The fasting plasma glucose level was measured on a Beckman ASTRA-8 automated system (Beckman, Brea, Calif.). To control for the overrepresentation of subjects with hyperlipidemia in our population, we included a term for the criterion used in selecting the subject (random sample vs. hyperlipidemia) as a covariate.
Dependent Variables
The study population was surveyed annually to ascertain deaths, and reported deaths were confirmed by death certificates. Using the International Classification of Diseases, 9th Revision, Clinical Modification, 11 a certified nosologist assigned the underlying cause of deaths due to coronary heart disease to one of the codes from 410 through 414 and those due to cardiovascular disease to a code from 400 through 444. Follow-up for mortality was complete for all patients.
Statistical Analysis
Ninety subjects with isolated small-vessel peripheral arterial disease were excluded from our analyses, since this condition is epidemiologically and pathophysiologically distinct from large-vessel peripheral arterial disease12 and by definition does not overlap with it. After this additional exclusion, 475 subjects remained for analysis: 34 men with large-vessel peripheral arterial disease and 183 men with no evidence of such disease (normal men), and 33 women with large-vessel peripheral arterial disease and 225 women with no evidence of such disease (normal women). After we excluded subjects with a history of cardiovascular disease (defined as a history of myocardial infarction, coronary-artery bypass surgery, stroke, or stroke-related surgery) at base line, there remained 162 normal men and 24 men with large-vessel peripheral arterial disease, and 204 normal women and 26 women with large-vessel peripheral arterial disease. We calculated crude, sex-specific rates of death from all causes, from cardiovascular disease, and from coronary heart disease for normal subjects, all subjects with large-vessel peripheral arterial disease, and subjects with various subcategories of large-vessel peripheral arterial disease. Cox proportional-hazards models were used to adjust for age, selected covariates, and differences in follow-up time.13 Cox models were run with and without the inclusion of the subjects who had evidence of cardiovascular disease at base line. Kaplan–Meier survival curves14 were calculated for the normal subjects, the subjects with asymptomatic large-vessel peripheral arterial disease, the subjects with symptomatic disease, and the subgroup of subjects with severe symptomatic disease.
Results
Table 1Table 1
Crude, Sex-Specific 10-Year Mortality Rates per 100 Subjects and Age-Adjusted Relative Risks (RR) of Death According to the Presence or Absence of Large-Vessel Peripheral Arterial Disease (LV-PAD).* shows crude, sex-specific rates of death due to all causes, cardiovascular disease, coronary heart disease, and noncardiovascular causes for normal subjects and subjects with large-vessel peripheral arterial disease, and the relative risks, adjusted for age and follow-up time, for these events for subjects with large-vessel peripheral arterial disease as compared with normal subjects. For both sexes, the death rates were sharply higher among those with large-vessel peripheral arterial disease; although the absolute rates were lower in women, the relative risks were similar to those in men. The elevated risk of death from all causes was due mostly to increased rates of death from coronary heart disease and cardiovascular disease, since the rates for other causes were only marginally (and not significantly) elevated. The results were similar after the exclusion of subjects with a history of cardiovascular disease at base line, except for a lower relative risk of death from coronary heart disease among women (relative risk, 1.9; 95 percent confidence interval, 0.2 to 18.5). Because the association of large-vessel peripheral arterial disease with mortality was similar for men and women, subsequent analyses were performed for both sexes combined. Table 2Table 2
Cox Proportional-Hazards Analysis of the Relative Risk (RR) of Death among Subjects with Large-Vessel Peripheral Arterial Disease.* shows relative risks and 95 percent confidence intervals derived from proportional-hazards models adjusted for age, sex, number of cigarettes smoked per day, systolic blood pressure, HDL cholesterol level, LDL cholesterol level, the logarithm of the triglyceride level, fasting plasma glucose level, body-mass index, and selection criterion. Among all subjects, there was little change after adjustment in the relative risks of death from all causes, cardiovascular disease, and coronary heart disease. In similar analyses conducted after we excluded subjects with evidence of cardiovascular disease at base line, the relative risks for mortality from all causes and mortality due to cardiovascular disease were essentially unchanged. The relative risk of mortality due to coronary heart disease decreased somewhat, from 6.6 to 4.3, but the latter was still significant.Table 3Table 3
Relative Risk of Death among Subjects with Various Categories of Large-Vessel Peripheral Arterial Disease (LV-PAD).* shows the relative risks and 95 percent confidence intervals derived from proportional-hazards models for mortality among subjects with various categories of peripheral arterial disease. Minor discrepancies in the number of subjects in each category reflect missing information about three subjects in Table 3 and two subjects in Table 4Table 4
Relative Risk of Death among Subjects with Various Categories of Large-Vessel Peripheral Arterial Disease (LV-PAD), after the Exclusion of Subjects with Evidence of Cardiovascular Disease (CVD) at Base Line.*. Subjects with bilateral large-vessel peripheral arterial disease had only a slightly higher risk of death from cardiovascular disease or coronary heart disease than those with unilateral disease. By contrast, subjects with symptomatic disease or severe disease had sharply higher risks of death due to cardiovascular disease and coronary heart disease than subjects with asymptomatic or moderately severe disease. Table 4 shows similar results after the exclusion of subjects with cardiovascular disease at base line. The results were essentially unchanged from those shown in Table 3, although the contrasts between subjects with moderate and severe large-vessel peripheral arterial disease and those with asymptomatic and symptomatic disease were even greater after this exclusion.Thirty-one of 64 subjects with large-vessel peripheral arterial disease had an abnormality limited to reduced or absent flow velocity in the posterior tibial artery (Table 3). None of these subjects had symptomatic disease. After the exclusion of subjects with evidence of cardiovascular disease at base line, 28 of the 48 subjects had isolated posterior tibial disease (Table 4). Their risks of death due to coronary heart disease and cardiovascular disease were slightly lower than those for subjects with other types of large-vessel peripheral arterial disease, an expected finding since their disease was asymptomatic and moderate. Nonetheless, their risks of mortality due to coronary heart disease and cardiovascular disease were still elevated as compared with those in the normal group.
Figure 1Figure 1
Kaplan–Meier Survival Curves Based on Mortality from All Causes among Normal Subjects and Subjects with Symptomatic or Asymptomatic Large-Vessel Peripheral Arterial Disease (LV-PAD). shows survival curves (based on mortality from all causes) for normal subjects, subjects with asymptomatic large-vessel peripheral arterial disease, subjects with symptomatic disease, and a subgroup of subjects with severe symptomatic disease. Asymptomatic disease was associated with markedly reduced survival as compared with the normal group, and symptomatic disease with an even poorer prognosis. The subgroup of subjects with severe symptomatic large-vessel peripheral arterial disease had the worst prognosis; only one in four survived 10 years. Figure 2Figure 2Kaplan–Meier Survival Curves Based on Mortality from All Causes among Normal Subjects and Subjects with Symptomatic or Asymptomatic Large-Vessel Peripheral Arterial Disease (LV-PAD), after the Exclusion of Subjects with Evidence of Cardiovascular Disease at Base Line. shows similar results after the exclusion of the subjects who had evidence of cardiovascular disease at base line.Discussion
These findings confirm and extend our earlier report of a strong and independent association of large-vessel peripheral arterial disease (as diagnosed by noninvasive testing) with subsequent mortality from all causes and demonstrate that the excess risk of death is due almost entirely to an increase in deaths from cardiovascular disease, especially coronary heart disease. Because the risk estimates for mortality from all causes, from cardiovascular disease, and from coronary heart disease among subjects with large-vessel peripheral arterial disease did not change substantially after adjustment for a number of cardiovascular risk factors, the independent prognostic importance of large-vessel peripheral arterial disease was confirmed. The minimal change in the relative risks of death due to cardiovascular disease and coronary heart disease after adjustment for risk factors for cardiovascular disease was unexpected, given the strong association of risk factors with large-vessel peripheral arterial disease in this population.12 However, the distributions of risk factors among subjects with and without cardiovascular disease overlap considerably, and the presence of large-vessel peripheral arterial disease may reflect a particular susceptibility to the development of atherosclerosis.
The small change in the relative risks after the exelusion of subjects who had evidence of cardiovascular disease at base line confirms that the association could not be explained by clinically apparent preexisting disease. The relative risk of death due to coronary heart disease did fall from 6.6 to 4.3 after the exclusion of subjects who had cardiovascular disease at base line. However, the lower value still indicates a sharp and statistically significant elevation of risk. These results suggest that the presence of severe or symptomatic large-vessel peripheral arterial disease may indicate a sharply increased probability of clinically important (although possibly silent) atherosclerosis in the coronary or cerebrovascular arteries as well.
We found that unilateral, moderately severe, or asymptomatic disease and disease isolated in the posterior tibial artery increased the risk of death from coronary heart disease and cardiovascular disease three- to six-fold, suggesting a markedly increased risk among persons with large-vessel peripheral arterial disease that would not ordinarily come to clinical attention. For patients with symptomatic or severe disease who are likely to be seen clinically, the 10-year risk of death due to coronary heart disease or cardiovascular disease was 10 to 15 times greater than for subjects who were free of large-vessel peripheral arterial disease. A further analysis of the risk of subsequent mortality in the subjects with severe and symptomatic large-vessel arterial disease revealed a relative risk of about 15 for both death due to coronary heart disease and death due to cardiovascular disease, indicating a grave prognosis for such patients. After we excluded subjects who had cardiovascular disease at base line, these relative risks were even higher. The survival curves (Fig. 1 and 2) confirm the poor overall prognosis for persons with large-vessel peripheral arterial disease, and the increasingly poor prognosis with increasing severity of disease. However, they also illustrate the markedly increased risk even for asymptomatic patients, whose disease frequently would not be detected clinically.
Many previous studies have reported an approximate doubling of the mortality rate among patients with intermittent claudication.15 16 17 18 19 A recent study had similar findings20 and confirmed our earlier finding of equally high risks for patients with atypical as compared with classic claudication.1 However, the accuracy of self-reported claudication in diagnosing large-vessel peripheral arterial disease is limited,21 , 22 and the results of this study show that patients with severe or symptomatic large-vessel peripheral arterial disease actually have 4 to 7 times the risk of mortality from all causes, and a risk of mortality from cardiovascular disease that may be up to 15 times higher, than that of persons who do not have large-vessel peripheral arterial disease.
We suggest that patients with documented large-vessel peripheral arterial disease receive a careful cardiovascular evaluation and, if appropriate, treatment of cardiovascular disease and management of known cardiovascular risk factors. Among these, cigarette smoking,23 , 24 hyperlipidemia,25 26 27 and hypertension28 29 30 are of prime importance. Other risk factors, such as a sedentary lifestyle, obesity, and glucose intolerance, may also be amenable to intervention, but the long-term effect of the modification of these risk factors on cardiovascular disease is unknown.
Supported by grants (HL 22255 and HL 42973) from the NIH.
Source Information
From the Divisions of Epidemiology (M.H.C., R.D.L., H.S.F., M.R.K., T.J.M.) and Health Care Sciences (D.B.), Department of Community and Family Medicine; the Division of Cardiology, Department of Medicine (M.H.C.); and the Division of General Surgery, Department of Surgery (A.F.), University of California, San Diego, School of Medicine, La Jolla. Address reprint requests to Dr. Criqui at the Department of Community and Family Medicine, Division of Epidemiology-0607, University of California, San Diego, School of Medicine, La Jolla, CA 92093–0607.
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