Baseline characteristics of the study population in the Diabetes Atherosclerosis Intervention Study (DAIS). World Health Organization Collaborating Centre for the Study of Atherosclerosis in Diabetes.

The Diabetes Atherosclerosis Intervention Study (DAIS) is the first study designed a priori to determine whether correcting dyslipoproteinemia in type II diabetes will alter coronary atherosclerosis. It is a multinational randomized double-blind, placebo-controlled trial using micronized fenofibrate. Its primary end point is a change in the average mean segment diameter determined on coronary angiograms taken at the beginning and end of the treatment period. This study describes the population baseline characteristics. Four hundred eighteen individuals (305 men and 113 women) were randomized; 168 patients were from Canadian clinics and 250 from those in Europe. Because the patients in both regions were very similar, it was possible to pool their data. All had > or = 1 minimally visible lesion on coronary angiography. Their average (+/-SD) lipid levels were: triglycerides 2.42 +/- 1.00 mmol/L, total cholesterol 5.57 +/- 0.70 mmol/L, low-density lipoprotein cholesterol 3.43 +/- 0.70 mmol/L, and high-density lipoprotein cholesterol 1.03 +/- 0.20 mmol/L. They were in very good glycemic control (hemoglobin A1c [HbA1c] 7.51 +/- 1.20%). The remainder of the coronary risk factors and demographic characteristics are described in the following. The characteristics of the DAIS population should determine whether correcting the dyslipoproteinemia seen in type II diabetes alters the progression and/or regression of angiographically determined coronary disease, to ascertain whether there is a difference between those with previous coronary intervention and those without, and to determine whether there is a gender effect.

A cholesterol intervention program for public health nurses in the rural southeast: description of the intervention, study design, and baseline results.

Residents of the rural South are at high risk for heart disease and are frequently identified as having high blood cholesterol, but sources for nutrition counseling in rural areas are often limited. To increase the availability of high quality nutrition counseling, the Food for Heart Program was developed for public health nurses and is designed to circumvent many of the obstacles common to dietary counseling. We conducted a randomized trial to assess the effectiveness of this program to lower blood cholesterol. In this report, we describe the study design, intervention program, and baseline characteristics of participants. Nurses at 17 health departments screened 781 subjects to enroll 468 with high blood cholesterol: three-quarters of the subjects were female, the mean age was 55, and 80% were white. Participants were at high risk for heart disease: 60% had two or more risk factors for coronary disease, the majority were overweight with a mean BMI of 29, and the mean cholesterol was 257 mg/dL. Reported baseline dietary intake included relatively modest consumption of high fat meats and snack foods, excessive consumption of sweets, modest intake of complex carbohydrates, and inadequate consumption of fruits and vegetables.

An analysis of perioperative surgical mortality and morbidity in the asymptomatic carotid atherosclerosis study. ACAS Investigators. Asymptomatic Carotid Atherosclerosis Study.

BACKGROUND AND PURPOSE: Our aim was to determine the perioperative morbidity and mortality rates of patients in the surgical arm of the multi-institutional, prospective, randomized Asymptomatic Carotid Atherosclerosis Study (ACAS). METHODS: Of 828 patients with carotid stenosis of 60% or more randomized to the surgical arm of ACAS, 721 underwent carotid endarterectomy (CEA). To qualify for participation, surgeons were required to have performed at least 12 CEAs per year with a combined neurological morbidity and mortality rate no greater than 3% for asymptomatic patients and 5% for symptomatic patients. Clinical centers had to demonstrate arteriographic morbidity less than 1% and mortality less than 0.1% per year. Primary events were stroke and death in the period between randomization and 30 days after surgery; secondary events were transient ischemic attack and myocardial infarction occurring in the same period. RESULTS: Of the 721 patients who underwent CEA, 1 died and 10 others had strokes within 30 days (1.5%). Of the 415 who underwent arteriography after randomization but before CEA, 5 (1.2%) suffered transient ischemic attack or stroke caused by arteriography. Thus, a nearly equal risk of stroke was associated with both CEA and carotid arteriography. In addition, 6 transient ischemic attacks and 3 myocardial infarctions could be directly linked to CEA, for a total CEA event rate of 2.6%. CONCLUSIONS: Patients with asymptomatic internal carotid artery stenosis exceeding 60% reduction in diameter who are acceptable candidates for elective operation may be considered for CEA if the combined arteriographic and surgical complication rates are 3% or less.

Surgical revascularization versus thrombolysis for nonembolic lower extremity native artery occlusions: results of a prospective randomized trial. The STILE Investigators. Surgery versus Thrombolysis for Ischemia of the Lower Extremity.

PURPOSE: Early results of a prospective study that compared surgical revascularization and thrombolysis for lower extremity arterial and graft occlusions have been published. This report details the final results in patients who have native artery occlusions. METHODS: Two hundred thirty-seven patients who had lower extremity ischemia as a result of iliac-common femoral (IF; 69 patients) or superficial femoral-popliteal (FP; 168 patients) occlusion, and had symptomatically deteriorated within the past 6 months were randomized to catheter-directed thrombolysis (150 patients) or surgical revascularization (87 patients). After diagnostic arteriographic examination but before randomization, the optimal surgical procedure was determined. Lytic patients were randomized to recombinant tissue plasminogen activator (rt-PA; 84 patients) or urokinase (UK; 66 patients). Recurrent ischemia, morbidity, amputation, and death rates were determined at 30 days, 6 months, and 1 year, and were analyzed on an intent-to-treat basis. RESULTS: For patients randomized to lysis, a catheter was properly positioned and the lytic agent delivered in 78%. This provided a reduction in the predetermined surgical procedure in 58% of patients who had an FP occlusion and 51% of those who had an IF occlusion. rt-PA and UK were equally effective and safe, but lysis time was shorter with rt-PA (8 vs 24 hr; p < 0.05). At 1 year, the incidence of recurrent ischemia (64% vs 35%; p < 0.0001) and major amputation (10% vs 0%; p = 0.0024) was increased in patients who were randomized to lysis. Factors associated with a poor lytic outcome included FP occlusion, diabetes, and critical ischemia. No differences in mortality rates were observed at 1 year between the lysis and surgical groups. CONCLUSION: Surgical revascularization for lower extremity native artery occlusions is more effective and durable than thrombolysis. Thrombolysis used initially provides a reduction in the surgical procedure for a majority of patients; however, long-term outcome is inferior, particularly for patients who have an FP occlusion, diabetes, or critical ischemia.

Results of a prospective, randomized trial of surgery versus thrombolysis for occluded lower extremity bypass grafts.

PURPOSE: The purpose of this study was to prospectively evaluate the treatment of patients with occluded lower extremity bypass grafts, comparing surgical revascularization with catheter-directed thrombolysis. MATERIALS AND METHODS: One hundred twenty-four patients (68% male and 32% female) with lower limb bypass graft occlusion (46 autogenous and 78 prosthetic) were prospectively randomized to surgery (n = 46) or intra-arterial catheter-directed thrombolysis (n = 78) with recombinant tissue plasminogen activator (rt-PA) 0.1 mg/kg/h modified to 0.05 mg/kg/h for up to 12 hours, or urokinase (UK) 250,000 U bolus followed by 4,000 U/min for 4 hours, then 2,000 U/min for up to 36 hours. A composite clinical outcome including death, amputation, ongoing/recurrent ischemia, and major morbidity was analyzed on an intent-to-treat basis at 30 days and 1 year. RESULTS: The average duration of graft occlusion was 34.0 days, with 58 (48%) presenting with acute ischemia (0 to 14 days) and 64 (52%) with chronic ischemia (> 14 days). Thirty-nine percent randomized to lysis failed catheter placement and required surgical revascularization. Overall, there was a better composite clinical outcome at 30 days (P = 0.023) and 1 year (P = 0.04) in the surgical group compared with lysis, due predominately to a reduction in ongoing/recurrent ischemia, most notable in autogenous grafts. However, following successful catheter placement, patency was restored by lysis in 84%, and 42% had a major reduction in their planned operation. One-year results of successful lysis compared favorably with the best surgical procedure, which was new graft placement. Acutely ischemic patients (0 to 14 days) randomized to lysis demonstrated a trend toward a lower major amputation rate at 30 days (P = 0.074) and significantly at 1 year (P = 0.026) compared with surgical patients, while those with > 14 days ischemia showed no difference in limb salvage but higher ongoing/recurrent ischemia in lytic patients (P < 0.001). Patients with occluded prosthetic grafts had greater major morbidity than did those with occluded autogenous grafts (P < 0.02). CONCLUSIONS: Proper catheter positioning currently limits the potential of catheter-directed thrombolysis for lower extremity bypass graft occlusion. Patients with graft occlusion > 14 days have a significantly better outcome when treated surgically, with a new bypass being the best surgical option. However, in patients with acute limb ischemia (< 14 days) successful thrombolysis of occluded lower extremity bypass grafts improves limb salvage and reduces the magnitude of the planned surgical procedure. Patients with occluded prosthetic grafts suffer more major morbid events compared with occluded autogenous grafts.

Is transcranial Doppler a worthwhile addition to screening tests for cerebrovascular disease?

PURPOSE: Carotid duplex imaging has become the standard diagnostic evaluation for patients with suspected cerebrovascular disease. Transcranial Doppler ultrasonography expands the noninvasive diagnostic capabilities to the intracranial circulation. The purpose of this study was to evaluate the results of routine transcranial Doppler studies on patients referred for noninvasive cerebrovascular evaluation. METHODS: A total of 670 patients had routine transcranial Doppler examinations as part of their noninvasive cerebrovascular evaluation. Patients were categorized clinically and according to their severity of extracranial internal carotid artery stenosis (< 50%, 50% to 79%, 80% to 99%, occlusion). Transcranial Doppler examinations were classified as normal or abnormal (intracranial stenosis, collateral pathway, > 30% velocity difference normal or abnormal (intracranial stenosis, collateral pathway, > 30% velocity difference between sides, flow reversal, and velocities +/- SD from normal). RESULTS: Forty-eight percent of the patients were women, and 52% were men. The average age was 65.5 years. Fifty-four percent of the patients were white, 42% were black, 3% were Hispanic, and 1% were other. Forty-eight percent presented with hemispheric symptoms, 34% had no symptoms, and 18% had nonhemispheric symptoms. Forty-five percent (304 of 670) had an interpretable transcranial Doppler examination. The ability to insonate the basal cerebral arteries through the temporal bone was significantly reduced in women (p < 0.0001), black patients (p < 0.0001), and older patients (p < 0.0001). The results of forty-four percent of interpretable examinations were normal, 19% demonstrated side-to-side velocity differences, 13% showed collateral pathways, 11% showed velocities +/- 2 SD, 10% showed an intracranial stenosis, and 4% showed reversed flow pattern. Although 56% of the patients had notable findings, no patient had their diagnostic or therapeutic plan altered by the transcranial Doppler results. CONCLUSION: Less than 50% of the patients referred for first-time cerebrovascular examination had access for an interpretable transcranial Doppler examination. Though the number of positive findings is reasonably high, no material impact on diagnostic or treatment plans was seen in the patients in this series. These results indicate that selection criteria for examination of the intracranial arteries should be refined and that transcranial Doppler scanning should not be incorporated as part of the "routine" noninvasive cerebrovascular examination.

Efficacy and safety of once-daily vs twice-daily dosing with fluvastatin, a synthetic reductase inhibitor, in primary hypercholesterolemia.

BACKGROUND: Fluvastatin sodium is a new, entirely synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor that may be an effective lipid-lowering agent in patients whose hyperlipidemia does not respond to dietary therapy. We conducted a study to evaluate the effects of fluvastatin on lipoprotein levels in subjects with primary hypercholesterolemia and to compare the efficacy and safety of two fluvastatin sodium dosing regimens: 20 mg once daily vs 10 mg twice daily. DESIGN: We conducted a double-blind, placebo-controlled, multicenter trial involving 207 patients with low-density lipoprotein cholesterol levels of 4.15 mmol/L (160 mg/dL) or higher despite dietary intervention and with triglyceride levels of 3.38 mmol/L or lower. Three parallel treatment groups received 6 weeks of treatment with 20 mg of fluvastatin sodium once daily, 10 mg of fluvastatin sodium twice daily, or a placebo. RESULTS: Total cholesterol and low-density lipoprotein cholesterol levels were reduced from baseline by 16% and 22%, respectively, with 20 mg of fluvastatin sodium once daily (P < .001) and by 17% and 23%, respectively, with 10 mg of fluvastatin sodium twice daily (P < .001). Fluvastatin was well tolerated, and there were no serious clinical or biochemical adverse events ascribable to the drug. CONCLUSIONS: Fluvastatin therapy demonstrated excellent short-term safety and efficacy in reducing total and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia. Fluvastatin sodium, the first totally synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to be used in clinical trials, appears to be both effective and well tolerated at 20 mg/d, given in either a single or divided dose.

Computer-assisted data collection in multicenter epidemiologic research. The Atherosclerosis Risk in Communities Study.

The Atherosclerosis Risk in Communities (ARIC) Study uses a computer-assisted data collection (CADC) system in which staff at four Field Centers directly record into microcomputers much of the data obtained from the 16,000 study participants during 4 hours of interviews and exams. A pilot study was conducted to evaluate the feasibility of training Field Center staff in the use of a CADC system and to assess study participants' reaction to such a system. When asked to compare CADC to a paper-based system, all five of the pilot study staff members preferred the CADC system. The 16 pilot study participants either had no preference (63%) or preferred CADC (37%). With respect to data quality, no systematic differences between the two methods of data collection were evident in the pilot study. The CADC system required approximately 10% longer for data collection, keying, and editing than the paper-based system took for collection alone. Immediate data entry in a CADC system may improve data quality by eliminating a transcription step and by allowing prompt detection of suspicious values while the participant is still available to provide confirmation or correction. CADC simplifies data collection by automating complex branching questions and can enhance data completeness. The ARIC CADC system is based on commercially available software customized by the study's Coordinating Center. The microcomputer-based CADC system described in this report may serve as the prototype for future epidemiologic studies that collect standardized data on large numbers of participants at a small number of sites.

Nutrient intakes among selected North American populations in the Lipid Research Clinics Prevalence Study: composition of fat intake.

Components of fat and their relationship to total energy are described for 2,368 white male and 2,200 white female adults, aged 20-59 years, for whom 24-hour dietary recalls were completed between 1972 and 1975 in nine North American populations as a part of the Lipid Research Clinics (LRC) Program Prevalence Study. Men had higher absolute intakes of total fat and cholesterol than women, although both sexes consumed diets similar in relative composition of polyunsaturated, saturated, and monounsaturated fatty acids. Marked geographical differences in intakes of energy, total fat, and dietary cholesterol were observed. Compared with data from dietary surveys conducted in the 1960's the LRC data showed that consumption of cholesterol had decreased by the early 1970's, whereas consumption of polyunsaturated fatty acids appears to have increased, resulting in a higher ratio of polyunsaturated to saturated fatty acids. However, comparison of current dietary guidelines with these data, which are based on a single dietary recall, showed that few LRC participants met the recommendations of the Senate Select Committee on Nutrition and Human needs for dietary fat intake.

Nutrient intakes among selected North American populations in the Lipid Research Clinics Prevalence Study: composition of energy intake.

Mean energy intake and its components are presented for 4,568 white adults, 20-59 years, who participated in a population survey at nine North American Lipid Research Clinics (LRC). Nutrient intake was evaluated by a 24-hour dietary recall. Mean energy intakes ranged from 3200 kcal at age 20 to 2400 kcal at age 59 for men (2150-1650 for women). Protein intake, about 15% of energy intake, exceeded 1 g/kg body weight at all ages. Carbohydrate intake was about 40-45% of kcal, starch provided 14-20%, and estimated sucrose intake provided about 6-14%. Sex- and age-related differences varied for each macronutrient. Mean alcohol intake, for those reporting alcohol consumption, contributed 6-18% of energy for women, and 8-15% for men. Comparisons are made with data from the Health and Nutrition Examination Survey I and from the USDA Nationwide Food Consumption Survey, with the Recommended Dietary Dietary Allowances, and with the Dietary Goals.