James D. Hosking

Surgical revascularization versus thrombolysis for nonembolic lower extremity native artery occlusions: Results of a prospective randomized trial

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.

Assessment of quality of life as observed from the baseline data of the Studies of Left Ventricular Dysfunction (SOLVD) trial quality-of-life substudy

The improvement of aspects of a patients quality of life may be as important as prolonging survival in evaluating clinical trials of heart failure. The purpose of this study was to analyze the psychometric properties of the baseline measures from the quality-of-life substudy from the Studies of Left Ventricular Dysfunction (SOLVD) trial. The measures included the 6-Minute Walk Test, Dyspnea Scale, Living with Heart Failure, Physical Limitations, Psychologic Distress and Health Perceptions, as reported by both patients and staff. Cognitive functioning, such as Vocabulary, Digit Span and Trails Making, was also assessed. Patients were classified as New York Heart Association class I (n = 158) versus II or III (n = 150). The internal consistencies (i.e., reliabilities) of the self-report measures were high, except for the Health Perceptions of Class II or III patients. Reliability of the SOLVD quality-of-life battery was confirmed by significantly better life quality among New York Heart Association class I patients versus class II or III patients combined on the Walk Test, Physical Limitations, Dyspnea, Living with Heart Failure, Psychologic Distress and staff perceptions of patient health. In accordance with prior studies, the measures were uncorrelated with left ventricular ejection fraction. By demonstrating strong internal consistencies, reliability based on physician reports, and independence of ejection fraction levels, use of this quality-of-life assessment battery in this and other clinical trials of compromised ventricular functioning is supported.

The Depression Interview and Structured Hamilton (DISH): Rationale, development, characteristics, and clinical validity

Objective The Depression Interview and Structured Hamilton (DISH) is a semistructured interview developed for the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study, a multicenter clinical trial of treatment for depression and low perceived social support after acute myocardial infarction. The DISH is designed to diagnose depression in medically ill patients and to assess its severity on an embedded version of Williams’ Structured Interview Guide for the Hamilton Depression scale (SIGH-D). This article describes the development and characteristics of the DISH and presents a validity study and data on its use in ENRICHD. Methods In the validity study, the DISH and the Structured Clinical Interview for DSM-IV (SCID) were administered in randomized order to 57 patients. Trained interviewers administered the DISH, and clinicians administered the SCID. In ENRICHD, trained research nurses administered the DISH and recorded a diagnosis. Clinicians reviewed 42% of the interviews and recorded their own diagnosis. The Beck Depression Inventory (BDI) was administered in both studies. Results In the validity study, the SCID diagnosis agreed with the DISH on 88% of the interviews (weighted &kgr; = 0.86). In ENRICHD, the clinicians agreed with 93% of the research nurses’ diagnoses. The BDI and the Hamilton depression scores derived from the DISH in the two studies correlated 0.76 (p < .0001) in the validity study and 0.64 (p < .0001) in ENRICHD. Conclusions These findings support the validity of the DISH as a semistructured interview to assess depression in medically ill patients. The DISH is efficient in yielding both a DSM-IV depression diagnosis and a 17-item Hamilton depression score.

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.

Aspects of social support associated with depression at hospitalization and follow-up assessment among cardiac patients.

PURPOSE High levels of depressive symptoms have been shown to affect the morbidity, mortality, and functioning of patients with myocardial infarction (MI). Findings have shown that social support is associated with depression in both patient and community samples. This study examined various aspects of social support as they relate to depressive symptoms in patients with MI, both in the hospital and 2 weeks later. METHODS As part of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) pilot study, measures of perceived social support, social networks, social support received, and social conflict were administered to 196 patients with MI. These patients also were administered the Beck Depression Inventory and the Hamilton Rating Scale for Depression. Depression was reassessed 2 weeks later. Relations between social support indicators and the depression measures were examined. RESULTS The prevalence of depression symptoms was high, especially among poorer and younger patients. There was modest improvement across time. Patients with high social support scores, particularly those reflecting perceived support, had lower scores on depression measures at baseline. High levels of perceived support and low social conflict at baseline were associated with less follow-up depression, as measured by the Beck cognitive scale, but not the Beck somatic scale nor the Hamilton scale. There were few associations with measures of social networks and received support. CONCLUSIONS Social support indicators were differentially related to depression among patients with MI while in the hospital and 2 weeks later. The pattern of associations also depended on the measure of depression. A broad assessment strategy of both social support and depression is needed for a full understanding of their interrelations.

A randomized controlled trial of a public health nurse directed treatment program for rural patients with high blood cholesterol.

BACKGROUND Many rural residents do not have access to high-quality nutrition counseling for high blood cholesterol. The objective of this study was to assess the effectiveness of an intervention program designed to facilitate dietary counseling for hypercholesterolemia by rural public health nurses. METHODS Eight health departments (216 participants) were randomized to give the special intervention (SI) and nine (252 participants) to give the minimal intervention (MI). The SI consisted of three individual diet counseling sessions given by a public health nurse, using a structured dietary intervention (Food for Heart Program), referral to a nutritionist if lipid goals were not achieved at 3-month follow-up, and a reinforcement phone call and newsletters. Diet was assessed by the Dietary Risk Assessment (DRA), a validated food frequency questionnaire, at baseline, 3-, and 12-month follow-up; blood lipids and weight were assessed at baseline, 3-, 6-, and 12-month follow-up. RESULTS Participants were largely female (71%), older (mean age 55), and white (80%). At 3-month follow-up, the average reduction (indicating dietary improvement) in total Dietary Risk Assessment score was 3.7 units greater in the SI group (95% confidence interval [CI] 1.9 to 5.5, P = 0.0006), while both groups experienced a similar reduction in blood cholesterol, 14.1 mg/dL (0.37 mmol/L) for SI and 14.5 mg/dL (0.38 mmol/L) for minimal intervention group (difference -0.4 mg/dL [-0.010 mmol/L], 95% CI -12.5 to 11.7 [-0.32 to 0.30], P = 0.9). At 12-month follow-up, the reduction in total Dietary Risk Assessment score was 2.1 units greater in the SI group (95% CI 0.8 to 3.5, P = 0.005), while the reduction in blood cholesterol was similar in both groups, 18.4 mg/dL (0.48 mmol/L) for SI and 15.6 mg/dL (0.40 mmol/L) for minimal intervention group (difference 2.8 mg/dL [0.07 mmol/L], 95% CI -7.5 to 13.1 [-0.19 to 0.34], P = 0.6). During follow-up, weight loss was greater in the SI group; the difference between groups was statistically significant at 3 (1.9 lb [0.86 kg], 95% CI 0.3 to 3.4 [0.14 to 1.55], P = 0.022) and 6 months (2.1 lb [0.95 kg], 95% CI 0.1 to 4.1 [0.04 to 1.86], P = 0.04). At 12 months, the difference was not significant (1.6 lb [0.73 kg], 95% CI -0.05 to 3.7 [-0.02 to 1.68], P = 0.13). CONCLUSIONS Improvement in self-reported dietary intake was significantly greater in the SI group, while reduction in blood cholesterol was similar in both groups.

Baseline Characteristics of the Study Population in the Diabetes Atherosclerosis Intervention Study (DAIS)

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.

Nonorthogonal Analysis of Variance Programs: An Evaluation

Recently, at least four methods have been suggested for the analysis of nonorthogonal designs. However, even researchers who have decided which method is appropriate often do not know which computer programs are capable of performing the desired analysis. In addition, available programs differ widely in their accuracy and ease of use. We have evaluated some widely used ANOVA computer programs with respect to their capabilities for performing analyses using all four methods, their accuracy in performing these analyses, and other characteristics which influence their utility.