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At least 757 records · Page 42Linked to original sources
PubMed1996

Outcomes of a field trial to improve children's dietary patterns and physical activity. The Child and Adolescent Trial for Cardiovascular Health. CATCH collaborative group.

OBJECTIVE: To assess the outcomes of health behavior interventions, focusing on the elementary school environment, classroom curricula, and home programs, for the primary prevention of cardiovascular disease. DESIGN: A randomized, controlled field trial at four sites with 56 intervention and 40 control elementary schools. Outcomes were assessed using prerandomization measures (fall 1991) and follow-up measures (spring 1994). PARTICIPANTS: A total of 5106 initially third-grade students from ethnically diverse backgrounds in public schools located in California, Louisiana, Minnesota, and Texas. INTERVENTION: Twenty-eight schools participated in a third-grade through fifth-grade intervention including school food service modifications, enhanced physical education (PE), and classroom health curricula. Twenty-eight additional schools received these components plus family education. MAIN OUTCOME MEASURES: At the school level, two primary end points were changes in the fat content of food service lunch offerings and the amount of moderate-to-vigorous physical activity in the PE programs. At the level of the individual student, serum cholesterol change was the primary end point and was used for power calculations for the study. Individual level secondary end points included psychological factors, recall measures of eating and physical activity patterns, and other physiologic measures. RESULTS: In intervention school lunches, the percentage of energy intake from fat fell significantly more (from 38.7% to 31.9%) than in control lunches (from 38.9% to 36.2%)(P<.001). The intensity of physical activity in PE classes during the Child and Adolescent Trial for Cardiovascular Health (CATCH) intervention increased significantly in the intervention schools compared with the control schools (P<.02). Self-reported daily energy intake from fat among students in the intervention schools was significantly reduced (from 32.7% to 30.3%) compared with that among students in the control schools (from 32.6% to 32.2%)(P<.001). Intervention students reported significantly more daily vigorous activity than controls (58.6 minutes vs 46.5 minutes; P<.003). Blood pressure, body size, and cholesterol measures did not differ significantly between treatment groups. No evidence of deleterious effects of this intervention on growth or development was observed. CONCLUSION: The CATCH intervention was able to modify the fat content of school lunches, increase moderate-to-vigorous physical activity in PE, and improve eating and physical activity behaviors in children during 3 school years.

Analysis of Variance↗
PubMed2000

Intravenous ancrod for treatment of acute ischemic stroke: the STAT study: a randomized controlled trial. Stroke Treatment with Ancrod Trial.

CONTEXT: Approved treatment options for acute ischemic stroke in the United States and Canada are limited at present to intravenous tissue-type plasminogen activator, but bleeding complications, including intracranial hemorrhage, are a recognized complication. OBJECTIVE: To evaluate the efficacy and safety of the defibrinogenating agent ancrod in patients with acute ischemic stroke. DESIGN: The Stroke Treatment with Ancrod Trial (STAT), a randomized, parallel-group, double-blind, placebo-controlled trial conducted between August 1993 and January 1998. SETTING: Forty-eight centers, primarily community hospitals, in the United States and Canada. PATIENTS: A total of 500 patients with an acute or progressing ischemic neurological deficit were enrolled and included in the intent-to-treat analysis. INTERVENTIONS: Patients were randomly assigned to receive ancrod (n=248) or placebo (n =252) as a continuous 72-hour intravenous infusion beginning within 3 hours of stroke onset, followed by infusions lasting approximately 1 hour at 96 and 120 hours. The ancrod regimen was designed to decrease plasma fibrinogen levels to 1.18 to 2.03 micromol/L. MAIN OUTCOME MEASURES: The primary efficacy end point was functional status, with favorable functional status defined as survival to day 90 with a Barthel Index of 95 or more or at least the prestroke value, compared by treatment group. Primary safety variables included symptomatic intracranial hemorrhage and mortality. RESULTS: Favorable functional status was achieved by more patients in the ancrod group (42.2%) than in the placebo group (34.4%; P=.04) by the prespecified covariate-adjusted analysis. Mortality was not different between treatment groups (at 90 days, 25.4% for the ancrod group and 23% for the placebo group; P=.62), and the proportion of severely disabled patients was less in the ancrod group than in the placebo group (11.8% vs 19.8%; P=.01). The favorable functional status observed with ancrod vs placebo was consistent in all subgroups defined for age, stroke severity, sex, prestroke disability, and time to treatment (< or = 3 or > 3 hours after stroke onset). There was a trend toward more symptomatic intracranial hemorrhages in the ancrod group vs placebo (5.2% vs 2.0%; P=.06), as well as a significant increase in asymptomatic intracranial hemorrhages (19.0% vs 10.7%; P=.01). CONCLUSION: In this study, ancrod had a favorable benefit-risk profile for patients with acute ischemic stroke.

Ancrod↗
PubMed2000

Efficacy of 3 commonly used hearing aid circuits: A crossover trial. NIDCD/VA Hearing Aid Clinical Trial Group.

CONTEXT: Numerous studies have demonstrated that hearing aids provide significant benefit for a wide range of sensorineural hearing loss, but no carefully controlled, multicenter clinical trials comparing hearing aid efficacy have been conducted. OBJECTIVE: To compare the benefits provided to patients with sensorineural hearing loss by 3 commonly used hearing aid circuits. DESIGN: Double-blind, 3-period, 3-treatment crossover trial conducted from May 1996 to February 1998. SETTING: Eight audiology laboratories at Department of Veterans Affairs medical centers across the United States. PATIENTS: A sample of 360 patients with bilateral sensorineural hearing loss (mean age, 67.2 years; 57% male; 78.6% white). INTERVENTION: Patients were randomly assigned to 1 of 6 sequences of linear peak clipper (PC), compression limiter (CL), and wide dynamic range compressor (WDRC) hearing aid circuits. All patients wore each of the 3 hearing aids, which were installed in identical casements, for 3 months. MAIN OUTCOME MEASURES: Results of tests of speech recognition, sound quality, and subjective hearing aid benefit, administered at baseline and after each 3-month intervention with and without a hearing aid. At the end of the experiment, patients ranked the 3 hearing aid circuits. RESULTS: Each circuit markedly improved speech recognition, with greater improvement observed for soft and conversationally loud speech (all 52-dB and 62-dB conditions, P</=.001). All 3 circuits significantly reduced the frequency of problems encountered in verbal communication. Some test results suggested that CL and WDRC circuits provided a significantly better listening experience than PC circuits in word recognition (P =.002), loudness (P =.003), overall liking (P =.001), aversiveness of environmental sounds (P =.02), and distortion (P =.02). In the rank-order ratings, patients preferred the CL hearing aid circuits more frequently (41.6%) than the WDRC (29.8%) and the PC (28.6%) (P =.001 for CL vs both WDRC and PC). CONCLUSIONS: Each circuit provided significant benefit in quiet and noisy listening situations. The CL and WDRC circuits appeared to provide superior benefits compared with the PC, although the differences between them were much less than the differences between the aided vs unaided conditions. JAMA. 2000;284:1806-1813.

Adult↗
PubMed1991

A double-blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer. A collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic.

This trial was conducted to determine if the reported superiority of tamoxifen (TAM) plus prednisolone (PRDLN) over TAM alone in postmenopausal women with metastatic breast cancer could be corroborated. A total of 326 patients were randomized on a double-blind trial to TAM (10 mg twice daily) plus placebo or TAM plus PRDLN (5 mg twice daily). Six patients (2%) were disqualified. Considering 256 patients with measurable or evaluable disease, objective responses were seen in 48 (38%) of 126 TAM patients and 61 (47%) of 130 TAM plus PRDLN patients (chi-square, P = 0.15). Considering all 320 evaluated patients, median time to disease progression was 11 months for TAM and 10 months for TAM plus PRDLN (log rank, P = 0.81), and median survival time was 35 and 32 months, respectively (P = 0.40). Covariate analyses showed no significant association between treatment and outcome. Weight gain and edema were significantly greater with TAM plus PRDLN. The addition of PRDLN to TAM is not advocated for the management of postmenopausal women with metastatic breast cancer.

Adult↗
PubMed1997

A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin. The Stroke Prevention in Reversible Ischemia Trial (SPIRIT) Study Group.

Aspirin is only modestly effective in the secondary prevention after cerebral ischemia. Studies in other vascular disorders suggest that anticoagulant drugs in patients with cerebral ischemia of presumed arterial (noncardiac) origin might be more effective. The aim of the Stroke Prevention in Reversible Ischemia Trial (SPIRIT) therefore was to compare the efficacy and safety of 30 mg aspirin daily and oral anticoagulation (international normalized ratio [INR] 3.0-4.5). Patients referred to a neurologist in one of 58 collaborating centers because of a transient ischemic attack or minor ischemic stroke (Rankin grade < or =3) were eligible. Randomization was concealed, treatment assignment was open, and assessment of outcome events was masked. The primary measure of outcome was the composite event "death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction, or nonfatal major bleeding complication." The trial was stopped at the first interim analysis. A total of 1,316 patients participated; their mean follow-up was 14 months. There was an excess of the primary outcome event in the anticoagulated group (81 of 651) versus 36 of 665 in the aspirin group (hazard ratio, 2.3; 95% confidence interval [CI], 1.6-3.5). This excess could be attributed to 53 major bleeding complications (27 intracranial; 17 fatal) during anticoagulant therapy versus 6 on aspirin (3 intracranial; 1 fatal). The bleeding incidence increased by a factor of 1.43 (95% CI, 0.96-2.13) for each 0.5 unit increase of the achieved INR. Anticoagulant therapy with an INR range of 3.0 to 4.5 in patients after cerebral ischemia of presumed arterial origin is not safe. The efficacy of a lower intensity anticoagulation regimen remains to be determined.

Aged↗
PubMed2002

Immunosuppressive therapy in lupus nephritis: the Euro-Lupus Nephritis Trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide.

OBJECTIVE: Glomerulonephritis is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment, followed by azathioprine (AZA) as a remission-maintaining treatment. METHODS: In this multicenter, prospective clinical trial (the Euro-Lupus Nephritis Trial [ELNT]), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose IV CYC regimen (6 monthly pulses and 2 quarterly pulses; doses increased according to the white blood cell count nadir) or a low-dose IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by AZA. Intent-to-treat analyses were performed. RESULTS: Followup continued for a median of 41.3 months in the low-dose group and 41 months in the high-dose group. Sixteen percent of those in the low-dose group and 20% of those in the high-dose group experienced treatment failure (not statistically significant by Kaplan-Meier analysis). Levels of serum creatinine, albumin, C3, 24-hour urinary protein, and the disease activity scores significantly improved in both groups during the first year of followup. Renal remission was achieved in 71% of the low-dose group and 54% of the high-dose group (not statistically significant). Renal flares were noted in 27% of the low-dose group and 29% of the high-dose group. Although episodes of severe infection were more than twice as frequent in the high-dose group, the difference was not statistically significant. CONCLUSION: The data from the ELNT indicate that in European SLE patients with proliferative lupus nephritis, a remission-inducing regimen of low-dose IV CYC (cumulative dose 3 gm) followed by AZA achieves clinical results comparable to those obtained with a high-dose regimen.

Adolescent↗
PubMed2001

Use of odds ratio or relative risk to measure a treatment effect in clinical trials with multiple correlated binary outcomes: data from the NINDS t-PA stroke trial.

In clinical trials, when a single outcome is not sufficient to describe the underlying concept of interest, it may be necessary to compare treatment groups on multiple correlated outcomes. A global test based on a logit link function provides an estimate of the odds ratio for assessing a common treatment effect among correlated binary outcomes. In this paper we extend the use of generalized estimating equations (GEE) to calculate a common relative risk from correlated binary outcomes based on a log link function. In the context of global tests, we discuss the equivalence and difference between logit and log links and their estimates. We also derive a formula for calculating a common risk difference between two treatment groups based on multiple correlated binary outcomes with categorical covariates, assuming the asymptotic equivalency between the logit and log-linear links. We discuss the statistical tools to be used in choosing between the logit and log links when models on different links yield contrasting results. Examples using data from the NINDS t-PA Stroke Trials are provided. We conclude, in a study of correlated binary outcomes, that the choice of the logit or log link could be based on a comparison of goodness-of-link.

Drug Evaluation↗
PubMed1996

Quality of life on treatment with metoprolol in dilated cardiomyopathy: results from the MDC trial. Metoprolol in Dilated Cardiomyopathy trial.

Quality of life in heart failure patients is receiving increased attention as a reflection of a treatment's potential secondary benefit of general well-being and daily functioning. The Metoprolol in Dilated Cardiomyopathy (MDC) trial was conducted as a large, multicenter trial to establish the effects of metoprolol on mortality and need for heart transplantation in patients with symptomatic idiopathic cardiomyopathy. It was found that metoprolol was well tolerated, improved symptoms and cardiac function, and prevented clinical deterioration in patients with symptomatic idiopathic dilated cardiomyopathy. Quality of life was evaluated as a secondary endpoint in 345 out of 383 randomized patients using a disease-specific questionnaire, the Quality of Life in Heart Failure Questionnaire, depicting physical activity, somatic symptoms, emotions, and life satisfaction. In a comparison of patients treated with metoprolol or placebo, patients treated with metoprolol noted a significantly more favorable response than those treated with placebo in terms of the overall treatment evaluation (p < 0.05). Additionally, an analysis of the changes from baseline to 18 months, using 95% confidence intervals, revealed that patients treated with metoprolol showed a significant improvement from baseline to 18 months in life satisfaction, physical activity, and the total score, while patients treated with placebo did not change at all. The improvement in quality of life was supported by the correlations with improvement in traditional clinical parameters.

Adrenergic beta-Antagonists↗
PubMed2006

A randomized controlled trial comparing hydration therapy to additional hemodialysis or N-acetylcysteine for the prevention of contrast medium-induced nephropathy: the Dialysis-versus-Diuresis (DVD) Trial.

Contrast medium-induced nephropathy (CIN) is a serious complication with increasing frequency and an unfavorable prognosis. Previous analyses of surrogate parameters have suggested beneficial effects of hemodialysis that are assessed in this randomized clinical trial. We performed a prospective single-center trial in 424 consecutive patients with serum creatinine concentrations between 1.3- 3.5 mg/dl who underwent elective coronary angiography. Patients were randomized to one of three treatment strategies with all patients receiving pre- and postprocedural hydration: One group received no additional therapy, patients in the second group were hemodialyzed once, and the third group received oral N-acetylcysteine. The frequency of CIN (defined as an increase in serum creatinine>or=0.5 mg/dl) from 48 to 72 h after catheterization was 6.1% in the hydration-only group, 15.9% with hemodialysis treatment, and 5.3% in the N-ACC group (intention-to-treat analysis; P=0.008). There were no differences between the treatment groups with regard to increased (>or=0.5 mg/dl) serum creatinine concentrations after 30-60 days (4.8%, 5.1%, and 3.1%, respectively; P=0.700). Analyses of long-term follow-up (range 63 to 1316 days) by Cox regressions models of the study groups found quite similar survival rates (P=0.500). In contrast to other (retrospective) studies, long-term survival of patients with vs those without CIN within 72 h was not different, but patients who still had elevated creatinine concentrations at 30-60 days suffered from a markedly higher 2-year mortality (46% vs 17%, P=0.002). In conclusion, hemodialysis in addition to hydration therapy for the prevention of CIN provided no evidence for any outcome benefit but evidence for probable harm. Increased creatinine concentrations at 30-60 days, but not within 72 h, were associated with markedly reduced long-term survival.

Acetylcysteine↗
PubMed1991

Multi-Hospital Eastern Atlantic Restenosis Trial. II: A placebo-controlled trial of thromboxane blockade in the prevention of restenosis following coronary angioplasty.

Since platelet interactions appear to play an important role in the development of restenosis, attenuation of thromboxane-mediated reactions may improve the long-term outcome following coronary angioplasty. Phase II of the Multi-Hospital Eastern Atlantic Restenosis Trial (M-HEART) is a prospective, randomized, placebo-controlled study of thromboxane blockade in the prevention of restenosis following successful coronary angioplasty. Two forms of thromboxane blockade are evaluated: aspirin (a nonspecific inhibitor of thromboxane synthesis) and sulotroban (a specific thromboxane receptor antagonist). The design of this multicenter trial and the rationale for use of sulotroban in the prevention of restenosis are reviewed in this report.

Angioplasty, Balloon, Coronary↗
PubMed1990

Effects of enalapril and neuroendocrine activation on prognosis in severe congestive heart failure (follow-up of the CONSENSUS trial). CONSENSUS Trial Study Group.

This study enrolled 253 patients with severe heart failure (New York Heart Association functional class IV) from 35 centers in Scandinavia, randomly assigned to treatment with placebo or enalapril, in addition to their usual treatment for heart failure. After an initial titration period, the daily doses of enalapril ranged from 2.5 to 40 mg. At the end of the trial, 46% of the placebo-treated patients and 61% of the enalapril-treated patients were alive (p = 0.003); the survival figures at 8 months after completion of the trial were 32 and 48%, respectively (p = 0.001); and 21 and 30%, respectively (p = 0.006) at the 2-year follow-up. In the placebo group, there was a significant positive association between mortality and baseline levels of norepinephrine, epinephrine, angiotensin II, aldosterone and atrial natriuretic peptide; no such association was found in the enalapril-treated patients. The results suggest that the effects of enalapril on mortality are related to a counteraction of the neuroendocrine activation in general and to the renin-angiotensin system in particular.

Enalapril↗
PubMed1986

Relationship between baseline risk factors and coronary heart disease and total mortality in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group.

The relationship between selected baseline risk factors and subsequent coronary heart disease (CHD) death and total mortality among participants in the Multiple Risk Factor Intervention Trial (MRFIT) was studied in order to determine whether the three risk factors used to identify high-risk men for the trial were associated with CHD death; whether other risk factors measured at baseline, especially lipoprotein cholesterol levels, were associated with CHD and total mortality; and whether there were any differences between special intervention (SI) and usual care (UC) participants in the relationship of the specific levels of risk factors to CHD or total mortality. The three main risk factors (blood cholesterol, cigarette smoking, and diastolic blood pressure) and age were significantly associated with CHD mortality; age, diastolic blood pressure, and cigarette smoking were associated with total mortality. The risk score based on the multiple logistic equation developed from the Framingham Study was also strongly associated with CHD mortality. When the joint associations of selected baseline risk factors with CHD and total mortality were considered, age, diastolic blood pressure, cigarette smoking, and low- and high-density lipoprotein cholesterol were significantly associated with CHD mortality; age, cigarette smoking, and low-density lipoprotein cholesterol were positively associated with total mortality. Systolic blood pressure significantly improved the prediction of CHD mortality for SI and UC men when it was added to a regression model that included age, diastolic blood pressure, cigarettes smoked per day, body mass index, and lipoprotein levels, but improved the prediction of total mortality only for SI men. In similar analyses, serum thiocyanate improved the prediction of both CHD and total mortality for UC men. Among SI men the improved prediction gained by considering serum thiocyanate was less pronounced and not significant for CHD death. This latter finding may be due in part to the changes made in smoking behavior by SI participants during the course of the study. The estimated regression coefficients for CHD and total mortality endpoints were not significantly different between the SI and UC groups.

Adult↗
PubMed1992

Double-blind trial of aspirin in primary prevention of myocardial infarction in patients with stable chronic angina pectoris. The Swedish Angina Pectoris Aspirin Trial (SAPAT) Group.

Clinical trials have demonstrated a prophylactic role for aspirin in myocardial infarction and in unstable angina pectoris. The Swedish Angina Pectoris Aspirin Trial (SAPAT) is the first prospective study of aspirin in stable angina. 2035 patients were randomised double-blind to treatment with aspirin 75 mg daily or placebo. All patients were treated with sotalol for control of symptoms. The median duration of follow-up was 50 months. Compared with the placebo+sotalol group, the aspirin+sotalol group had a 34% (81 vs 124 patients) reduction in primary outcome events (myocardial infarction and sudden death; 95% confidence interval 24-49%; p = 0.003) and the reduction observed in secondary outcome events (vascular events, vascular death, all cause mortality, stroke) ranged from 22% to 32%. Treatment withdrawal caused by adverse events occurred in 109 patients in the aspirin+sotalol group and 100 in patients in the placebo+sotalol group; major bleeds, including haemorrhagic stroke, occurred in 20 and 13 patients, respectively (not significant). The addition of a low dose of aspirin to sotalol treatment showed significant benefit in terms of cardiovascular events, including a significant reduction in the incidence of first myocardial infarction in patients with symptoms of stable angina pectoris.

Aged↗
PubMed1993

A method for the analysis of randomized trials with compliance information: an application to the Multiple Risk Factor Intervention Trial.

The standard approach to analyzing randomized trials ignores information on postrandomization compliance. Application of these methods results in estimates that may lack the desired causal interpretation. We employ a new method of estimation and analyze data from the Multiple Risk Factor Intervention Trial (MRFIT) to estimate the causal effect of quitting cigarette smoking. Our procedure utilizes a method proposed by Robins and Tsiatis and allows us to take advantage of postrandomization smoking history without requiring untenable assumptions about the comparability of compliers and noncompliers. We contrast the performance of our method and the standard intent-to-treat analysis in the MRFIT data and in simulated data in which compliance rates are varied.

Adult↗
PubMed1993

Comparative case fatality analysis of the International Tissue Plasminogen Activator/Streptokinase Mortality Trial: variation by country beyond predictive profile. The Investigators of the International Tissue Plasminogen Activator/Streptokinase Mortality Trial.

OBJECTIVES: This study was designed to examine the variation in mortality rates among countries participating in the International Tissue Plasminogen Activator/Streptokinase Mortality Trial. BACKGROUND: Despite uniform inclusion and exclusion criteria and protocol in this trial, 30-day mortality rates (irrespective of treatment allocation) ranged from 4.2% to 14.8% among the participating countries. METHODS: With use of the risk factors identified by a multi-variate logistic model, the total study group was classified into deciles on the basis of each patient's risk profile and individual probability of dying within 30 days. Expected mortality rates were then calculated and compared with actual mortality for each decile of the total study group, as well as for patients from each country. RESULTS: Independent risk factors for mortality were older age (odds ratio 1.97 for each 10-year increment), systolic hypotension (blood pressure < 95 mm Hg) at entry (odds ratio 3.7), Killip class > 1 at entry (odds ratio 3.5), history of antecedent angina (odds ratio 1.23 to 1.49), history of diabetes mellitus (odds ratio 1.64), previous infarction (odds ratio 1.23) and history of never smoking (odds ratio 1.37). The overall mortality rate among the 1,612 patients in risk deciles 9 and 10 was 26%; for the 1,606 patients in deciles 1 and 2 it was 1.2%, with a sensitivity of 58.6% and a specificity of 83.7%. The logistic model closely predicted and explained the different mortality rates for most countries (the differences between expected and actual mortality were nonsignificant). However, in the total study group, the difference between the expected and actual mortality was significant (p < 0.001). This difference was mainly ascribed to the two countries with the highest and lowest mortality rates. When the patients from these two countries were excluded from the analysis, the overall difference became nonsignificant. CONCLUSIONS: These findings suggest that the recognized risk factors associated with increased case fatality in acute myocardial infarction account only in part for mortality differences across or within populations.

Aged↗
PubMed1995

Effect of high dose angiotensin-converting enzyme inhibition on restenosis: final results of the MARCATOR Study, a multicenter, double-blind, placebo-controlled trial of cilazapril. The Multicenter American Research Trial With Cilazapril After Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MARCATOR) Study Group.

OBJECTIVES: We conducted a randomized, double-blind, placebo-controlled trial to assess the effect of low and high dose angiotensin-converting enzyme inhibition with cilazapril on angiographic restenosis prevention after percutaneous transluminal coronary angioplasty. BACKGROUND: Angiotensin-converting enzyme inhibitors possess antiproliferative effects in animal models of vascular injury. However, a recent clinical trial using low dose cilazapril, a long-acting angiotensin-converting enzyme inhibitor, failed to prevent restenosis. METHODS: Patients received either cilazapril (1 or 2.5 mg in the evening after successful coronary angioplasty, then 1, 5 or 10 mg twice daily for 6 months) or matched placebo. All patients received aspirin for 6 months. Coronary angiograms before and after angioplasty and at 6-month follow-up were quantitatively analyzed. In addition, the clinical, procedural and angiographic factors associated with restenosis were determined with the use of stepwise logistic analysis. RESULTS: A total of 1,436 patients with a successful coronary angioplasty were recruited. As assessed by an intention-to-treat analysis, the mean difference in minimal coronary lumen diameter (mean +/- 1 SD) between the postangioplasty and follow-up angiogram at 6 months (primary end point) was -0.35 +/- 0.51 for the placebo group and -0.37 +/- 0.52, -0.45 +/- 0.52 and -0.412 +/- 0.53, respectively, for the 1-, 5- and 10-mg twice daily cilazapril groups (p = NS). Clinical events during follow-up did not differ among the four study groups. Multivariate analysis revealed only six variables as independent predictors of the loss of minimal lumen diameter: duration of angina < 6 months, history of myocardial infarction, minimal lumen diameter before and after angioplasty as well as a proximal lesion location and reference diameters. Traditional risk factors for atherosclerosis did not relate to restenosis. CONCLUSIONS: Long-term angiotensin-converting enzyme inhibition with cilazapril in high as well as low dosages does not prevent restenosis and does not favorably influence the overall clinical and angiographic outcome after coronary angioplasty. Few factors are predictive of restenosis.

Angioplasty, Balloon, Coronary↗
PubMed1995

Directional atherectomy versus balloon angioplasty for coronary ostial and nonostial left anterior descending coronary artery lesions: results from a randomized multicenter trial. The CAVEAT-I investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

OBJECTIVES: We hypothesized that atherectomy would be superior to balloon angioplasty for ostial and nonostial left anterior descending coronary artery lesions. BACKGROUND: Balloon angioplasty of ostial coronary artery lesions has been associated with a lower procedural success rate and a higher rate of complications and of restenosis than angioplasty of nonostial stenoses. Directional coronary atherectomy has been proposed as an alternative therapy for ostial lesions. METHODS: In the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), 1,012 patients were randomized to undergo either procedure; 563 patients had proximal left anterior descending coronary artery lesions, of which 74 were ostial. We compared balloon angioplasty with directional atherectomy for early and 6-month results for ostial as well as nonostial proximal left anterior descending coronary artery lesions. RESULTS: Directional atherectomy led to an initially higher gain in minimal lumen diameter for ostial lesions (1.13 vs. 0.56 mm, respectively, p < 0.001) but a higher rate of adjudicated non-Q wave myocardial infarction (24% vs. 13%, respectively, p < 0.001) than balloon angioplasty and no improvement in restenosis rates (48% vs. 46%, respectively). In the nonostial proximal left anterior descending coronary artery lesions, angiographic restenosis was reduced (51% vs. 66%, p = 0.012), but this was also associated with a higher rate of periprocedural myocardial infarction (8% vs. 2%, p = 0.008 by site and 24% vs. 8%, p < 0.001 by adjudication) and no difference in the need for subsequent coronary artery bypass surgery (7.3% vs. 8.4%, respectively) or repeat percutaneous coronary intervention (24% vs. 26%, respectively). CONCLUSIONS: For ostial left anterior descending coronary artery stenoses, both procedures yielded similar rates of initial success and restenosis, but atherectomy was associated with more non-Q wave myocardial infarction. In this trial the predominant angiographic benefit (increased early gain and less angiographic restenosis) of atherectomy for the left anterior descending coronary artery was in proximal nonostial lesions. However, the tradeoffs for this angiographic advantage were more in-hospital myocardial infarctions and no decrease in clinical restenosis.

Angioplasty, Balloon↗
PubMed2005

Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial.

OBJECTIVE: Ovarian cancer screening with transvaginal ultrasound (TVU) and CA-125 was evaluated in the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial. STUDY DESIGN: This was a randomized controlled trial of screening versus usual care. Baseline screening results are reported. RESULTS: Of 39,115 women randomized to receive screening, 28,816 received at least 1 test. Abnormal TVU was found in 1338 (4.7%), and abnormal CA-125 in 402 (1.4%). Twenty-nine neoplasms were identified (26 ovarian, 2 fallopian, and 1 primary peritoneal neoplasm). Nine were tumors of low malignant potential and 20 were invasive. The positive predictive value for invasive cancer was 3.7% for an abnormal CA-125, 1.0% for an abnormal TVU, and 23.5% if both tests were abnormal. CONCLUSION: The effect of screening on ovarian cancer mortality in the PLCO cohort has yet to be evaluated and will require longer follow-up. Screening identified both early- and late-stage neoplasms, and the predictive value of both tests was relatively low.

Aged↗