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Results for “Randomized trial”

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PubMed2002

All-cause mortality in randomized trials of cancer screening.

BACKGROUND: The most widely accepted end point in randomized cancer screening trials is disease-specific mortality. The validity of this end point, however, rests on the assumption that cause of death can be determined accurately. An alternative end point is all-cause mortality, which depends only on the accurate ascertainment of deaths and when they occur. We compared disease-specific and all-cause mortality in published randomized cancer-screening trials to indirectly assess the validity of the disease-specific mortality end point. METHODS: We examined all 12 published randomized trials of cancer screening for which both end points were available (seven of mammography, three of fecal occult blood detection, and two of chest x-ray screening for lung cancer). For each randomized trial, we subtracted disease-specific mortality observed in the screened group from that observed in the control group and all-cause mortality in the screened group from that in the control group. We then compared the differences in these two mortality measures. RESULTS: In five of the 12 trials, differences in the two mortality rates went in opposite directions, suggesting opposite effects of screening. In four of these five trials, disease-specific mortality was lower in the screened group than in the control group, whereas all-cause mortality was the same or higher. In two of the remaining seven trials, the mortality rate differences were in the same direction but their magnitudes were inconsistent; i.e., the difference in all-cause mortality exceeded the disease-specific mortality in the control group. Thus, results of seven of the 12 trials were inconsistent in their direction or magnitude. CONCLUSION: Major inconsistencies were identified in disease-specific and all-cause mortality end points in randomized cancer screening trials. Because all-cause mortality is not affected by bias in classifying the cause of death, it should be examined when interpreting the results of randomized cancer-screening trials.

Bias↗

PubMed1985

The treatment of psoriasis with 0.1% domoprednate (a D-homocorticosteroid) and 0.1% betamethasone valerate ointment. A double-blind, randomized trial.

In 85 patients with psoriasis vulgaris the efficacy and tolerance of domoprednate and betamethasone valerate were studied in a double-blind, randomized trial lasting 4 weeks. Complete or satisfactory remission was obtained in 36% in the domoprednate group and in 53% in the betamethasone group. This difference is not statistically significant (p greater than 0.10). 3 patients on each treatment experienced some local irritation. No laboratory abnormalities were found during the study.

Adolescent↗

PubMed1994

Analysis of complications in a prospective randomized trial comparing two brachytherapy low dose rates in cervical carcinoma.

PURPOSE: The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented. METHODS AND MATERIALS: Between 1985 and 1988, 204 patients with Stage I and limited Stage II cervical cancer were randomized to receive one of two preoperative brachytherapy low-dose rates (0.4 and 0.8 Gy/hr). The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic arsenal for this patient population, in terms of survival, local control, and complications. The type and severity of all complications were evaluated according to a common glossary and a strict follow-up schedule was established given that the treatment of cervical cancer is multidisciplinary, involving gynecologists, surgeons, and radiotherapists. RESULTS: Overall survival: 85% at 2 years and local control: 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%) and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12). Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs. 45% at 2 years (p = 0.03). CONCLUSION: The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. This underlines the importance of the regular follow-up of patients and of coding, not only the occurrence of all complications, but also their evolution over time.

Brachytherapy↗

PubMed1983

A randomized trial of adjuvant BCG immunotherapy in head and neck cancer.

Fifty-two patients with locally advanced squamous cell cancer were entered into a randomized trial of BCG vaccine following definitive local therapy. Patients were stratified and randomized to receive BCG vaccine (25 patients) or no adjuvant immunotherapy (27 patients). The BCG vaccine therapy began two weeks following definitive therapy with 2 to 4 X 10(6) Tice strain BCG organisms given intradermally (ID) in alternating sides of the neck every two weeks six times, then every four weeks nine times. In addition, all patients received methotrexate prior to definitive therapy. Median duration of follow-up at the time of analysis was 41 months. Groups were balanced by sex, disease site and stage, histologic grade, and prior therapy. Thirteen (52%) of the BCG vaccine-treated group remain disease free v seven (26%) of the controls. Similarly, 17 (68%) of the BCG vaccine-treated group survived v 11 (41%) of the controls. We conclude regional ID BCG vaccine increases disease-free and actuarial survival in this study population and adjuvant immunotherapy should be further explored in ear, nose, and throat cancer.

Adult↗

PubMed1993

A prospective randomized trial comparing manual and automated endoscope disinfection methods.

OBJECTIVE: To compare the efficacy of endoscope disinfection using automated and manual systems. DESIGN: Prospective randomized trial. SETTING: A 1,000-bed tertiary care referral center. METHODS: All endoscopes underwent a three-stage decontamination process including brushing and cleaning with water and detergent, manual or automated disinfection with 2% glutaraldehyde, and 70% alcohol rinse with forced air drying. Cultures were obtained from endoscopes from both groups before and after alcohol rinse and then after overnight storage. RESULTS: Cultures from 8/30 (27%) automated and 11/30 (37%) manually disinfected (P = 0.58) endoscopes grew gram-negative bacteria and/or nontuberculous mycobacteria before the alcohol rinse. After alcohol rinse, 3 (10%) of 30 automated and 8 (27%) of 30 manually disinfected endoscopes remained contaminated (P = 0.28). Manually disinfected endoscopes were contaminated more frequently with coliform bacteria, whereas endoscopes undergoing automated disinfection were more frequently contaminated with nontuberculous mycobacteria, but the differences were not statistically significant. After alcohol rinse and forced air drying, there was no difference in contamination rates between freshly disinfected endoscopes and those stored overnight (7/30 (23%) versus 4/30 (13%), P = 0.50). Colonoscopes and duodenoscopes were contaminated more often than gastroscopes (P = 0.00001). CONCLUSION: The persistent endoscope contamination after manual and automated disinfection indicates the importance of developing more reliable and effective disinfection methods.

Automation↗

PubMed2004

[Cognitive behavioral therapy for depressed older outpatients--a controlled, randomized trial].

OBJECTIVE: There is a lack of scientific evidence of psychotherapy with depressed elderly. In a controlled randomized trial we compare a cognitive behavioral group intervention with a waiting list control condition. It is expected that cognitive behavior therapy is more efficient in reducing depressive symptoms than the control group at post-treatment as well as at follow-up. METHOD: A total of 100 older adults presently fulfilling the diagnosis of a depressive disorder but not showing any signs of cognitive impairment were randomly assigned (ratio 2 : 1) to either cognitive behavior therapy (N=65) or to waiting list condition (N=35). Assessment took place at pre-treatment, after 3 months of treatment or waiting, and after 6 months follow-up. RESULTS: As expected, cognitive behavior group therapy was superior to waiting list control in all measures at post-treatment as well as at follow-up (intent-to-treat analysis). These effects are statistically and clinically relevant and not influenced by parallel treatment with antidepressant medication. After cognitive behavior therapy 36 patients were in complete remission but only 4 after three months of waiting. Six patients in the control group became even worse during the 3 months waiting while only 1 patient under cognitive behavior therapy has to be considered as treatment failure. DISCUSSION: Cognitive behavioral group treatment is a well accepted, successful intervention for older adults. Waiting for treatment is problematic. It does not only produce no changes in symptomatology but even leads to worsening of depression in a large number of subjects.

Aged↗

PubMed1996

Schistosomiasis japonica and childhood nutritional status in northeastern Leyte, the Philippines: a randomized trial of praziquantel versus placebo.

The hypothesis that infection with Schistosoma japonicum causes decreased nutritional status was studied in a randomized trial among 170 males and females, mean (SD) age 11.4 (3.5) years, residing in an endemic region of northeastern Leyte, Philippines. The S. japonicum-infected children were randomized to receive praziquantel or placebo and followed-up six months after randomization. Stature, weight, triceps, subscapular, and calf skinfold thicknesses and their sum, and hemoglobin level were measured at baseline and follow-up. Schistosoma japonicum eggs were detected in Kato-Katz stool smears and the intensity of infection was assessed by quantitative egg count. Intensities of hookworm, ascaris, and trichuris infections were also measured. The six-month levels of the anthropometric measures and hemoglobin were adjusted for age and their baseline levels and then compared between the praziquantel and placebo groups. Treatment interactions were also analyzed by sex. Baseline anthropometric and hemoglobin levels and parasite infection intensities were the same in the two groups. At six months, the praziquantel group had significantly higher hemoglobin levels (P < 0.001) and sum of skinfolds (P < 0.001) than the placebo group. Males had a significantly greater increase in hemoglobin levels with treatment than did females. The hemoglobin increase was not due to changes in hookworm intensity. The results show that schistosomiasis japonica caused decreased nutritional status in children and probably is partly responsible for the malnutrition and reduction in growth for age described in prior cross-sectional studies.

Adolescent↗

PubMed1990

Inhaled or intravenous pentamidine therapy for Pneumocystis carinii pneumonia in AIDS. A randomized trial.

OBJECTIVE: To compare inhaled pentamidine with intravenous pentamidine for the treatment of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome (AIDS). DESIGN: A randomized trial. SETTING: Community teaching hospital and hospital-based outpatient treatment center. PATIENTS: Twenty-one homosexual men with pneumocystis pneumonia; 11 received inhaled pentamidine and 10 received intravenous pentamidine. INTERVENTION: Inhaled (8 mg/kg body weight) or intravenous (4 mg/kg body weight) pentamidine administered daily for 21 days. MEASUREMENTS AND MAIN RESULTS: All patients responded to intravenous pentamidine, whereas 6 of 11 (55%; 95% CI, 23% to 83%; P = 0.02, Fisher exact test) responded to inhaled pentamidine therapy. Two patients who failed inhaled pentamidine therapy eventually died despite appropriate intravenous therapy (mortality rate, 18%; CI, -6% to 42%). Nonresponders to inhaled pentamidine had a greater severity of illness compared with responders to this therapy, as shown by a lower mean (+/- SE) Pao2 (8.0 +/- 0.4 kPa compared with 10.8 +/- 0.6 kPa; P = 0.005) and higher alveolararterial Po2 difference (6.8 +/- 0.6 kPa compared with 2.8 +/- 0.8 kPa; P = 0.003). CONCLUSIONS: Inhaled pentamidine is probably as effective as intravenous pentamidine in patients with mild pneumocystis pneumonia. However, its use as sole therapy in patients with moderate to severe pneumocystis pneumonia is not supported by the results of our study and is not warranted.

Acquired Immunodeficiency Syndrome↗

PubMed2007

Prolonged effect of calcium supplementation on risk of colorectal adenomas in a randomized trial.

BACKGROUND: Calcium supplementation has been shown to decrease the risk of recurrence of colorectal adenomas in randomized trials. However, the duration of this protective effect after cessation of active supplementation is not known. METHODS: In the Calcium Polyp Prevention Study, 930 subjects with a previous colorectal adenoma were randomly assigned from November 1988 through April 1992 to receive placebo or 1200 mg of elemental calcium daily for 4 years. The Calcium Follow-up Study was an observational phase of the trial that tracked adenoma occurrence for an average of 7 years after the end of randomized treatment and gathered information regarding the use of medications, vitamins, and supplements during that time. We obtained follow-up information for 822 subjects, 597 of whom underwent at least one colonoscopy after the end of study treatment and are included in this analysis. Generalized linear models were used to compute relative risks (RRs) and 95% confidence intervals (CIs) for the effect of randomized calcium treatment on risk of adenoma recurrence during the first 5 years after study treatment ended and during the subsequent 5 years. Statistical tests were two-sided. RESULTS: During the first 5 years after randomized treatment ended, subjects in the calcium group still had a substantially and statistically significantly lower risk of any adenoma than those in the placebo group (31.5% versus 43.2%; adjusted RR = 0.63, 95% CI = 0.46 to 0.87, P = .005) and a smaller and not statistically significant reduction in risk of advanced adenomas (adjusted RR = 0.85, 95% CI = 0.43 to 1.69, P = .65). However, the randomized treatment was not associated with the risk of any type of polyp during the next 5 years. The findings were broadly similar when the analysis was restricted to subjects who did not report use of any calcium supplements after the treatment phase of the trial ended. CONCLUSION: The protective effect of calcium supplementation on risk of colorectal adenoma recurrence extends up to 5 years after cessation of active treatment, even in the absence of continued supplementation.

Adenoma↗

PubMed1987

A randomized trial of dexamethasone and acetazolamide for acute mountain sickness prophylaxis.

Forty-seven climbers participated in a double-blind, randomized trial comparing acetazolamide 250 mg, dexamethasone 4 mg, and placebo every eight hours as prophylaxis for acute mountain sickness during rapid, active ascent of Mount Rainier (elevation 4,392 m). Forty-two subjects (89.4 percent) achieved the summit in an average of 34.5 hours after leaving sea level. At the summit or high point attained above base camp, the group taking dexamethasone reported less headache, tiredness, dizziness, nausea, clumsiness, and a greater sense of feeling refreshed (p less than or equal to 0.05). In addition, they reported fewer problems of runny nose and feeling cold, symptoms unrelated to acute mountain sickness. The acetazolamide group differed significantly (p less than or equal to 0.05) from other groups at low elevations (1,300 to 1,600 m), in that they experienced more feelings of nausea and tiredness, and they were less refreshed. These drug side effects probably obscured the previously established prophylactic effects of acetazolamide for acute mountain sickness. Separate analysis of an acetazolamide subgroup that did not experience side effects at low elevations revealed a prophylactic effect of acetazolamide similar in magnitude to the dexamethasone effect but lacking the euphoric effects of dexamethasone. This study demonstrates that prophylaxis with dexamethasone can reduce the symptoms associated with acute mountain sickness during active ascent and that acetazolamide can cause side effects that may limit its effectiveness as prophylaxis against the disease.

Acetazolamide↗

PubMed2001

Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma.

PURPOSE: A prospective randomized trial was performed to evaluate the contribution of neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. PATIENTS AND METHODS: Patients with locoregionally advanced nasopharyngeal carcinoma were treated either with radiotherapy alone (RT group) or neoadjuvant chemotherapy plus radiotherapy (CT/RT group). Neoadjuvant chemotherapy consisting of two to three cycles of cisplatin (100 mg/m(2), day 1), bleomycin (10 mg/m(2), days 1 and 5), and fluorouracil (5-FU; 800 mg/m(2), days 1 through 5, continuous infusion) followed by radiotherapy was given to the CT/RT group. All patients were treated in a uniform fashion by definitive-intent radiation therapy in both groups. RESULTS: Between July 1993 and July 1994, 456 patients were entered onto the study, with 228 patients randomized to each treatment arm, and 449 patients (225 in the RT group and 224 in the CT/RT group) were assessable. All 456 patients were included in survival analysis according to the intent-to-treat principle. The 5-year overall survival (OS) rates were 63% for the CT/RT group and 56% for the RT group (P =.11). The median relapse-free survival (RFS) time was 50 months for the RT group and not reached for the CT/RT group. The 5-year RFS rate was 49% for the RT group versus 59% for the CT/RT group (P =.05). The 5-year freedom from local recurrence rate was 82% for the CT/RT group and 74% for the RT group (P =.04). There was no significant difference in freedom from distant metastasis between the two treatment groups (CT/RT group, 79%; RT group, 75%; P =.40). CONCLUSION: This randomized study failed to demonstrate any significant survival benefit with the addition of neoadjuvant chemotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. Therefore, neoadjuvant chemotherapy for nasopharyngeal carcinoma should not be used outside of the context of a clinical trial.

Adult↗

PubMed1990

Failure of surgery to improve outcome in hypertensive putaminal hemorrhage. A prospective randomized trial.

Hypertensive putaminal hemorrhage remains a major cause of hemorrhagic stroke carrying extremely high morbidity. Considerable controversy remains regarding the optimal form of therapy. Between 1983 and 1989 we conducted a prospective randomized trial with three treatment strategies: best medical management, best medical management plus intracranial pressure monitoring, and surgical evacuation. Only patients with significant deficit harboring a putaminal hematoma at least 3.0 cm in diameter were entered. The study was interrupted after 21 patients had been studied (9, best medical management; 4, intracranial pressure monitoring; and 8, surgical evacuation). No differences were found among groups for age, admission blood pressure, and time interval between onset of symptoms and arrival at hospital. None of the subjects were capable of returning to prestroke activity. Fifteen (71%) died or remained vegetative at 6 months, and only 4 (19%) were capable of independent life at home. Of the 9 patients in the best medical management arm, 7 were dead or vegetative. In the surgical group, 4 patients died and only 2 were capable of independent life. These results suggest that current medical and neurosurgical therapies remain ineffective in preventing the devastating neurologic consequences of hypertensive putaminal hemorrhage.

Adult↗

PubMed1998

Single-dose antibiotic prophylaxis in transurethral resection of the prostate: a prospective randomized trial.

OBJECTIVE: To evaluate the efficacy of single-dose antibiotic prophylaxis in transurethral resection of the prostate (TURP). PATIENTS AND METHODS: A total of 139 patients were entered into a prospective randomized trial comparing single-dose antibiotic prophylaxis with no antibiotic before surgery. Twelve patients were excluded because they had significant bacteriuria before surgery (defined as > or = 10(5) bacteria/mL). Of the remaining 127 patients, 62 were allocated to the single-dose group (A) and 65 to the no-antibiotic group (B). All 62 patients in group A received 1 g of ceftriaxone intravenously 1-2 h before surgery with the anaesthetic premedication, the 65 in group B receiving none. Urine cultures were collected post-operatively as the catheter was removed and again 4 weeks after hospitalization. RESULTS: The incidence of post-operative bacteriuria was statistically significantly different, occurring in five patients (9%) in group A and 16 patients (26%) in group B (Fisher's exact test, one-tail P = 0.009). There was no significant difference between the groups 4 weeks after hospitalization. The overall incidence of bacteriuria post-operatively and 4 weeks after hospitalization was 11 patients (18%) in group A and 22 patients (34%) in group B (P = 0.03). CONCLUSION: Single-dose antibiotic prophylaxis with 1 g of ceftriaxone intravenously is effective in patients undergoing TURP and is recommended for such surgery.

Antibiotic Prophylaxis↗

PubMed1988

A prospective randomized trial of alpha 2B-interferon/gamma-interferon or the combination in advanced metastatic renal cell carcinoma.

Eighty-nine patients with advanced measurable metastatic renal cell carcinoma were entered into a prospective randomized trial comparing alpha-interferon to gamma-interferon and to the combination. The trial was performed in order to confirm the activity of gamma-interferon and assess the potential clinical synergism. Response rates were 5, 10, and 5%, respectively. The low response rate may have been due to the inability to raise the doses of the interferons to higher levels. Clinical synergy at this dose, route, and schedule of administration in renal cell carcinoma does not exist.

Carcinoma, Renal Cell↗

PubMed1996

Randomized trial of the cardioprotective agent ICRF-187 in pediatric sarcoma patients treated with doxorubicin.

PURPOSE: We conducted an open-label, randomized trial to determine whether ICRF-187 would reduce doxorubicin-induced cardiotoxicity in pediatric sarcoma patients. METHODS: Thirty-eight patients were randomized to receive doxorubicin-containing chemotherapy (given as an intravenous bolus) with or without ICRF-187. Resting left ventricular ejection fraction (LVEF) was monitored serially with multigated radionuclide angiography (MUGA) scan. The two groups were compared for incidence and degree of cardiotoxicity, response rates to four cycles of chemotherapy, event-free and overall survival, and incidence and severity of noncardiac toxicities. RESULTS: Eighteen ICRF-187-treated and 15 control patients were assessable for cardiac toxicity. ICRF-187-treated patients were less likely to develop subclinical cardiotoxicity (22% v 67%, P < .01), had a smaller decline in LVEF per 100 mg/m2 of doxorubicin (1.0 v 2.7 percentage points, P = .02), and received a higher median cumulative dose of doxorubicin (410 v 310 mg/m2, P < .05) than did control patients. Objective response rates were identical in the two groups, with no significant differences seen in event-free or overall survival. ICRF-187-treated patients had a significantly higher incidence of transient grade 1 serum transaminase elevations and a trend toward increased hematologic toxicity. CONCLUSION: ICRF-187 reduces the risk of developing short-term subclinical cardiotoxicity in pediatric sarcoma patients who receive up to 410 mg/m2 of doxorubicin. Response rates to chemotherapy, event-free and overall survival, and noncardiac toxicities appear to be unaffected by the use of ICRF-187. Additional clinical trials with larger numbers of patients are needed to determine if the short-term cardioprotection afforded by ICRF-187 will reduce the incidence of late cardiac complications in long-term survivors of childhood cancer.

Adolescent↗

PubMed2001

A randomized trial of amifostine as a cytoprotective agent in patients receiving chemotherapy for small cell lung cancer.

A randomized trial was conducted to determine whether administration of Amifostine with chemotherapy for small cell lung cancer could decrease the toxicity. 84 patients with small cell lung cancer of favourable prognosis (limited disease, performance status 0-1; limited disease with performance status 2 but normal sodium and alkaline phosphatase, or extensive disease with performance status 0-1, normal sodium and alkaline phosphatase) received treatment with Ifosfamide 3 g/m(2)intravenously, Carboplatin (Glomerular filtration rate + 25) x6 mg intravenously, Etoposide 50 mg orally, twice daily, for 7 days, every 3 weeks. Patients were randomized to receive amifostine 740 mg/m(2)immediately prior to the intravenous drugs (n = 42) or to receive chemotherapy alone (n = 42). The two groups were similar with respect to baseline prognostic factors. There was no significant difference in the occurrence of grade III or IV neutropenia or thrombocytopenia between the two groups, nor in the response rate or overall survival, for which the median was 11 months in the chemotherapy only group and 14 months in the group treated with amifostine. This study has not shown a protective effect from the use of amifostine with this regimen and there does not appear to be any effect upon the efficacy of treatment.

Adult↗

PubMed2000

Eversion versus conventional carotid endarterectomy: late results of a prospective multicenter randomized trial.

OBJECTIVE: The durability of carotid endarterectomy (CEA) may be affected by carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surgery. The optimal CEA technique to reduce perioperative complications and restenosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversion CEA. Previously published perioperative results of this study did not show statistically significant differences in study endpoints between the eversion and standard techniques. METHODS: From October 1994 to March 1997, 1353 patients with surgical indications for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdrawal from the assigned treatment occurred in 1.6% of the patients (in 13 assigned to eversion CEA, and in nine assigned to standard CEA). The clinical and duplex scan follow-up examination was 99% complete, and the mean follow-up interval was 33 months (range, 12 to 55 months). The primary outcomes were perioperative and late major stroke and death, carotid restenosis (stenosis >/= 50% of the lumen diameter detected at duplex scanning), and carotid occlusion. The primary evaluation of study outcomes was conducted on the basis of an intention-to-treat analysis. RESULTS: Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, the restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cerebral angiography that confirmed restenosis in all cases. The cumulative restenosis risk at 4 years was significantly lower in the group that underwent treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P =.01), with an absolute risk reduction of 5. 6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment with eversion CEA to prevent one restenosis during the 4-year period. The incidence rate of ipsilateral stroke was 3.3% in the eversion population and 2.2% in the standard group. There were no significant differences in the cumulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standard; P =.2) and death (13.1% for eversion, and 12.7% for standard; P =.7)) in the two groups. Of the 18 variables that were examined for their influence on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P =.0004) and patch CEA (hazard ratio, 0.2; 95% confidence interval, 0.07 to 0.6; P =. 002) were negative independent predictors of restenosis with multivariate Cox proportional hazards regression analysis. CONCLUSION: The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial) showed that eversion CEA is safe, effective, and durable. No statistically significant differences were found in late outcome between the eversion and standard techniques at the available follow-up examination.

Actuarial Analysis↗

PubMed1988

The community-based randomized trials of pharmacologic treatment of mild-to-moderate hypertension.

The value of pharmacologic treatment of mild-to-moderate hypertension remains controversial despite the availability of data from eight community-based randomized trials including over 34,000 subjects with entry diastolic blood pressures ranging from 85 to 120 mmHg. To obtain more reliable estimates of the effects of treatment, the authors conducted an overview of the data from all of these individual trials, and they found a significant 18% reduction in vascular mortality among subjects allocated to treatment, due chiefly to reductions in fatal stroke and myocardial infarction. Subjects allocated to treatment experienced highly significant reductions of approximately 40% in all stroke (typical odds ratio = 0.60, 95% confidence interval = 0.51-0.71) and fatal stroke (0.58, 0.44-0.77). For myocardial infarction, the proportional reductions were much smaller than those for stroke and were 9% for all and 8% for fatal events. While suggestive of protective effects, the typical odds ratios did not achieve statistical significance for either all (0.91, 0.82-1.01) or for fatal myocardial infarction (0.92, 0.78-1.08). This overview demonstrates a significant benefit of pharmacologic treatment of mild-to-moderate hypertension on vascular mortality and on all as well as fatal stroke. It also suggests possible benefits of treatment on all and fatal myocardial infarction which should be investigated further.

Antihypertensive Agents↗