Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Comparison of the early results of coronary artery bypass grafting with and without extracorporeal circulation. Short-stay intensive care after coronary artery bypass surgery: randomized clinical trial on safety and cost-effectiveness. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Predictors of smoking cessation after coronary artery bypass graft surgery. Results of a randomized trial with 5-year follow-up. Efficacy of oral anticoagulants compared with aspirin after infrainguinal bypass surgery (The Dutch Bypass Oral Anticoagulants or Aspirin Study): a randomised trial. Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results. Neuropsychologic and quality-of-life outcomes after coronary artery bypass surgery with and without cardiopulmonary bypass: a prospective randomized trial.
There has been little research on the treatment of depression after coronary artery bypass surgery.
                To test the efficacy of 2 nonpharmacological interventions for depression after coronary artery bypass surgery compared with usual care.
                A 12-week, randomized, single-blind clinical trial with outcome evaluations at 3, 6, and 9 months.
                Outpatient research clinic at Washington University School of Medicine, St Louis, Missouri.
                One hundred twenty-three patients who met the DSM-IV criteria for major or minor depression within 1 year after surgery.
                Twelve weeks of cognitive behavior therapy or supportive stress management. Approximately half of the participants were taking nonstudy antidepressant medications.
                Remission of depression, defined as a score of less than 7 on the 17-item Hamilton Rating Scale for Depression.
                Remission of depression occurred by 3 months in a higher proportion of patients in the cognitive behavior therapy (71%) and supportive stress-management (57%) arms than in the usual care group (33%) (chi(2)(2) = 12.22, P = .002). Covariate-adjusted Hamilton scores were lower in the cognitive behavior therapy (mean [standard error], 5.5 [1.0]) and the supportive stress-management (7.8 [1.0]) arms than in the usual care arm (10.7 [1.0]) at 3 months. The differences narrowed at 6 months, but the remission rates differed again at 9 months (73%, 57%, and 35%, respectively; chi(2)(2) = 12.02, P = .003). Cognitive behavior therapy was superior to usual care at most points on secondary measures of depression, anxiety, hopelessness, stress, and quality of life. Supportive stress management was superior to usual care only on some of the measures.
                Both cognitive behavior therapy and supportive stress management are efficacious for treating depression after coronary artery bypass surgery, relative to usual care. Cognitive behavior therapy had greater and more durable effects than supportive stress management on depression and several secondary psychological outcomes.
                clinicaltrials.gov Identifier: NCT00042198. To compare the safety and efficacy of coronary artery bypass grafting without using extracorporeal circulation with standard cardiopulmonary bypass technique, based on certain early postoperative criteria, we designed a fully randomized and prospective study on two similar groups of 25 patients (off-pump and on-pump groups). The groups were compared for hemodynamic data (cardiac index, systemic vascular resistance, left- and right-ventricular stroke-work indices, inotropic and mechanical support needs) and enzyme levels (CK-MB and SGOT), as well as mortality, perioperative infarction rate, homologous transfusion requirements, and the symptomatology in the first follow-ups. There was no mortality or perioperative myocardial infarction in either group. Inotropic (25% vs. 4%) and mechanical (4% vs. 0) support requirements and homologous blood consumption (percentages of patients that needed no transfusion: 20% vs. 72%) were greater in the on-pump group. Results were otherwise similar. It is concluded that, in technically suitable cases, off-pump coronary artery bypass surgery is as safe and efficient as the standard on-pump technique and can be used in particular when cannulation, hypothermia, or cardiopulmonary bypass must be avoided. With these properties, this technique could take an important place in the cardiac surgeon's armamentarium. To evaluate the safety and cost-effectiveness of short-stay intensive care (SSIC) treatment for low-risk coronary artery bypass patients.
                Randomized clinical equivalence trial.
                University Hospital Maastricht, the Netherlands.
                Low-risk coronary artery bypass patients.
                A total of 600 patients were randomly assigned to undergo either SSIC treatment (8 hrs of intensive care treatment) or control treatment (care as usual, overnight intensive care treatment).
                The primary outcome measures were intensive care readmissions and total hospital stay. The secondary outcome measures were total hospital costs, quality of life, postoperative morbidity, and mortality. Hospital costs consisted of the cost of hospital admission or admissions and outpatient costs.
                The difference in intensive care readmission between the two groups of 1.13% was very small and not significantly different (p = .241; 95% confidence interval, -0.9% to 2.9%). The total hospital stay (p = .807; 95% confidence interval, 1.2 to -0.4) and postoperative morbidity were comparable between the groups. The SSIC group's quality of life improved more compared with the control group's quality of life (p = .0238; 95% confidence interval, 0.0012 to 0.0464). The total hospital costs for SSIC were significantly lower (95% confidence interval, -1,581 to -174) compared with those for the control group (4,625 and 5,441, respectively). The estimated incremental cost-effectiveness ratio (cost/delta quality-adjusted life months) thus showed the dominance of SSIC. Bootstrap and sensitivity analyses confirm the robustness of the study findings.
                Compared with usual care, SSIC is a safe and cost-effective approach. SSIC can be considered as an alternative for conventional postoperative intensive care treatment for low-risk coronary artery bypass graft patients. Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this.
                To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.
                Randomized, controlled trial.
                University departments of medicine and surgery and an affiliated private hospital.
                80 adults with mild to moderate obesity (body mass index, 30 kg/m2 to 35 kg/m2) from the general community. Interventions: Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group).
                Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.
                At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores).
                The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.
                Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program. In patients with obstructive jaundice caused by malignant stricture of the extrahepatic bile duct we compared survival time, complication rates, hospitalisation requirements, and quality of life after palliation by endoscopic endoprosthesis or bypass surgery. During diagnostic endoscopic cholangiography 50 patients were randomised to the two treatment alternatives. All 25 patients randomised to endoprosthesis were treated by this procedure, whereas only 19 of 25 patients randomised to bypass surgery underwent operative biliary-digestive anastomosis. Life table analysis revealed no difference in survival between treatment groups or randomisation groups. No differences were found when other variables were compared. We conclude, that palliation of obstructive jaundice in malignant bile duct obstruction with endoscopically introduced endoprosthesis is as effective as operative bypass. To test the efficacy of a smoking cessation program for inpatients recovering from coronary artery bypass graft surgery and to identify predictors of cessation.
                Randomized, controlled clinical trial.
                Postoperative cardiac surgery unit of a large teaching hospital.
                Patients scheduled for coronary artery bypass surgery by participating surgeons between 1 July 1986 and 1 July 1987 who had smoked 1 or more packs of cigarettes in the 6 months before admission. Of 120 eligible patients, 93 enrolled and 87 were discharged alive. All survivors were followed for at least 1 year; 94% were followed for a median of 5.5 years.
                A three-session, nurse-delivered behavior modification program using a videotape and face-to-face counseling was compared to usual care.
                Smoking status was assessed six times in the year after surgery and 5.5 years after surgery. Self-reported nonsmoking was validated by saliva cotinine assay 1 and 5.5 years after surgery.
                No statistically significant differences were found between control (n = 43) and intervention (n = 44) groups at baseline. One and 5.5 years after hospital discharge, validated continuous nonsmoking rates were identical in intervention and control groups (51% at 1 year; 44% at 5.5 years). Multiple logistic regression identified four factors that were independently associated with nonsmoking for 1 year: fewer than 3 previous attempts to quit (odds ratio, 7.4; 95% Cl, 1.9 to 29.1); more than 1 week of preoperative nonsmoking (odds ratio, 10.0; Cl, 2.0 to 50.2); definite intention to quit smoking (odds ratio, 12.0; Cl, 2.6 to 55.1); and no difficulty not smoking in the hospital (odds ratio, 9.6; Cl, 1.8 to 52.2). Nonsmoking for 5.5 years was independently associated with two of these factors: fewer than three previous attempts to quit and intention to quit smoking after surgery. Cessation was not related to demographic factors, daily cigarette consumption, disease severity, hospital course, social support, or beliefs and attitudes.
                Even without specific intervention, nearly one half of smokers quit for 5 years after coronary artery bypass surgery. A short inpatient education program did not increase this rate. Future efforts should target the time after discharge and focus on increasing motivation in patients who have repeatedly failed to quit. Oral anticoagulants and aspirin are antithrombotic drugs that are commonly used in patients with vascular disease. We investigated whether either of these treatments prevented more effectively than the other bypass complications after infrainguinal bypass surgery.
                We did a multicentre, randomised, open trial. 2690 patients who had undergone infrainguinal grafting were randomly assigned oral anticoagulants (target international normalised ratio 3.0-4.5, n=1339) or aspirin (80 mg daily, n=1351). We followed up patients for a mean of 21 months. The primary outcome was graft occlusion.
                308 graft occlusions occurred in the oral-anticoagulants group compared with 322 in the aspirin group (hazard ratio 0.95 [95% CI 0.82-1.11]), which suggested no overall advantage for either treatment. Oral anticoagulants were beneficial in patients with vein grafts (0.69 [0.54-0.88]), whereas aspirin had better results for nonvenous grafts (1.26 [1.03-1.55]). The composite outcome of vascular death, myocardial infarction, stroke, or amputation occurred 248 times in the oral-anticoagulants group and 275 times in the aspirin group (0.89 [0.75-1.06]). Patients treated with oral anticoagulants had more major bleeding episodes than those treated with aspirin (108 vs 56; 1.96 [1.42-2.71]).
                Oral anticoagulation was better for the prevention of infrainguinal-vein-graft occlusion and for lowering the rate of ischaemic events. Aspirin was better for the prevention of non-venous graft occlusion, and was associated with fewer bleeding episodes. Banded gastric bypass has been reported to result in superior weight loss compared with standard nonbanded gastric bypass. However, an adequate comparison of these procedures has not yet been reported.
                A total of 90 patients were enrolled in this prospective randomized double-blind trial comparing banded and nonbanded open gastric bypass for the treatment of super obesity. The banding technique involved placement of a 1.5 x 5.5-cm polypropylene band around the proximal gastric pouch of a standard gastric bypass procedure using the technique of Capella. Chi-square testing and analysis of variance were performed to find any differences in patient characteristics (gender, age, and initial body mass index), percentage of excess weight lost at 6, 12, 24, and 36 months postoperatively, improvement or resolution of co-morbidities, and complications in the banded versus nonbanded gastric bypass groups.
                As expected, no differences were present in the patient characteristics or incidence of co-morbidities between the banded (n = 46) and nonbanded (n = 44) groups. The body mass index, percentage of women, and mean age was 59.5 and 56.5 kg/m2, 64% and 73.8% (P = .09), and 40.6 +/- 7.4 and 42.6 +/- 7.2 years for the banded and nonbanded groups, respectively; all differences were nonsignificant. No significant differences were found in the resolution of co-morbidities. No significant difference was present in the percentage of excess weight loss at 6, 12, and 24 months (43.1% versus 24.7%, 64.0% versus 57.4%, and 64.2% versus 57.2%, respectively) postoperatively; however, the banded patients had achieved a significantly greater percentage of excess weight loss at 36 months (73.4% versus 57.7%; P <.05). The incidence of intolerance to meat and bread was greater in the banded patients. The overall number of complications was 12 (26%) in the banded and 13 (29.5%) in the nonbanded group, a nonsignficant difference. No band erosions had occurred at the last follow-up visit, and no patients in either group died.
                These results suggest that although the initial weight loss was not significantly different between the 2 groups, the banded patients continued to lose weight for < or = 3 years. The polypropylene band appeared to be well tolerated. We plan longer follow-up to confirm the possibility of additional weight loss and the prevention of weight regain in the banded group, as well as to document any long-term band complications. The objective of this study was to compare neuropsychologic and quality-of-life outcomes of patients undergoing off-pump coronary artery bypass surgery to those undergoing coronary artery bypass graft surgery using conventional cardiopulmonary bypass.
                A prospective randomized trial of coronary artery bypass graft surgery with and without the use of cardiopulmonary bypass.
                A cardiothoracic surgery unit at a tertiary hospital.
                Sixty-six patients undergoing coronary artery bypass graft surgery and a control group of 50 participants not undergoing cardiac surgery.
                Patients were randomized to receive coronary artery bypass graft surgery with cardiopulmonary bypass or randomized to coronary artery bypass graft surgery without the use of cardiopulmonary bypass.
                The proportions of neuropsychologic deficits and improvement in quality-of-life were comparable regardless of whether patients were randomized to receive off-pump coronary artery bypass graft surgery or conventional coronary artery graft surgery with cardiopulmonary bypass.
                Patients receiving coronary artery bypass grafts without cardiopulmonary bypass did not show fewer cognitive deficits or greater improvement in quality of life.
There is limited evidence for the effectiveness of bypass surgery compared with other treatments; no studies compared bypass to no treatment. Further large trials are required.