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TACT is an National Institutes of Health-sponsored, randomized, double-blind, placebo-controlled, 2 × 2 factorial clinical trial testing the benefits and risks of 40 infusions of a multicomponent disodium EDTA chelation solution compared with placebo and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow up 1,708 patients for an average of approximately 4 years. The primary end point is a composite of all-cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900-patient substudy will examine quality-of-life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary end point for each treatment factor. Enrollment began in September 2003 and was completed in October 2010. [ABSTRACT FROM AUTHOR]

Context: Despite the routine use of prophylactic systemic antibiotics, sternal wound infection still occurs in 5% or more of cardiac surgical patients and is associated with significant excess morbidity, mortality, and cost. The gentamicin-collagen sponge, a surgically implantable topical antibiotic, is currently approved in 54 countries. A large, 2-center, randomized trial in Sweden reported in 2005 that the sponge reduced surgical site infection by 50% in cardiac patients.Objective: To test the hypothesis that the sponge prevents infection in cardiac surgical patients at increased risk for sternal wound infection.Design, Setting, and Participants: Phase 3 single-blind, prospective randomized controlled trial, 1502 cardiac surgical patients at high risk for sternal wound infection (diabetes, body mass index >30, or both) were enrolled at 48 US sites between December 21, 2007, and March 11, 2009.Intervention: Single-blind randomization to insertion of 2 gentamicin-collagen sponges (total gentamicin of 260 mg) between the sternal halves at surgical closure (n = 753) vs no intervention (control group: n = 749). All patients received standardized care including prophylactic systemic antibiotics and rigid sternal fixation.Main Outcome Measures: The primary end point was sternal wound infection occurring through 90 days postoperatively as adjudicated by a clinical events classification committee blinded to study treatment group. The primary study comparison was done in the intent-to-treat population. Secondary outcomes included (1) superficial wound infection (involving subcutaneous tissue but not extending down to sternal fixation wires), (2) deep wound infection (involving the sternal wires, sternal bone, and/or mediastinum), and (3) score for additional treatment, presence of serous discharge, erythema, purulent exudate, separation of the deep tissues, isolation of bacteria, and duration of inpatient stay (ASEPSIS; minimum score of 0 with no theoretical maximum).Results: Of 1502 patients, 1006 had diabetes (67%) and 1137 were obese (body mass index >30) (76%). In the primary analysis, there was no significant difference in sternal wound infection in 63 of 753 patients randomized to the gentamicin-collagen sponge group (8.4%) compared with 65 of 749 patients randomized to the control group (8.7%) (P = .83). No significant differences were observed between the gentamicin-collagen sponge group and the control group, respectively, in superficial sternal wound infection (49/753 [6.5%] vs 46/749 [6.1%]; P = .77), deep sternal wound infection (14/753 [1.9%] vs 19/749 [2.5%]; P = .37), ASEPSIS score (mean [SD], 1.9 [6.4] vs 2.0 [7.2]; P = .67), or rehospitalization for sternal wound infection (23/753 [3.1%] vs 24/749 [3.2%]; P = .87).Conclusion: Among US patients with diabetes, high body mass index, or both undergoing cardiac surgery, the use of 2 gentamicin-collagen sponges compared with no intervention did not reduce the 90-day sternal wound infection rate.Trial Registration: clinicaltrials.gov Identifier: NCT00600483. [ABSTRACT FROM AUTHOR]

We examined associations between positive emotion (PE) and functional status (Duke Activity Status Inventory) in 948 coronary artery disease (CAD) patients (35.1% women; age M = 70.1 years, SD = 6.3). Emotion and function measures were gathered during hospitalization and annually for 3 years. We used random coefficient models to examine PE during hospitalization and follow-up, as a predictor of change in function. Analyses adjusted for baseline functional status, negative emotion, social support, marital status, and disease severity. Sex was examined as a moderator of effects. PE assessed during hospitalization was a significant predictor of change in function such that lower levels of PE were associated with accelerated decline in function. Lower levels of PE during follow-up were also related to increasing decline in function but only in men. Thus, our findings indicate that PE is associated with less decline in functional status following hospitalization for CAD. [ABSTRACT FROM AUTHOR]

ICD Therapy and Prior Coronary Revascularization. Introduction:We conducted this study to examine the effect of the ICD on the outcomes of patients with prior coronary revascularization enrolled in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and to assess the association of time from coronary revascularization to enrollment with death and sudden cardiac death (SCD).Methods and Results:We included in this analysis patients with ischemic heart disease not randomized to the amiodarone arm. Cox proportional hazards models were used to examine the association of priorCABG and of prior PCI with each outcome. Interactions between randomized treatment and each revascularization type and time were tested in each model. Of the 882 patients who met these inclusion criteria, 255 (29%) had no prior revascularization, 178 (20%) had prior PCI only, 284 (32%) had prior CABG only, and 165 (19%)had prior PCI and CABG. There was no significant difference in ICD benefit across the revascularization subgroups (all P>0.1). There was a trend toward improved survival with an ICD in patients who had their CABG>2 years before randomization (HR [CI]=0.71 [0.49, 1.04]) that was not observed in patients who had their CABG > 2 years before randomization (HR [CI] = 1.40 [0.61, 3.24]).Conclusion: In SCD-HeFT, there was no significant difference in ICD benefit across the revascularization subgroups. Patients who had their CABG>2 years before randomization showed a trend toward improved survival with an ICD that was not observed in patients who had their CABG < or equal to 2 years before randomization. [ABSTRACT FROM AUTHOR]

The association between coping and personality was examined in a sample of 204 cardiac catheterization patients who were asked to evaluate the use of specific coping strategies used to deal with their cardiac catheterization. Personality, as measured by the NEO Five-Factor Inventory (FFI), was moderately correlated with coping measures. In multivariate analyses, after considering confounding factors, Neuroticism was positively and Extraversion was negatively related to avoidance coping and Neuroticism was negatively associated with counting one's blessings as a coping strategy. Personality was not related to either problem solving or seeking social support coping strategies for individuals experiencing a cardiac catheterization. However, important covariates were associated with coping strategies. Not being married was negatively correlated with use of seeking social support and not having a confidant was negatively related with seeking social support and positively with avoidance. These results suggest that there are specific relationships between personality and coping, but these relationships are, for the most part, moderate in persons coping with a cardiac catheterization, and that coping processes are associated with individual differences in available social resources. [ABSTRACT FROM AUTHOR]

Background: We assessed in a randomised trial the long-term outcomes for potent adjunctive antiplatelet therapy given at the time of coronary stenting.Methods: In 63 hospitals in the USA and Canada, 2399 patients were randomly assigned stenting with abciximab, stenting with placebo, or balloon angioplasty with abciximab. Standard adjunctive therapy with aspirin, ticlopidine, and heparin was used. The major outcomes of death and myocardial infarction were assessed at 1-year follow-up by intention to treat. We also investigated the 1-year cost-effectiveness of combined stenting and abciximab therapy.Findings: At 1-year follow-up, eight (1.0%) of 794 patients in the stent plus abciximab group had died, compared with 19 (2.4%) of 809 in the stent plus placebo group (hazard ratio 0.43 [95% CI 0.19-0.97], p=0.037). The combined endpoint of death or large myocardial infarction occurred in 42 (5.3%) and 89 (11.0%), respectively (0.46 [0.32-0.67], p<0.001). By multivariate modelling, the factors independently associated with improved survival were assignment to stenting with abciximab (p=0.027) and greater preprocedural stenosis (p=0.002); those associated with worse survival were age greater than 70 years (p<0.001), previous heart failure (p=0.001), diabetes treated with insulin (p=0.02), and postprocedural occlusion (p<0.001). Relative to stenting plus placebo and balloon angioplasty plus abciximab, the incremental 1-year costs of stenting plus abciximab were US$581 and $932. The corresponding cost-effectiveness ratios were US$5291 and $6213 per added life-year.Interpretation: Coronary stenting with abciximab, compared with stenting alone or balloon angioplasty with abciximab, is associated with improved survival and is an economically attractive therapy by conventional standards. [ABSTRACT FROM AUTHOR]

Objective: To compare return-to-work rates after coronary angioplasty, coronary bypass surgery, and medical therapy in patients with coronary disease.Design: Prospective cohort study.Setting: Tertiary care referral center.Patients: Between March 1986 and June 1990, we enrolled 1252 patients who were younger than 65 years, who had not had previous coronary revascularization, and who were employed. All patients were followed for 1 year.Main Outcome Measure: One-year employment status.Results: After 1 year, 84% of patients who had coronary angioplasty were still working compared with 79% of patients who had bypass surgery and with 76% of patients who received medicine. After adjusting for the more favorable baseline characteristics of patients who had angioplasty (less severe coronary artery disease, better left ventricular function, and less functional impairment), however, no significant differences were noted in 1-year employment rates among the three groups. These adjusted 1-year return-to-work rates were 84% for angioplasty, 80% for surgery, and 79% for medicine (P > 0.05). In a random subset of 72 patients, 23 patients who had angioplasty returned to work after a median of 18 days (mean, 27 days) compared with 54 days (mean, 67 days) for 24 patients having bypass surgery and with 14 days (mean, 45 days) for 25 patients receiving medicine (P = 0.002).Conclusions: Patients who had coronary angioplasty were able to return to work earlier than those who had bypass surgery, but by 1 year no significant difference was noted in employment rates. Neither revascularization strategy improved employment rates when compared with initial treatment using medical therapy. [ABSTRACT FROM AUTHOR]