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Background Cardiac mortality and myocardial infarction (MI) rates are used to evaluate the efficacy of coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). We compared 5-year cardiac mortality and MI rates in 1829 patients with multivessel disease randomized to CABG or PTCA. Methods and Results The 5-year cardiac mortality rate was 8.0% in patients assigned to PTCA compared with 4.9% in those assigned to CABG (relative risk [RR] of 1.55 with a 95% confidence interval [CI] of 1.07 to 2.23; P =.022). In a subgroup of 1476 nondiabetic patients, there were no significant differences between treatment groups in cardiac mortality either overall (4.6% versus 4.2%; RR=1.04, 95% CI, 0.65 to 1.66; P =.908) or in subgroups based on symptoms, left ventricular function, number of diseased vessels, or stenotic proximal left anterior descending artery. The two treatment groups had similar event rates for the combined end point of cardiac death or MI. The RR for cardiac mortality in 264 patients who sustained an MI compared with those who did not was 5.9 ( P <.001). MIs were more common after CABG during index hospitalization ( P =.004), but in the PTCA group, they were more common after discharge ( P <.001). Conclusions The Bypass Angioplasty Revascularization Investigation (BARI) trial indicates 5-year cardiac mortality in patients with multivessel disease was significantly greater after initial treatment with PTCA than with CABG. The difference was manifest in diabetic patients on drug therapy. There were no significant differences overall for the composite end point of cardiac mortality or MI between treatment groups or for cardiac mortality in nondiabetic patients regardless of symptoms, left ventricular function, number of diseased vessels, or stenotic proximal left anterior descending artery.

Background The NHLBI Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry followed 1345 consecutive patients with first PTCA between 1977 and 1981 (registry 1) and 2136 consecutive patients with PTCA between 1985 and 1986 (registry 2). Changes in patient selection and in immediate and 1-year outcome are presented. This report extends to 5 years the comparison of the effects of early and more recent management with PTCA. Methods and Results Sixteen participating centers entered consecutive patients who had angioplasty for the first time between 1977 and 1981 and between 1985 and 1986. Patients with recent myocardial infarction (MI) were excluded. Vessel disease was defined according to the Coronary Artery Surgery Study. Successful dilatation required ≥20% reduction in luminal narrowing and <50% lumen diameter stenosis after intervention. Routine annual follow-up was conducted by telephone interview. The product-limit method was used to estimate freedom from untoward events, Cox regression analysis to model relative risk and adjusted relative risk of events between the two registries, and logistic regression when the exact time of outcome (such as recurrence of symptoms) was not known. Long-term event rates were computed by vessel disease for all patients and for the cohort of patients with initially successful PTCA. After adjustment for extent of disease, diabetes, prior bypass surgery (CABG), hypertension, age, and sex, the 5-year risk of death was similar in the two registry cohorts. However, rates of MI, CABG, and a combined outcome measure of death, MI, and/or CABG were significantly lower in the registry 2 cohort both for all patients and for patients who were initially treated successfully. Use of repeated PTCA was higher, and freedom from symptoms without adverse events was significantly better in the latter cohort. Conclusions Compared with registry 1, the management of the registry 2 cohort resulted in lower 5-year morbid event rates and reduced CABG operations. Mortality rates remained similar. When symptomatic status was considered in combination with events, a significantly better outcome was seen overall and in the initially successful cohort. In registry 2, repeated PTCA was used with much greater frequency early after the initial procedure.

BACKGROUND Coronary revascularization with bypass has been shown to improve survival in patients with coronary artery disease and left ventricular dysfunction. In these patients, use of nonsurgical revascularization with percutaneous transluminal coronary angioplasty (PTCA) is increasing, although their long-term outcome has not been well delineated. The purpose of this investigation was to characterize the outcome of angioplasty in patients with decreased left ventricular function and contrast it with the results in patients with normal left ventricular function. METHODS AND RESULTS In the 1985-1986 National Heart, Lung, and Blood Institute's PTCA Registry, of 1,802 patients undergoing PTCA, 244 patients (13.5%) had an ejection fraction of < or = 45% (mean, 39.6 +/- 6.8%). These patients had a higher incidence of prior infarction, a longer and worse history of manifestations of coronary disease, and more extensive coronary artery disease than patients with well-preserved function; 88% and 91%, respectively, had successful dilation of at least one lesion (nonsignificant difference). However, patients with decreased left ventricular function had a decreased frequency of successful dilation of all lesions in which PTCA was attempted (76% versus 84%, p < 0.01). There were no statistically significant differences in in-hospital complications--death occurred in 0.8% and 0.7%, nonfatal myocardial infarction occurred in 4.9% and 4.5%, and emergency surgical revascularization was performed in 4.5% and 3.2%, respectively. Patients were followed for a mean of 4.1 years; during this time, patients with decreased left ventricular function had significantly worse survival and combined event-free survival. Despite this, at 4 years, 87% of the patients with a mean ejection fraction of 39.6% remained alive, and 77% were alive and had not experienced infarction or required bypass. CONCLUSIONS PTCA is effective in selected patients with depressed left ventricular function. Initial outcome and risk-benefit ratio are excellent. Successful dilation of at least one vessel was achieved in 88% of patients with depressed left ventricular function and in 91% of patients with more normal left ventricular function. The former group, however, had a decreased incidence of successful dilation in all lesions in which dilation was attempted (76% versus 84%, p < 0.01). There was no significant difference in in-hospital complications between the two groups. During follow-up, patients with decreased left ventricular function had worse event-free survival, although 77% were alive without infarction or bypass grafting at 4 years.

Background —Patients with treated diabetes in the randomized-trial segment of the Bypass Angioplasty Revascularization Investigation (BARI) who were randomized to initial revascularization with PTCA had significantly worse 5-year survival than patients assigned to CABG. This treatment difference was not seen among diabetic patients eligible for BARI who opted to select their mode of revascularization. We hypothesized that differences in patient characteristics, assessed and unmeasured, together with the treatment selection in the registry, at least partially account for this discrepancy. Methods and Results —Among diabetics taking insulin or oral hypoglycemic drugs at entry, angiographic and clinical presentations were comparable between randomized and registry patients. However, more registry patients were white, and registry diabetics tended to be more educated and more physically active and to report better quality of life. Procedural characteristics and in-hospital complications were comparable. The 5-year all-cause mortality rate was 34.5% in randomized diabetic patients assigned to PTCA versus 19.4% in CABG patients ( P =0.0024; relative risk [RR]=1.87); corresponding cardiac mortality rates were 23.4% and 8.2%, respectively ( P =0.0002; RR=3.10). The CABG benefit was more apparent among patients requiring insulin. In the registry, all-cause mortality was 14.4% for PTCA versus 14.9% for CABG ( P =0.86, RR=1.10), with corresponding cardiac mortality rates of 7.5% and 6.0%, respectively ( P =0.73; RR=1.07). These RRs in the registry increased to 1.29 and 1.41, respectively, after adjustment for all known differences between treatment groups. Conclusions —BARI registry results are not inconsistent with the finding in the randomized trial that initial CABG is associated with better long-term survival than PTCA in treated diabetic patients with multivessel coronary disease suitable for either surgical or catheter-based revascularization.

Abstract Background: Genome-wide association studies (GWAS) identified variants at 19p13.1 and ZNF365 (10q21.2) as risk factors for breast cancer among BRCA1 and BRCA2 mutation carriers, respectively. We explored associations with ovarian cancer and with breast cancer by tumor histopathology for these variants in mutation carriers from the Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA). Methods: Genotyping data for 12,599 BRCA1 and 7,132 BRCA2 mutation carriers from 40 studies were combined. Results: We confirmed associations between rs8170 at 19p13.1 and breast cancer risk for BRCA1 mutation carriers [HR, 1.17; 95% confidence interval (CI), 1.07–1.27; P = 7.42 × 10−4] and between rs16917302 at ZNF365 (HR, 0.84; 95% CI, 0.73–0.97; P = 0.017) but not rs311499 at 20q13.3 (HR, 1.11; 95% CI, 0.94–1.31; P = 0.22) and breast cancer risk for BRCA2 mutation carriers. Analyses based on tumor histopathology showed that 19p13 variants were predominantly associated with estrogen receptor (ER)-negative breast cancer for both BRCA1 and BRCA2 mutation carriers, whereas rs16917302 at ZNF365 was mainly associated with ER-positive breast cancer for both BRCA1 and BRCA2 mutation carriers. We also found for the first time that rs67397200 at 19p13.1 was associated with an increased risk of ovarian cancer for BRCA1 (HR, 1.16; 95% CI, 1.05–1.29; P = 3.8 × 10−4) and BRCA2 mutation carriers (HR, 1.30; 95% CI, 1.10–1.52; P = 1.8 × 10−3). Conclusions: 19p13.1 and ZNF365 are susceptibility loci for ovarian cancer and ER subtypes of breast cancer among BRCA1 and BRCA2 mutation carriers. Impact: These findings can lead to an improved understanding of tumor development and may prove useful for breast and ovarian cancer risk prediction for BRCA1 and BRCA2 mutation carriers. Cancer Epidemiol Biomarkers Prev; 21(4); 645–57. ©2012 AACR.

Context Perioperative antibiotics are widely used to improve the outcomes of endoscopic sinus surgery. Objective The aim of this study was to summarize the evidence on the effect of perioperative antibiotic prophylaxis on outcomes of endoscopic sinus surgery. Data Sources and Review Methods We searched electronic databases from inception through May 2011 for any relevant clinical trials or observational studies. Two reviewers working independently extracted study characteristics, quality, and the outcomes of interest. Random‐effects meta‐analysis was used to pool the relative risks (RRs) and the standardized mean differences (SMDs) across trials. Results We found 4 eligible trials with varying quality, of which 3 were included in the quantitative analysis. Antibiotic prophylaxis was associated with a nonsignificant reduction in the incidence of infections (relative risk, 0.76; 95% confidence interval [CI], 0.64 to 1.09), symptoms scores (SMD, −0.04; 95% CI, −0.46 to 0.38), and endoscopic scores (SMD, −0.09; 95% CI, 0.30 to 0.13). The heterogeneity associated with the analysis was significant only for the outcome of change in symptoms score (I‐squared values, 0%, 70%, and 0% for the 3 outcomes, respectively). Conclusions Trial data available to date are unable to demonstrate a statistically significant reduction in infection, symptom scores, or endoscopic scores to support the routine use of postoperative prophylactic antibiotics following endoscopic sinus surgery. Our analysis was limited by the number of published trials related to this topic.

Epileptic spasms, or seizures marked by flexor, extensor, or flexor-extensor spasms, are not always responsive to medical management. The purpose of our study was to evaluate the outcome of epilepsy surgery in children with medically intractable epileptic spasms. We identified 11 children with epileptic spasms who underwent lesionectomy (36%), lobectomy (27%), multi-lobectomy (9%), hemispherectomy (18%), or corpus callosotomy (9%). At the time of surgery, 6 children had developed other concurrent seizure type(s), including simple partial (9%), complex partial (27%), partial undifferentiated (9%), primary generalized tonic clonic (9%), tonic (9%), atonic (27%), and myoclonic (9%) seizures. Six children (55%) were seizure free at last follow-up from initial surgery. Predictors of favorable outcome included lack of focal slowing and the presence of less than 2 interictal epileptiform abnormalities on postoperative electroencephalogram ( P = .035 and .035, respectively). Favorable outcome was significantly associated with parent/caregiver report of improved postoperative developmental outcomes ( P = .026).