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This study assesses demographic and clinical variables associated with perioperative and late stroke in diabetes mellitus patients after multivessel coronary artery bypass grafting (CABG). Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) is the largest randomized trial of diabetic patients undergoing multivessel CABG. FREEDOM patients had improved survival free of death, myocardial infarction, or stroke and increased overall survival after CABG compared to percutaneous intervention. However, the stroke rate was greater following CABG than percutaneous intervention. We studied predictors of stroke in CABG-treated patients analyzing separately overall, perioperative (≤30 days after surgery), and late (>30 days after surgery) stroke. For long-term outcomes (overall stroke and late stroke), Cox proportional hazards regression was used, accounting for time to event, and logistic regression was used for perioperative stroke. Independent perioperative stroke predictors were previous stroke (odds ratio [OR] 6.96, 95% confidence interval [CI] 1.43 to 33.96; p = 0.02), warfarin use (OR 10.26, 95% CI 1.10 to 96.03; p = 0.02), and surgery outside the United States or Canada (OR 9.81, 95% CI 1.28 to 75.40; p = 0.03). Independent late stroke predictors: renal insufficiency (hazard ratio [HR] 3.57, 95% CI 1.01 to 12.64; p = 0.048), baseline low-density lipoprotein ≥105 mg/dl (HR 3.28, 95% CI 1.19 to 9.02; p = 0.02), and baseline diastolic blood pressure (each 1 mm Hg increase reduces stroke hazard by 5%; HR 0.95, 95% CI 0.91 to 0.99; p = 0.03). There was no overlap between predictors of perioperative versus late stroke. In conclusion, late post-CABG strokes were associated with well-described risk factors. Nearly half of the strokes were perioperative. Independent risk factors for perioperative stroke: previous stroke, previous warfarin use, and CABG performed outside the United States or Canada.

In this trial, patients with diabetes and multivessel coronary disease had a lower risk of MI and death if they were treated with CABG, as compared with coronary stenting with drug-eluting stents. However, the CABG group had an increased risk of stroke. Revascularization for patients with multivessel coronary artery disease is performed commonly throughout the world. In the United States alone, approximately 700,000 patients undergo multivessel coronary revascularization yearly. Of these patients, 25% have diabetes. 1 , 2 In the Bypass Angioplasty Revascularization Investigation (BARI) trial, patients with diabetes and multivessel disease who underwent coronary-artery bypass grafting (CABG) lived longer than did patients undergoing balloon angioplasty, a finding that led to guideline recommendations for CABG as the preferred approach for revascularization in such patients. 3 , 4 Outcomes from CABG improved with the advent of antithrombotic therapy and the use of arterial conduits. 5 , 6 In subsequent . . .

Summary Aims The aim of this study was to assess cardiovascular (CV) safety of testosterone replacement therapy (TRT) in a large, diverse cohort of European men with hypogonadism (HG). Methods The Registry of Hypogonadism in Men (RHYME) was designed as a multi‐national, longitudinal disease registry of men diagnosed with hypogonadism (HG) at 25 clinical sites in six European countries. Data collection included a complete medical history, physical examination, blood sampling and patient questionnaires at multiple study visits over 2–3 years. Independent adjudication was performed on all mortalities and CV outcomes. Results Of 999 patients enrolled with clinically diagnosed HG, 750 (75%) initiated some form of TRT. Registry participants, including both treated and untreated patients, contributed 23 900 person‐months (99.6% of the targeted) follow‐up time. A total of 55 reported CV events occurred in 41 patients. Overall, five patients died of CV‐related causes (3 on TRT, 2 untreated) and none of the deaths were adjudicated as treatment‐related. The overall CV incidence rate was 1522 per 100 000 person‐years. CV event rates for men receiving TRT were not statistically different from untreated men (P=.70). Regardless of treatment assignment, CV event rates were higher in older men and in those with increased CV risk factors or a prior history of CV events. Conclusions Age and prior CV history, not TRT use, were predictors of new‐onset CV events in this multi‐national, prospective hypogonadism registry.

Purpose: To examine the 4-year outcomes from Carotid Revascularization using Endarterectomy or Stenting Systems (CaRESS) in light of the current reimbursement guidelines for carotid artery stenting (CAS) from the Centers for Medicare and Medicaid Services (CMS). Methods: CaRESS was designed as a prospective, nonrandomized comparative cohort study of a broad-risk population of symptomatic and asymptomatic patients with carotid stenosis. In all, 397 patients (247 men; mean age 71 years, range 43–89) were enrolled and underwent carotid endarterectomy (CEA; n=254) or protected CAS (n=143). More than 90% of patients had >75% stenosis; two thirds were asymptomatic. The primary endpoints included (1) all-cause mortality, (2) any stroke, and (3) myocardial infarction (MI), as well as the composite endpoints of (4) death and any nonfatal stroke and (5) death, nonfatal stroke, and MI. The secondary endpoints were restenosis, repeat angiography, and carotid revascularization. All patients were classified with respect to surgical risk, symptom status, and stenosis grade based on criteria published by the CMS. In addition, separate analyses were performed comparing genders and octogenarians to those <80 years old. Results: No significant differences in the primary outcome measures were found between the CEA and CAS groups in the 4-year analysis. The incidences of any stroke at 4 years were 9.6% for CEA and 8.6% for CAS (p=0.444); when combined with death, the composite death/nonfatal stroke rates were 26.5% for CEA versus 21.8% for CAS (p=0.361). The composite endpoint of death, nonfatal stroke, and MI at 4 years was 27.0% in CEA versus 21.7% in CAS (p=0.273) patients. The secondary endpoints of restenosis (p=0.014) and repeat angiography (p=0.052) were higher in the CAS arm. There were no differences in any of the subgroups stratified according the CMS guidelines or in the gender comparison. Four-year incidences of death/nonfatal stroke and death/nonfatal stroke/MI were higher in the CEA arm among patients <80 years of age (p=0.049 and p=0.030, respectively). There were no significant differences between these incidences in the octogenarian subgroup. Conclusion: The risk of death or nonfatal stroke 4 years following CAS with distal protection is equivalent to CEA in a broad category of patients with carotid stenosis. There were no significant differences in stroke or mortality rates between high-risk and non–high-risk patients and no differences in outcomes between symptomatic and asymptomatic patients. After 4 years, CAS had a 2-fold higher restenosis rate compared to CEA. The risk of death/stroke or death/stroke/MI appears to be higher following CEA than CAS among patients <80 years of age, yet there is no statistically significant relationship between death, stroke, or MI among octogenarians.

Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

The 95% confidence intervals for the composite endpoints of death/ stroke/Ml (CAS: 14.38% to 29.08%; CEA: 20.62% to 33.36%) and death/stroke (CAS: 14.45% to 29.23%; CEA: 20.07% to 32.89%), as well as individual events such as all-cause mortality, stroke, and Ml, were quite reasonably narrow. [...] the data do justify the assumption of equivalence. [...] it is not appropriate to consider symptomatic patients as \"confounders.\" Symptomatic patients made up only one third of the overall population, as was the case in the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) prospective randomized trial.3 As can be seen in Table 5 of the article,1 the 4-year rate of the composite endpoint death/ stroke/Ml, for example, was higher in the symptomatic CEA patients compared with asymptomatic CEA patients; the opposite was true for CAS: asymptomatic CAS patients had a higher composite event rate compared with symptomatic CAS patients at 4 years. 3.

Background: Severe skin and soft-tissue infections (SSTIs), particularly diabetic foot infections, are a source of considerable morbidity and mortality. Inappropriate antimicrobial therapy may contribute to the increasing emergence of bacterial resistance, as well as to increased health care costs. Thus, there is a continuing search for reasonably safe, well-tolerated, and effective antimicrobial agents that are less susceptible to the development of resistance than older agents. Objective: The Department of Veterans Affairs (VA) Medical Center in Nashville, Tennessee, was 1 site in a multicenter, Phase III, randomized, investigator-blinded clinical trial comparing the safety and efficacy of clinafloxacin with those of piperacillin/tazobactam in the treatment of adult patients with SSTI. Methods: Over an 18-month period, patients aged ≥18 years with physical findings of acute bacterial SSTI requiring hospitalization and intravenous antimicrobial therapy were randomized in a 1:1 ratio to receive either clinafloxacin 200 mg IV every 12 hours or piperacillin/tazobactam 3.375 g IV every 6 hours. After a minimum of 3 days of intravenous therapy, a switch to oral therapy with clinafloxacin 200 mg PO every 12 hours or amoxicillin/clavulanate 500 mg PO every 8 hours could be made in the respective treatment groups. Results: The center enrolled 84 patients (42 in each group), all but 1 of whom were male, reflecting the typical VA medical center population. The mean age was 60 years (range, 36–80 years) in the clinafloxacin group and 65 years (range, 35–87) in the piperacillin/tazobactam group; the latter group was significantly older ( P = 0.0482), which could have affected recovery rates. Sixty-six patients were white and 18 were black. The mean (±SD) duration of treatment was 10.69 ± 5.34 days in the clinafloxacin group and 12.07 ± 5.06 days in the piperacillin/tazobactam group; the mean length of stay was 10.83 ± 10.28 days and 14.95 ± 19.20 days, respectively. Fifty-three (63%) patients were switched to oral therapy (21 in the clinafloxacin group, 32 in the piperacillin/tazobactam group). The most commonly isolated pathogens were Staphylococcus aureus, Enterococcus faecalis, Pseudomonas aeruginosa, and Enterobacter cloacae. Clinical cure rates and microbiologic eradication rates were similar between the 2 treatments. The piperacillin/tazobactam arm experienced more all-cause adverse events than the clinafloxacin arm, although the difference was not statistically significant. The clinafloxacin arm experienced significantly more adverse events (eg, photosensitivity) that were judged by the investigator to be drug related ( P = 0.034). Conclusions: In this study population of hospitalized adults, clinafloxacin was as effective as piperacillin/tazobactam in the treatment of complicated SSTIs. Appropriate precautions must be taken against exposure to sunlight and ultraviolet light in patients receiving clinafloxacin, and adequate monitoring is necessary. Further investigation is necessary into how the phototoxic effects of the fluoroquinolones can be limited.