Optimized Duration of Clopidogrel Therapy Following Treatment with the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice (OPTIMIZE) Trial: Rationale and design of a large-scale, randomized, multicenter study

Background Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel >= 12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. Methods The OPTIMIZE trial is a large, prospective, multicenter, randomized (1: 1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. Conclusions The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention. (Am Heart J 2012;164:810-816.e3.)

A multiple time scale survival model with a cure fraction

Many recent survival studies propose modeling data with a cure fraction, i.e., data in which part of the population is not susceptible to the event of interest. This event may occur more than once for the same individual (recurrent event). We then have a scenario of recurrent event data in the presence of a cure fraction, which may appear in various areas such as oncology, finance, industries, among others. This paper proposes a multiple time scale survival model to analyze recurrent events using a cure fraction. The objective is analyzing the efficiency of certain interventions so that the studied event will not happen again in terms of covariates and censoring. All estimates were obtained using a sampling-based approach, which allows information to be input beforehand with lower computational effort. Simulations were done based on a clinical scenario in order to observe some frequentist properties of the estimation procedure in the presence of small and moderate sample sizes. An application of a well-known set of real mammary tumor data is provided.

Juvenile myoclonic epilepsy: The impact of clinical variables and psychiatric disorders on executive profile assessed with a comprehensive neuropsychological battery

Executive dysfunction is reported in juvenile myoclonic epilepsy (JME). However, batteries employed in previous studies included no more than three tests of executive function. In this study, we aimed to assess executive and attentional functions in JME using a comprehensive battery of eight tests (encompassing fifteen subtests). We also evaluated neuropsychological profiles using a clinical criterion of severity and correlated these findings with epilepsy clinical variables and the presence of psychiatric disorders. We prospectively evaluated 42 patients with JME and a matched control group with Digit Span tests (forward and backward), Stroop Color-Word Test, Trail Making Test, Wisconsin Card-Sorting Test, Matching Familiar Figures Test and Word Fluency Test. We estimated IQ with the Matrix Reasoning and Vocabulary subtests of the Wechsler Abbreviated Intelligence Scale. The patients with JME showed specific deficits in working memory, inhibitory control, concept formation, goal maintenance, mental flexibility, and verbal fluency. We observed attentional deficits in processes such as alertness and attention span and those requiring sustained and divided attention. We found that 83.33% of the patients had moderate or severe executive dysfunction. In addition, attentional and executive impairment was correlated with higher frequency of seizures and the presence of psychiatric disorders. Furthermore, executive dysfunction correlated with a longer duration of epilepsy. Our findings indicate the need for comprehensive neuropsychological batteries in patients with JME, in order to provide a more extensive evaluation of attentional and executive functions and to show that some relevant deficits have been overlooked. (C) 2012 Elsevier Inc. All rights reserved.

Frontal assessment battery in a Brazilian sample of healthy controls: normative data

Objective: To show data on the performance of healthy subjects in the Frontal Assessment Battery (FAB), correlating with gender, age, education, and scores in the Mini-Mental State Examination (MMSE). Methods: Two hundred and seventy-five healthy individuals with mean age of 66.4 +/- 10.6 years-old were evaluated. Mean total FAB scores were established according to the educational level. Results: Mean total FAB scores according to the educational level were 10.9 +/- 2.3, for one to three years; 12.8 +/- 2.7, for four to seven years; 13.8 +/- 2.2, for eight to 11 years; and 15.3 +/- 2.3, for 12 or more years. Total FAB scores correlated significantly with education (r=0.47; p<0.0001) and MMSE scores (r=0.39; p<0.0001). No correlation emerged between FAB scores, age, and gender. Conclusion: In this group of healthy subjects, the Brazilian version of the FAB proved to be influenced by the education level, but not by age and gender.

Multi-objective evolutionary algorithm for single and multiple fault service restoration in large-scale distribution systems

Network reconfiguration for service restoration (SR) in distribution systems is a complex optimization problem. For large-scale distribution systems, it is computationally hard to find adequate SR plans in real time since the problem is combinatorial and non-linear, involving several constraints and objectives. Two Multi-Objective Evolutionary Algorithms that use Node-Depth Encoding (NDE) have proved able to efficiently generate adequate SR plans for large distribution systems: (i) one of them is the hybridization of the Non-Dominated Sorting Genetic Algorithm-II (NSGA-II) with NDE, named NSGA-N; (ii) the other is a Multi-Objective Evolutionary Algorithm based on subpopulation tables that uses NDE, named MEAN. Further challenges are faced now, i.e. the design of SR plans for larger systems as good as those for relatively smaller ones and for multiple faults as good as those for one fault (single fault). In order to tackle both challenges, this paper proposes a method that results from the combination of NSGA-N, MEAN and a new heuristic. Such a heuristic focuses on the application of NDE operators to alarming network zones according to technical constraints. The method generates similar quality SR plans in distribution systems of significantly different sizes (from 3860 to 30,880 buses). Moreover, the number of switching operations required to implement the SR plans generated by the proposed method increases in a moderate way with the number of faults.