A comparison of clinical outcomes of Chinese sirolimus-eluting stents versus foreign sirolimus-eluting stents for the treatment of coronary artery disease

Background

Chinese sirolimus-eluting stents (SES) have been widely used in recent years. However, the comparison of clinical outcomes between Chinese and foreign SES remains unknown.

Objectives

To compare the outcomes of Chinese SES (Firebird) with foreign SES (Cypher Select) in the treatment of patients undergoing percutaneous coronary intervention (PCI).

Methods

4000 consecutive patients treated with SESs from January 2008 to December 2009 were included in this study. Based on the differences of the stents, the patients were divided into a Chinese SES group (Firebird; n = 2008) and a foreign SES group (Cypher Select; n = 1992). Outcomes were monitored for 1 year. The primary clinical endpoint was major adverse cardiac events (MACE): a composite of death, non-fatal myocardial infarction (MI) and target-vessel revascularisation (TVR).

Results

No differences were observed in the incidence of MACE (17.8% vs. 18.6%, p = 0.514) and TVR rate (9.0% vs. 8.6%, p = 0.632) during 1-year follow-up.

Conclusions

Chinese SES and foreign SES have similar effects on 1-year clinical outcomes and safety.     

妊娠期肝内胆汁淤积症256例临床分析

目的:探讨改善妊娠期肝内胆汁淤积症患者围生结局及围生儿预后的方法。方法:对2006年3月-2011年3月在我院住院分娩的256例ICP患者及从我院住院无并发症正常分娩的10112个患者中随机抽取的256例患者的产检情况、分娩方式、围生儿结局进行回顾性分析。结果:ICP组与对照组在分娩方式、产后出血、早产、新生儿窒息、羊水粪染、围产儿死亡等方面比较差异均具有统计学意义(P<0.05);产检组与未检组在产后出血、早产、新生儿窒息、羊水粪染、围产儿死亡等方面比较差异有统计学意义(P<0.05)。结论:妊娠期肝内胆汁淤积症可增加早产、胎儿宫内窘迫、新生儿窒息、产后出血发生率,重视产前检查和孕期保健,对ICP患者做到早发现、早诊断、早治疗,选择适当分娩方式、适时终止妊娠,对改善围生结局及围生儿预后有积极的意义。     

Assessing treatment effect heterogeneity in clinical trials with blocked binary outcomes

This paper addresses treatment effect heterogeneity (also referred to, more compactly, as 'treatment heterogeneity') in the context of a controlled clinical trial with binary endpoints. Treatment heterogeneity, variation in the true (causal) individual treatment effects, is explored using the concept of the potential outcome. This framework supposes the existance of latent responses for each subject corresponding to each possible treatment. In the context of a binary endpoint, treatment heterogeniety may be represented by the parameter, pi2, the probability that an individual would have a failure on the experimental treatment, if received, and would have a success on control, if received. Previous research derived bounds for pi2 based on matched pairs data. The present research extends this method to the blocked data context. Estimates (and their variances) and confidence intervals for the bounds are derived. We apply the new method to data from a renal disease clinical trial. In this example, bounds based on the blocked data are narrower than the corresponding bounds based only on the marginal success proportions. Some remaining challenges (including the possibility of further reducing bound widths) are discussed.     

Surgical issues surrounding use of aromatase inhibitors

There are important surgical issues related to the use of the third generation aromatase inhibitors in both the neoadjuvant and adjuvant settings. Neoadjuvant hormone therapy is effective at downstaging tumours, particularly large tumours initially thought to be inoperable or requiring mastectomy. Randomised trials have shown that the newer aromatase inhibitors letrozole and anastrozole increase the numbers of women who are suitable for breast-conservation compared with tamoxifen, and that letrozole is superior to tamoxifen in terms of clinical response.

Aromatase inhibitors are most effective in ER-rich tumours and are clinically and biologically effective in both HER2 positive and negative tumours, whereas HER2 positive tumours show a level of resistance to tamoxifen.

In neoadjuvant studies comparing aromatase inhibitors with tamoxifen, the duration of use has been 3–4 months, by which time any response is usually evident but longer treatment periods produce continued shrinkage and response. The re-excision rate following breast conservation surgery after neoadjuvant hormone therapy is favourable compared with the rates following immediate wide local excision. Local recurrence rates are acceptable in patients undergoing neoadjuvant therapy and breast-conserving surgery providing post-operative radiotherapy is given.

Adjuvant aromatase inhibitors, as well as having an effect on metastatic disease and survival, reduce local and regional recurrence.     

Bayesian latent variable models for mixed discrete outcomes

In studies of complex health conditions, mixtures of discrete outcomes (event time, count, binary, ordered categorical) are commonly collected. For example, studies of skin tumorigenesis record latency time prior to the first tumor, increases in the number of tumors at each week, and the occurrence of internal tumors at the time of death. Motivated by this application, we propose a general underlying Poisson variable framework for mixed discrete outcomes, accommodating dependency through an additive gamma frailty model for the Poisson means. The model has log-linear, complementary log-log, and proportional hazards forms for count, binary and discrete event time outcomes, respectively. Simple closed form expressions can be derived for the marginal expectations, variances, and correlations. Following a Bayesian approach to inference, conditionally-conjugate prior distributions are chosen that facilitate posterior computation via an MCMC algorithm. The methods are illustrated using data from a Tg.AC mouse bioassay study.     

Growth and reproduction in the Icelandic common seal (Phoca vitulina L., 1758)

Length, weight and maturity were studied in relation to age in the common seal (Phoca vitulina vitulina L., 1758), collected during the periods 1979-1983 and 1990-2000 in Icelandic waters. The maximum age of common seal observed was 36 years for females and 30 years for males. For common seal females and males, asymptotic length and weight were 161 cm and 93 kg and 174 cm and 97 kg, respectively, showing slight sexual dimorphism in size. The condition of adult females, measured as fat thickness at the lower end of the sternum, was lower in the period 1979-1983 than in 1990-2000 during June-September, the breeding and mating time of the Icelandic common seal. Males reached sexual maturity between 5 and 7 years, whereas 50% of females did so at age 4 years. Including the length and age interaction term in the logistic regression model for the maturity of females significantly improved it. Thus, body size matters in the onset of maturity. The mean birthing date for the Icelandic common seal was found to be in early June. A comparison of animals collected in the two periods 1979-1983 and 1990-2000 did not show significant differences in growth and the average age of sexual maturity for either males or females. The observed decline of the Icelandic common seal population is most probably caused by increased mortality, due to exploitation and accidental by-catch in gill-nets, rather than a decrease in fecundity.     

Modelling multivariate outcomes in hierarchical data, with application to cluster randomised trials

In the cluster randomised study design, the data collected have a hierarchical structure and often include multivariate outcomes. We present a flexible modelling strategy that permits several normally distributed outcomes to be analysed simultaneously, in which intervention effects as well as individual-level and cluster-level between-outcome correlations are estimated. This is implemented in a Bayesian framework which has several advantages over a classical approach, for example in providing credible intervals for functions of model parameters and in allowing informative priors for the intracluster correlation coefficients. In order to declare such informative prior distributions, and fit models in which the between-outcome covariance matrices are constrained, priors on parameters within the covariance matrices are required. Careful specification is necessary however, in order to maintain non-negative definiteness and symmetry between the different outcomes. We propose a novel solution in the case of three multivariate outcomes, and present a modified existing approach and novel alternative for four or more outcomes. The methods are applied to an example of a cluster randomised trial in the prevention of coronary heart disease. The modelling strategy presented would also be useful in other situations involving hierarchical multivariate outcomes.     

A nonlinear model with latent process for cognitive evolution using multivariate longitudinal data

Cognition is not directly measurable. It is assessed using psychometric tests, which can be viewed as quantitative measures of cognition with error. The aim of this article is to propose a model to describe the evolution in continuous time of unobserved cognition in the elderly and assess the impact of covariates directly on it. The latent cognitive process is defined using a linear mixed model including a Brownian motion and time-dependent covariates. The observed psychometric tests are considered as the results of parameterized nonlinear transformations of the latent cognitive process at discrete occasions. Estimation of the parameters contained both in the transformations and in the linear mixed model is achieved by maximizing the observed likelihood and graphical methods are performed to assess the goodness of fit of the model. The method is applied to data from PAQUID, a French prospective cohort study of ageing.