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Milan Milojevic Patrick W. Serruys Joseph F. Sabik David E. Kandzari Erick Schampaert Ad J. van Boven Ferenc Horkay Imre Ungi Samer Mansour Adrian P. Banning David P. Taggart Manel Sabaté Anthony H. Gershlick Andrzej Bochenek Jose Pomar Nicholas J. Lembo Nicolas Noiseux John D. Puskas Arie Pieter Kappetein 《Journal of the American College of Cardiology》2019,73(13):1616-1628
Background
The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown.Objectives
In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG.Methods
Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes.Results
The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65).Conclusions
In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776) 相似文献3.
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Lukas Frase Peter Selhausen Lukas Krone Sulamith Tsodor Friederike Jahn Bernd Feige Jonathan G. Maier Florian Mainberger Hannah Piosczyk Marion Kuhn Stefan Klöppel Annette Sterr Chiara Baglioni Kai Spiegelhalder Dieter Riemann Michael A. Nitsche Christoph Nissen 《Brain stimulation》2019,12(3):674-683
Background
Arousal and sleep represent basic domains of behavior, and alterations are of high clinical importance.Objective/hypothesis
The aim of this study was to further elucidate the neurobiology of insomnia disorder (ID) and the potential for new treatment developments, based on the modulation of cortical activity through the non-invasive brain stimulation technique transcranial direct current stimulation (tDCS). Specifically, we tested the hypotheses that bi-frontal anodal tDCS shortens and cathodal tDCS prolongs total sleep time in patients with ID, compared to sham stimulation. Furthermore, we tested for differences in indices of arousal between ID patients and healthy controls and explored their potential impact on tDCS effects.Methods
Nineteen ID patients underwent a within-subject repeated-measures sleep laboratory study with adaptation, baseline and three experimental nights. Bifrontal anodal, cathodal and sham tDCS was delivered in a counterbalanced order immediately prior to sleep. Wake EEG was recorded prior to and after tDCS as well as on the following morning. Subsequently, we compared patients with ID to a healthy control group from an earlier dataset.Results
Against our hypothesis, we did not observe any tDCS effects on sleep continuity or sleep architecture in patients with ID. Further analyses of nights without stimulation demonstrated significantly increased levels of arousal in ID patients compared to healthy controls, as indexed by subjective reports, reduced total sleep time, increased wake after sleep onset and increased high frequency EEG power during wakefulness and NREM sleep. Of note, indices of increased arousal predicted the lack of effect of tDCS in ID patients.Conclusions
Our study characterizes for the first time differential effects of tDCS on sleep in patients with ID and healthy controls, presumably related to persistent hyperarousal in ID. These findings suggest that adapted tDCS protocols need to be developed to modulate arousal and sleep dependent on baseline arousal levels. 相似文献8.
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Comparison of the PTSD Checklist (PCL) Administered via a Mobile Device Relative to a Paper Form 下载免费PDF全文
Matthew Price Eric Kuhn Julia E. Hoffman Josef Ruzek Ron Acierno 《Journal of traumatic stress》2015,28(5):480-483
Mobile devices are increasingly used to administer self‐report measures of mental health symptoms. There are significant differences, however, in the way that information is presented on mobile devices compared to the traditional paper forms that were used to administer such measures. Such differences may systematically alter responses. The present study evaluated if and how responses differed for a self‐report measure, the PTSD Checklist (PCL), administered via mobile device relative to paper and pencil. Participants were 153 trauma‐exposed individuals who completed counterbalanced administrations of the PCL on a mobile device and on paper. PCL total scores (d = 0.07) and item responses did not meaningfully or significantly differ across administrations. Power was sufficient to detect a difference in total score between administrations determined by prior work of 3.46 with a d = 0.23. The magnitude of differences between administration formats was unrelated to prior use of mobile devices or participant age. These findings suggest that responses to self‐report measures administered via mobile device are equivalent to those obtained via paper and they can be used with experienced as well as naïve users of mobile devices. 相似文献
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