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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Community implementation of evidence-based practices (EBPs) for Attention Deficit/Hyperactivity Disorder (ADHD) is greatly lacking. A recent randomized community-based trial of an EBP for ADHD (Supporting Teens’ Autonomy Daily; STAND) demonstrated suboptimal implementation and effectiveness outcomes. In the present study, we conducted an Innovation Tournament (IT) with agency staff stakeholders (N?=?26) to identify barriers to successful implementation of STAND and implementation strategies for a revised service delivery model. We conducted member-checking of agency staff-generated ideas with parents (N?=?226) and subsequent querying of additional parent (N?=?226) and youth-generated (N?=?205) strategies to improve care. Go-Zone plots were utilized to identify strategies with the highest feasibility and importance. Practical barriers (i.e., transportation, scheduling difficulties) and parent/youth engagement were the most commonly cited obstacles to successful implementation of STAND in community contexts. Eighteen “winning” implementation strategies were identified that survived member checking. These were classified as train and educate stakeholders (n?=?5; e.g., train agency supervisors to deliver supervision, digitize treatment materials and trainings), engage consumers (n?=?9; e.g., begin treatment with rapport building sessions, increase psychoeducation), provide interactive assistance (n?=?2; e.g., add group supervision, increase roleplay in supervision), and use of evaluative/iterative strategies (n?=?2; e.g., perform fidelity checks, supervisor review of session recordings). Parents and youth desired longer duration of treatment and increased focus on maintenance. Strategies will be developed and tested as part of a pilot effectiveness trial designed to refine STAND’s service delivery model.
Trial Registration NCT02694939 www.clinicaltrials.gov
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