Koskinas Konstantinos C, Siontis George C M, Piccolo Raffaele, Franzone Anna, Haynes Alan, Rat-Wirtzler Julie, Silber Sigmund, Serruys Patrick W, Pilgrim Thomas, Räber Lorenz, Heg Dik, Jüni Peter, Windecker Stephan
From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.
Diabetes mellitus and angiographic coronary artery disease complexity are intertwined and unfavorably affect prognosis after percutaneous coronary interventions, but their relative impact on long-term outcomes after percutaneous coronary intervention with drug-eluting stents remains controversial. This study determined drug-eluting stents outcomes in relation to diabetic status and coronary artery disease complexity as assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score.
In a patient-level pooled analysis from 4 all-comers trials, 6081 patients were stratified according to diabetic status and according to the median SYNTAX score ≤11 or >11. The primary end point was major adverse cardiac events, a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization within 2 years. Diabetes mellitus was present in 1310 patients (22%), and new-generation drug-eluting stents were used in 4554 patients (75%). Major adverse cardiac events occurred in 173 diabetics (14.5%) and 436 nondiabetic patients (9.9%; P<0.001). In adjusted Cox regression analyses, SYNTAX score and diabetes mellitus were both associated with the primary end point (P<0.001 and P=0.028, respectively; P for interaction, 0.07). In multivariable analyses, diabetic versus nondiabetic patients had higher risks of major adverse cardiac events (hazard ratio, 1.25; 95% confidence interval, 1.03-1.53; P=0.026) and target lesion revascularization (hazard ratio, 1.54; 95% confidence interval, 1.18-2.01; P=0.002) but similar risks of cardiac death (hazard ratio, 1.41; 95% confidence interval, 0.96-2.07; P=0.08) and myocardial infarction (hazard ratio, 0.89; 95% confidence interval, 0.64-1.22; P=0.45), without significant interaction with SYNTAX score ≤11 or >11 for any of the end points.
In this population treated with predominantly new-generation drug-eluting stents, diabetic patients were at increased risk for repeat target-lesion revascularization consistently across the spectrum of disease complexity. The SYNTAX score was an independent predictor of 2-year outcomes but did not modify the respective effect of diabetes mellitus.
URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00297661, NCT00389220, NCT00617084, and NCT01443104.
糖尿病与血管造影显示的冠状动脉疾病复杂性相互交织，对经皮冠状动脉介入治疗后的预后产生不利影响，但它们对药物洗脱支架经皮冠状动脉介入治疗后长期结局的相对影响仍存在争议。本研究根据紫杉醇洗脱支架与心脏外科手术协同作用（SYNTAX）评分评估了与糖尿病状态和冠状动脉疾病复杂性相关的药物洗脱支架结局。
在一项来自4项纳入所有患者的试验的患者水平汇总分析中，6081例患者根据糖尿病状态以及SYNTAX评分中位数≤11或>11进行分层。主要终点是主要不良心脏事件，即2年内心脏死亡、心肌梗死和临床指征的靶病变血运重建的复合事件。1310例患者（22%）患有糖尿病，4554例患者（75%）使用了新一代药物洗脱支架。173例糖尿病患者（14.5%）和436例非糖尿病患者（9.9%）发生了主要不良心脏事件（P<0.001）。在调整后的Cox回归分析中，SYNTAX评分和糖尿病均与主要终点相关（分别为P<0.001和P=0.028；交互作用P=0.07）。在多变量分析中，糖尿病患者与非糖尿病患者相比，发生主要不良心脏事件（风险比，1.25；95%置信区间，1.03-1.53；P=0.026）和靶病变血运重建（风险比，1.54；95%置信区间，1.18-2.01；P=0.002）的风险更高，但心脏死亡（风险比，1.41；95%置信区间，0.96-2.07；P=0.08）和心肌梗死（风险比，0.89；95%置信区间，0.64-1.22；P=0.45）的风险相似，对于任何终点，均未与SYNTAX评分≤11或>11产生显著交互作用。
在这个主要使用新一代药物洗脱支架治疗的人群中，糖尿病患者在疾病复杂性的整个范围内，重复靶病变血运重建的风险持续增加。SYNTAX评分是2年结局的独立预测因素，但并未改变糖尿病的各自影响。
网址：http://www.clinicaltrials.gov。唯一标识符：NCT00297661、NCT00389220、NCT00617084和NCT01443104。
