Willich S N, Müller-Riemenschneider F, McBride D, Silber S, Kuck K-H, Nienaber C A, Schneider S, Senges J, Brüggenjürgen B
Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Luisenstr. 57, 10117, Berlin, Germany,
Herz. 2012 Feb 2. doi: 10.1007/s00059-012-3581-5.
The purpose of the economic evaluation of the German Drug-Eluting Stent (DES) registry includes the investigation of the economic impact and cost-effectiveness of DES compared to bare-metal stents (BMS) and between paclitaxel-eluting (PES) and sirolimus-eluting stents (SES). Here, methodology and initial results are presented. METHODS: Patients were recruited in 2005 and 2006 in 87 centres across Germany. Selection of PES, SES, or BMS was made at the discretion of the cardiologists in charge. Clinical, economic, and quality of life (QoL) data were collected at baseline and up to 12 months. Group comparisons were conducted using Fisher's exact and t test. RESULTS: Overall, 3,930 patients were enrolled: 3,471 (75% male, 65 ± 11 years) received DES and 458 (74% male, 67 ± 11 years) BMS. Among the DES patients, 1,821 received PES (75% male, 65 ± 10 years) and 1,600 SES (76% male, 65 ± 11 years). There were baseline differences in clinical and procedural characteristics but not in QoL. During the hospital stay, major adverse cardiac and cerebrovascular events occurred in 1.6% of DES (PES 1.9%, SES 1.1%) and 2.2% of BMS patients (BMS vs. DES, PES, and SES p = 0.327, 0.706, and 0.098, respectively). Hospital treatment costs were 4,989 ± 1,284
德国药物洗脱支架(DES)注册研究的经济学评估目的包括调查DES与裸金属支架(BMS)相比以及紫杉醇洗脱支架(PES)和西罗莫司洗脱支架(SES)之间的经济影响和成本效益。本文介绍了其方法和初步结果。方法:2005年和2006年在德国87个中心招募患者。PES、SES或BMS的选择由负责的心脏病专家自行决定。在基线时和长达12个月时收集临床、经济和生活质量(QoL)数据。采用Fisher精确检验和t检验进行组间比较。结果:总体上,共纳入3930例患者:3471例(75%为男性,65±11岁)接受DES,458例(74%为男性,67±11岁)接受BMS。在DES患者中,1821例接受PES(75%为男性,65±10岁),1600例接受SES(76%为男性,65±11岁)。临床和手术特征存在基线差异,但生活质量无差异。住院期间,DES患者(PES为1.9%,SES为1.1%)和BMS患者(2.2%)发生主要不良心脑血管事件(BMS与DES、PES和SES相比,p分别为0.327、0.706和0.098)。DES和BMS患者的住院治疗费用分别为4989±1284欧元和3609±924欧元(p<0.001),PES和SES之间无显著差异。结论:大型DES注册研究的经济学评估表明,与BMS相比,DES的初始住院费用增加。对DES的经济影响和成本效益的进一步分析将为决策者提供关于大量“真实世界”患者群体的估计,并有助于德国和其他医疗保健系统内DES的报销决策。