Fricke Frank-Ulrich, Silber Sigmund
Fricke & Pirk GmbH, Nürnberg.
Herz. 2005 Jun;30(4):332-8. doi: 10.1007/s00059-005-2694-5.
It is generally known and accepted that percutaneous coronary intervention (PCI) has undergone a patient-relevant innovation with the introduction of drug-eluting stents (DES): prospective, randomized, controlled studies with a primary clinical endpoint have shown that DES, especially those releasing sirolimus from a polymer (SES) or those releasing paclitaxel from a polymer (PES), significantly and relevantly reduce the restenosis rate and hence the number of needed reinterventions in the target vessel (target vessel revascularization [TVR]) as compared to bare metal stents (BMS). For this improvement of quality of life, cost-effectiveness analyses comparing DES and BMS in the US and German health care systems have been reported. For the comparison of DES and coronary artery bypass graft surgery (CABG), no economic data regarding the German health care system have been published. The goal of the present study is to provide such an economic analysis investigating the question whether DES can reduce costs as compared to CABG within the German health care system.
Based on the clinical data for PCI with a PES for long and complex lesions (TAXUS VI) and for CABG (ARTS I), the comparison was calculated for the time interval of 1 year. The analysis of the PCI group was derived from a TVR of 11% including a CABG rate of 1%; the CABG group analysis was based on a TVR of 3.8% including a PCI rate of 3.1% and a re-CABG rate of 0.7%. At a stent factor of 2.75, the costs per stent were calculated to be 250 Euro for the BMS and 1,500 Euro for the PES. The total costs for 12 months included the follow-up costs for reinterventions. The results were tested for stability according to a sensitivity analysis.
Patients' demographics were well comparable between the PCI and the CABG groups. The primary costs, including the reinterventions, were 7,841 Euro for PCI and 12,415 Euro for CABG. The sensitivity analysis revealed that only at more than eight stents per patient and a need for reintervention of ca. 10% did the cost of PCI with PES reach the level of the cost for CABG.
Within the German health care system, in patients with a social insurance, PCI of long and complex lesions with PES significantly reduces costs as compared to CABG to the amount of 4,574 Euro per patient. The cost-effectiveness analyses of currently ongoing prospective, randomized trials (SYNTAX und FREEDOM) will provide more insight into the economic comparison of PCI with DES and CABG.
众所周知且已被认可的是，随着药物洗脱支架（DES）的引入，经皮冠状动脉介入治疗（PCI）实现了与患者相关的创新：以主要临床终点为指标的前瞻性、随机、对照研究表明，DES，尤其是那些从聚合物释放西罗莫司的支架（SES）或从聚合物释放紫杉醇的支架（PES），与裸金属支架（BMS）相比，能显著且切实地降低再狭窄率，从而减少靶血管所需再次干预的次数（靶血管血运重建[TVR]）。为了这种生活质量的改善，在美国和德国医疗保健系统中比较DES和BMS的成本效益分析已有报道。对于DES与冠状动脉旁路移植术（CABG）的比较，德国医疗保健系统尚无经济数据发表。本研究的目的是进行这样一项经济分析，探讨在德国医疗保健系统中DES与CABG相比是否能降低成本这一问题。
基于使用PES治疗长而复杂病变的PCI（TAXUS VI）和CABG（ARTS I）的临床数据，计算了1年时间间隔内的比较结果。PCI组的分析源自11%的TVR，其中包括1%的CABG率；CABG组的分析基于3.8%的TVR，其中包括3.1%的PCI率和0.7%的再次CABG率。在支架系数为2.75时，计算得出BMS每个支架的成本为250欧元，PES为1500欧元。12个月的总成本包括再次干预的随访成本。根据敏感性分析对结果进行稳定性测试。
PCI组和CABG组患者的人口统计学特征具有良好的可比性。包括再次干预在内的主要成本，PCI为7841欧元，CABG为12415欧元。敏感性分析表明，仅在每位患者植入超过8个支架且再次干预需求约为10%时，使用PES的PCI成本才达到CABG的成本水平。
在德国医疗保健系统中，对于参加社会保险的患者，使用PES治疗长而复杂病变的PCI与CABG相比，每位患者可显著降低成本达4574欧元。当前正在进行的前瞻性、随机试验（SYNTAX和FREEDOM）的成本效益分析将为PCI与DES及CABG的经济比较提供更多见解。
