van Hout B A, Serruys P W, Lemos P A, van den Brand M J B M, van Es G-A, Lindeboom W K, Morice M-C
Universitair Medisch Centrum, Julius Centrum, Utrecht, The Netherlands.
Heart. 2005 Apr;91(4):507-12. doi: 10.1136/hrt.2004.034454.
To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study.
Multicentre, double blind, randomised trial.
Percutaneous coronary intervention for single de novo coronary lesions.
238 patients with stable or unstable angina.
Randomisation to sirolimus eluting stent or bare stent implantation.
Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs.
At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166.
The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined.
在RAVEL(西罗莫司洗脱Bx Velocity球囊扩张支架治疗初发冠状动脉病变的随机研究)研究中,评估西罗莫司洗脱支架治疗单一原发性冠状动脉病变的成本效益平衡。
多中心、双盲、随机试验。
针对单一原发性冠状动脉病变的经皮冠状动脉介入治疗。
238例稳定性或不稳定性心绞痛患者。
随机分为西罗莫司洗脱支架植入组或裸支架植入组。
对患者随访1年,治疗效果以1年无主要不良心脏事件(MACE)生存率表示。成本按资源利用情况与荷兰单位成本的乘积估算。
1年时,无MACE生存率的绝对差异为23%,西罗莫司洗脱支架组占优。在首次手术时,西罗莫司洗脱支架植入的估计额外手术成本为1286。然而,1年时,由于西罗莫司组再次血运重建需求减少(0.8%对23.6%;p<0.01),估计的额外成本差异降至54。根据血管造影随访结果对实际结果进行调整后(基于BENESTENT(比利时荷兰支架)II研究的数据校正),无MACE生存率差异估计为11.1%,1年额外成本为166。
RAVEL研究的1年数据表明,西罗莫司洗脱支架治疗单一原发性冠状动脉病变在成本效益方面具有吸引力。药物洗脱支架在更复杂病变亚组中的成本效益仍有待确定。