Canoui-Poitrine Florence, Jeanblanc Grégoire, Alberti Corinne, Armoogum Priscilla, Cebrian Ana, Carrié Didier, Henry Patrick, Teiger Emmanuel, Slama Michel, Spaulding Christian, Durand-Zaleski Isabelle
Assistance Publique - Hopitaux de Paris (AP-HP), Henri Mondor Hospital, EA 4393, Paris 12 Medical School, Créteil, France.
Appl Health Econ Health Policy. 2009;7(1):19-29. doi: 10.1007/BF03256139.
Drug-eluting stents have been shown to reduce the rate of repeat revascularization after percutaneous coronary intervention for acute myocardial infarction (AMI) as compared with bare metal stents (BMS). A few studies have reported the cost effectiveness of sirolimus-eluting stents (SES) in several countries, but none in the particular setting of AMI in France.
To assess the cost effectiveness of SES compared with BMS in a pre-specified subgroup of French patients with AMI in the randomized, multicentre TYPHOON trial.
A prospective economic evaluation was conducted for the 337 patients in the TYPHOON trial who were enrolled in the French centres. In the TYPHOON trial, patients with AMI with ST-segment elevation less than 12 hours after the onset of chest pain were randomized to undergo percutaneous coronary intervention with either SES or BMS. Data on clinical outcomes and resource use were collected prospectively over a 1-year follow-up period (from October 2003 to October 2005). Unit costs were applied to the resource utilization data. The main outcome measure was the incremental cost-effectiveness ratio (ICER) for additional cost per target-vessel revascularization (TVR) avoided. The perspective of the study was the French healthcare system and costs were expressed in 2007 values.
SES significantly reduced the rate of TVR (6.6% vs 22.2% with BMS, p < 0.0001). There was no difference in the rate of death, recurrent myocardial infarction or stent thrombosis after 1 year of follow-up between the SES and BMS groups. Mean index admission costs, including the angioplasty procedure, were increased by 282 Euro per patient in the SES group, mostly driven by the price of the SES. Mean follow-up costs were 140 Euro per patient lower in the SES group. Mean aggregate 1-year costs showed a euro 1142 per-patient increase in the SES group compared with the BMS group. The ICER was 7321 Euro per TVR avoided.
In this pre-specified subgroup analysis of the TYPHOON trial, the use of SES in patients with AMI with ST-segment elevation less than 12 hours after the onset of chest pain reduced the rate of TVR compared with BMS. However, SES had a debatable ICER for the payer if it was based only on the specific benefit of TVR avoided.
与裸金属支架（BMS）相比，药物洗脱支架已被证明可降低急性心肌梗死（AMI）经皮冠状动脉介入治疗后再次血管重建的发生率。一些研究报告了西罗莫司洗脱支架（SES）在几个国家的成本效益，但在法国AMI的特定环境中尚无相关研究。
在随机、多中心的TYPHOON试验中，评估SES与BMS相比在法国AMI患者预先指定亚组中的成本效益。
对TYPHOON试验中纳入法国中心的337例患者进行前瞻性经济评估。在TYPHOON试验中，胸痛发作后12小时内ST段抬高的AMI患者被随机分配接受SES或BMS经皮冠状动脉介入治疗。在1年的随访期（2003年10月至2005年10月）前瞻性收集临床结局和资源使用数据。将单位成本应用于资源利用数据。主要结局指标是避免每次靶血管重建（TVR）额外成本的增量成本效益比（ICER）。研究视角为法国医疗保健系统，成本以2007年价值表示。
SES显著降低了TVR发生率（6.6%对比BMS的22.2%，p<0.0001）。SES组和BMS组在随访1年后的死亡率、再发心肌梗死或支架血栓形成发生率无差异。SES组每位患者的平均首次住院成本（包括血管成形术）增加了282欧元，主要是由SES的价格驱动。SES组每位患者的平均随访成本低140欧元。SES组与BMS组相比，平均1年总费用显示每位患者增加1142欧元。ICER为避免每次TVR 7321欧元。
在TYPHOON试验的这一预先指定亚组分析中，对于胸痛发作后12小时内ST段抬高的AMI患者，与BMS相比，使用SES降低了TVR发生率。然而，如果仅基于避免TVR的特定益处，SES对支付方而言ICER存在争议。
