第二代DES的安全性关注与思考.ppt

ESC2006年会上RAVEL、BASKET-LATE试验及其他研究显示出药物洗脱支架与金属裸支架相比可能增加迟发性支架内血栓事件及远期临床不良事件（死亡及心肌梗死）的问题后，药物洗脱支架的安全性引起全球介入医生和患者的广泛关注。RAVEL试验共入选238例患者,随机分为药物洗脱支架(SES)和裸支架（BMS）治疗。5年随访结果显示,SES组无心脏不良事件的生存率为74.2%,而BMS为64.8%(P=0.034)。但如果以死亡或心肌梗死作为观察终点,SES组较BMS组有增高的趋势。BASKET-LATE试验的目是比较药物洗脱支架（DES）和裸支架（BMS）在晚期(使用6个月氯吡格雷停用以后)与支架血栓相关的临床事件的发生率。PCI术后6个月剔除死亡及有事件发生者,最后DES组和BMS组分别入选502例和244例患者。12个月随访结果显示,DES组和BMS组心源性死亡或非致命性心肌梗死的发生率为分别为4.9%和1.3%(P=0.01)，血栓相关临床事件发生率分别为2.4%和0.8%(P=0.14),所有血栓相关事件发生率分别为2.6%和1.3%(P=0.23)。 2007年3月发表在新英格兰医学杂志上的瑞典冠脉造影及介入治疗注册研究(SCAAR)3年随访结果则进一步显示药物洗脱支架（DES）的安全性值得关注。虽然与裸支架（BMS）相比,3年随访两组死亡和心肌梗死的复合终点无明显差别，而且在头6个月内,DES组复合终点发生率有较低的趋势，但6个月之后，DES组每年死亡风险增加0.5%~1.0%，3年总死亡风险相对增加18%，而6个月至3年期间死亡风险相对增加32% * Key Discussion Point: Following the early case reports regarding DES safety, the BASKET-LATE study added to the concern by demonstrating a consistent trend (although not significant) in thrombosis-related clinical events. In the original BAsel Stent Kosten-Effektivit?ts Trial (BASKET), 826 patients were randomly assigned in a 2:1 fashion to a DES (n = 545) or a BMS (n = 281). The DES studied were the CYPHER stent (n = 264) and the TAXUS stent (n = 281). Patients were followed for death, nonfatal MI, and TVR. The 746 patients who survived the first 6 months without nonfatal MI or repeat TVR were enrolled in the BASKET Late Thrombotic Events (BASKET-LATE) study and were followed for an additional 12 months. Following the completion of the overall study, rates of 18-month cardiac death/MI were found not to be different between the patients with DES and those with BMS. However, after clopidogrel discontinuation (between months 7 and 18), a discrepancy in cardiac death/MI between the DES (4.9%) and BMS (1.3%) groups began to appear. Also, the documented rate of LST and related death/target vessel MI were twice as frequent in the DES group versus the BMS group (2.6% vs 1.3%, respectively). Although this was not a significant difference, a consistent trend was observed. In addition, af