Four-year clinical follow-up of the rapamycin-eluting stent evaluated at Rotterdam cardiology hospital registry
Four-year clinical follow-up of the rapamycin-eluting stent evaluated at Rotterdam cardiology hospital registry
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DOI：
10.1016/j.amjcard.2007.11.074
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发表时间：
2008-04-15
影响因子：
2.8
通讯作者：
Serruys, Patrick W.
中科院分区：
文献类型：
--
作者：
Daemen, Jocst;Kukreja, Neville;Serruys, Patrick W.
尽管药物洗脱支架的安全性受到了相当大的审查，但可获得的真实世界随访数据有限，最长可达4年。随机临床试验精心挑选了患者，并没有反映日常实践。2002年4月至10月，连续508例接受西罗莫司洗脱支架(SES)治疗的患者入选。对照组为前6个月内接受裸金属支架治疗的450例患者。经过4年的随访，SES组的复合主要不良临床事件(全因死亡、心肌梗死或靶血管再血管化)的发生率显著降低(23.0%比28.7%，调整风险比0.66，95%可信区间0.51~0.86)，靶血管再血管化率(12.2%比17.8%，调整风险比0.57，95%可信区间0.39~0.83)显著降低。在全因死亡率(SES组10.5%比裸金属支架10.6%，p=0.9)和心源性死亡率(4.5%比6.9%，p=0.1)方面没有差异。尽管总体支架血栓发生率无差异(2.3%vs 2.2%，p=1.0)，但SES的晚期支架血栓发生率较高(1.4%vs 0%，p=0.02)，而早期支架血栓发生率较低(0.4%vs 1.8%，p=0.05)。综上所述，4年后，与裸金属支架相比，SES仍然安全有效。然而，较高的支架晚期血栓发生率仍然是一个令人担忧的问题。将需要更长期的后续行动来确定这个问题的严重程度。(C)2008 Elsevier Inc.保留所有权利。
Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem. (C) 2008 Elsevier Inc. All rights reserved.