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新一代依维莫司洗脱支架与早期药物洗脱支架相比的极晚期冠状动脉支架血栓形成:一项前瞻性队列研究。

Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study.

机构信息

Department of Cardiology, Bern University Hospital, Bern, Switzerland.

出版信息

Circulation. 2012 Mar 6;125(9):1110-21. doi: 10.1161/CIRCULATIONAHA.111.058560. Epub 2012 Feb 1.

Abstract

BACKGROUND

Early-generation drug-eluting stents releasing sirolimus (SES) or paclitaxel (PES) are associated with increased risk of very late stent thrombosis occurring >1 year after stent implantation. It is unknown whether the risk of very late stent thrombosis persists with newer-generation everolimus-eluting stents (EES).

METHODS AND RESULTS

We assessed the risk of stent thrombosis in a cohort of 12 339 patients with unrestricted use of drug-eluting stents (3819 SES, 4308 PES, 4212 EES). Results are incidence rates per 100 person-years after inverse probability of treatment weighting to adjust for group differences. During follow-up of up to 4 years, the overall incidence rate of definite stent thrombosis was lower with EES (1.4 per 100 person-years) compared with SES (2.9; hazard ratio, 0.41; 95% confidence interval, 0.27-0.62; P<0.0001) and PES (4.4; hazard ratio, 0.33; 95% confidence interval, 0.23-0.48; P<0.0001). The incidence rate per 100 person-years of early (0-30 days), late (31 days-1 year), and very late stent thrombosis amounted to 0.6, 0.1, and 0.6 among EES-treated patients; 1.0, 0.3, and 1.6 among SES-treated patients; and 1.3, 0.7, and 2.4 among PES-treated patients. Differences in favor of EES were most pronounced beyond 1 year, with a hazard ratio of 0.33 (EES versus SES; P=0.006) and 0.34 (EES versus PES; P<0.0001). There was a lower risk of cardiac death or myocardial with EES compared with PES (hazard ratio, 0.65; 95% confidence interval, 0.56-0.75; P<0.0001), which was directly related to the lower risk of stent thrombosis-associated events (EES versus PES: hazard ratio, 0.36; 95% confidence interval, 0.23-0.57).

CONCLUSION

Current treatment with EES is associated with a lower risk of very late stent thrombosis compared with early-generation drug-eluting stents.

摘要

背景

第一代药物洗脱支架(雷帕霉素洗脱支架[SES]或紫杉醇洗脱支架[PES])释放的药物与支架植入 1 年后发生极晚期支架血栓形成的风险增加有关。尚不清楚新一代依维莫司洗脱支架(EES)是否会持续存在极晚期支架血栓形成的风险。

方法和结果

我们评估了 12339 例无限制使用药物洗脱支架(3819 例 SES、4308 例 PES、4212 例 EES)患者队列中支架血栓形成的风险。结果为经逆概率治疗加权后调整组间差异的每 100 人年的发生率。在长达 4 年的随访期间,EES(1.4/100 人年)的总体明确支架血栓形成发生率低于 SES(2.9;危险比,0.41;95%置信区间,0.27-0.62;P<0.0001)和 PES(4.4;危险比,0.33;95%置信区间,0.23-0.48;P<0.0001)。EES 治疗患者的早期(0-30 天)、晚期(31 天-1 年)和极晚期支架血栓形成的发生率分别为 0.6、0.1 和 0.6;SES 治疗患者分别为 1.0、0.3 和 1.6;PES 治疗患者分别为 1.3、0.7 和 2.4。EES 治疗的优势在 1 年以上最为明显,SES 与 SES 相比的危险比为 0.33(P=0.006),EES 与 PES 相比的危险比为 0.34(P<0.0001)。EES 治疗的心脏死亡或心肌梗死风险低于 PES(危险比,0.65;95%置信区间,0.56-0.75;P<0.0001),这与支架血栓形成相关事件风险较低直接相关(EES 与 PES 相比:危险比,0.36;95%置信区间,0.23-0.57)。

结论

与第一代药物洗脱支架相比,目前 EES 的治疗与极晚期支架血栓形成的风险降低有关。

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