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MISSION! 干预研究的 5 年临床随访:ST 段抬高型心肌梗死患者中,西罗莫司洗脱支架与裸金属支架置入的随机对照试验。

Five-year clinical follow-up from the MISSION! Intervention Study: sirolimus-eluting stent versus bare metal stent implantation in patients with ST-segment elevation myocardial infarction, a randomised controlled trial.

机构信息

Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

EuroIntervention. 2012 Jan;7(9):1021-9. doi: 10.4244/EIJV7I9A164.

DOI:10.4244/EIJV7I9A164
PMID:22207227
Abstract

AIMS

To evaluate the clinical outcomes of sirolimus-eluting stent (SES) versus bare metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) at long-term follow-up.

METHODS AND RESULTS

After five years, 310 STEMI patients randomly assigned to implantation of either SES or BMS, were compared. Survival rates were comparable between groups (SES 94.3% vs. BMS 92.8%, p=0.57), as were the rates of reinfarction (10.6% vs. 13.7%, p=0.40), freedom of death/re-MI (84.4% vs. 79.8%, p=0.29) and target vessel failure (14.9% vs. 21.7%, p=0.11). Likewise, rates of overall stent thrombosis (ST) (5.4% vs. 2.7%, p=0.28) and very late ST (4.1% vs. 0.7%, p=0.07) did not significantly differ between the SES- and BMS-group. In 184 patients with IVUS data, definite and definite/probable VLST was more common in those with late stent malapposition versus those without late stent malapposition (4.3% and 6.6% vs. no events [p=0.018 and p=0.004], respectively). The cumulative incidences of target vessel and target lesion revascularisation (TVR and TLR) were not significantly lower in the SES-group (11.2% vs. 17.9%, p=0.09 and 7.2% vs. 12.9%, p=0.08), as was the rate of clinically driven TLR (6.6% vs. 9.5%, p=0.30).

CONCLUSIONS

SES implantation was neither associated with increased rates of major adverse cardiac events, nor with a reduction in re-intervention, compared to implantation of a BMS in patients with STEMI after five years. However, a trend of more very late stent thrombosis was observed after SES implantation (ISRCTN62825862).

摘要

目的

评估在长期随访中,雷帕霉素洗脱支架(SES)与金属裸支架(BMS)植入治疗 ST 段抬高型心肌梗死(STEMI)患者的临床结果。

方法和结果

五年后,比较了 310 名随机分配至 SES 或 BMS 植入的 STEMI 患者。两组的生存率无差异(SES 94.3% vs. BMS 92.8%,p=0.57),再梗死率(10.6% vs. 13.7%,p=0.40)、无死亡/再心梗率(84.4% vs. 79.8%,p=0.29)和靶血管失败率(14.9% vs. 21.7%,p=0.11)也无差异。同样,SES 组和 BMS 组的总体支架血栓形成率(ST)(5.4% vs. 2.7%,p=0.28)和极晚期 ST(4.1% vs. 0.7%,p=0.07)也无显著差异。在 184 名接受 IVUS 数据的患者中,与无晚期支架贴壁不良的患者相比,晚期支架贴壁不良的患者更常见明确和明确/可能极晚期 ST(4.3%和 6.6% vs. 无事件[ p=0.018 和 p=0.004])。SES 组的靶血管和靶病变血运重建(TVR 和 TLR)累积发生率也没有显著降低(11.2% vs. 17.9%,p=0.09 和 7.2% vs. 12.9%,p=0.08),临床驱动的 TLR 发生率也没有降低(6.6% vs. 9.5%,p=0.30)。

结论

与 5 年后接受 BMS 植入的 STEMI 患者相比,SES 植入术既不会增加主要不良心脏事件的发生率,也不会减少再次介入治疗的发生率。然而,SES 植入术后观察到极晚期支架血栓形成的趋势增加(ISRCTN62825862)。

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