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药物洗脱支架与金属裸支架在 ST 段抬高型心肌梗死中的长期安全性和有效性比较:来自格思里卫生非适应证支架(GHOST)注册研究的结果。

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents in ST elevation myocardial infarction: findings from the Guthrie Health Off-label Stent (GHOST) Registry.

机构信息

Guthrie Clinic, Sayre, Pennsylvania 18840, USA.

出版信息

J Interv Cardiol. 2012 Apr;25(2):118-25. doi: 10.1111/j.1540-8183.2011.00703.x. Epub 2012 Feb 10.

Abstract

BACKGROUND

Multiple randomized trials and observational studies have shown drug-eluting stents (DES) to be safe and effective at 3-year follow-up in stent thrombosis (ST)-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). However, outcomes data beyond 3-4 years after DES implantation are sparse.

METHODS

We studied 554 STEMI patients who underwent successful PCI with either DES or bare metal stent (BMS). Primary study end-points were time to occurrence of ST and the composite of death or myocardial infarction (MI). Secondary end-points were time to occurrence of major adverse cardiac events (MACEs) and discrete events that comprise MACE (death, MI, and target vessel revascularization [TVR]). Outcomes of the DES and BMS groups were assessed by survival analysis and multivariable Cox regression.

RESULTS

There were 205 (37%) patients who received DES and 349 (63%) patients who received BMS. At a median follow-up of 41.4 months after PCI, there were no differences in the unadjusted incidence of ST (ST, 3.4 vs. 4.3%, log-rank P = 0.61) and MI (6.8% vs. 8%, P = 0.61) between DES versus BMS groups, respectively. However, DES implantation was associated with lower unadjusted incidence of death or MI (11% vs. 23.5%, P = 0.0002), MACE (16% vs. 34%, P < 0.0001), death (6.3% vs. 17%, P = 0.0004), and TVR (9.8% vs. 18%, P = 0.008) than BMS implantation. In multivariable analyses, DES implantation was associated with significantly lower incidence of MACE (adjusted HR = 0.47 [95% CI: 0.31-0.76], P = 0.0007) than BMS implantation.

CONCLUSION

In our study of STEMI patients, DES implantation was safer than BMS implantation and was associated with lower MACE at long-term follow-up.

摘要

背景

多项随机试验和观察性研究表明,在经皮冠状动脉介入治疗(PCI)治疗的 ST 段抬高型心肌梗死(STEMI)患者中,药物洗脱支架(DES)在 3 年随访时安全且有效。然而,DES 植入后 3-4 年以上的结果数据很少。

方法

我们研究了 554 例接受成功 PCI 的 STEMI 患者,这些患者分别接受了 DES 或裸金属支架(BMS)治疗。主要研究终点是发生 ST 和死亡或心肌梗死(MI)的复合终点的时间。次要终点是发生主要不良心脏事件(MACE)和构成 MACE 的离散事件(死亡、MI 和靶血管血运重建[TVR])的时间。DES 和 BMS 组的结果通过生存分析和多变量 Cox 回归进行评估。

结果

205 例(37%)患者接受 DES 治疗,349 例(63%)患者接受 BMS 治疗。在 PCI 后中位随访 41.4 个月时,DES 组与 BMS 组未调整的 ST 发生率(ST,3.4%比 4.3%,对数秩 P = 0.61)和 MI 发生率(6.8%比 8%,P = 0.61)无差异。然而,DES 植入与未调整的死亡率或 MI 发生率较低(11%比 23.5%,P = 0.0002)、MACE 发生率较低(16%比 34%,P < 0.0001)、死亡率较低(6.3%比 17%,P = 0.0004)和 TVR 发生率较低(9.8%比 18%,P = 0.008)相关。多变量分析显示,与 BMS 植入相比,DES 植入与较低的 MACE 发生率显著相关(调整后的 HR = 0.47[95%CI:0.31-0.76],P = 0.0007)。

结论

在我们对 STEMI 患者的研究中,DES 植入比 BMS 植入更安全,并且在长期随访中与较低的 MACE 发生率相关。

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