药物洗脱支架治疗冠状动脉分叉病变：前瞻性多中心德国药物洗脱支架注册研究第一阶段的结果。

Treatment of coronary bifurcation lesions with drug-eluting stents: insights from the first phase of the prospective multicenter german drug-eluting stent registry.

机构信息

Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

出版信息

J Interv Cardiol. 2012 Aug;25(4):344-52. doi: 10.1111/j.1540-8183.2011.00718.x. Epub 2012 Mar 12.

DOI:10.1111/j.1540-8183.2011.00718.x

PMID:22409587

Abstract

BACKGROUND

Controversy exists about the impact of treating bifurcations on overall outcome of coronary interventions using drug-eluting stents (DES). We sought to investigate 1-year outcome of the treatment of bifurcation lesions using DES in a large "real-world" cohort.

METHODS AND RESULTS

Among 5,126 patients enrolled in phase I of the multicenter German Drug-Eluting Stent Registry, 814 (16%) were treated for a bifurcation lesion. Patients with bifurcations were compared to those without bifurcations in terms of baseline characteristics, major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) at 1 year. Usage of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) was also evaluated. In total, 1,021 and 5,189 stents were implanted in the bifurcation (1.25 stents/patient) and nonbifurcation (1.2 stents/patient) group, respectively, but 64.5% of bifurcation lesions were treated with a single stent. More complex lesion and procedural characteristics were observed in the bifurcation group. However, there was no difference in 1-year MACCE rates (a composite of death, myocardial infarction, and stroke) between the bifurcation group and nonbifurcation group (8.1% vs. 8.3%, P = 0.85). Rates of TVR (11.2% vs. 10.8%, P = 0.75) and Academic Research Consoritum-defined definite stent thrombosis (0.9% vs. 0.8%, P = 0.67) were also comparable. MACCE and TVR rates remained similar after adjustment for differences in baseline characteristics. MACCE and TVR in SES patients were 7.2% and 12.6% versus 8.7% and 10.2% in PES patients (P = 0.46 and P = 0.30, respectively).

CONCLUSION

In this large multicenter registry, treatment of bifurcation lesions with DES appears effective and safe. The presence of bifurcations did not affect 1-year outcomes after DES implantation. The outcomes for SES and PES were similar.

摘要

背景

使用药物洗脱支架（DES）治疗分叉病变对冠状动脉介入治疗的整体结果存在争议。我们旨在调查使用 DES 治疗大型“真实世界”分叉病变患者的 1 年结果。

方法和结果

在多中心德国药物洗脱支架注册研究的 I 期研究中，共有 5126 例患者入组，其中 814 例（16%）患者因分叉病变接受治疗。比较了分叉病变患者和无分叉病变患者的基线特征、主要不良心脏和脑血管事件（MACCE）以及 1 年时的靶血管血运重建（TVR）。还评估了西罗莫司洗脱支架（SES）与紫杉醇洗脱支架（PES）的使用情况。在分叉病变组（1.25 个支架/患者）和非分叉病变组（1.2 个支架/患者）中分别植入了 1021 和 5189 个支架，但 64.5%的分叉病变采用单支架治疗。分叉病变组观察到更复杂的病变和操作特征。然而，分叉病变组和非分叉病变组的 1 年 MACCE 发生率（死亡、心肌梗死和中风的复合终点）没有差异（8.1% vs. 8.3%，P=0.85）。TVR 发生率（11.2% vs. 10.8%，P=0.75）和学术研究联合会定义的明确支架血栓形成发生率（0.9% vs. 0.8%，P=0.67）也相似。在调整基线特征差异后，MACCE 和 TVR 发生率仍相似。SES 患者的 MACCE 和 TVR 发生率分别为 7.2%和 12.6%，而 PES 患者的发生率分别为 8.7%和 10.2%（P=0.46 和 P=0.30）。