西罗莫司洗脱支架治疗广泛临床实践中无保护与有保护的左主干冠状动脉疾病：来自前瞻性多中心德国西普（Cypher）注册研究的6个月和3年临床随访结果

Sirolimus-eluting stent treatment for unprotected versus protected left main coronary artery disease in widespread clinical routine: 6-month and 3-year clinical follow-up results from the prospective multicentre German Cypher Registry.

作者信息

Khattab Ahmed A, Hamm Christian W, Senges Jochen, Toelg Ralph, Geist Volker, Bonzel Tassilo, Kelm Malte, Levenson Benny, Neumann Franz-Josef, Nienaber Christoph A, Pfannebecker Thomas, Sabin Georg, Schneider Steffen, Tebbe Ulrich, Richardt Gert

机构信息

Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Akademisches Lehrkrankenhaus der Universität Kiel, Bad Segeberg, Germany.

出版信息

Heart. 2007 Oct;93(10):1251-5. doi: 10.1136/hrt.2007.104703.

DOI:10.1136/hrt.2007.104703

PMID:17890701

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2000930/

Abstract

BACKGROUND

Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery.

OBJECTIVE

To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry.

SETTING AND PATIENTS

The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point.

RESULTS

One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2).

CONCLUSION

Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.

摘要

背景

在裸支架时代，经皮冠状动脉介入治疗（PCI）左主干冠状动脉（LMCA）疾病受到高再狭窄率的限制，这最终导致无保护病例的猝死。药物洗脱支架已大幅降低了临床和血管造影再狭窄率，因此尽管缺乏与冠状动脉旁路移植术的直接对比研究，但该PCI适应证得以恢复。

目的

评估使用西罗莫司洗脱支架治疗无保护LMCA狭窄患者的急性、中期和长期结局，并将其与同期德国西罗莫司洗脱支架注册研究中接受保护LMCA疾病治疗的患者结局进行比较。

地点和患者

德国西罗莫司洗脱支架注册研究纳入了6755例患者。将82例接受无保护LMCA疾病治疗的患者与118例接受保护LMCA狭窄治疗的患者进行比较。所有患者均接受西罗莫司洗脱支架治疗。主要终点是随访6个月时的死亡、心肌梗死（MI）和靶血管血运重建。长期无MI生存被视为安全性终点。

结果

两组中三分之一的患者接受了左主干远端分叉病变的治疗。两组的血管造影成功率均为98.5%。无保护LMCA组6个月时全因死亡、非致命性MI和靶血管血运重建的累积联合发生率为14.1%，保护组为13.1%（风险比=0.81（95%CI 0.37至1.74），p=0.8）。长期来看，保护组中有20.2%（95%CI 13.5%至29.6%）报告发生死亡/MI，无保护组为11.8%（95%CI 6.3%至21.4%）（p=0.2）。