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新一代聚合物基38毫米依维莫司洗脱支架治疗患者的一年随访:P38研究

One-year follow-up of patients treated with new-generation polymer-based 38 mm everolimus-eluting stent: the P38 study.

作者信息

Sgueglia Gregory A, Belloni Flavia, Summaria Francesco, Conte Micaela, Cortese Bernardo, Silva Pedro Leon, Ricci Roberto, Lioy Ernesto, Pucci Edoardo, Gaspardone Achille

机构信息

Division of Cardiology, Sant'Eugenio Hospital, Rome, Italy.

出版信息

Catheter Cardiovasc Interv. 2015 Feb 1;85(2):218-24. doi: 10.1002/ccd.25542. Epub 2014 May 26.

Abstract

OBJECTIVES

To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES).

BACKGROUND

Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents.

METHODS

Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria.

RESULTS

Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one.

CONCLUSIONS

The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

摘要

目的

评估在现实世界中使用38毫米雅培血管Xience Prime依维莫司洗脱支架(EES)治疗长冠状动脉病变患者1年随访时的临床结局。

背景

长病变给介入心脏病学家带来特殊挑战,包括再狭窄、围手术期损伤、边缘夹层及支架输送性风险增加。实际上,较短支架治疗较简单病变所获结果对较长支架的适用性有限。

方法

连续入选经皮冠状动脉介入治疗长冠状动脉病变且至少植入一枚38毫米EES的患者。前瞻性记录其临床数据。主要不良心脏事件(MACE)定义为心源性死亡、非致死性心肌梗死(根据通用定义)和靶血管血运重建的复合事件。支架血栓形成根据学术研究联盟标准定义。

结果

总体而言,203例现实世界患者(152例男性,68±9岁)入选P38研究。1年随访时,6例(3.0%)患者死于心脏原因,7例(3.4%)发生非致死性心肌梗死,8例(3.9%)接受靶血管血运重建,MACE累积发生率为10.3%。2例患者发生支架血栓形成(1例确诊,1例可能)。在植入或未植入与38毫米支架重叠的额外支架的患者之间,事件发生率未发现显著差异。

结论

在未选择的长病变现实世界人群中使用新一代基于聚合物的38毫米EES,在12个月随访时具有优异的手术结果和良好的临床结局。

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