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临床试验/NCT02356510
NCT02356510已完成不适用

Which One Should be Treated in the Setting of Acute ST Elevation Myocardial Infarction - Culprit Lesion or Culprit Vessel?

Samsun Education and Research Hospital0 个研究点目标入组 637 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
637
主要终点
MACE

研究概览

简要总结

The current guidelines still recommend emergent PCI of the culprit lesion and state that primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is based on a high number of studies. However, several studies are present about the safety and efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly going on about the PCI of the non-culprit arteries during the index event with newer prospective randomized studies. Besides, it is still unclear for the culprit artery whether to treat only the culprit lesion or all the other lesions in the culprit vessel during the index event. The present report describes a retrospective comparison between the two strategies during primary PCI for STEMI, looking for their influence on the clinical and angiographic course of the patients.

详细描述

Patient selection: This multi-centre retrospective study included patients from 3 high-volume primary PCI centres in Turkey. A total number of 5512 patients underwent emergent PCI for acute STEMI between January 2011 and December 2013. From this patient population, patients were looked for the presence of an additional lesion to the culprit lesion (CL). Additional lesion was defined as the presence of an angiographically severe (≥70%) lesion other than the CL either proximal or distal to it in the same coronary artery after the distal flow was observed most commonly as a result of guide-wire passage or PTCA of the total occlusion.

Exclusion criteria: - Presence of LMCA lesion

  • Cardiogenic shock
  • Previous CABG operation
  • Decision for CABG operation after primary PCI
  • Severe valvular disease including aortic stenosis of mitral insufficiency
  • Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis)
  • Rejection of second PCI by the patient after the index event

The eligible patients were retrospectively sought from the database of the relevant hospital. The basal characteristics of the patients like age, sex, presence of coronary risk factors (smoking, hypertension, diabetes mellitus and hyperlipidemia), vital signs and location of STEMI at admission were noted. The emergent coronary angiograms of the patients were then examined and several angiographic and post-PCI features which are defined in detail in the following sections were addressed. Follow-up of these patients were succeeded either by phone call, routine polyclinic visits or from the database of hospital.

Study groups: Patients were grouped into 2 according to the PCI strategy; culprit vessel (CV) group including patients who underwent emergent PCI of all severe (≥70 stenosis in CAG) lesions in the culprit vessel and culprit lesion (CL) group including patients who underwent emergency PCI only for the CL and staged PCI in 2 weeks for the other additional lesions in the CV. Both groups underwent staged PCI for the severe lesion(s) in non-culprit vessel(s) if necessary in a different session in 28 days after the index event. Staged PCI was the preferred strategy in both groups if necessary because staged PCI has been found to be at least non-inferior to other strategies in several studies [3, 4, 10, 13].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent primary PCI for acute STEMI and had >1 lesion in the culprit artery

排除标准

  • Presence of LMCA lesion
  • Cardiogenic shock
  • Previous CABG operation
  • Decision for CABG operation after primary PCI
  • Severe valvular disease including aortic stenosis of mitral insufficiency
  • Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis)
  • Rejection of second PCI by the patient after the index event

结局指标

主要结局

MACE

时间窗: 18 months

次要结局

未报告次要终点

研究者

发起方
Samsun Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ugur ARSLAN

Associate Proffessor of Cardiology, Head of Department

Samsun Education and Research Hospital

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