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临床试验/NCT04878133
NCT04878133招募中不适用

OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease

A.O.U. Città della Salute e della Scienza12 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
460
试验地点
12
主要终点
Major adverse cardiovascular events (MACE)

研究概览

简要总结

STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT

详细描述

In patients with ST segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significally reduces the risk of cardiovascular death. How to manage in this setting non-culprit lesion in patients with multivessel disease still remain a matter of debate. Recently, the COMPLETE trial showed that complete PCI of every coronary stenosis > 70% (or 50-69% lesions with FFR < 0.8) reduces risk of myocardial infarction (MI) and unstable angina (UA) at 3 years compared with culprit-lesion PCI [1]. Whether this findings are related to revascularization of every obstructive lesions rather than lesions with vulnerable-plaque characteristics, still remain unclear.

In high risk patients such as STEMI patients, physiopathology of coronary plaque deeply differs from stable angina, mainly due to peculiar features of plaque. STEMI lesions, when evaluated at autopsy or at intracoronary imaging, showed a pro-thrombotic pattern, with high prevalence of thin cap fibro-atheroma, plaque rupture or thrombus, and a larger amount of lipids and macrophage [2-6]. In this setting, angiography, even when combined with fractional flow reserve evaluation (which can describe more accurately the functional impact of the plaque), has intrinsic limitations because of lack of information about plaque characteristics [7,8].

Optical coherence tomography (OCT) is the latest development in intravascular coronary imaging. Similarly to intravascular ultrasound (IVUS), OCT provides cross-sectional images of the vessel. However, instead of sound, OCT employs light for tissue analysis that enables visualization of the coronary lesions with almost microscopic precision [9,10].

This tool can find high risk vulnerable plaque without angiographic or functional signs of severity, helping from misdiagnosing and under-treating these lesions, that could benefit from PCI even more than obstructive lesions without vulnerable plaque characteristics.

In an OCT substudy of the COMPLETE trial, researchers determined that half of patients had obstructive nonculprit lesions with vulnerable plaque, which could explain why complete revascularization conferred better outcomes than culprit lesion-only revascularization in the main trial. This substudy pointed out also a 20% of non-obstructive non-culprit lesions with vulnerable plaque caracteristics and up to 30% of obstructive non-culprit lesions without high risk morphology [11]. It suggest that a morphological approach to PCI in high risk patients can provide a more specific treatment compared with standard angiographic/functional approach. A correct identification of coronary plaque instability in a setting of STEMI patients could deeply impact in these patients risk of cardiovascular events, angina and re- hospitalization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with STEMI and residual non culprit CAD
  • Informed consent

排除标准

  • Refusal or inability to provide informed consent.
  • < 18 years of age
  • Cardiogenic shock
  • Previous Coronary Artery Bypass Grafting (CABG
  • Indication for revascularization by CABG.
  • eGFR < 30 ml/min/m2
  • ULM stenosis
  • Estimated life expectancy < 3 year
  • Non culprit CTO lesion

结局指标

主要结局

Major adverse cardiovascular events (MACE)

时间窗: 24 mounth after the recruitment in the study

Composite endopoint of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization.

次要结局

  • Secondary efficacy end-points(24 mounth after the recruitment in the study)

研究者

发起方
A.O.U. Città della Salute e della Scienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabrizio D'Ascenzo

Cardiologist

A.O.U. Città della Salute e della Scienza

研究点 (12)

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