A Retrospective, One Center Comparison of Outcomes Between Complete Revascularization by PCI at the Time of PPCI or During the Index Hospital Admission in One Hundred MVD Patients With ST-elevation MI Uncomplicated by Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- one year all-cause mortality
研究概览
简要总结
The study aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(MVD) patients presenting with ST-elevation myocardial infarction(STEMI) uncomplicated by cardiogenic shock.
详细描述
Complete revascularisation in MVD patients with STEMI uncomplicated by cardiogenic shock has been shown to improve outcomes, however the optimal timing of treatment of the non-culprit lesions is not known. The 2018 ESC/EACTS Guidelines on myocardial revascularization states that "routine revascularization of non-IRA (infarct related artery) lesions should be considered in patients with multivessel disease before hospital discharge". Our trial showed that among the fore mentioned patients there was no difference regarding outcomes when using a strategy of complete revascularization with non-culprit lesions PCI during PPCI or during the same hospital admission.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI ( PCI for STEMI should be primary PCI in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index PPCI procedure or during a different procedure performed before index hospital discharge.
- •Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
- •At least 75% diameter stenosis (visual estimation) or
- •At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80
- •Age between 18 and 90 years
- •Written informed consent could be obtained from all the patients
排除标准
- •Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis
- •Cardiogenic shock
- •Non-cardiovascular known co-morbidity reducing life expectancy to < 2 years
- •Any factor precluding 1year follow-up
- •Prior Coronary Artery Bypass Graft (CABG) Surgery
- •A different operator from the previously designated
- •Unable to provide consent for any other reason
结局指标
主要结局
one year all-cause mortality
时间窗: one year
death at one year
MACCE at one year
时间窗: one year
major adverse cardiac and cerebrovascular events including cardiac death, stroke, symptom-driven revascularization, myocardial infarction
次要结局
未报告次要终点
研究者
Nichita-Brendea Mihnea-Traian
MD
University of Oradea