In-hospital Versus After-discharge Complete Revascularization in STEMI Patients With Multivessel Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Impact in hospital stay
研究概览
简要总结
Patients with STEMI and multivessel disease in whom the culprit lesion has been successfully revascularized during prmimary PCI, will be randomized to in-hospital or after-discharge complete revascularization.
The purpose of this study is to evaluate the impact of these two different strategies in terms of hospital stay.
详细描述
STEMI patients with mutivessel disease are, after successful primary angioplasty, randomized 1:1 ratio to either in-hospital complete revascularization or after-discharge complete revascularization strategy.
Eligible non-culprit coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between ≥50% and <70 in proximal segments can be randomized.
Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial infarction. On the other hand, patients in the after-discharge group will undergo to non-culprit PCI within 4-6 weeks after STEMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Acute onset of chest pain <12 hours duration.
- •ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
- •Culprit lesion in a major native vessel, with successful primary PCI.
- •Presence of at least one non-culprit lesion more than or equal to 70% of stenosis in a vessel more than 2mm of diameter or more than or equal to 50% stenosis in proximal segments.
- •The patient is able to give written consent for participation in the study.
排除标准
- •Pregnancy.
- •Significant left main stenosis.
- •Stent thrombosis.
- •Chronic total occlusion.
- •Severe stenosis of non-culprit vessels with distal flow less than TIMI
- •Significant non-culprit stenosis no candidate to revascularization.
- •Presence of valvulopathy candidate for cardiac surgery.
- •Cardiogenic shock status at admission.
- •The patient is not able to give written consent for participation in the study.
结局指标
主要结局
Impact in hospital stay
时间窗: 6 months
To evaluate the impact of two different revascularization strategies (in-hospital versus after-discharge) in terms of hospital stay (days) in patients with a STEMI and multivessel disease.
次要结局
- Fractional flow reserve of angiographically moderate stenosis(6 months)
- Cardiovascular death, acute myocardial infarction or revascularization.(1 year)
研究者
Eva Rumiz González
Principal investigator
Hospital General Universitario de Valencia