In-hospital Versus After-discharge Complete Revascularization in STEMI Patients With Multivessel Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- STEMI - ST Elevation Myocardial Infarction
- Sponsor
- Hospital General Universitario de Valencia
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Impact in hospital stay
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eva Rumiz González
Principal investigator
Hospital General Universitario de Valencia
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Impact in hospital stay
Time Frame: 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.
Secondary Outcomes
- Fractional flow reserve of angiographically moderate stenosis(6 months)
- Cardiovascular death, acute myocardial infarction or revascularization.(1 year)