In-hospital Versus After-discharge Complete Revascularization

Not Applicable

Completed

• Conditions: STEMI - ST Elevation Myocardial Infarction; Multivessel Coronary Artery Disease
• Interventions: Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI); Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)

• Registration Number: NCT04743154
• Lead Sponsor: Hospital General Universitario de Valencia

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.

Study Timeline

• Study Start: 2018-01-20
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Primary Completion: 2021-11-25
• Study Completion: 2022-12-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 TIMI3.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-hospital complete revascularization group.	In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)	Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.
After-discharge complete revascularization group.	After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)	Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.

Primary Outcome Measures

Name	Time	Method
Impact in hospital stay	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 Outcome Measures

Name	Time	Method
Fractional flow reserve of angiographically moderate stenosis	6 months	Evaluate the presence of ischemia by analyzing the fractional flow reserve of angiographically moderate stenoses (≥50% and \<70) in proximal segments of the anterior descending, circumflex, or right coronary artery.
Cardiovascular death, acute myocardial infarction or revascularization.	1 year	Composite of cardiovascular death, myocardial infarction, or ischemia driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two strategies.

Trial Locations

Locations (1)

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain