Clinical trial NCT04743154: In-hospital Versus After-discharge Complete Revascularization
Official title: In-hospital Versus After-discharge Complete Revascularization in STEMI Patients With Multivessel Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Multivessel Coronary Artery Disease
Keywords: STEMI
Multivessel
PCI
Lead sponsor: Hospital General Universitario de Valencia
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: Impact in hospital stay
timeFrame: 6 months
Secondary outcomes:
measure: Cardiovascular death, acute myocardial infarction or revascularization.
timeFrame: 1 year
measure: Fractional flow reserve of angiographically moderate stenosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: Hospital General Universitario de Valencia
name: Eva Rumiz Gonzalez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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