In-hospital Versus After-discharge Complete Revascularization (REVIVA-ST)

Hospital General Universitario de Valencia

Status: Completed

Conditions: Multivessel Coronary Artery Disease; STEMI - ST Elevation Myocardial Infarction

Treatments: Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI); Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04743154

HGUValencia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

In-hospital complete revascularization group.

Other group

Description:

Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.

Treatment:

Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)

After-discharge complete revascularization group.

Other group

Description:

Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.

Treatment:

Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)