One-Time Complete Revascularization Versus Staged PCI in MVD During Pharmaco-Invasive STEMI Strategy

NCT07519590 | Completed

• 1 other identifier: 50-2023
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. The study evaluates whether one-time complete revascularization, in which the culprit and significant non-culprit lesions are treated during the same percutaneous coronary intervention (PCI) session, is better than a staged strategy, in which non-culprit lesions are treated in a separate percutaneous coronary intervention (PCI) procedure within 1 month. The hypothesis is that one-time complete revascularization may reduce hospitalization time, cost, and recurrent ischemic symptoms without increasing short-term complications. Participants are adults with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who had successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention (PCI). Outcomes include total hospitalization time, total expenses, contrast-induced nephropathy (CIN) within 72 hours, and major adverse cardiovascular events (MACE) during 3 months of follow-up.

Conditions

Myocardial Infarction; Coronary Artery Disease

Keywords

ST-elevation myocardial infarction; Multivessel coronary artery disease; Pharmaco-invasive strategy; Complete revascularization; Staged percutaneous coronary intervention; Fibrinolysis; Non-culprit lesion intervention; Primary percutaneous coronary intervention delay

Outcome Measures

Primary Outcomes (1)

• Total hospitalization time

  Total duration of hospitalization in days. For participants assigned to staged revascularization, the duration of the staged admission was added to the index admission to calculate the total hospitalization time.

  up to 1 month post operatively

Secondary Outcomes (6)

• Total expenses

  up to 1 month post operatively

• Contrast-induced nephropathy

  Within 72 hours after percutaneous coronary intervention

• Angina-related hospitalization

  Within 3 months after index percutaneous coronary intervention

• Left ventricular ejection fraction

  Baseline and 3 months after index percutaneous coronary intervention

• Wall motion score index

  Baseline and 3 months after index percutaneous coronary intervention

Study Arms (2)

One-Time Complete Revascularization

EXPERIMENTAL

Participants underwent one-time complete revascularization during the index percutaneous coronary intervention after successful fibrinolysis. The culprit coronary artery and all significant non-culprit lesions were treated during the same procedure.

Procedure: One-Time Complete Revascularization

Staged Percutaneous Coronary Intervention

ACTIVE COMPARATOR

Participants underwent culprit-only percutaneous coronary intervention during the index procedure after successful fibrinolysis. Significant non-culprit lesions were treated in a separate staged percutaneous coronary intervention session within 1 month after discharge.

Procedure: Staged Percutaneous Coronary Intervention

Interventions

One-Time Complete Revascularization PROCEDURE

Revascularization strategy in which the culprit coronary artery and all significant non-culprit lesions are treated during the index percutaneous coronary intervention session after successful fibrinolysis.

One-Time Complete Revascularization

Staged Percutaneous Coronary Intervention PROCEDURE

Revascularization strategy in which only the culprit coronary artery is treated during the index percutaneous coronary intervention session after successful fibrinolysis, with treatment of significant non-culprit lesions deferred to a separate staged percutaneous coronary intervention within 1 month after discharge.

Staged Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 18 years.
• Acute ST-elevation myocardial infarction treated with a pharmaco-invasive strategy.
• Successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention.
• Multivessel coronary artery disease.
• Ability to provide written informed consent.

You may not qualify if:

• Primary percutaneous coronary intervention.
• Unsuccessful fibrinolysis requiring rescue percutaneous coronary intervention.
• Candidacy for coronary artery bypass grafting after angiography.
• Failed complete revascularization.
• Cardiogenic shock.
• Single-vessel coronary artery disease treated with a pharmaco-invasive strategy.
• Stent thrombosis.
• Chronic total occlusion.
• Planned percutaneous transluminal coronary angioplasty to a non-culprit lesion in a vessel smaller than 2.5 millimeters with more than 70 percent stenosis.
• Severe valvular heart disease.
• Pregnancy.
• Prior cardiac surgery.
• Congenital heart disease.
• Severe hepatic impairment.
• Severe renal impairment.

Sponsors & Collaborators

• Helwan University: collaborator
• Tanta University: lead

Study Sites (1)

Helwan University Hospital

Cairo, Cairo Governorate, 11795, Egypt

Location

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study. Participants, care providers, and investigators were aware of treatment assignment because the timing and extent of revascularization differed by protocol. No formal masking of outcome assessment was specified.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Cardiology

Model Details: Participants were randomized in a parallel two-arm design to undergo either one-time complete revascularization during the index percutaneous coronary intervention or culprit-only percutaneous coronary intervention followed by staged non-culprit percutaneous coronary intervention within 1 month after discharge.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 30, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the study results and will remain available for 5 years.
• Access Criteria: Access will be provided to qualified researchers for scientifically sound research purposes after submission and approval of a methodologically appropriate proposal. Requests should include the study objectives, analysis plan, and intended use of the data. Data sharing will require approval by the principal investigator and institution, and may require a signed data use agreement.

Locations

EG (1)