Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI (MVD)

Clinical Hospital Center Zemun

Status: Completed

Conditions: Myocardial Infarction

Treatments: Procedure: dobutamine stress echocardiography; Procedure: PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT02756000

ZEM-CARD-003

Details and patient eligibility

About

The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.

Full description

This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as >70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical and electrocardiographic signs of first ever ST elevation myocardial infarction (chest pain lasting less than 12 hours with persistent ST elevation of ≥ 1mm in two contiguous leads on ECG recording)
• Multivessel coronary artery disease (MVD) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels
• Treated with primary PCI of infarct related artery (IRA) only.

Exclusion criteria

• Hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (IABP) implantation and mechanical ventilation prior, during and after primary PCI;
• Presence of significant valvular disease;
• Decision that patient needs to be treated with coronary artery bypass graft (CABG) and/or valvular replacement or reconstruction surgery after initial culprit only PCI;
• Myocardial infarction is caused by stent thrombosis:
• Chronic total occlusion of any of the coronary arteries on initial angiogram;
• Previously treated by CABG surgery;
• Estimated life expectancy less than one year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

complete PCI at initial hospitalization

Experimental group

Description:

Staged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction

Treatment:

Procedure: PCI

complete PCI after 30 days

Experimental group

Description:

Staged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction

Treatment:

Procedure: PCI

Dobutamine stress testing

Active Comparator group

Description:

Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography

Treatment:

Procedure: PCI

Procedure: dobutamine stress echocardiography