Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy. (Prague-13)

St. Anne's University Hospital Brno, Czech Republic

Status: Completed

Conditions: Coronary Artery Stenosis

Treatments: Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01332591

NT11412

Details and patient eligibility

About

The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Full description

Introduction:

Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.

Aim of study:

The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Hypothesis:

Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with acute myocardial infarction with ST segment elevation (STEMI)
• Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
• One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
• Enrollment ≥48 hours following onset of symptoms

Exclusion criteria

• Stenosis of the left main of left coronary artery ≥ 50%
• Hemodynamically significant valvular disease
• Patients in cardiogenic shock during STEMI
• Hemodynamic instability
• Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Complete revascularization

Active Comparator group

Description:

Percutaneous coronary intervention of "non-infarct" coronary arteries

Treatment:

Procedure: Percutaneous coronary intervention

Conservative management

No Intervention group

Description:

standard guideline-based medical therapy