Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Stenosis
- Sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- composite endpoint of death, nonfatal acute myocardial infarction and stroke
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Ota Hlinomaz, MD, PhD
Ota Hlinomaz, MD, PhD
St. Anne's University Hospital Brno, Czech Republic
Eligibility Criteria
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
Outcomes
Primary Outcomes
composite endpoint of death, nonfatal acute myocardial infarction and stroke
Time Frame: 2 years
Secondary Outcomes
- changes of left ventricular ejection fraction(2 years)
- target lesion revascularization(2 years)
- recurrent myocardial infarction(2 years)
- hospitalization for heart failure(2 years)
- hospitalization for unstable angina pectoris(2 years)
- target vessel revascularization(2 years)
- target vessel failure(2 years)
- cardiovascular death(2 years)
- stroke(2 years)
- outcomes of questionnaire regarding angina pectoris(2 years)