Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
- Conditions
- Coronary Artery Stenosis
- Interventions
- Procedure: Percutaneous coronary intervention
- Registration Number
- NCT01332591
- Lead Sponsor
- St. Anne's University Hospital Brno, Czech Republic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Complete revascularization Percutaneous coronary intervention Percutaneous coronary intervention of "non-infarct" coronary arteries
- Primary Outcome Measures
Name Time Method composite endpoint of death, nonfatal acute myocardial infarction and stroke 2 years
- Secondary Outcome Measures
Name Time Method changes of left ventricular ejection fraction 2 years target lesion revascularization 2 years non infarct artery
recurrent myocardial infarction 2 years hospitalization for heart failure 2 years hospitalization for unstable angina pectoris 2 years target vessel revascularization 2 years non infarct artery
target vessel failure 2 years progression of studied stenosis of non-culprit artery
cardiovascular death 2 years stroke 2 years outcomes of questionnaire regarding angina pectoris 2 years
Trial Locations
- Locations (1)
Department of Cardioangiology, St. Anne University Hospital
🇨🇿Brno, Czech Republic