Coronary Artery Stenosis
Conditions
Keywords
STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
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.
Interventions
PROCEDUREPercutaneous coronary intervention
PCI of significant stenoses of non-infarct coronary arteries
Sponsors
Bulgarian Cardiac Institute
Tomas Bata Hospital, Czech Republic
St. Anne's University Hospital Brno, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite endpoint of death, nonfatal acute myocardial infarction and stroke | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrent myocardial infarction | 2 years | — |
| target vessel failure | 2 years | progression of studied stenosis of non-culprit artery |
| stroke | 2 years | — |
| hospitalization for heart failure | 2 years | — |
| cardiovascular death | 2 years | — |
| hospitalization for unstable angina pectoris | 2 years | — |
| outcomes of questionnaire regarding angina pectoris | 2 years | — |
| target vessel revascularization | 2 years | non infarct artery |
| target lesion revascularization | 2 years | non infarct artery |
| changes of left ventricular ejection fraction | 2 years | — |
Countries
Czechia
Outcome results
None listed