Clinical trial NCT01332591: Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
Official title: Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Stenosis
Keywords: STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
Collaborators: name: Bulgarian Cardiac Institute
name: Tomas Bata Hospital, Czech Republic
First posted: 2011-04-11
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: composite endpoint of death, nonfatal acute myocardial infarction and stroke
timeFrame: 2 years
Secondary outcomes:
measure: cardiovascular death
timeFrame: 2 years
measure: recurrent myocardial infarction
timeFrame: 2 years
measure: target vessel failure
timeFrame: 2 years
measure: stroke
timeFrame: 2 years
measure: hospitalization for heart failure
timeFrame: 2 years
measure: changes of left ventricular ejection fraction
timeFrame: 2 years
measure: hospitalization for unstable angina pectoris
timeFrame: 2 years
measure: outcomes of questionnaire regarding angina pectoris
timeFrame: 2 years
measure: target vessel revascularization
timeFrame: 2 years
measure: target lesion revascularization
timeFrame: 2 years
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Department of Cardioangiology, St. Anne University Hospital
Study officials:
affiliation: +420604273627
name: Ota Hlinomaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: