Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)
In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.
ST-elevation Myocardial Infarction.
Multi Vessel Disease.
Procedure: Percutaneous coronary intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention|
- All cause death, myocardial infarction or revascularization [ Time Frame: 48 months ] [ Designated as safety issue: No ]Composite of all cause death, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure
- Cardiac death or myocardial infarction [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Angina status and quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Wall motion index (WMI) determined by echocardiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Culprit lesion revascularization
Only the culprit lesion is treated whereas other study lesions are left un-treated.
|Procedure: Percutaneous coronary intervention|
Active Comparator: Full revascularization
Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
|Procedure: Percutaneous coronary intervention Procedure: FFR|
STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).
Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.
Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960933
|Contact: Steffen Helqvist, MD, DMScifirstname.lastname@example.org|
|Contact: Lars Køber, MD, DMSciemail@example.com|
|Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9100|
|Contact: Hans Henrik T Hansen, MD, PhD|
|Principal Investigator: Hans Henrik T Hansen, MD|
|Skejby University Hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Hans E Bøtker, MD, DMSci|
|Principal Investigator: Hans E Bøtker, MD, DMSci|
|Rigshospitalet, University of Copenhagen||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Steffen Helqvist, MD, DMSci +4535452017 firstname.lastname@example.org|
|Sub-Investigator: Lene Holmvang, MD, DMSci|
|Sub-Investigator: Peter Clemmensen|
|Sub-Investigator: Erik Jørgensen, MD|
|Sub-Investigator: Kari Saunamäki, MD. DMSci|
|Sub-Investigator: Frants Pedersen, MD, DMSci|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Lisette Okkels, MD, DMSci|
|Principal Investigator: Lisette Okkels, MD, DMSci|
|Study Chair:||Steffen Helqvist, MD, DMSci||Rigshospitalet, University of Copenhagen, Denmark|
|Principal Investigator:||Thomas Engstrøm, MD, DMSci||Rigshospitalet, University of Copenhagen, Denmark|
|Principal Investigator:||Henning Kelbæk, MD. DMSci||Rigshospitalet, University of Copenhagen, Denmark|
|Principal Investigator:||Lars Køber, MD, Prof., DMSci||Rigshospitalet, University of Copenhagen, Denmark|