Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 650
- Locations
- 4
- Primary Endpoint
- All cause death, myocardial infarction or revascularization
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years.
- •Acute onset of chest pain of < 12 hours' duration.
- •ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
- •Culprit lesion in a major native vessel.
- •MVD (non-culprit vessels with angiographic stenosis >50%)
- •Successful primary PCI
Exclusion Criteria
- •Pregnancy.
- •Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
- •Inability to understand information or to provide informed consent.
- •Haemorrhagic diathesis or known coagulopathy.
- •Stent thrombosis
- •Significant left main stem stenosis
- •Cardiogenic shock at admittance
Outcomes
Primary Outcomes
All cause death, myocardial infarction or revascularization
Time Frame: 1 year
Composite of all cause mortality, 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
Secondary Outcomes
- Angina status and quality of life(1 year)
- Cardiac death or myocardial infarction(1 year)
- Infarct size in relation to area at risk as determined by MRI(3 months)
- Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions(2 years)
- Hospitalization for acute coronary syndrome or acute heart failure(1 year)
- Wall motion index (WMI) determined by echocardiography(1 year)
Investigators
Thomas Engstrom
MD, Senior Consultant, DMSCi
Rigshospitalet, Denmark