Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization

Not Applicable

Active, not recruiting

• Conditions: ST-elevation Myocardial Infarction; Multi Vessel Disease
• Interventions: Procedure: Percutaneous coronary intervention; Procedure: FFR

• Registration Number: NCT01960933
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2015-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culprit lesion revascularization	Percutaneous coronary intervention	Only the culprit lesion is treated whereas other study lesions are left un-treated.
Full revascularization	Percutaneous coronary intervention	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.
Full revascularization	FFR	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.

Primary Outcome Measures

Name	Time	Method
All cause death, myocardial infarction or revascularization	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 Outcome Measures

Name	Time	Method
Infarct size in relation to area at risk as determined by MRI	3 months
Angina status and quality of life	1 year
Cardiac death or myocardial infarction	1 year
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

Trial Locations

Locations (2)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark