The Use Of FFR Guided PCI Versus Complete Revascularization and Treatment Of Infarct Related Artery Only In Patients With STEMI

Phase 3

• Conditions: Multivessel Coronary Artery Disease; STEMI; FFR Guided PCI
• Interventions: Procedure: FFR guided PCI; Procedure: Angio guided PCI

• Registration Number: NCT02637440
• Lead Sponsor: University of Limerick

Brief Summary

In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.

The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well.

The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention.

In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization

Detailed Description

To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization.

Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-17
• Last Update Submitted: 2015-12-21
• Study First Posted: 2015-12-22
• Last Update Posted: 2015-12-23
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1. Patients with STEMI and multi-vessel disease on initial angiogram.
2. Above 18 years of age
3. Able to give consent

Exclusion Criteria

1. Patients with indication for CABG
2. Left main stem lesion of >50%
3. Cardiogenic shock
4. Intractable angina during hospital admission
5. Patients with limited life expectancy
6. Patients with severe chronic kidney disease
7. Patients with contraindication to dual antiplatelet therapy
8. Patients with very complex lesions that deemed not favourable for PCI
9. Pregnancy or childbearing age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFR guided	FFR guided PCI	FFR group will undergo FFR at 4 weeks of the index primary PCI as OPD. If FFR is less than 0.8, then PCI will be performed
angiogram guided	Angio guided PCI	The group will undergo PCI for all significant lesions more than 50

Primary Outcome Measures

Name	Time	Method
Composite of cardiovascular death, myocardial infarction and / or revascularization	1 year

Secondary Outcome Measures

Name	Time	Method
Cardiovascular morality	1 year
stroke	1 year
Myocardial infarction	1 year
Revascularization	1 year	Revascularization procedure because of symptoms and evidence of ischaemia
Costs	1 year	total procedural costs, hospital stay costs, medications costs.
Heart failure	1 year	documented episode of presentation with symptoms consistent with heart failure and evidence from echocardiogram or laboratory test consistent with the diagnosis of heart failure

Trial Locations

Locations (2)

Galway University Hospital; 🇮🇪 Galway, Ireland

University Hospital Limerick; 🇮🇪 Limerick, Ireland