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

STEMI Clinical Trial

— FAIO  

Official title:

Multi Centre Open Label Randomised Controlled Parallel-group Three Arm Trial To Compare The Use Of Fractional Flow Reserve (FFR) Guided and Angiographically Guided Revascularization To The Treatment Of Infarct Related Artery Only In Patients With STEMI And Multivessel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02637440
• Other study ID #: FA 2015
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 17, 2015
• Last updated: December 21, 2015
• Start date: December 2015
• Est. completion date: November 2019

Study information

• Verified date: December 2015
• Source: University of Limerick
• Contact: Thomas J Kiernan, MD
• Phone: +35361482684
• Email: tom_kiernan[@]hotmail.com
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• FFR Guided PCI
• Multivessel Coronary Artery Disease
• Myocardial Ischemia
• STEMI

Intervention

Procedure:
• FFR guided PCI
Patients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8
• Angio guided PCI
Patients receive PCI without FFR measurement

Locations

Country	Name	City	State
Ireland	Galway University Hospital	Galway
Ireland	University Hospital Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3—PRIMULTI Investigators. Comple — View Citation

Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038. — View Citation

Levine GN, O'Gara PT, Bates ER, Blankenship JC, Kushner FG, Bailey SR, Bittl JA, Brindis RG, Casey DE Jr, Cercek B, Chambers CE, Chung MK, de Lemos JA, Diercks DB, Ellis SG, Fang JC, Franklin BA, Granger CB, Guyton RA, Hollenberg SM, Khot UN, Krumholz HM, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding	any major bleeding (TIMI 3)	1 year	Yes
Primary	Composite of cardiovascular death, myocardial infarction and / or revascularization		1 year	No
Secondary	Cardiovascular morality		1 year	No
Secondary	Myocardial infarction		1 year	No
Secondary	Revascularization	Revascularization procedure because of symptoms and evidence of ischaemia	1 year	No
Secondary	stroke		1 year	No
Secondary	Heart failure	documented episode of presentation with symptoms consistent with heart failure and evidence from echocardiogram or laboratory test consistent with the diagnosis of heart failure	1 year	No
Secondary	Costs	total procedural costs, hospital stay costs, medications costs.	1 year	No