FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease

Acute Myocardial Infarction Clinical Trial

— FRAME-AMI  

Official title:

Comparison of Clinical Outcomes Between Fractional Flow Reserve-guided Strategy and Angiography-guided Strategy in Treatment of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715518
• Other study ID #: FRAME16453143
• Status: Completed
• Phase: N/A
• Start date: August 19, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare clinical outcomes following fractional flow reserve (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel disease

Prospective, open-label, randomized, multicenter trial to test the clinical outcomes following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in patients with acute AMI with multivessel disease.

Description:

The presence of ischemia is a prerequisite for the improvement of clinical outcomes with percutaneous coronary intervention (PCI). It is well-known that the discrepancy exists between angiographic stenosis severity and the presence of myocardial ischemia. This discrepancy cannot completely overcome with even more precise invasive imaging modalities such as intravascular ultrasound or optical coherence tomography.

Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia.

However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from non-acute myocardial infarction patients.1, 3-5 Recently FAMOUS-NAMI trial evaluated 176 patients with acute non-ST elevation myocardial infarction (NSTEMI) with multivessel disease, and demonstrated feasibility of FFR measurement in acute NSTEMI patients and also presented that FFR-guided decision making for non-infarct related artery (IRA) stenosis was significantly reduced unnecessary stent implantation without any difference in major adverse cardiovascular events at 1-year as well as medical cost, compared with angiography-only guided decision making process.

Nevertheless, there have been no evidence in clinical setting of acute myocardial infarction (AMI). Since about 30-50% of patients with AMI possess multivessel disease, the ability to accurately assess the functional significance of non-IRA stenoses at the time of initial primary PCI would potentially facilitate revascularization decisions with potential for health and economic benefit. Moreover, avoiding unnecessary stent implantation for non-IRA stenoses in patients with AMI with multivessel disease would reduce the possibility of stent- or procedure related complications, and enhance long-term prognosis of patients.

Therefore, the FRAME-AMI trial will compare clinical outcomes after index primary PCI between FFR-guided strategy versus angiography only-guided strategy for management of non-IRA stenoses in AMI with multivessel disease patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1292
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

(1) Inclusion Criteria

1. Subject must be at least 19 years of age

2. Acute ST-segment elevation myocardial infarction (STEMI) A. ? STEMI: "ST-segment elevation =0.1 mV in =2 contiguous leads B. or documented newly developed left bundle-branch block "

3. Acute non-ST-segment elevation myocardial infarction (NSTEMI)

A. ? NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:

4. Symptoms of ischaemia.

5. New or presumed new significant ST-T wave changes

6. Development of pathological Q waves on electrocardiography (ECG).

7. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.

8. Intracoronary thrombus detected on angiography.

9. Primary percutaneous coronary intervention (PCI) in < 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset)

10. Multivessel disease (at least one stenosis of >50% in a non-culprit vessel = 2.0 mm by visual estimation)

11. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

(2) Exclusion criteria

1. Severe stenosis with TIMI flow = II of the non-IRA artery

2. Unprotected left main coronary artery disease (stenosis > 50% by visual estimation)

3. Non-IRA stenosis not amenable for PCI treatment by operators' decision)

4. Chronic total occlusion in non-IRA

5. Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI

6. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus

7. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)

8. Pregnancy or breast feeding

9. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

10. Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis

11. Patients with a history of Coronary Artery Bypass Graft (CABG) or treated with fibrinolytic Therapy

12. Unwillingness or inability to comply with the procedures described in this protocol.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• PCI using 2nd generation drug-eluting stent
Percutaneous coronary intervention (PCI) using 2nd generation drug-eluting stent for non-IRA stenosis will be decided according to the allocated arms. FFR-guided strategy arm Angiography-guided strategy arm

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (19)

Lead Sponsor

Collaborator

Samsung Medical Center

Ajou University School of Medicine, Chonnam National University Hospital, Chosun University Hospital, Chungbuk National University Hospital, Gyeongsang National University Hospital, Incheon St.Mary's Hospital, Inha University Hospital, Inje University, Kangbuk Samsung Hospital, KangWon National University Hospital, Keimyung University Dongsan Medical Center, Kosin University Gospel Hospital, Samsung Changwon Hospital, Sejong General Hospital, Seoul National University Hospital, Uijeongbu St. Mary Hospital, Wonju Severance Christian Hospital, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-oriented composite outcome	a composite of death, myocardial infarction, or repeat revascularization	24 months
Secondary	All-cause mortality	All-cause mortality	24 months
Secondary	Cardiac death	Cardiac death	24 months
Secondary	Any myocardial infarction without procedure-related myocardial infarction	Any myocardial infarction without procedure-related myocardial infarction	24 months
Secondary	Any myocardial infarction with periprocedural myocardial infarction	Any myocardial infarction with periprocedural myocardial infarction	24 months
Secondary	Any revascularization	ischemia-driven or all	24 months
Secondary	Infarct-related artery (IRA) repeat revascularization	ischemia-driven or all	24 months
Secondary	Non-IRA repeat revascularization	ischemia-driven or all	24 months
Secondary	Stent thrombosis	ARC-defined definite stent thrombosis	24 months
Secondary	Stroke	ischemic and hemorrhagic	24 months
Secondary	Total amount of contrast use	From primary PCI to end of the procedure including amount of staged procedure	1 week
Secondary	Incidence of contrast-induced nephropathy	defined as an increase in serum creatinine of =0.5mg/dL or =25% from baseline within 48-72 hours after contrast agent exposure	3 days
Secondary	Seattle Angina Questionnaires	Angina severity	12-month
Secondary	Seattle Angina Questionnaires	Angina severity	24-month
Secondary	All-cause death and myocardial infarction	A composite of all-cause death and any myocardial infarction (MI) according to the ARC consensus	24-month
Secondary	Death, spontaneous myocardial infarction, or repeat revascularization	A composite of Death, spontaneous myocardial infarction, or repeat revascularization	24-month