An interventional study of PCI using 2nd generation drug-eluting stent in Acute Myocardial Infarction, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 1,292 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
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(1) Inclusion Criteria
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:
(2) Exclusion criteria
FFR measurement for non-IRA stenosis (\>50% visual estimation) will be performed by continuous infusion of adenosine (140\~180ug/kg/min) or intracoronary nicorandil (2mg bolus) injection. The FFR ≤ 0.80 will be targeted for PCI using 2nd generation drug-eluting stent. In case of non-IRA stenosis \> 90%, we will judge FFR value of ≤ 0.80. The evaluation of non-IRA stenosis by FFR will be recommended to perform during same intervention with primary PCI for IRA. However, exceptions can be made for complex lesions including ACC/AHA classification B2/C lesion where the operator estimates that the revascularization procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a staged procedure during the same hospitalization.
Device: PCI using 2nd generation drug-eluting stent
Non-IRA stenosis with \> 50% stenosis will be the target of PCI using 2nd generation drug-eluting stent. As for the angiography-guided strategy arm, PCI for non-IRA stenosis will be recommended during same procedure. However, exceptions can be made for complex lesions including ACC/AHA classification B2/C lesion where the operator estimates that the revascularization procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a staged procedure during the same hospitalization.
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. 1. FFR-guided strategy arm 2. Angiography-guided strategy arm
Patient-oriented composite outcome
a composite of death, myocardial infarction, or repeat revascularization
Time frame: 24 months
All-cause mortality
All-cause mortality
Time frame: 24 months
Cardiac death
Cardiac death
Time frame: 24 months
Any myocardial infarction without procedure-related myocardial infarction
Any myocardial infarction without procedure-related myocardial infarction
Time frame: 24 months
Any myocardial infarction with periprocedural myocardial infarction
Any myocardial infarction with periprocedural myocardial infarction
Time frame: 24 months
Any revascularization
ischemia-driven or all
Time frame: 24 months
Infarct-related artery (IRA) repeat revascularization
ischemia-driven or all
Time frame: 24 months
Non-IRA repeat revascularization
ischemia-driven or all
Time frame: 24 months
Stent thrombosis
ARC-defined definite stent thrombosis
Time frame: 24 months
Stroke
ischemic and hemorrhagic
Time frame: 24 months
Total amount of contrast use
From primary PCI to end of the procedure including amount of staged procedure
Time frame: 1 week
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
Time frame: 3 days
Seattle Angina Questionnaires
Angina severity
Time frame: 12-month
Seattle Angina Questionnaires
Angina severity
Time frame: 24-month
All-cause death and myocardial infarction
A composite of all-cause death and any myocardial infarction (MI) according to the ARC consensus
Time frame: 24-month
Death, spontaneous myocardial infarction, or repeat revascularization
A composite of Death, spontaneous myocardial infarction, or repeat revascularization
Time frame: 24-month
Plan to share: Yes — After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Supporting information: Study protocol, Sap
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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