Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812963
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-02-22
Brief Title:
IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRAME-AMI2
Brief Summary:
The aim of the study is to compare clinical outcomes between intravascular ultrasound IVUS-guided treatment decision versus fractional flow reserve FFR-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction AMI and multivessel disease
Detailed Description:
The treatment of choice of acute myocardial infarction AMI including ST-segment elevation myocardial infarction STEMI and non-ST segment elevation myocardial infarction NSTEMI is reperfusion therapy preferably with percutaneous coronary intervention PCI While need of treating the infarct related artery IRA is obvious need for routine revascularization of non-infarct related artery non-IRA has been a topic of debate until recent years Through a number of observational studies randomized trials and meta-analyses the benefits of non-IRA PCI have been continuously implied and COMPLETE trial with 4041 patients of STEMI and multivessel coronary artery disease in 2019 demonstrated superiority of complete revascularization to culprit-only PCI in terms of cardiovascular death or MI primary end point and cardiovascular death MI or ischemia-driven revascularization co-primary end point As such complete revascularization of a significant non-IRA stenosis is recommended after successful PCI for IRA in patients with AMI and multivessel disease in current clinical guidelines
Nevertheless it has been unclear which criteria should be used to decide non-IRA PCI Although potential significance of non-IRA lesions can be estimated by angiography the limitation of angiographic visual assessment or quantitative coronary angiography has been well known Various measurements are used for incremental information in addition to angiographic assessment in guiding PCI - namely intravascular ultrasound IVUS and fractional flow reserve FFR IVUS provides anatomical information regarding the lumen plaque and plaque characteristics and can optimize stent placement minimizing stent-related problems and lead to better clinical outcomes On the other hand FFR provides information on amount of ischemia which the stenosis in question is causing and also improves the quality of PCI which has been demonstrated by multiple previous trials and current practice guidelines recommend the use of FFR to determine revascularization strategy as Class IA recommendation Recent trials evaluated comparative prognosis between FFR-guided versus angiograph-guided PCI for non-IRA in patients with acute MI and multivessel disease FLOWER-MI trial showed comparable clinical outcome between FFR-guided versus angiography-guided PCI for non-IRA in STEMI patients at 1-year follow-up FRAME-AMI trial showed superiority of FFR-guided PCI over angiography-guided PCI in reducing death MI or repeat revascularization during median 35 years of follow-up in patients with STEMI or NSTEMI and multivessel disease
Although IVUS and FFR differ in underlying basic concepts previous studies demonstrated clinical outcomes following treatment decision by IVUS and FFR was similar between the 2 groups However these studies mainly evaluated low-risk stable ischemic heart disease patients with intermediate stenosis and does not reflect population with acute myocardial infarction undergoing complete revascularization Currently the data directly comparing the benefit of IVUS and FFR for non-IRA PCI in AMI is lacking Considering that coronary atherosclerotic plaque in non-IRA of STEMI patients is associated with significantly higher risk of future clinical events IVUS would have potential strength of detecting high risk plaque in non-IRA and treatment decision based on plaque characteristics Conversely FFR-guided treatment decision for non-IRA would detect functionally significant non-IRA stenosis and treatment decision based on functional significance would reduce unnecessary PCI as demonstrated by previous trials
In this regard randomized controlled trial comparing clinical outcome following non-IRA PCI in AMI patients with multivessel disease guided by IVUS or FFR would provide valuable evidence to enhance patients prognosis after treatment of STEMI Therefore FRAME-AMI 2 trial is designed to compare clinical outcomes after non-IRA PCI using either IVUS-guided or FFR-guided strategy
Nevertheless it has been unclear which criteria should be used to decide non-IRA PCI Although potential significance of non-IRA lesions can be estimated by angiography the limitation of angiographic visual assessment or quantitative coronary angiography has been well known Various measurements are used for incremental information in addition to angiographic assessment in guiding PCI - namely intravascular ultrasound IVUS and fractional flow reserve FFR IVUS provides anatomical information regarding the lumen plaque and plaque characteristics and can optimize stent placement minimizing stent-related problems and lead to better clinical outcomes On the other hand FFR provides information on amount of ischemia which the stenosis in question is causing and also improves the quality of PCI which has been demonstrated by multiple previous trials and current practice guidelines recommend the use of FFR to determine revascularization strategy as Class IA recommendation Recent trials evaluated comparative prognosis between FFR-guided versus angiograph-guided PCI for non-IRA in patients with acute MI and multivessel disease FLOWER-MI trial showed comparable clinical outcome between FFR-guided versus angiography-guided PCI for non-IRA in STEMI patients at 1-year follow-up FRAME-AMI trial showed superiority of FFR-guided PCI over angiography-guided PCI in reducing death MI or repeat revascularization during median 35 years of follow-up in patients with STEMI or NSTEMI and multivessel disease
Although IVUS and FFR differ in underlying basic concepts previous studies demonstrated clinical outcomes following treatment decision by IVUS and FFR was similar between the 2 groups However these studies mainly evaluated low-risk stable ischemic heart disease patients with intermediate stenosis and does not reflect population with acute myocardial infarction undergoing complete revascularization Currently the data directly comparing the benefit of IVUS and FFR for non-IRA PCI in AMI is lacking Considering that coronary atherosclerotic plaque in non-IRA of STEMI patients is associated with significantly higher risk of future clinical events IVUS would have potential strength of detecting high risk plaque in non-IRA and treatment decision based on plaque characteristics Conversely FFR-guided treatment decision for non-IRA would detect functionally significant non-IRA stenosis and treatment decision based on functional significance would reduce unnecessary PCI as demonstrated by previous trials
In this regard randomized controlled trial comparing clinical outcome following non-IRA PCI in AMI patients with multivessel disease guided by IVUS or FFR would provide valuable evidence to enhance patients prognosis after treatment of STEMI Therefore FRAME-AMI 2 trial is designed to compare clinical outcomes after non-IRA PCI using either IVUS-guided or FFR-guided strategy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None