Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04626882
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2020-11-02
Brief Title:
Timing of FFR-guided PCI for Non-IRA in STEMI and MVD OPTION-STEMI
Sponsor:
Chonnam National University Hospital
Organization:
Chonnam National University Hospital
Study Overview
Official Title:
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease OPTION-STEMI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Patients with STEMI ST-segment elevation myocardial infarction with multivessel disease which have PCI percutaneous coronary intervention-suitable non-IRA infarct related artery will be randomized to immediate complete revascularization group or staged revascularization group by 11 fashion Non-IRA lesion which have equal or more than 70 diameter stenosis by visual estimation will be revascularized without FFR fractional flow reserve evaluation Non-IRA lesion with diameter stenosis 50-70 by visual estimation will be evaluated using FFR device In case of FFR value more than 08 non-IRA lesion wll be deferred without PCI If FFR value was equal or less than 08 non-IRA lesion will be revascularized
Detailed Description:
Study objectives
To determine the optimal timing of non-infarct related artery IRA percutaneous coronary intervention PCI with the aid of FFR fractional flow reserve immediate complete revascularization during primary angioplasty vs staged procedure for non-IRA PCI in patients with ST-segment elevation myocardial infarction with multivessel disease MVD
Study hypothesis
Complete revascularization CR at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA
Background
Multivessel coronary artery disease MVD is a common clinical condition about 40-65 of all primary angioplasty encountered by interventional cardiologists in ST-segment elevation myocardial infarction STEMI and it is associated with poorer clinical outcomes than single-vessel disease Older guidelines recommended culprit-vessel only revascularization CVR during primary angioplasty except in patient that are hemodynamically unstable Several recent studies have reported improved clinical outcomes in these patients with multivessel percutaneous coronary intervention PCI and others reported promising results from CVR followed by elective second-stage PCI at non-infarct related artery non-IRA with significant stenosis However there has been no consensus of optimal revascularization strategy in this circumstance
Recently several large-scaled randomized controlled trials were conducted about this issue and confirmed the benefit of immediate complete revascularization during primary angioplasty compared to CVR Furthermore fractional flow reserve FFR-guided PCI at non-IRA was more effective than angiography-guided PCI at non-IRA for reducing repeat revascularization by either immediate multivessel PCI strategy or staged PCI strategy in the other trials
Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis the most studies regarding FFR enrolled patients without acute myocardial infarction AMI Timing of non-IRA PCI is also uncertain After promising results of above-mentioned randomized trials current guideline recommendation of multivessel PCI immediate or staged was upgraded However current guidelines simply mentioned about the timing of non-IRA PCI which recommends complete revascularization during initial hospitalization by either of immediate of staged PCI strategy
Therefore the investigators planned to perform prospective open-label multicenter non-inferiority trial to evaluate the efficacy and safety of immediate complete revascularization PCI for both IRA and non-IRA during primary angioplasty compared to staged PCI strategy of non-IRA primary angioplasty for IRA followed by non-IRA PCI after several days PCI procedure at non-IRA with diameter stenosis between 50 and 70 should be conducted with the aid of FFR and non-IRA with diameter stenosis 70 will be revascularized without FFR
Study procedure
Patients will be randomized after primary PCI for IRA Non-IRA lesion which have equal or more than 70 diameter stenosis by visual estimation will be revascularized without FFR evaluation Non-IRA lesion with diameter stenosis 50-70 by visual estimation will be evaluated using FFR device In case of FFR value more than 08 non-IRA lesion wll be deferred without PCI If FFR value was equal or less than 08 non-IRA lesion will be revascularized
To determine the optimal timing of non-infarct related artery IRA percutaneous coronary intervention PCI with the aid of FFR fractional flow reserve immediate complete revascularization during primary angioplasty vs staged procedure for non-IRA PCI in patients with ST-segment elevation myocardial infarction with multivessel disease MVD
Study hypothesis
Complete revascularization CR at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA
Background
Multivessel coronary artery disease MVD is a common clinical condition about 40-65 of all primary angioplasty encountered by interventional cardiologists in ST-segment elevation myocardial infarction STEMI and it is associated with poorer clinical outcomes than single-vessel disease Older guidelines recommended culprit-vessel only revascularization CVR during primary angioplasty except in patient that are hemodynamically unstable Several recent studies have reported improved clinical outcomes in these patients with multivessel percutaneous coronary intervention PCI and others reported promising results from CVR followed by elective second-stage PCI at non-infarct related artery non-IRA with significant stenosis However there has been no consensus of optimal revascularization strategy in this circumstance
Recently several large-scaled randomized controlled trials were conducted about this issue and confirmed the benefit of immediate complete revascularization during primary angioplasty compared to CVR Furthermore fractional flow reserve FFR-guided PCI at non-IRA was more effective than angiography-guided PCI at non-IRA for reducing repeat revascularization by either immediate multivessel PCI strategy or staged PCI strategy in the other trials
Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis the most studies regarding FFR enrolled patients without acute myocardial infarction AMI Timing of non-IRA PCI is also uncertain After promising results of above-mentioned randomized trials current guideline recommendation of multivessel PCI immediate or staged was upgraded However current guidelines simply mentioned about the timing of non-IRA PCI which recommends complete revascularization during initial hospitalization by either of immediate of staged PCI strategy
Therefore the investigators planned to perform prospective open-label multicenter non-inferiority trial to evaluate the efficacy and safety of immediate complete revascularization PCI for both IRA and non-IRA during primary angioplasty compared to staged PCI strategy of non-IRA primary angioplasty for IRA followed by non-IRA PCI after several days PCI procedure at non-IRA with diameter stenosis between 50 and 70 should be conducted with the aid of FFR and non-IRA with diameter stenosis 70 will be revascularized without FFR
Study procedure
Patients will be randomized after primary PCI for IRA Non-IRA lesion which have equal or more than 70 diameter stenosis by visual estimation will be revascularized without FFR evaluation Non-IRA lesion with diameter stenosis 50-70 by visual estimation will be evaluated using FFR device In case of FFR value more than 08 non-IRA lesion wll be deferred without PCI If FFR value was equal or less than 08 non-IRA lesion will be revascularized
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