Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04968808
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2021-07-09
Brief Title:
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD OPTION-NSTEMI
Sponsor:
Chonnam National University Hospital
Organization:
Chonnam National University Hospital
Study Overview
Official Title:
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction OPTION-NSTEMI
Status:
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:
Many patients with non-ST-segment elevation myocardial infarction NSTEMI have multivessel coronary artery disease MVD which is associated with poor clinical outcomes However there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD Therefore we planned to perform prospective open-label randomized trial to evaluate the efficacy and safety of immediate complete revascularization percutaneous coronary intervention PCI for both infarct-related artery IRA and non-IRA during index PCI compared to staged PCI strategy of non-IRA PCI for IRA followed by non-IRA PCI after several days PCI procedure at non-IRA with diameter stenosis between 50 and 69 should be conducted with the aid of fractional flow reserve FFR and non-IRA with diameter stenosis 70 will be revascularized without FFR
Detailed Description:
Many patients with non-ST-segment elevation myocardial infarction NSTEMI have multivessel coronary artery disease MVD which is associated with poor clinical outcomes In cases of hemodynamically stable ST-segment elevation myocardial infarction STEMI and MVD many studies demonstrated the superiority of complete revascularization CR by both one-stage and multistage procedures compared to culprit-only revascularization COR The 2017 European Society of Cardiology ESC guidelines for STEMI recommend routine revascularization for non infarct-related artery IRA lesions before hospital discharge in patients without cardiogenic shock
However there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD Only one randomized controlled trial the SMILE trial J Am Coll Cardiol 201667264-72 compared one-stage and multi-stage multivessel revascularization MVR in these patients Although the results of most studies analyzing interventional strategies in patients with NSTEMI and MVD showed superior results of MVR compared to COR they did not provide information about staged revascularization One-stage MVR was associated with better clinical outcomes compared to multi-stage MVR in the SMILE trial while one-stage and multi-stage MVR had similar incidences of adverse outcomes in large registry data Although the 2018 ESCEuropean Association for Cardio-Thoracic Surgery EACTS guidelines for myocardial revascularization recommend complete one-stage revascularization in NSTEMI and MVD it emphasizes individualization based on clinical status and comorbidities as well as disease severity In 2020 ESC guidelines for non-ST-segment elevation acute coronary syndrome this strategy is maintained CR during index percutaneous coronary intervention PCI is recommended in NSTEMI patients with MVD class IIb level B
Whether to revascularize non-IRA using angiography or fractional flow reserve FFR is also problematic FFR is a useful tool for assessing hemodynamic significance of non-IRA during both acute and subacute stage and FFR-guided PCI for non-IRA lesion is recommended during index PCI class IIb level B In the SMILE trial a 258 of study patients received FFR-guided PCI for non-IRA 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
However the recommendations in current guidelines which recommends CR during index PCI is not sufficiently powered to assess differences in clinical outcomes between interventional strategy There are also few studies regarding this issue and discrepancy in clinical outcomes between randomized trial and observational studies Furthermore FFR-guided PCI for non-IRA is not mandatory in these studies
Therefore we planned to perform prospective open-label randomized trial to evaluate the efficacy and safety of immediate complete revascularization PCI for both IRA and non-IRA during index PCI compared to staged PCI strategy of non-IRA PCI for IRA followed by non-IRA PCI after several days PCI procedure at non-IRA with diameter stenosis between 50 and 69 should be conducted with the aid of FFR and non-IRA with diameter stenosis 70 will be revascularized without FFR
However there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD Only one randomized controlled trial the SMILE trial J Am Coll Cardiol 201667264-72 compared one-stage and multi-stage multivessel revascularization MVR in these patients Although the results of most studies analyzing interventional strategies in patients with NSTEMI and MVD showed superior results of MVR compared to COR they did not provide information about staged revascularization One-stage MVR was associated with better clinical outcomes compared to multi-stage MVR in the SMILE trial while one-stage and multi-stage MVR had similar incidences of adverse outcomes in large registry data Although the 2018 ESCEuropean Association for Cardio-Thoracic Surgery EACTS guidelines for myocardial revascularization recommend complete one-stage revascularization in NSTEMI and MVD it emphasizes individualization based on clinical status and comorbidities as well as disease severity In 2020 ESC guidelines for non-ST-segment elevation acute coronary syndrome this strategy is maintained CR during index percutaneous coronary intervention PCI is recommended in NSTEMI patients with MVD class IIb level B
Whether to revascularize non-IRA using angiography or fractional flow reserve FFR is also problematic FFR is a useful tool for assessing hemodynamic significance of non-IRA during both acute and subacute stage and FFR-guided PCI for non-IRA lesion is recommended during index PCI class IIb level B In the SMILE trial a 258 of study patients received FFR-guided PCI for non-IRA 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
However the recommendations in current guidelines which recommends CR during index PCI is not sufficiently powered to assess differences in clinical outcomes between interventional strategy There are also few studies regarding this issue and discrepancy in clinical outcomes between randomized trial and observational studies Furthermore FFR-guided PCI for non-IRA is not mandatory in these studies
Therefore we planned to perform prospective open-label randomized trial to evaluate the efficacy and safety of immediate complete revascularization PCI for both IRA and non-IRA during index PCI compared to staged PCI strategy of non-IRA PCI for IRA followed by non-IRA PCI after several days PCI procedure at non-IRA with diameter stenosis between 50 and 69 should be conducted with the aid of FFR and non-IRA with diameter stenosis 70 will be revascularized without FFR
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