Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508697
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CT-Angiography-Derived Plaque Characteristics on Cardiac Events in Deferral Patients by Invasive Fractional Flow Reserve
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPTURE
Brief Summary:
Fractional flow reserve FFR-guided PCI for chronic coronary syndromes CCS is reported to improve the outcomes compared with angiography-guided PCI However cardiac-events still occur in FFR-deferral patients in long-term follow-up Coronary computed tomography angiography CTA-defined high-risk-plaque HRP is known to relate future cardiac events We hypothesized that CTA might identify plaque features linked to future cardiac events in deferral patients
Detailed Description:
Although fractional flow reserve FFR-guided percutaneous-coronary-intervention PCI has improved short- and middle-term outcome compared with angiography-guided PCI alone cardiac-events still occur in FFR-deferral patients in long-term1-4 Recent J-CONFIRM registry examined 1263 patients with 1447 lesions in whom revascularization was deferred based on FFR in the 28 centers5 While 2-year target vessel failure TVF rate was 55 in deferred lesions in the J-CONFIRM registry 5-year TVF raised up 116 in deferred lesions5 6 The TVF rate raised up from 55 to 116 in the last 3 years mainly due to clinically driven target-vessel-revascularization TVR in the registry5 6 In the DEFER trial patients with FFR 075 were randomly assigned to PCI deferral Defer or performance Perform and patients showing FFR 075 underwent PCI Reference3 The 5-year cardiac death and acute myocardial infarction AMI rate were excellent in the Defer group as compared to Perform and Reference groups 33 79 and 157 p 0003 respectively4 However 15-year follow-up of the DEFER study revealed that all cause of mortality and TVR were similar among Defer Perform and Reference groups mortality 330 vs 311 vs 361 p 0441 respectively and TVR 363 vs 278 vs 354 p 0522 respectively7 Favorable initial 5-year clinical outcome in deferral patients has been lost during 15-year follow-up in the DEFER study It is urgent issue to disclose the factor to predict future cardiac events in deferral lesions The failure of PCI to modify long-term outcomes may stem from its inability to modify the underlying atherosclerotic process
Furthermore recent PREVENT study disclosed that in patients with non-flow-limiting FFR 080 vulnerable coronary plaques identified by intracoronary imaging preventive PCI reduced major adverse cardiac events MACE arising from high-risk vulnerable plaques compared with optimal medical therapy OMT alone8 Although their high-risk vulnerable plaques were defined using intracoronary imaging but not coronary CT angiography CTA in the PREVENT study the presence of high-risk vulnerable plaque without flow-limiting FFR 080 frequently caused the subsequent cardiac events in patients without the initial PCI
While CTA is known to be useful to evaluate coronary artery plaque features as well as stenosis severity high-risk plaque HRP on coronary CTA defined as a combination of positive remodeling PR and low attenuation plaque LAP has been reported to be associated with the future cardiac events9-12 Gallone and coworkers reported in their meta-analysis that high-risk coronary plaque characteristics significantly predicted patient-level and lesion-level major adverse cardiac event MACE in the future using various high-risk coronary plaque definitions by several intracoronary imaging modalities and CTA13 We hypothesized that CTA could identify plaque features linked to future cardiac events in deferral patients To determine the predictive factors for future cardiac events in FFR-based deferral patients we examined clinical features and plaque characteristics on CTA in the deferral lesions based on invasive FFR in consecutive 373 patients with chronic coronary syndromes CCS
Furthermore recent PREVENT study disclosed that in patients with non-flow-limiting FFR 080 vulnerable coronary plaques identified by intracoronary imaging preventive PCI reduced major adverse cardiac events MACE arising from high-risk vulnerable plaques compared with optimal medical therapy OMT alone8 Although their high-risk vulnerable plaques were defined using intracoronary imaging but not coronary CT angiography CTA in the PREVENT study the presence of high-risk vulnerable plaque without flow-limiting FFR 080 frequently caused the subsequent cardiac events in patients without the initial PCI
While CTA is known to be useful to evaluate coronary artery plaque features as well as stenosis severity high-risk plaque HRP on coronary CTA defined as a combination of positive remodeling PR and low attenuation plaque LAP has been reported to be associated with the future cardiac events9-12 Gallone and coworkers reported in their meta-analysis that high-risk coronary plaque characteristics significantly predicted patient-level and lesion-level major adverse cardiac event MACE in the future using various high-risk coronary plaque definitions by several intracoronary imaging modalities and CTA13 We hypothesized that CTA could identify plaque features linked to future cardiac events in deferral patients To determine the predictive factors for future cardiac events in FFR-based deferral patients we examined clinical features and plaque characteristics on CTA in the deferral lesions based on invasive FFR in consecutive 373 patients with chronic coronary syndromes CCS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None