To characterize, using paired coronary computed tomography angiography (CCTA), longitudinal changes in coronary atherosclerotic plaque, lumen dimensions, and vessel remodeling between baseline and mid-term follow-up in de novo coronary lesions successfully treated with drug-coated balloon (DCB)-only angioplasty. No additional imaging examination, intervention, or clinical visit is mandated by the study protocol.
Age ≥18 years
Presence of ≥1 de novo coronary lesion treated with successful DCB-only PCI
No stent implantation within the target segment during the index procedure
Diagnostic-quality CCTA performed before the index PCI and/or diagnostic-quality follow-up CCTA performed 3 to 12 months after DCB angioplasty
In-stent restenosis as the target lesion
Bailout or planned stent implantation within the target segment during the index procedure
CCTA of insufficient diagnostic quality for quantitative analysis of the target segment because of severe calcification, motion artifact, misregistration, or other technical limitations
Follow-up CCTA performed outside the prespecified time window
Adult patients with coronary artery disease who underwent successful DCB-only PCI for at least 1 de novo coronary lesion at participating centers, with either a diagnostic-quality CCTA performed before the index PCI and/or a diagnostic-quality follow-up CCTA performed within 12 months (minimum 3 months).
Cohort
Retrospective
Not listed
Change in CCTA-Derived Total Coronary Plaque Volume (mm³)
Absolute change in total coronary plaque volume, expressed in cubic millimeters (mm³), within the DCB-treated coronary segment, calculated as follow-up total plaque volume minus baseline total plaque volume, as measured by an independent CCTA core laboratory.
Change in CCTA-Derived Calcified Plaque Volume (mm³)
Absolute change in calcified plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline calcified plaque volume.
Number of Lesions With Binary Restenosis at Follow-up (≥50% Diameter Stenosis)
Number of DCB-treated lesions with ≥50% diameter stenosis on follow-up CCTA.
Change in CCTA-Derived Noncalcified Plaque Volume (mm³)
Absolute change in noncalcified plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline noncalcified plaque volume.
Change in CCTA-Derived Low-Attenuation Plaque Volume (mm³)
Absolute change in low-attenuation plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline low-attenuation plaque volume.
Number of Participants With Target Lesion Failure
Clinical Outcome Measure - Number of participants experiencing target lesion failure, defined as the composite of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization.
Number of Participants With Any Myocardial Infarction (Target-Vessel or Non-Target-Vessel)
Clinical Outcome Measure - Number of participants experiencing myocardial infarction attributable to any coronary territory, target-vessel or non-target-vessel.
Number of Participants With BARC Type ≥3 Major Bleeding
Clinical Outcome Measure - Number of participants experiencing Bleeding Academic Research Consortium (BARC) type ≥3 bleeding, as defined in the study protocol.
Number of Participants With All-Cause Death
Clinical Outcome Measure.
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