This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Unlike conventional stenting, DCB treatment delivers an antiproliferative drug to the vessel wall without leaving a permanent metallic implant. The absence of a permanent implant allows non-invasive assessment of the treated coronary artery during follow-up using coronary CT angiography (CCTA).
Participants will undergo two CCTA examinations: an early scan within two weeks after PCI and a follow-up scan after nine months. CT-derived fractional flow reserve (CT-μFR) will be calculated from both scans to assess changes in μFR of the treated coronary artery over time. CCTA will also be used to evaluate changes in coronary plaque and vessel characteristics.
The primary objective is to determine whether CT-μFR changes between early and nine-month follow-up after DCB-PCI. Secondary objectives include evaluating changes in plaque and vessel characteristics on CCTA and assessing clinical outcomes during follow-up.
Age ≥ 18 years;
Presence of a de novo lesion;
Successful DCB-PCI of a native coronary artery or major side branch.
No Protégé DCB was used;
Previous CABG;
Known renal insufficiency, i.e. eGFR ≤ 30 mL/min/1.73m²;
Known hypersensitivity or contraindication to CT contrast agents;
Consecutive patients aged 18 years or older scheduled for PCI of a native coronary artery will be screened for inclusion in the trial. Patients will be included at the Amsterdam UMC.
Cohort
Prospective
Not listed
Difference in CT-μFR
The change in non-invasive CT-μFR between post-procedure and 9-month follow-up within the treated coronary segment treated with DCB.
Late lumen loss (LLL)
Late lumen loss (LLL) in mm in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.
Change in Minimal Lumen Area (MLA)
Change in Minimal Lumen Area (MLA) in mm² in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.
Change in Plaque Burden (PB)
Change in Percent Plaque Burden (PB) in the target lesion measured on CCTA be tween post-procedure and at 9-month follow-up.
Clinical outcomes
MACE, TLR, and BARC-3 or 5 bleeding (according to the Bleeding ARC) at 1-month, 1-year, 3-years and 5-years follow-up.
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