The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries).
The main questions the study aims to answer are:
* Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone? * Is this treatment safe for patients?
Participants will:
* Undergo imaging of their coronary arteries during their planned heart procedure (PCI) * Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment * Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure. * Undergo a second heart catherization 9 months later to examine changes in the plaque.
Presenting with acute coronary syndrome (ACS);
Successful PCI of a native coronary artery or major side branch;
At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and >2 mm and <6 mm reference vessel diameter.
Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes);
Known hypersensitivity to paclitaxel;
Procedural complications of the index PCI;
Known renal insufficiency, i.e. eGFR <30 mL/min/1.73 m2;
Parallel
Paclitaxel-eluting balloon
DeviceParticipants in the intervention group will receive local treatment of non-obstructive, lipid-rich coronary plaques using a paclitaxel-coated drug-eluting balloon (DCB) in addition to guideline-directed medical therapy (GDMT). The DCB will be applied to plaques identified as high-risk based on near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) imaging, defined by a maxLCBI4mm ≥325. The balloon catheter diameter will be sized 1:1 according to the true lumen diameter as derived from IVUS. Balloon length will be sized to the LRP length as measured with IVUS including a 5 mm margin on each side. The balloon will be inflated at nominal pressure (6-8 ATM) during a period of at least 60 seconds, but preferably for 90 seconds if tolerated. A 5 mm margin is taken into account to differentiate between single or multiple LRPs within the same coronary artery.
Difference in maxLCBI4mm of the target LRP
The mean difference in maxLCBI4mm of the target LRP between baseline and 9 month follow-up compared between the two randomization groups.
Difference in maxLCBI4mm in non-treated LRPs
The change in maxLCBI4mm as measured with IVUS/NIRS from baseline to 9 month follow-up in identified additional LRPs that are not treated with DCB.
The change in IVUS- and angiography-derived measurements
The change in IVUS- and angiography-derived measurements (plaque burden, minimal lumen area, mean plaque area, diameter stenosis and minimal lumen diameter) between baseline and 9 month follow-up.
The change in CCTA-derived measurements
The change in CCTA-derived measurements using AI-QCT (total plaque volume, noncalcified plaque volume, calcified plaque volume, lumen volume and presence of the following high-risk plaque features: positive remodeling \[remodeling index \>1.1\] and low-density plaque).
Flow-limiting dissection necessitating bail-out stent implantation
Flow-limiting dissection necessitating bail-out stent implantation.
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