Drug-coated balloon treatment versus medication for fat-rich coronary plaques

Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial

This trial will test whether using a paclitaxel-coated balloon during PCI can reduce the fat content of dangerous coronary plaques in adults with acute coronary syndrome compared with standard medication alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT07107971 on ClinicalTrials.gov

What this trial studies

Adults presenting with acute coronary syndrome who undergo successful PCI will receive intravascular imaging (IVUS with NIRS) to identify lipid-rich plaques and then be randomly assigned to receive a paclitaxel-eluting balloon treatment at the vulnerable plaque or no additional local treatment in addition to guideline-directed medical therapy. Non-invasive CCTA will be performed within two weeks and again at about nine months, and invasive coronary imaging will be repeated at nine months to measure changes in lipid burden (LCBI) and plaque characteristics. The primary outcomes focus on change in lipid-core burden index and safety of the drug-coated balloon approach. Imaging comparisons will also explore AI-quantified CT parameters against IVUS-NIRS findings to evaluate noninvasive monitoring strategies.

Who should consider this trial

Good fit: Adults with acute coronary syndrome who had a successful PCI and have at least two native coronary arteries accessible for invasive imaging (reference vessel diameter 2–6 mm) are ideal candidates.

Not a fit: Patients who lack lipid-rich plaques, are hemodynamically unstable, have severe renal insufficiency, allergy to paclitaxel or contrast that cannot be premedicated, or a life expectancy under one year are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the treatment could lower the risk of future coronary events by reducing lipid content in vulnerable plaques.

How similar studies have performed: A prior pilot (DEBuT-LRP) showed the paclitaxel-coated balloon approach was safe, but larger randomized evidence of plaque lipid reduction and clinical outcome benefit remains limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication;
* Presence of a comorbid condition with a life expectancy of less than one year;
* Body weight \>250 kg;
* Subject belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.

Where this trial is running

Amsterdam

• Amsterdam UMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Bimmer E.P.M. Claessen, MD, PhD — Amsterdam UMC
• Study coordinator: Bimmer E.P.M. Claessen, MD, PhD

Conditions Coronary Artery Disease; Atheroscleroses; Cardiovascular Disease; Vulnerable Coronary Plaques; Vulnerable Plaque; Lipid-Rich Atherosclerosis of Coronary Artery; Acute Coronary Syndromes; Lipid-rich plaque