Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Difference in maxLCBI4mm of the target LRP
研究概览
简要总结
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.
详细描述
Rationale:
Acute coronary syndromes (ACS) are often caused by rupture or erosion of certain high-risk vulnerable plaques. These plaques demonstrate specific features, such as a large lipid-rich necrotic core, a thin fibrous cap, and inflammation. Half of patients presenting with non-ST-segment elevation ACS have an additional vulnerable plaque, which increases their risk for non-culprit events during follow-up. Coronary intravascular ultrasound (IVUS) with the addition of near-infrared spectroscopy (NIRS) enables the identification of coronary lesions with high lipid content, quantified using the lipid-core burden index (LCBI) and is therefore able to distinguish plaques at risk to cause future non-culprit events. In addition, computed tomography coronary angiography (CCTA) is a non-invasive imaging modality that can identify high-risk plaque characteristics such as positive remodeling, low attentuation plaque, napkin-ring sign, and spotty calcification. Incorporating CCTA into this trial offers a unique opportunity to explore the potential of AI-based quantitative CT (AI-QCT) paramters by comparing them to IVUS-NIRS findings and clinical outcomes, which may support the future role of CCTA as a non-invasive tool for identifying and monitoring vulnerable plaques.
The main question remains whether local and systemic treatment of such high-risk plaques decreases the risk for adverse clinical outcome.
In our previous pilot study, DEBuT-LRP, we demonstrated that it was safe and feasible to treat vulnerable lipid-rich plaques with a drug-coated balloon (DCB) and that it was able to reduce the maximum LCBI on a 4 mm segment (maxLCBI4mm) after 9 months. In this randomized controlled trial, we intend to investigate the impact of DCB treatment on the maxLCBI4mm of lipid-rich plaques when compared to guideline-directed medical therapy alone.
Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Drug-coated balloon treatment of non-culprit lipid-rich plaque on top of guideline-directed medical therapy
干预措施: Paclitaxel-eluting balloon (Device)
Control group
Guideline-directed medical therapy alone
结局指标
主要结局
Difference in maxLCBI4mm of the target LRP
时间窗: From baseline to 9 month follow-up.
The mean difference in maxLCBI4mm of the target LRP between baseline and 9 month follow-up compared between the two randomization groups.
次要结局
- The change in CCTA-derived measurements(From baseline to 9 month follow-up.)
- Difference in maxLCBI4mm in non-treated LRPs(From baseline to 9 month follow-up.)
- The change in IVUS- and angiography-derived measurements(From baseline to 9 month follow-up.)
- Flow-limiting dissection necessitating bail-out stent implantation(From baseline to 9 month follow-up.)
- Periprocedural myocardial infarction(From baseline to 9 month follow-up.)
- Bleeding (BARC-3 and -5)(From baseline to 5 year follow-up.)
- LRP lesion failure(From baseline to 5 year follow-up.)
- Patient-oriented composite outcome(From baseline to 5 year follow-up.)
研究者
Bimmer Claessen
Interventional Cardiologist, Department of Cardiology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)