Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 8
- 主要终点
- Late-lumen loss
研究概览
简要总结
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
详细描述
Drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are eligible for percutaneous coronary intervention (PCI).1 During long-term follow-up, remained metallic stent strut continuously related with stent-related cardiovascular events.2 As an alternative option to DES, drug-coated balloon (DCB) which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT),3,4 its use has been established in in-stent restenosis of bare-metal stents and DES.5 Furthermore, recent RCTs demonstrated efficacy and safety of DCB in de novo coronary lesions in small vessels with reference vessel size <3.0mm.6,7 For the patients with de novo, non-complex coronary artery lesions, REC-CAGEFREE I tested the non-inferiority of DCB angioplasty with DES implantation, irrespective of vessel diameter.8 Overall, 2272 patients were randomly assigned to the DCB or the DES group. At 2 years, adverse events occurred in 6.4% of DCB group and 3.4% of DES group and failed to prove the non-inferiority of DCB angioplasty (P for non-inferiority=0.65). Regarding the heterogenous results, it is questionable that DCB angioplasty for large de novo lesions is safe and effective compared with DES implantation.
On this background, the current study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 19 years of age
- •Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily
- •Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥3.0 mm
排除标准
- •Patients unable to provide consent
- •Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- •Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting
- •Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
- •Patients who may result in protocol non-compliance (site investigator's medical judgment)
- •Patients with cardiogenic shock or cardiac arrest
- •Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- •Patients with severe valvular heart disease requiring open heart surgery
- •Pregnant or lactating women
研究组 & 干预措施
Drug-eluting stent
In DES group, latest second-generation DES will be used in accordance with standard practice guideline.
干预措施: Drug-eluting stent implantation (Procedure)
Drug-coated balloon
In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds.
干预措施: Drug-coated balloon angioplasty (Procedure)
结局指标
主要结局
Late-lumen loss
时间窗: 9 months after last patient enrollment
Mean difference of late-lumen loss between DCB and DES in IVUS
次要结局
- BARC type 2, 3, or 5 bleeding(1 year after last patient enrollment)
- Minimal lumen diameter in QCA(9 months after last patient enrollment)
- % diameter stenosis in QCA(9 months after last patient enrollment)
- Minimal lumen diameter in IVUS(9 months after last patient enrollment)
- Cardiovascular death(1 year after last patient enrollment)
- All-cause death(1 year after last patient enrollment)
- Rate of target vessel-MI(1 year after last patient enrollment)
- Rate of non-fatal MI(1 year after last patient enrollment)
- Rate of target lesion revascularization(1 year after last patient enrollment)
- Rate of target vessel revascularization(1 year after last patient enrollment)
- Rate of any revascularization(1 year after last patient enrollment)
- Rate of vessel or stent thrombosis(1 year after last patient enrollment)
- Target lesion failure(1 year after last patient enrollment)
- Cardiovascular death, target-vessel MI, or vessel or stent thrombosis(1 year after last patient enrollment)
- Cardiovascular death or target vessel-related myocardial infarction(1 year after last patient enrollment)
- All-cause death or non-fatal MI(1 year after last patient enrollment)
- Target vessel failure(1 year after last patient enrollment)
- All-cause death, non-fatal myocardial infarction, or target vessel revascularization(1 year after last patient enrollment)
- Cerebrovascular accident(1 year after last patient enrollment)
研究者
Young Joon Hong
Professor
Chonnam National University Hospital