Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,272
- 试验地点
- 1
- 主要终点
- Device-oriented Composite Endpoint (DoCE)
研究概览
简要总结
The introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections. Later on, higher restenosis rates due to exaggerated neointimal growth in BMS has led to the development of drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduce the restenosis rate. However, late stent thrombosis and restenosis, with a hazard of nearly 2% per year after implantation, remained a concern and motivated the development of drug-coated balloons (DCB).
The advantages of DCB are that leaving no metal in the blood vessel and respect the vessel anatomy.
Recently, studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. In the BASKET-SMALL 2 trial, which compared SeQuent Please DCB with EES or Taxus DES in the vessels that have reference diameter<3mm, showed that at 12-month follow-up, DCB was non-inferior to DES (MACE [cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation] rates: 8% vs. 9%).
Although some small-scale RCT using surrogate endpoints have reported that no significant difference in MLD or late lumen loss between the two groups in large vessels, up to now, there is no large-scale RCT comparing the clinical outcomes of DCB versus DES in large vessels with de novo lesions.
Therefore, the investigators hypothesized that in patients undergoing non-complex percutaneous coronary intervention (PCI) for de-novo stenoses, drug-coated balloon (DCB) is non-inferior to drug-eluting stents (DES).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for PCI due to acute or chronic coronary syndrome
- •Patients with de-novo, non-complex lesion* and underwent successful pre-dilation**
- •Patients who are able to complete the follow-up and compliant to the prescribed medication
- •Non-complex PCI is defined as
- •1. Vessels treated<3; stents implanted<3; lesions treated<3 or Total stent length<60 mm
- •Bifurcation does not require 2 stents
- •Non left main lesion
- •Non venous or arterial graft lesion
- •Non chronic total occlusion lesion
- •Do not require the use of atherectomy device
- •**Successful pre-dilation is defined as fulfilling all the following criteria
- •Thrombolysis In Myocardial Infarction [TIMI] flow =3
- •Without dissections type D, E, and F
- •Residual stenoses <30% after balloon pre-dilation (visual).
- •Without serious complication requiring the termination of PCI
排除标准
- •Under the age of 18
- •Unable to give informed consent
- •The patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- •Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
- •Currently participating in another trial and not yet at its primary endpoint
- •The concurrent medical condition with a life expectancy of less than 2 years
- •Previous intracranial hemorrhage
- •In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel)
- •Atrial fibrillation
- •Cardiogenic shock
结局指标
主要结局
Device-oriented Composite Endpoint (DoCE)
时间窗: 24 months
DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and Clinically and physiologically indicated target lesion revascularization (CI-TLR).
次要结局
- BARC type 3 or 5 bleeding events(1, 12, 24, 36, and 60 months)
- BARC defined type 2, 3 or 5 bleeding events(1, 12, 24, 36, and 60 months)
- Device-oriented Composite Endpoint (DoCE)(1, 12, 36, and 60 months)
- Any stroke(1, 12, 24, 36, and 60 months)
- Cardiac cause death(1, 12, 24, 36, and 60 months)
- Clinically and physiologically indicated target lesion revascularization (CI-TLR)(1, 12, 24, 36, and 60 months)
- Any revascularisation(1, 12, 24, 36, and 60 months)
- Clinical and physiologically indicated target vessel revascularization(1, 12, 24, 36, and 60 months)
- Definite/Probable Stent thrombosis rates(1, 12, 24, 36, and 60 months)
- Target vessel myocardial infarction (TV-MI)(1, 12, 24, 36, and 60 months)
- Any MI(1, 12, 24, 36, and 60 months)
- Net adverse clinical events (NACE)(1, 12, 24, 36, and 60 months)
- Patient-oriented composite endpoint (PoCE)(1, 12, 24, 36, and 60 months)
- All-cause death(1, 12, 24, 36, and 60 months)
- Any clinically and physiologically indicated revascularisation(1, 12, 24, 36, and 60 months)
- Target vessel failure (TVF)(1, 12, 24, 36, and 60 months)
- Device success(0 day (during index PCI))
- Procedure success during PCI(7 days)
- Clinically relevant ischemic or bleeding events(1, 12, 24, 36, and 60 months)
研究者
LingTao
Professor in Cardiology, Director of the department of Cardiology
Xijing Hospital