A ProSpecTivE, RaNdomIzed Trial of Drug Coated Balloon For tReating the Side
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Late lumen loss for both main branch and side branch
研究概览
简要总结
Hypothesis: In patients undergoing coronary stenting for the true bifurcation lesions, main branch stenting followed by side branch dilatation with drug coated balloon is superior to the provisional-stenting strategy in terms of late lumen loss at 12 months.
详细描述
Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent an alternative therapeutic strategy in certain anatomic conditions. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent clinical data demonstrate promising results in de novo small-vessel disease, myocardial infarction and bifurcation settings.
Patients with coronary bifurcation lesions account for approximately 15% to 20% of all coronary lesions in coronary interventional procedures. Despite the use of drug-eluting stents, treating bifurcation lesions remains challenging especially in settings of side branch involvment. PCI of such lesions is associated with lower immediate angiographic and clinical success and higher rates of restenosis, which, in addition, are more challenging to treat compared to non-bifurcated lesions.
The optimal treatment of patients with biffurcations lesions involving SB is as yet undefined. Despite provisional stenting strategy is the preferred technique for most patients. Several studies demonstrated that two-stent techniques may be preferable in patients with true bifurcation lesions. However, as a general approach, the EBC suggests conducting PCI procedures with the aim of limiting the amount of stent metal implanted.
In this settings the use of DCB for bifurcation lesions may have some advantages. DCB provides a smaller profile compared with DES, allowing better SB access. The lack of foreign body implantation with DCB obviates the risk for stent thrombosis and may allow for a shorter duration of dual-antiplatelet therapy compared with DES.
To date, there have been very few clinical trials on the treatment of bifurcation lesions with drug-eluting balloons and all of these included only a small cohort of patients.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main branch and side branch diameter both >2.5 mm, evaluated based on coronary angiography, performed no later than 6 month before baseline visit;
- •Patient ≥18 years old;
- •Signed informed consent;
- •True bifurcation lesion type 1:1:1 or 0:1:1 or 1:0:1 and
- •ischemic symptoms, or
- •positive non-invasive imaging for ischemia, or
- •positive fractional flow reserve
排除标准
- •ST Elevation Miocardial Infarction <72 hours preceding;
- •Cardiogenic shock;
- •Chronic total occlusion of either main or side branch of the bifurcation;
- •>2 other coronary lesions planned for treatment;
- •SYNTAX score >32;
- •Left main stenosis;
- •In-stent restenosis;
- •Renal function insufficiency: Serum creatinine > 177 mmol/l; or undergoing hemodialysis;
- •Left ventricular ejection fraction ≤ 30%;
- •Patient life expectancy less than 12 months;
- •Patient's inability to fully cooperate with the study protocol
结局指标
主要结局
Late lumen loss for both main branch and side branch
时间窗: 12 months
Measured by quantitative coronary angiography.
次要结局
- Major Adverse Cardiac Events (MACE)(3,6,12 months)
- All-cause death(3,6,12 months)
- Angiographic Binary Restenosis(12 months)
- Angina status(3,6,12 months)
- Angiographic success in main branch and side branch(immediately after the procedure)
- Target Lesion Revascularization(3,6,12 months)
- Stent/vessel thrombosis(3,6,12 months)
- Target Vessel Revascularization(3,6,12 months)
- Fluoroscopic time(immediately after the procedure)
研究者
Dmitrii Khelimskii
MD, PhD
Meshalkin Research Institute of Pathology of Circulation