Drug-Coated Balloons Versus Drug-Eluting Stents for De Novo Small-Vessel Coronary Artery Disease: A Prospective, Multicenter, Non-Randomized Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels.
The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.
详细描述
Small-vessel coronary artery disease remains a challenging setting for percutaneous coronary intervention because the limited vessel diameter increases the potential clinical impact of neointimal proliferation and restenosis. Second-generation drug-eluting stents represent an established treatment strategy, whereas drug-coated balloons deliver an antiproliferative agent without leaving a permanent metallic scaffold.
This is a prospective, multicenter, non-randomized observational study of consecutive patients undergoing percutaneous coronary intervention for de novo small-vessel coronary lesions. Lesion preparation and all procedural decisions will be performed according to contemporary clinical practice. Following adequate lesion preparation, the selection of a drug-coated balloon or a second-generation drug-eluting stent will be made by the treating interventional cardiologist on the basis of clinical, angiographic, and procedural considerations. The study protocol does not assign treatment and does not alter routine patient care.
Baseline demographic and clinical characteristics, angiographic findings, lesion characteristics, procedural details, device-related information, and in-hospital events will be recorded prospectively. Participants will undergo clinical follow-up for 12 months to document cardiovascular events, repeat coronary revascularization, and other relevant clinical outcomes. Outcomes will be compared between the drug-coated balloon and drug-eluting stent cohorts, taking into consideration the non-randomized nature of treatment selection and potential baseline differences between the groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older. Chronic coronary syndrome or non-ST-elevation acute coronary syndrome requiring percutaneous coronary intervention.
- •De novo lesion in a native coronary artery. Reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Angiographic diameter stenosis greater than 70%. Successful lesion preparation, defined as residual stenosis of 30% or less, TIMI grade 3 flow, and absence of an NHLBI type C-F flow-limiting dissection.
- •Treatment with a drug-coated balloon or a second-generation drug-eluting stent, selected at the discretion of the treating interventional cardiologist.
- •Ability to provide informed consent and comply with clinical follow-up.
排除标准
- •ST-elevation myocardial infarction requiring primary percutaneous coronary intervention.
- •In-stent restenosis. Cardiogenic shock or hemodynamic instability at the time of the index procedure.
- •Contraindication to antiplatelet therapy or to any component of the devices used.
- •Life expectancy of less than 12 months because of a non-cardiovascular condition.
- •Pregnancy. Inability to provide informed consent or complete the planned follow-up.
研究组 & 干预措施
Drug Coated Balloon Group
Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a drug-coated balloon after adequate lesion preparation. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care.
干预措施: Drug coated balloon (Device)
Drug Eluting Stent Group
Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a second-generation drug-eluting stent. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care.
干预措施: Drug Eluting stent (Device)
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: From the index procedure through 12 months
Number of participants experiencing at least one major adverse cardiovascular event, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or clinically driven target lesion revascularization.
次要结局
- Cardiovascular Death(Through 12 months)
- Nonfatal Myocardial Infarction(Through 12 months)
- Target Vessel Revascularization(Through 12 months)
- Procedural Success(During the index procedure)
- Major Bleeding(During hospitalization and through 12 months)
- Bailout Stent Implantation(During the index procedure)
研究者
Nikolaos Tsiamis
Cardiology Resident and PhD Candidate
National and Kapodistrian University of Athens