Drug Or No Drug (DOND): Systematic Review and Meta-Analysis on Drug-Coated Balloon Angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in De-novo Femoropopliteal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,400
- 主要终点
- Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
研究概览
简要总结
Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal disease.
详细描述
Peripheral arterial disease is the third leading entity of atherosclerosis. The femoropopliteal segment is affected in most patients. Endovascular revascularisation is one possible treatment option, but high rates of restenosis, especially in complex lesions, are a limiting factor. Bare-metal stents failed to show a long-term superiority in a Cochrane systematic review. Another approach to prevent restenosis is local delivery of an antiproliferative drug (e.g. Paclitaxel) via Drug-Coated Balloon Angioplasty. New studies did report their results since the publication of earlier meta-analyses. It's time for an up-to-date systematic review. Prior systematic reviews did not address risk of bias nor did they take differences in treatment strategy despite the used balloon catheter into consideration.Some previous reviews did compare results from different points in time, e.g. analysis of 6 months' results together with 24 months' results.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Randomized controlled trials
- •DCB vs. POBA
- •focus on de-novo femoropopliteal lesions
- •registration in a clinical trials registry
- •available study protocol (either in clinical trial registry or published)
排除标准
- •non-randomized controlled trials
- •focus on below-the-knee interventions
- •focus on iliac artery interventions
- •focus on treatment of critical limb ischemia
- •focus on treatment of in-stent restenosis
- •usage of additional devices except for bare-metal stent (e.g. atherectomy)
结局指标
主要结局
Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
时间窗: 24 months
Freedom from repeated intervention of the index lesion (due to binary restenosis \> 50% and/or recurrent symptoms)
次要结局
- Primary Patency (PP)(12 and 24 months)
- Late Lumen Loss (LLL)(6 and 12 months)
- Rutherford-Becker Classification(12 and 24 months)
- Functional outcome(12 and 24 months)
- Quality of Life (QoL)(12 and 24 months)
- ABI(12 and 24 months)
- Secondary Patency (SP)(12 and 24 months)
研究者
Ulf Teichgräber
Prof. Dr. med.
Jena University Hospital