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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Jena University Hospital
- Enrollment
- 1400
- Primary Endpoint
- Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ulf Teichgräber
Prof. Dr. med.
Jena University Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
Time Frame: 24 months
Freedom from repeated intervention of the index lesion (due to binary restenosis \> 50% and/or recurrent symptoms)
Secondary Outcomes
- 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)