Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease (DOND)

Jena University Hospital

Status: Completed

Conditions: Intermittent Claudication; Peripheral Arterial Disease

Treatments: Device: DCB; Device: POBA

Study type: Observational

Funder types: Other

Identifiers

NCT02927574

IDIR/005/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,400 participants in 2 patient groups

DCB

Description:

Treatment with Paclitaxel drug-coated balloon angioplasty (DCB)

Treatment:

Device: DCB

POBA

Description:

Treatment with plain old balloon angioplasty (POBA)

Treatment:

Device: POBA