Clinical trial NCT02927574: Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Keywords: drug-coated balloon angioplasty
angioplasty
plain old balloon angioplasty
peripheral arterial disease
intermittent claudication
systematic review
meta-analysis
Paclitaxel
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with intermittent claudication due to de novo femoropopliteal peripheral arterial disease.

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.

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)

Primary outcomes:
measure: Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
timeFrame: 12 months
measure: Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
timeFrame: 24 months
Secondary outcomes:
measure: Primary Patency (PP)
timeFrame: 12 and 24 months
measure: Secondary Patency (SP)
timeFrame: 12 and 24 months
measure: Late Lumen Loss (LLL)
timeFrame: 6 and 12 months
measure: ABI
timeFrame: 12 and 24 months
measure: Rutherford-Becker Classification
timeFrame: 12 and 24 months
measure: Functional outcome
timeFrame: 12 and 24 months
measure: Quality of Life (QoL)
timeFrame: 12 and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Jena
name: Ulf Teichgräber, Prof.
role: PRINCIPAL_INVESTIGATOR
References: