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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peripheral Arterial Disease, Intermittent Claudication

Intervention / Treatment
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* Device: DCB
* Device: POBA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DCB<br>Treatment with Paclitaxel drug-coated balloon angioplasty (DCB) | Device: DCB<br> <br> |
| POBA<br>Treatment with plain old balloon angioplasty (POBA) | Device: POBA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR) | Freedom from repeated intervention of the index lesion (due to binary restenosis > 50% and/or recurrent symptoms) | 12 months | 
| Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR) | Freedom from repeated intervention of the index lesion (due to binary restenosis > 50% and/or recurrent symptoms) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency (PP) | freedom from repeated intervention (FfTLR) and freedom from binary restenosis > 50% [comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The primary patency is a commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.] | 12 and 24 months | 
| Secondary Patency (SP) | freedom from binary restenosis after single repeated endovascular revascularization or no repeated Intervention [comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The secondary patency is another commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.] | 12 and 24 months | 
| Late Lumen Loss (LLL) | Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure | 6 and 12 months | 
| ABI | Ankle-Brachial-Index | 12 and 24 months | 
| Rutherford-Becker Classification | Clinical stage of disease according to Rutherford-Becker Classification | 12 and 24 months | 
| Functional outcome | Functional result eg. Walking Impairment Questionnaire (WIQ) or treadmill test | 12 and 24 months | 
| Quality of Life (QoL) | Quality of Life outcome eg. EQ5D | 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-coated balloon angioplasty, angioplasty, plain old balloon angioplasty, peripheral arterial disease, intermittent claudication, systematic review, meta-analysis, Paclitaxel