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

Completed

• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Interventions: Device: POBA; Device: DCB

• Registration Number: NCT02927574
• Lead Sponsor: Jena University Hospital

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POBA	POBA	Treatment with plain old balloon angioplasty (POBA)
DCB	DCB	Treatment with Paclitaxel drug-coated balloon angioplasty (DCB)

Primary Outcome Measures

Name	Time	Method
Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)	24 months	Freedom from repeated intervention of the index lesion (due to binary restenosis \> 50% and/or recurrent symptoms)

Secondary Outcome Measures

Name	Time	Method
Primary Patency (PP)	12 and 24 months	freedom from repeated intervention (FfTLR) and freedom from binary restenosis \> 50% \[comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The primary patency is a commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.\]
Late Lumen Loss (LLL)	6 and 12 months	Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure
Rutherford-Becker Classification	12 and 24 months	Clinical stage of disease according to Rutherford-Becker Classification
Functional outcome	12 and 24 months	Functional result eg. Walking Impairment Questionnaire (WIQ) or treadmill test
Quality of Life (QoL)	12 and 24 months	Quality of Life outcome eg. EQ5D
ABI	12 and 24 months	Ankle-Brachial-Index
Secondary Patency (SP)	12 and 24 months	freedom from binary restenosis after; 1. single repeated endovascular revascularization or; 2. no repeated Intervention \[comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The secondary patency is another commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.\]