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

Jena University Hospital1,400 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,400

Conditions

Peripheral Arterial Disease Intermittent Claudication

Interventions

DCBDEVICE

POBADEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Freedom from repeated intervention of the index lesion (due to binary restenosis \> 50% and/or recurrent symptoms)

Time frame: 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)

Time frame: 24 months

Secondary Outcomes

Primary Patency (PP)

freedom from repeated intervention (FfTLR) and freedom from binary restenosis \> 50% \[comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The primary patency is a commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.\]

Time frame: 12 and 24 months

Secondary Patency (SP)

freedom from binary restenosis after 1. single repeated endovascular revascularization or 2. no repeated Intervention \[comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The secondary patency is another commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.\]

Time frame: 12 and 24 months

Late Lumen Loss (LLL)

Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure

Time frame: 6 and 12 months

ABI

Ankle-Brachial-Index

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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