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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Intervention / Treatment: Device: DCB; Device: POBA

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 Type: Observational
• Enrollment (Actual): 1400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with intermittent claudication due to de novo femoropopliteal peripheral arterial disease.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DCB; Treatment with Paclitaxel drug-coated balloon angioplasty (DCB)	Device: DCB
POBA; Treatment with plain old balloon angioplasty (POBA)	Device: POBA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Ulf Teichgräber, Prof., University Hospital Jena

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 7, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: systematic review; meta-analysis; Paclitaxel; intermittent claudication; angioplasty; peripheral arterial disease; drug-coated balloon angioplasty; plain old balloon angioplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: IDIR/005/2016