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

Peripheral Arterial Disease Clinical Trial

— DOND  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927574
• Other study ID #: IDIR/005/2016
• Status: Completed
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2020
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• DCB

• POBA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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
Secondary	Late Lumen Loss (LLL)	Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure	6 and 12 months
Secondary	ABI	Ankle-Brachial-Index	12 and 24 months
Secondary	Rutherford-Becker Classification	Clinical stage of disease according to Rutherford-Becker Classification	12 and 24 months
Secondary	Functional outcome	Functional result eg. Walking Impairment Questionnaire (WIQ) or treadmill test	12 and 24 months
Secondary	Quality of Life (QoL)	Quality of Life outcome eg. EQ5D	12 and 24 months