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Cochrane Database of Systematic Reviews

Drug‐eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in‐stent restenosis of the femoropopliteal arteries

This is not the most recent version

view the current version 26 January 2019

Information

DOI:
https://doi.org/10.1002/14651858.CD012510Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 19 January 2017see what's new
Type:
  1. Intervention
Stage:
  1. Protocol
Cochrane Editorial Group:

  1. Cochrane Vascular Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Ahmed Kayssi

    Correspondence to: Division of Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada

    [email protected]

  • Wissam Al‐Jundi

    Division of Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada

  • Giuseppe Papia

    Division of Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada

  • Daryl S Kucey

    Division of Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada

  • Thomas Forbes

    Division of Vascular Surgery, Toronto General Hospital, University of Toronto, Toronto, Canada

  • Dheeraj K Rajan

    Division of Vascular and Interventional Radiology, University of Toronto, Toronto, Canada

  • Richard Neville

    Inova Heart and Vascular Institute, Falls Church, Virginia, USA

  • Andrew D Dueck

    Division of Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada

Contributions of authors

AK: protocol drafting, acquiring trial reports, trial selection, data extraction, data analysis, data interpretation, review drafting, future review updates, guarantor of the review
WAJ: protocol drafting, acquiring trial reports, trial selection, data extraction, data analysis, data interpretation, review drafting
GP: data interpretation, review drafting
DK: data interpretation, review drafting
TF: data interpretation, review drafting
DR: data interpretation, review drafting
RN: data interpretation, review drafting
AD: data interpretation, review drafting, future review updates

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.

    The Cochrane Vascular editorial base is supported by the Chief Scientist Office.

Declarations of interest

AK: none known
WAJ: none known
GP: received consultancy fees from WL Gore for acting as a reviewer of complications for a study involving an endovascular device and for support for speaking/lectures. He has received a grant from Gore for creation of a database for endovascular aneurysm repair research and from Abbott for development of a database for peripheral endovascular procedures. He has received honoraria for lectures and speaking from WL Gore and Medtronic.
DK: none known
TF: none known
DR: received consultancy fees for lectures around dialysis interventions and support for live case course from CR Bard.
RN: has declared that he has received payment for roles within the Scientific Advisory Boards of Graftworx, Cormatrix, and WL Gore; from Fresenius for presenting an educational program for podiatric audiences and for legal defence malpractice work. He has no financial relationships related to the topic of this review.
AD: none known

Acknowledgements

The authors would like to thank Drs Marlene Stewart and Cathryn Broderick for their guidance and expert help in preparing this protocol.

Version history

Published

Title

Stage

Authors

Version

2019 Jan 26

Drug‐eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in‐stent restenosis of the femoropopliteal arteries

Review

Ahmed Kayssi, Wissam Al‐Jundi, Giuseppe Papia, Daryl S Kucey, Thomas Forbes, Dheeraj K Rajan, Richard Neville, Andrew D Dueck

https://doi.org/10.1002/14651858.CD012510.pub2

2017 Jan 19

Drug‐eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in‐stent restenosis of the femoropopliteal arteries

Protocol

Ahmed Kayssi, Wissam Al‐Jundi, Giuseppe Papia, Daryl S Kucey, Thomas Forbes, Dheeraj K Rajan, Richard Neville, Andrew D Dueck

https://doi.org/10.1002/14651858.CD012510

Notes

Parts of the methods section of this protocol are based on a standard template established by Cochrane Vascular

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Table 1. Example summary of findings for the main comparison

Drug‐eluting balloon compared with uncoated balloon angioplasty

Patient or population: people with in‐stent restenosis of the femoropopliteal vessels
Setting: hospital
Intervention: drug‐eluting balloon angioplasty
Comparison: uncoated balloon angioplasty

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with uncoated balloon angioplasty

Risk with drug‐eluting balloon angioplasty

Amputation

Study population

not estimable

( studies)

0 per 1000

0 per 1000
(0 to 0)

Primary vessel patency

Study population

not estimable

( studies)

0 per 1000

0 per 1000
(0 to 0)

Target lesion revascularization

Study population

not estimable

( studies)

0 per 1000

0 per 1000
(0 to 0)

Binary restenosis

Study population

not estimable

( studies)

0 per 1000

0 per 1000
(0 to 0)

Death

Study population

not estimable

( studies)

0 per 1000

0 per 1000
(0 to 0)

Change in Rutherford category

The mean change in Rutherford category was 0

The mean change in Rutherford category in the intervention group was 0 undefined (0 to 0 )

‐

( studies)

Change in ankle brachial index

The mean change in ankle brachial index was 0

The mean change in ankle brachial index in the intervention group was 0 undefined (0 to 0 )

‐

( studies)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Figures and Tables -
Table 1. Example summary of findings for the main comparison
Navigate to table in Protocol