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Comparison of two drug-eluting balloons: a report from the SCAAR registry.

Bondesson, Per; Lagerqvist, Bo; James, Stefan K; Olivecrona, Göran LU ; Venetsanos, Dimitrios and Harnek, Jan LU (2012) In EuroIntervention 8(4). p.444-449
Abstract
Aims:

Recently, drug-eluting balloons have received a guideline class IIa recommendation in the treatment of in-stent restenosis after bare metal stent implantation. It is not known if different balloons perform equally. Using a large real world registry, restenosis frequency was reported for two drug-eluting balloons.



Methods and results:

From April 2009 until September 2011, 1,129 patients were treated with paclitaxel-eluting balloons in Sweden. Mean follow-up was 328±210 days. Nine hundred and nineteen patients were treated with a balloon using a contrast agent as a drug-carrier and 217 with a balloon without a contrast agent as a drug-carrier. The indications were predominantly de novo (45.4%) or... (More)
Aims:

Recently, drug-eluting balloons have received a guideline class IIa recommendation in the treatment of in-stent restenosis after bare metal stent implantation. It is not known if different balloons perform equally. Using a large real world registry, restenosis frequency was reported for two drug-eluting balloons.



Methods and results:

From April 2009 until September 2011, 1,129 patients were treated with paclitaxel-eluting balloons in Sweden. Mean follow-up was 328±210 days. Nine hundred and nineteen patients were treated with a balloon using a contrast agent as a drug-carrier and 217 with a balloon without a contrast agent as a drug-carrier. The indications were predominantly de novo (45.4%) or in-stent restenotic (51.8%) lesions. The overall incidence of restenosis at six months was 3.4% with the paclitaxel balloon using a contrast agent as carrier, compared with 12.5% with the paclitaxel-eluting balloon without a carrier (risk ratio: 0.42; 95% confidence interval [CI] [0.26-0.68]). After adjusting for indications, lesion types and procedural factors, the risk ratio was 0.39; 95% CI (0.24-0.65).



Conclusions:

This observational study from a large real world population shows a major difference between two paclitaxel-eluting balloons. The findings suggest that there are no class effects for drug-eluting balloons and factors other than the drug may be important for the clinical effect. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
EuroIntervention
volume
8
issue
4
pages
444 - 449
publisher
Société Europa Edition
external identifiers
  • wos:000309436400008
  • pmid:22917727
  • scopus:84871269683
ISSN
1969-6213
DOI
10.4244/EIJV8I4A70
language
English
LU publication?
yes
id
1376ad91-241c-4a20-8170-103c2c33e254 (old id 3047260)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/22917727?dopt=Abstract
date added to LUP
2012-09-05 20:46:47
date last changed
2017-07-09 04:30:50
@article{1376ad91-241c-4a20-8170-103c2c33e254,
  abstract     = {Aims: <br/><br>
Recently, drug-eluting balloons have received a guideline class IIa recommendation in the treatment of in-stent restenosis after bare metal stent implantation. It is not known if different balloons perform equally. Using a large real world registry, restenosis frequency was reported for two drug-eluting balloons. <br/><br>
<br/><br>
Methods and results: <br/><br>
From April 2009 until September 2011, 1,129 patients were treated with paclitaxel-eluting balloons in Sweden. Mean follow-up was 328±210 days. Nine hundred and nineteen patients were treated with a balloon using a contrast agent as a drug-carrier and 217 with a balloon without a contrast agent as a drug-carrier. The indications were predominantly de novo (45.4%) or in-stent restenotic (51.8%) lesions. The overall incidence of restenosis at six months was 3.4% with the paclitaxel balloon using a contrast agent as carrier, compared with 12.5% with the paclitaxel-eluting balloon without a carrier (risk ratio: 0.42; 95% confidence interval [CI] [0.26-0.68]). After adjusting for indications, lesion types and procedural factors, the risk ratio was 0.39; 95% CI (0.24-0.65). <br/><br>
<br/><br>
Conclusions: <br/><br>
This observational study from a large real world population shows a major difference between two paclitaxel-eluting balloons. The findings suggest that there are no class effects for drug-eluting balloons and factors other than the drug may be important for the clinical effect.},
  author       = {Bondesson, Per and Lagerqvist, Bo and James, Stefan K and Olivecrona, Göran and Venetsanos, Dimitrios and Harnek, Jan},
  issn         = {1969-6213},
  language     = {eng},
  number       = {4},
  pages        = {444--449},
  publisher    = {Société Europa Edition},
  series       = {EuroIntervention},
  title        = {Comparison of two drug-eluting balloons: a report from the SCAAR registry.},
  url          = {http://dx.doi.org/10.4244/EIJV8I4A70},
  volume       = {8},
  year         = {2012},
}