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Comparison of two drug-eluting balloons: a report from the SCAAR registry
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. (kardiologi)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. (kardiologi)
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2012 (English)In: EUROINTERVENTION, ISSN 1774-024X, Vol. 8, no 4, 444-449 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2012. Vol. 8, no 4, 444-449 p.
Keyword [en]
drug-eluting balloon, restenosis, in-stent restenosis, paclitaxel, revascularisation
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-184481DOI: 10.4244/EIJV8I4A70ISI: 000309436400008OAI: oai:DiVA.org:uu-184481DiVA: diva2:565732
Available from: 2012-11-08 Created: 2012-11-07 Last updated: 2013-01-09Bibliographically approved

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Lagerqvist, BoJames, Stefan K.

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