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.
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.
Authors: Francesco Burzotta; Marta Francesca Brancati; Carlo Trani; Giancarlo Pirozzolo; Gianluigi De Maria; Antonio Maria Leone; Giampaolo Niccoli; Italo Porto; Francesco Prati; Filippo Crea Journal: Heart Vessels Date: 2015-04-12 Impact factor: 2.037
Authors: Franz X Kleber; Antonia Schulz; Matthias Waliszewski; Telse Hauschild; Michael Böhm; Ulrich Dietz; Bodo Cremers; Bruno Scheller; Yvonne P Clever Journal: Clin Res Cardiol Date: 2014-10-28 Impact factor: 5.460
Authors: Franz X Kleber; Harald Rittger; Klaus Bonaventura; Uwe Zeymer; Jochen Wöhrle; Raban Jeger; Benny Levenson; Sven Möbius-Winkler; Leonhard Bruch; Dieter Fischer; Christian Hengstenberg; Tudor Pörner; Detlef Mathey; Bruno Scheller Journal: Clin Res Cardiol Date: 2013-08-28 Impact factor: 5.460
Authors: Franz X Kleber; Harald Rittger; Josef Ludwig; Antonia Schulz; Detlef G Mathey; Michael Boxberger; Ralf Degenhardt; Bruno Scheller; Ruth H Strasser Journal: Clin Res Cardiol Date: 2016-01-14 Impact factor: 5.460