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


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.
Department of Coronary Heart Disease, Skane University Hospital, Lund University, Sweden.
Per
P
Bondesson
Bo
B
Lagerqvist
Stefan K
SK
James
Göran K
GK
Olivecrona
Dimitrios
D
Venetsanos
Jan
J
Harnek
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000145:classification / Q000295:instrumentation* / Q000379:methods; D023903:Coronary Restenosis / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control*; D016503:Drug Delivery Systems / Q000145:classification / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use*; D012042:Registries; D012044:Regression Analysis; D012189:Retrospective Studies; D012307:Risk Factors; D013548:Sweden; D016896:Treatment Outcome
D017239:Paclitaxel