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Comparison of two drug-eluting balloons: a report from the SCAAR registry
Per Bondesson1, Bo Lagerqvist, Stefan K James
1Department of Coronary Heart Disease, Skane University Hospital, Lund University, Sweden.
Insights
Two paclitaxel-eluting balloons showed significantly different restenosis rates in a real-world study. The paclitaxel balloon using a contrast agent as a carrier demonstrated superior performance compared to one without a carrier.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-eluting balloons (DEBs) are recommended for in-stent restenosis.
- Performance differences between DEBs are not well understood.
- Real-world data is crucial for evaluating DEB efficacy.
Purpose of the Study:
- To compare the restenosis rates of two paclitaxel-eluting balloons in a large patient registry.
- To investigate potential differences in clinical outcomes based on drug-carrier composition.
Main Methods:
- A retrospective analysis of 1,129 patients treated with paclitaxel-eluting balloons from April 2009 to September 2011.
- Patients were categorized based on whether the balloon used a contrast agent or not as a drug carrier.
- Restenosis incidence at six months was compared between the two groups, with adjustments for clinical and procedural factors.
Main Results:
- The overall incidence of restenosis at six months was 3.4% for the paclitaxel balloon with a contrast carrier versus 12.5% for the balloon without a carrier.
- The adjusted risk ratio for restenosis was 0.39 (95% CI [0.24-0.65]) in favor of the balloon with a contrast carrier.
- The study included predominantly de novo (45.4%) and in-stent restenotic (51.8%) lesions.
Conclusions:
- Significant differences in restenosis rates exist between paclitaxel-eluting balloons.
- Clinical effectiveness of DEBs may depend on factors beyond the drug itself, such as the drug carrier.
- These findings challenge the notion of a class effect for drug-eluting balloons.
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.
