PEPCAD III: Paclitaxel-eluting balloon fails to demonstrate non-inferiority

Despite inferiority to a sirolimus-eluting stent, researchers see similarities with previously reported data on late lumen loss with paclitaxel-eluting stents.

American Heart Association Scientific Sessions 2009

A paclitaxel-eluting balloon was inferior to a sirolimus-eluting stent for a reduction in late lumen loss, according to study results presented yesterday.

Researchers for the PEPCAD III study enrolled 637 patients and randomly assigned them to receive either a paclitaxel-eluting balloon plus a bare metal stent (n=312) or a sirolimus-eluting stent (Cypher, Cordis Corporation; n=312). There were 296 patients (95.5%) in the paclitaxel-eluting balloon group evaluated at nine-month follow-up vs. 313 in the sirolimus-eluting stent group (96.6%). The primary study endpoint was in-stent late lumen loss at nine months.

The researchers reported that in-stent late lumen loss in the paclitaxel-eluting balloon group was 0.41 ± 0.51 mm vs. 0.16 ± 0.39 mm in the sirolimus-eluting stent group (P<.001), with an in-segment late lumen loss of 0.20 mm ± 0.52 mm in the balloon group vs. 0.11 ± 0.40 mm in the sirolimus-eluting stent group (P=.06). Mean luminal diameter prior to intervention was 0.67 ± 0.37 mm in the paclitaxel-eluting balloon group vs. 0.67 ± 0.38 mm in the sirolimus-eluting stent group (P=.97). Following intervention, final in-stent mean luminal diameter was 2.17 ± 0.63 mm in the paclitaxel-eluting balloon group and 2.62 ± 0.36 mm in the sirolimus-eluting stent group, with an in-segment meal luminal diameter of 1.95 ± 0.62 mm in the balloon group vs. 2.05 ± 0.50 mm in the sirolimus-eluting stent group (P=.07).

“The first drug-eluting balloon/stent system did not meet the non-inferiority criteria versus the sirolimus-eluting stent, and safety aspects need to be investigated,” Christian W. Hamm, MD, a professor of internal medicine and cardiology at the Kerckhoff Heart Center in Bad Nauheim, Germany, said in his presentation. “However, the late lumen loss is comparable to published data on paclitaxel-eluting stents, the in-segment analysis demonstrated efficacy at the stent margins and further design evolution is warranted to improve this new approach.” – by Eric Raible

Hamm C. LB01 #42. Presented at: American Heart Association Scientific Sessions; Nov. 14-18, 2009; Orlando, Fla.

The fact is that drug-eluting stents are moving forward at the same time [that drug-eluting balloons are]. It is not really fair to say that we are going to take an older stent to compare the balloon against and say that it is at least equal to or not inferior to it and that it is therefore a good technology. My take-away from this is that I would probably be somewhat depressed if I were in the drug-eluting balloon industry.

– Peter C. Block, MD

Cardiology Today Co-Section Editor