PEPCAD III trial investigated a new hybrid drug-eluting balloon/stent system as an alternative to drug-eluting stents
Orlando FL, Results of the PEPCAD III study presented at the AHA meeting in Orlando on November, 14th, by Christian Hamm (Bad Nauheim, Germany) for the first time demonstrated a drug-eluting stent like performance of the novel Coroflex® DEBlue system from B. Braun. Coroflex® DEBlue is a hybrid system of a paclitaxel coated drug-eluting balloon (DEB) with a premounted bare metal stent. In prior studies the DEB system when used as stand-alone therapy demonstrated a consistent low late lumen loss (LLL) of about 0.20 mm. The intention of the PEPCAD III trial was comparing the DEB with a premounted stent to a sirolimus-eluting DES, which has shown a comparable LLL in previous studies. Due to the rapid absorption of the antiproliferative drug a reduced time period for dual anti-platelet therapy and less restenosis at the stent edges have been expected from this study. The primary endpoint of the PEPCAD III trial was in-stent LLL at 9 month.
In this prospective, randomized European multi-center study a total of 637 subjects have been randomized either to Coroflex® DEBlue or to the Cypher® stent. With a LLL of 0.41 mm for Coroflex® DEBlue and 0.16 mm for the Cypher® stent the study failed to meet its primary endpoint of non-inferiority. However, the in-segment LLL of 0.20 mm for Coroflex® DEBlue compares well to other published DES trials and was statistically not different to the Cypher® stent with 0.11 mm (p=0.06). Target lesion revascularisation was 10.5 % for Coroflex® DEBlue versus 4.7 % for the Cypher® stent. There further was no statistically significant difference in definite stent thrombosis rate between the two groups. As a conclusion Christian Hamm commented, that this first DEB/stent system did not meet the non-inferiority criteria versus the Cypher® stent, but the LLL has demonstrated comparable results to published data on paclitaxel-eluting stents.
According to B. Braun, the results of this trial have not met the high expectations, but have pointed out the potential of the new technology. The low in-segment LLL of 0.20 mm confirms the efficacy of the drug coating at the edges of the stent. Different to DES systems the concept of the DEB/stent system allows the coating on the balloon extending the margins of the stent and thus protecting against restenosis. Further advantages of the DEB/stent hybrid approach compared to current DES technology are lower profile, improved flexibility and efficient drug-delivery without the need of a polymer matrix. For Coroflex® DEBlue only three months of dual anti-platelet therapy are required, thus offering a solution for those patients, who do not tolerate 12 months dual anti-platelet therapy required for current drug-eluting stents. The first generation of the Coroflex® DEBlue system appeared as safe and effective for clinical use in PEPCAD III, but did not show a significant clinically improvement to prior technology. Therefore, some further product advancement is intended before launching the product on the market. The CE mark certification process is still ongoing. The results from the PEPCAD I, II and V trials have demonstrated the superiority of the DEB system SeQuent® Please to a paclitaxel releasing DES. SeQuent® Please appeared as safe and effective for the treatment of in-stent restenosis, small vessel disease and bifurcations. The combination with a bare metal stent is currently under investigation in the PEPCAD IV and INDICOR trials. The innovative Coroflex® DEBlue conception represents an alternative to current DES systems, further development is ongoing.
About B. Braun Melsungen AG
B. Braun supplies the global healthcare market with products for anesthesia, intensive care, cardiology, extracorporeal blood treatment, and surgery and provides services for hospitals, private practitioners, and homecare. By maintaining an ongoing dialogue with the daily users of its products, B. Braun gains invaluable insight which in turn has a direct influence on product development. With its innovative products and services, the company helps optimize work flows in hospitals and practices worldwide while enhancing safety for both patients and medical staff. With some 38,000 employees in 50 countries, B. Braun generated sales of EUR 3.8 billion in 2008.
