PEPCAD II ISR study suggests that drug eluting balloons are safe and effective compared with drug eluting stents in treating in-stent restenosis

March 31, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [mailto:vkunadian@perfuse.org]

SCAI-ACCi2 08-Chicago, IL: Paclitaxel-eluting balloons are effective in reducing late lumen loss and 12 month major adverse cardiac events (MACE) compared with drug eluting stents. Dr Martin Unverdorben presented the results of the PEPCAD II ISR trial (Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease) at the SCAI-i2 summit Annual Scientific Sessions in Chicago today.

In-stent restenosis (ISR) following a bare metal stent implantation remains a major limitation of the technology. Drug-eluting stents have significantly reduced the incidence of ISR and the need for target vessel revascularization (TVR). The PEPCAD II ISR study evaluated the safety and efficacy of the SeQuent Please™ drug eluting balloon catheter. This technology utilizes the use of a drug coated balloon catheter that does not require a polymer coated stents.

This study is a randomized comparison of the SeQuent™ Please drug eluting balloon (DEB) catheter versus the TAXUS stent in the treatment of in-stent restenosis and provides 12 month follow-up of the PEPCAD II ISR study.

The PACCOCATH technology allows for the drug to be available at the target site for rapid absorption from the vessel wall. It is expected that there would be uniform and complete application of the drug after the first balloon inflation.

This study randomized 131 patients with in-stent restenosis to treatment with Taxus DES (n=65) or SeQuent™ Please DEB (N=66). The primary endpoint consisted of late lumen loss and the secondary endpoints consisted of procedural success (≤30% stenosis), 6 month binary restenosis, 6 month major adverse cardiac events (MACE), MACE at 1 and 3 years.

In an as treatment analysis (n=126), the use of DEB was associated with a significantly lower late lumen loss compared to the DES (0.19 ± 0.38 vs. 0.47 ± 0.71, p=0.03), binary restenosis in segment (3.4% vs. 20.4%, p=0.007) and target lesion revascularization (3.1% vs. 16.7%, p=0.02). The total MACE without cardiac death was also significantly reduced in the DEB group compared to the DES group (4.7% vs. 18.3%, p=0.02).

The investigators concluded that the SeQuent™ Please drug eluting balloon is safe and effective compared to Taxus drug eluting stent with significant reduction in 6 month late lumen loss and 12 month MACE.

Limitations of the study included the fact that there were a relatively small number of patients with ISR only. Further long-term follow-up from this trial is pending. The net lumen gain was not reported nor was the minimum lumen diamter at follow-up. The wider applicability of the study to patients with de novo coronary artery lesions requires further research in a randomized setting.

Source
Late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, March 31, 2008 Chicago