Data have been announced demonstrating the efficacy of iVascular’s Luminor drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) at six months. The results from the full clinical cohort of the EffPAC randomised study were presented in the DCB session at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 16-20 September, Copenhagen, Denmark).
Ulf Teichgräber, director of the Departement of Radiology of the University Hospital Jena, Germany, presented the new, primary endpoint late lumen loss and the clinical six-months results from the full cohort of the EFFPAC Randomized Control Study, demonstrating the effectiveness of Luminor DCB versus plain balloon angioplasty (POBA) in the superficial femoral artery (SFA).
Primary and secondary endpoints were achieved with high statistical significance. Primary endpoint revealed a late lumen loss (LLL) of 0.14mm in the DCB group vs 1.06mm in the POBA group (p<0.001). Target lesions revascularisation (TLR) was 1.3% (DCB) vs 17.1% (POBA) (p<0.001). Primary patency was 94.7% (DCB) vs 75% (POBA) (p<0.001). Rutherford stages were overall improved for 85.2% patients (DCB) vs 75% (POBA) (p=0.021), and by 3 stages for 44.6% patients (DCB) vs 27.8% (POBA) There was no amputation nor any product related adverse event in the DCB group. “The comparison with other published randomised controlled trials underline that Luminor DCB demonstrates higher efficacy than most other available DCBs,” according to an iVascular press release.
As stated by Teichgräber, “These incomparable outcomes are the result of the innovative coating technology of Luminor DCB, which is shown not only in the patency, LLL and TLR data, but also in significant improvement of patients’ clinical status”. The EffPAC trial enrolled 171 patients at 11 German centres who were randomised to treatment with either the Luminor DCB or PTA. The six-month data include a total of 153 patients (77 DCB and 76 PTA).
“EffPAC results are reinforcing the positive outcomes of the LUMINOR Registry” said Lluis Duocastella, CEO of iVascular SLU. “We are proud to continue to innovate and provide physicians with the latest technology to improve patients‘ outcomes”.