Six-month results from the randomised clinical trial, BIOLUX P-II, that compared the Passeo-18 Lux paclitaxel-releasing balloon (Biotronik) vs. plain old balloon angioplasty with the uncoated Passeo-18 balloon for the treatment of infrapopliteal artery lesions, have shown that treatment with the drug-eluting balloon results in significant clinical improvement of Rutherford 5 patients.
Koen Deloose, Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium, presented the results of the study at CIRSE 2014 (12–17 September, Glasgow, UK).
Deloose explained that BIOLUX P-II was a multicentre, randomised trial with follow-ups at 30 days, six and 12 months. The trial set out to assess the safety and performance of the Passeo-18 Lux vs. angioplasty with an uncoated balloon in the treatment of infrapopliteal lesions. “The safety and performance primary endpoints are major adverse events at 30 days and target lesion primary patency at six months (assessed by an independent angiographic core laboratory),” he said.
“Drug-eluting balloons have shown promising results in femoropopliteal disease; however, adequate evidence demonstrating improved outcomes in infrapopliteal arteries is currently lacking,” Deloose noted.
The researchers randomised 72 patients (79.2% men, mean age 71.3±9.7 years) in a 1:1 ratio to either receive angioplasty with a drug-eluting balloon or plain old balloon angioplasty. At baseline, subjects presented with hypertension (86.1%), hyperlipidemia (68.1%), diabetes (66.7%), and critical limb ischaemia (77.8%).
At 30 days, clinical results showed a composite major adverse events rate of 0% for the Passeo 18 Lux as compared to 8.3% for the angioplasty group (p=0.239). At six months angiographic follow-up, there was a trend in favour of the drug-eluting balloon which demonstrated a target lesion primary patency of 82.4% vs. 75.9% for the angioplasty group (p=0.452). The major amputation rate was 3.3% for the drug-eluting balloon vs. 5.7% for the angioplasty group (p=0.655). Clinical improvement at six months, reflected by improvement in Rutherford class, was 59% for in the drug-eluting balloon group vs. 47% in the control group. There were no patients who had worsening of disease in the drug-eluting balloon group vs. 6% who did in the plain balloon angioplasty group (p=0.326). Results from the trial showed that clinical improvement in Rutherford 5 patients was significant in the drug-eluting balloon group (p=0.002). In the angioplasty group, these patients did not see a significant improvement (p=0.058).