Biotronik’s Passeo-18 Lux DCB Evaluated in 5-Year Patient-Level Safety Data

April 28, 2022—Biotronik announced that new long-term data demonstrated the safety of the company’s Passeo-18 Lux paclitaxel drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD) in infrainguinal arteries.

The independent analysis was led by Ron Waksman, MD, Clinical Professor of Medicine, Georgetown University and Associate Director of Cardiology, MedStar Washington Hospital Center in Washington, DC. Dr. Waksman presented the data at the Charing Cross International Symposium held April 26-28 in London, United Kingdom.

According to Biotronik, individual patient-level data were pooled from three trials in the Passeo-18 Lux DCB clinical program: the BIOLUX P-I and P-II randomized controlled trials and the BIOLUX P-III all-comers registry. Investigators evaluated the 5-year follow-up data from 943 patients treated with Passeo-18 Lux DCB and 66 patients treated with percutaneous transluminal angioplasty (PTA).

The company reported that the analysis showed the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with an increase in all-cause mortality at 5 years compared to standard PTA (33.56% vs 43.79%; P = .47).

Dr. Ron Waksman commented in Biotronik’s press release, “Our recent analysis adds to the body of long-term evidence supporting paclitaxel-coated balloons, which are an essential and safe tool for the treatment of patients with PAD, who are presenting with increasingly challenging disease and are often at high risk of restenosis. In line with previous clinical data, the Passeo-18 Lux DCB has been shown to be safe at 5 years when compared to PTA.”

Biotronik noted that these results confirm a previous analysis of this data set by Dr. Waksman and colleagues, who reported similar mortality at 1 year irrespective of the treatment with DCB or PTA and clear reduction in the incidence of the composite endpoint of any amputation and target lesion/vessel revascularization compared to standard PTA. In December 2021, that data set was published by Brian J. Forrestal, MD, et al in Cardiovascular Revascularization Medicine (2021;33:49-54). Other recent data have also shown similar mortality rates in patients treated with paclitaxel-coated balloons compared to PTA, stated the company.

Additionally, Biotronik advised that BIOPACT-RCT, a randomized clinical trial, will provide a head-to-head comparison of the Passeo-18 Lux and the In.Pact Admiral DCB (Medtronic). The primary endpoint will be presented on completion of 12-month follow-up. In September 2021, the company announced that BIOPACT-RCT completed enrollment.