The Lutonix 035 drug-coated balloon (DCB) percutaneous transluminal angioplasty catheter (Bard) has been featured in a series of podium and special session presentations during the Leipzig International Course (LINC), Leipzig, Germany. According to a Bard release, these presentations have demonstrated continued, confirmatory Lutonix DCB clinical data.
Sabine Steiner, senior physician in the Division of Interventional Angiology in University Hospital Leipzig, Germany, presented the results of an investigator-sponsored and funded retrospective, single-centre study comparing real-world patients with complex femoropopliteal lesions treated with Lutonix and IN.PACT DCBs. The results revealed no significant difference at 18 months in target lesion revascularisation (TLR) and sustained clinical improvement between the Lutonix DCB and the IN.PACT DCB. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to DCB treatment.
A total of 575 limbs were treated in symptomatic peripheral artery disease patients undergoing femoropopliteal intervention (IN.PACT DCB n=398; Lutonix DCB n=177). Patients treated with the Lutonix 035 DCB demonstrated a freedom from TLR rate of 73.1% at 18 months (n=90), and patients treated with the IN.PACT DCB demonstrated a freedom from TLR rate of 74.8% at 18 months (n=44).
Improvement in Rutherford class was observed at 18 months in 66.4% of the patients treated with the Lutonix DCB (n=77) and in 59.5% of the patients treated with the IN.PACT DCB (n=41)—a 6.9% difference, although, this difference is not statistically significant.
Dierk Scheinert, head of the Department of Interventional Angiology at the University of Leipzig in Germany, comments, “These single-centre results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularisation following treatment with either of these two DCBs.”