Journal Article Randomized Controlled Trial Comparative Study Multicenter Study Ppublish
PubMed: 41432343 DOI: 10.23736/S0021-9509.25.13399-5
Head-to-head comparison of two paclitaxel-coated balloons for femoropopliteal lesions: 3-year results from the BIOPACT RCT.
J Cardiovasc Surg (Torino) 66(6):557-565
Authors: Maxim Peeters, Joren Callaert, Wouter Lansink, Marianne Brodmann, Martin Werner, Koen Keirse, Yann Gouëffic, Jürgen Verbist, Lieven Maene, Jeroen M Hendriks, Jerome Brunet, Eric Ducasse, Kara Levent, Antoine Sauguet, Elien Vernez, Koen R Deloose
Affiliations
- Department of Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium.
- Department of Thoracic and Vascular Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.
- Department of Angiology, Medical University of Graz, Graz, Austria.
- Department of Angiology, Hanusch Krankenhaus, Vienna, Austria.
- Department of Vascular Surgery, Regionaal Ziekenhuis Heilig Hart, Tienen, Belgium.
- Vascular and Endovascular Surgical Center, Groupe Hospitalier Paris Saint Joseph, Paris, France.
- Department of Thoracic and Vascular Surgery, Imeldaziekenhuis, Bonheiden, Belgium.
- Department of Vascular and Thoracic Surgery, AZORG, Aalst, Belgium.
- Department of Thoracic and Vascular Surgery, University Hospital Antwerpen, Edegem, Belgium.
- Cardiovascular Department, Clinique Rhône Durance, Avignon, France.
- Department of Vascular Surgery, Hospital Center University Bordeaux, Bordeaux, France.
- Institute of Radiology and Nuclear Medicine, Stadtspital Triemli, Zürich, Switzerland.
- Clinique-Pasteur, Toulouse Cedex, France.
- iD3 Medical, Sint-Agatha-Berchem, Belgium.
- Department of Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium -.
Abstract
BACKGROUND
Over the past decade, drug-coated balloons (DCBs) delivering paclitaxel have become widely used for the treatment of peripheral artery disease (PAD). The safety and efficacy of various DCBs have been extensively studied, but differences in device design and drug delivery matrices may influence outcomes. The publication aim was to report long-term safety and efficacy data of the Passeo-18 Lux DCB for the treatment of symptomatic PAD due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.
METHODS
Three hundred and two patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or to the IN.PACT Admiral DCB (control device) group for testing of noninferiority. An efficacy endpoint was freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months. In terms of safety, a composite endpoint of freedom from device-/procedure-related death at 30 days post-index procedure, - major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) at 36 months was investigated.
RESULTS
At 36 months, freedom from CD-TLR-was achieved in 119 out of 128 patients in the IN.PACT Admiral group (93.0%) and in 116 out of 127 patients in the Passeo-18 Lux group (91.3%). The null hypothesis of inferiority was rejected with a P value of 0.0095, confirming the non-inferiority of Passeo-18 Lux compared to IN.PACT Admiral in terms of efficacy. Both treatment groups demonstrated sustained clinical improvement, as shown by the evolution of the Rutherford Clinical Category (RCC). At 36 months, the mean change in target limb RCC class compared to baseline was -2.5 in both groups, indicating comparable and significant clinical improvement over time.
CONCLUSIONS
The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 36 months for femoropopliteal interventions.
MeSH
Constriction, Pathologic, Safety, Paclitaxel, Pharmaceutical Preparations, Arteries, Therapeutics, Wounds And Injuries