Aortic & peripheral vascular diseaseRandomised controlled trial
Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions
- Randomised controlled trial
- non-inferiority
- 1:1 randomisation
Authors' conclusion
The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.
Study context
- Population
- Symptomatic PAD caused by stenosis, restenosis or occlusion of the femoral and/or popliteal arteries
- Participants
- 302 participants
- Comparison
- Passeo-18 Lux drug-coated balloon (DCB) vs IN.PACT Admiral DCB
- Primary endpoint
- Freedom from clinically driven target lesion revascularization (efficacy); composite of freedom from device-/procedure-related death through 30 days, major target limb amputation and clinically driven target vessel revascularization (safety)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Freedom from clinically driven target lesion revascularization
Further findings
Primary patency (Kaplan-Meier estimate) · 1 year
- Primary patency (Kaplan-Meier estimate): control = IN.PACT Admiral; study device = Passeo-18 Lux
Safety
Primary safety endpoint: freedom from device-/procedure-related death through 30 days, major target limb amputation and clinically driven TVR · 12 months · non-inferiority
- Primary safety endpoint: freedom from device-/procedure-related death through 30 days, major target limb amputation and clinically driven TVR: control = IN.PACT Admiral; study device = Passeo-18 Lux
Primary safety endpoint: freedom from device-/procedure-related death through 30 days, major target limb amputation and clinically driven TVR · 12 months
- Null hypothesis of inferiority rejected
Original publication
Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions. JACC Cardiovasc Interv. Published 11 December 2023. doi:10.1016/j.jcin.2023.10.055
Summarised from the published abstract; every number is checked against it