New two-year results from the IN.PACT SFA Japan trial were presented at the Leipzig Interventional Course (LINC; 30 January–2 February, Leipzig, Germany) by Osamu Iida, Kansai Rosai Hospital, Hyogo, Japan. The results were consistent with two-year findings from the pivotal IN.PACT SFA study, showing a low clinically driven target lesion revascularisation rate and high patency rate.
The prospective trial was designed to assess the IN.PACT Admiral (Medtronic), a drug-coated balloon (DCB), for the interventional treatment of lesions in the superficial femoral artery and proximal popliteal artery. Safety and efficacy of the DCB was analysed in comparison to standard percutaneous transluminal angioplasty (PTA).
The trial design was similar to the previous IN.PACT SFA trials, which took place in Europe and the USA. “We are pleased to see comparable results in Japan at two-years with durable patency outcomes, low target lesion revascularisation, and no instances of thrombosis”, Iida said, adding “There has been a critical unmet need in Japan for new technologies that safely and effectively treat peripheral arterial disease, and we believe IN.PACT Admiral is well-positioned to meet this need.” The trial provided level 1 evidence in a Japanese population.
Patients with Rutherford Class 2–4 wounds, de novo or non-stented restenotic femoropopliteal lesions, and evidence of adequate distal run-off through the foot were enrolled at 11 centres in Japan and randomised 2:1 to treatment with DCB (n=68) or PTA (n=32). Sponsored by Medtronic, the trial was independently adjudicated by blinded Duplex ultrasound and angiographic labs as well as a clinical events committee.
The total cohort included 100 patients with similar mean age in each arm (DCB mean age 73.3±7.4; PTA 74.2±6.1, p=0.539) and lesion length (DCB 9.15±5.85cm; PTA 8.89±6.01cm, p=0.838). All patients in the PTA arm were treated for de novo lesions, while the DCB arm consisted of 62 (91.2%) patients with de novo as well as 6 (8.8%) patients with restenotic, non-stented lesions.
“The two-year primary patency by Kaplan-Meier estimate was significantly different between the groups, in favour of DCB with a rate of 79.8%, compared to 46.9% in PTA”, Iida said at LINC, where the data were first presented. Freedom from clinically driven target lesion revascularisation was “not significantly different” to the PTA arm Iida noted, measuring at 90.8% with DCB and 81.3% for PTA.
Safety outcomes showed very low major adverse event rates in both arms, with no cases of thrombosis or target limb major amputations at two years, and no device- or procedure-related deaths within 30 days. The primary safety endpoints also included clinically driven target vessel revascularisation and all-cause death. A primary safety composite favoured the DCB arm compared to the PTA (89.4% vs. 79.3%, p=0.207).
The one-year results of the IN.PACT SFA Japan trial were previously published in the Journal of Endovascular Therapy in 2017.