In a late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020; 6–8 November, virtual) Thomas Zeller (University Heart Center Freiburg, Bad Krozingen, Germany) presented new data from the IN.PACT Global study. Safety and efficacy of Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) has been sustained out to five years, Zeller revealed, adding that these results support use of the device for the management of real-world patients, including those with complex femoropopliteal artery lesions.
The IN.PACT Global study was a large, prospective, multicentre, single-arm study conducted at 64 international sites. Subjects with bilateral disease, multiple lesions (de novo or restenotic), TASC A, B, C, and D, in-stent restenosis, long lesions (≥15 cm) and chronic total occlusions (≥5cm) were enrolled.
The 1,406 intention-to-treat subjects with 1,774 target lesions were treated with the IN.PACT Admiral DCB and analysed as a part of the consecutively enrolled clinical cohort with safety and revascularisation events reviewed by an independent Clinical Events Committee. Assessments through five years using the Kaplan-Meier (K-M) method included freedom from clinically-driven target lesion revascularisation (CD-TLR), a safety composite (freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation through five years, and clinically-driven target vessel revascularisation through five years), and all-cause death.
The mean lesion length in this clinical cohort was 12.1±9.54cm, with 18% in-stent restenosis, 35.5% total occlusions, and 68.7% calcification. The K-M estimate of freedom from CD-TLR through five years was 69.4%, and the K-M estimated primary safety composite endpoint was 67.4% with a low major target limb amputation K-M cumulative incidence of 1.7%, through five years. The K-M estimate of freedom from all-cause death was 78.9%. This all-cause death rate was calculated after 96.4% vital status follow-up and was collected through five years.