November 6, 2020
5-Year Data From IN.PACT Global Study Show Sustained Safety and Efficacy for Medtronic’s In.Pact Admiral DCB
November 6, 2020—Five-year data from the IN.PACT Global study evaluated the real-world performance of the In.Pact Admiral drug-coated balloon (DCB) in patients with peripheral artery disease in the superficial femoral and popliteal arteries.
Professor Thomas Zeller, MD, who is Director of the Department of Angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany, presented the findings in a late-breaking clinical trials session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6-8, 2020.
According to the VIVA announcement of the presentation, the IN.PACT Global Study was a large, prospective, multicenter, single-arm study conducted at 64 international sites. The study enrolled patients with bilateral disease; multiple lesions (de novo or restenotic); TASC A, B, C, or D; in-stent restenosis; long lesions (≥ 15 cm); and chronic total occlusions (≥ 5 cm).
In the study, 1,406 intention-to-treat patients with 1,774 target lesions were treated with the In.Pact Admiral DCB and analyzed as a part of the consecutively enrolled clinical cohort with safety and revascularization events reviewed by an independent clinical events committee.
The mean lesion length in this clinical cohort was 12.10 ± 9.54 cm, with 18% in-stent restenosis, 35.5% total occlusions, and 68.7% calcification.
Assessments through 5 years using Kaplan-Meier (K-M) estimates included freedom from clinically driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related mortality through 30 days; freedom from major target limb amputation through 5 years; and clinically driven target vessel revascularization through 5 years), and all-cause death.
The investigators reported the following findings via K-M estimates through 5 years:
- Freedom from CD-TLR was 69.4%.
- The primary safety composite endpoint was 67.4% with a low major target limb amputation cumulative incidence of 1.7%.
- The all-cause death rate was 78.9%, which was calculated after 96.4% vital status follow-up was collected through 5 years
The study showed that since the results of this real-world study were first published, safety and effectiveness through 5 years have been sustained. These outcomes support the use of the In.Pact Admiral DCB for the management of real-world patients including complex femoropopliteal artery lesions, concluded the investigators in the VIVA press release.