Data Published for Medtronic's In.Pact Admiral DCB in De Novo In-Stent Restenosis
October 18, 2017—Findings from the IN.PACT Global study's de novo in-stent restenosis (ISR) imaging cohort were published by Marianne Brodmann, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:2113–2123). The study sought to evaluate the safety and effectiveness of the In.Pact Admiral drug-coated balloon (Medtronic) for the treatment of patients with de novo ISR.
As summarized in JACC: Cardiovascular Interventions, the IN.PACT Global study is an independently adjudicated prospective multicenter study that enrolled 1,535 patients with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the prespecified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period.
This analysis included a total of 131 patients with 149 ISR lesions (mean age, 67.8 years). The mean lesion length in the cohort was 17.17 ± 10.47 cm, including 34% total occlusions and 59.1% calcified lesions.
The investigators reported that the 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate.
These data demonstrated the safety and effectiveness of the In.Pact Admiral DCB in complex femoropopliteal lesions, including this challenging ISR subset, concluded the investigators in JACC: Cardiovascular Interventions.