Findings Presented From In-Stent Restenosis Imaging Cohort in Medtronic's IN.PACT Global Study

November 2, 2015—Marianne Brodmann, MD, presented new insights from the IN.PACT Global study during the first Late-Breaking Trials session at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The presentation focused on the study’s in-stent restenosis (ISR) imaging cohort of patients with lifestyle-limiting claudication who underwent drug-coated balloon (DCB) treatment. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

As summarized in the VIVA press release, IN.PACT Global is an independently adjudicated and monitored multicenter, prospective, single-arm study designed to expand the clinical evidence of the In.Pact Admiral DCB (Medtronic plc) in the treatment of more than 1,500 patients with real-world femoropopliteal lesions, including de novo ISR lesions.

To evaluate vessel patency of these ISR lesions, 131 patients with pure ISR lesions were enrolled into the ISR imaging cohort and underwent duplex ultrasound imaging at 12 months and after any reintervention within the follow-up period.

Dr. Brodmann presented the 12-month outcomes from this ISR imaging cohort.

The mean age of the patients in this cohort was 67.8 years, and 69.5% of the patients were men. The mean lesion length treated was 17.2 cm, including 34% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency (defined as freedom from clinically driven target lesion revascularization [TLR] and freedom from restenosis as determined by duplex ultrasound peak systolic velocity ratio ≤ 2.4) was 88.7%. The clinically driven TLR rate 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 clinically driven target vessel revascularization within 12 months, was 91.1%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate within the 12-month follow-up period.

Dr. Brodmann concluded that the 12-month results from the ISR imaging cohort of the IN.PACT Global study demonstrate remarkable patency and low clinically driven TLR results. These data confirm the safety and effectiveness of the In.Pact Admiral DCB in the treatment of complex superficial femoral artery lesions, including this challenging subset.