November 4, 2019
Four-Year Data Presented From Medtronic's IN.PACT Global Study
November 5, 2019—Medtronic announced that data from the IN.PACT Global Study reinforce the long-term durability and safety of the In.Pact Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) in the superficial femoral (SFA) and popliteal arteries. Professor Thomas Zeller, MD, presented the 4-year data from the full clinical cohort of the IN.PACT Global Study at VIVA 2019, the Vascular InterVentional Advances meeting, held November 4–7 in Las Vegas, Nevada.
According to the company, the 4-year fully adjudicated DCB data demonstrated durable effectiveness and a strong safety profile in a large, real-world population (n = 1,406) with the In.Pact Admiral DCB. Of the patients enrolled, the mean lesion length was 12.09 ± 9.54 cm, 18% had in-stent restenosis, 35.5% had occluded lesions, 39.9% had diabetes, and 68.7% had calcified lesions.
Medtronic reported that Kaplan-Meier estimates demonstrated freedom from clinically driven target lesion revascularization (CD-TLR) rate of 73.4%. The average time to first CD-TLRs in this complex patient population was approximately 570 days.
Based on Kaplan-Meier estimate, In.Pact Admiral demonstrated a solid safety profile through 4 years with a low major target-limb amputation cumulative incidence of 1.1%.
The freedom from all-cause death through 4 years was 83.5%, which is comparable to what would be expected in this patient population. This rate is based on data from all patients enrolled in the IN.PACT Global Study, among which 98% had known vital status.
An additional analysis was conducted to evaluate the performance of In.Pact Admiral through 4 years in patients with intermittent claudication and critical limb ischemia (CLI) based on Rutherford classification (RC). The Kaplan-Meier estimated freedom from CD-TLR was 74.5% (n = 1,246) in the intermittent claudication (RC 2/3) patient cohort and 64.8% (n = 156) in the CLI (RC 4/5) patient cohort.
In Medtronic’s announcement, Prof. Zeller commented, “The IN.PACT Global Study is the largest independently adjudicated real-world evaluation of any peripheral intervention undertaken and includes patients with the most complex lesions observed in any existing DCB clinical study, many of whom have commonly known risk factors for progressive PAD. Even in this real-world patient population, including those with CLI, we continue to see durable treatment effect through 4 years. These data further demonstrate the clinical benefit of In.Pact Admiral DCB and its ability to be a first-line therapy for patients with challenging lesions.” Prof. Zeller is Director of the Department of Angiology at Universitäts-Herzzentrum, Freiburg-Bad Krozingen, Germany.