One-Year Findings Published From Long Lesion Imaging Cohort of Medtronic's IN.PACT Global Study
October 4, 2018—The 12-month follow-up findings from the IN.PACT Global study's long lesion imaging cohort were published online in Circulation: Cardiovascular Interventions by Dierk Scheinert, MD, et al. The IN.PACT Global study investigators concluded that the In.Pact Admiral drug-coated balloon (DCB; Medtronic) was safe and highly effective at 12 months after treatment in a rigorous independently adjudicated analysis of real-world patients with lesions ≥ 15 cm in the superficial femoral arteries (SFAs) and/or popliteal arteries (P1–P3).
The investigators explained that the IN.PACT Global study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of the In.Pact Admiral DCB in the treatment of atherosclerotic disease of the SFA and/or popliteal arteries (P1–P3) in patients with intermittent claudication and/or rest pain. Prespecified patients were selected for core laboratory–adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥ 15 cm). Patients were followed for 12 months.
The primary safety endpoint was 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 through 12 months. An independent clinical events committee adjudicated all adverse events.
As summarized in Circulation: Cardiovascular Interventions, the primary effectiveness endpoint was primary patency at 12 months, as determined by duplex ultrasound. The long lesion imaging cohort included 157 patients (164 lesions). Mean lesion length was 26.40 ± 8.61 cm. Provisional stents were implanted in 39.4% (63/160) of lesions.
Primary patency by Kaplan-Meier estimate was 91.1%, and freedom from clinically driven target lesion revascularization was 94.2% at 12 months. The primary safety composite endpoint was achieved by 94% (126/134) of patients. The investigators in Circulation: Cardiovascular Interventions reported that there were no device- or procedure-related deaths or major target limb amputations.
The In.Pact Admiral DCB was first approved by the FDA to treat SFA and popliteal arteries in December 2014.
On April 23, 2018, Medtronic announced FDA approval for the device to treat long SFA lesions up to 360 mm in patients. Approval for the expanded indication was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global study, including long lesion in-stent restenosis and chronic total occlusion groups with lesion lengths > 180 mm. Across these groups, investigators analyzed a total of 227 patients with mean lesion lengths of 28.7 ± 7.1 cm. Data showed a 1-year patency rate of 89.1% by Kaplan-Meier estimate at day 360 and a clinically driven target revascularization rate of 7.1%.
On June 15, 2018, Medtronic announced FDA approval for 200- and 250-mm lengths of the In.Pact Admiral DCB to treat long SFA lesions.