Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically driven target lesion revascularization (TLR) among prespecified chronic total occlusion (CTO), long lesion and de novo in-stent restenosis (ISR) cohorts “continues to confirm long-term clinical safety and effectiveness” of the IN.PACT Admiral (Medtronic) drug-coated balloon (DCB) in the treatment of complex femoropopliteal lesions.
Results from the study—involving 417 patients—were delivered by Gunnar Tepe, MD, head of the department of diagnostic and interventional radiology at RoMed, Rosenheim, Germany, during a late-breaking session at Vascular Interventional Advances (VIVA) 2021 (Las Vegas, Oct. 5–7).
Tepe reported that mean lesion lengths were 22.8 ± 9.7cm, 26.4 ± 8.6cm, and 17.1 ± 10.5 cm in the CTO, long lesion, and de novo ISR cohorts, respectively. The majority of lesions were calcified, he said. Kaplan-Meier estimates of freedom from clinically driven TLR through five years were 69.8% for CTO, 67.3% for the long lesion group and 58% for ISR. The cumulative incidences of the composite safety endpoint were 69.8%, 65.7%, and 56% in the CTO, long lesion and ISR cohorts, respectively, Tepe continued.
The number of major target limb amputations were very low in all three cohorts, with no amputations in the CTO, two in the long lesion, and one in the de novo ISR cohorts, he told VIVA attendees. Kaplan-Meier estimates of five-year freedom from all-cause mortality rates with vital status were 78.2% (CTO), 75.2% (long lesion), and 81.4% (ISR).
“This is the first presentation of prospectively collected five-year data from prespecified in-stent restenosis, long lesion and chronic total occlusion cohorts from a large global DCB study,” said Tepe.
He concluded: “High five-year freedom from clinically driven TLR was demonstrated in all three prespecified cohorts, but it was slightly lower in the de novo ISR cohort, highlighting the challenging nature of ISR lesions. No safety issues were reported in any of the cohorts. Freedom from all-cause mortality with vital status at five years was 81.4% for de novo ISR, 75.2% for long lesions and 78.2% for CTOs. These data support incorporating the use of the IN.PACT Admiral DCB into clinical treatment algorithms for complex femoropopliteal disease.”
The IN.PACT Global study was a prospective, multicenter, single-arm study conducted at 64 international sites that enrolled 1,535 participants, including some with complex lesions. Assessments through five years included freedom from clinically driven TLR, safety composite and major adverse events.