Medtronic’s In.Pact Admiral DCB Demonstrates Safety and Effectiveness at 5 Years in CTO, LL, ISR Cohorts of IN.PACT Global Study

October 5, 2021—Gunnar Tepe, MD, presented long-term safety and effectiveness follow-up outcomes of three independent prespecified cohorts in the IN.PACT Global study of the In.Pact Admiral drug-coated balloon (DCB; Medtronic): femoropopliteal chronic total occlusion (CTO), long lesion (LL), and de novo in-stent restenosis (ISR) in real-world patients. The findings were presented by Dr. Tepe during late-breaking clinical trial results at VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

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 5 years included freedom from clinically driven target lesion revascularization (CD-TLR), safety composite, and major adverse events. Previous outcomes from the IN.PACT Global Study have demonstrated 1-year safety and effectiveness for angioplasty with In.Pact Admiral DCB in the CTO, LL, and de novo ISR cohorts.

According to the VIVA press release, the results presented by Dr. Tepe demonstrated long-term clinical effectiveness of the In.Pact Admiral DCB in all three cohorts, with high freedom from CD-TLR in LL and CTO through 5 years but slightly lower in de novo ISR, which highlights the challenging nature of ISR lesions. There were no safety issues observed, supporting the use of the In.Pact Admiral DCB in the management of femoropopliteal disease, concluded the investigators.

As summarized in the VIVA announcement, the mean lesion lengths were 22.8 ± 9.7 cm, 26.4 ± 8.6 cm, and 17.1 ± 10.5 cm in the CTO, LL, and de novo ISR cohorts, respectively. The majority of lesions were calcified.

The investigators reported the following findings:

• Kaplan-Meier estimates of freedom from CD-TLR through 5 years were 69.8% for CTO, 67.3% for LL, and 58.0% for de novo ISR
• The cumulative incidences of the composite safety endpoint were 69.8%, 65.7%, and 56.0 % in the CTO, LL, and de novo ISR cohorts, respectively
• The number of major target limb amputations were very low in all three cohorts, with no amputations in the CTO, two in the LL, and one in the de novo ISR
• Kaplan-Meier estimates of 5-year freedom from all-cause mortality rates with vital status were 78.2% (CTO), 75.2% (LL), and 81.4% (de novo ISR)