The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the Total IN.PACT Pooled Analysis of the IN.PACT Admiral drug-coated balloon in patients with peripheral arterial disease (PAD) in the superficial femoral (SFA) and popliteal arteries were presented in two late-breaking clinical trial presentations at the Vascular Interventional Advances conference (VIVA; 5–8 November, Las Vegas, USA).
IN.PACT SFA Trial
John Laird, medical director of the Adventist Heart and Vascular Institute and co-principal investigator for the IN.PACT SFA Trial presented the first, five-year clinical outcomes for a commercially available DCB, further demonstrating the durability, safety, and efficacy of IN.PACT Admiral DCB in patients with PAD.
Using time-to-event survival analysis, IN.PACT Admiral DCB continued to outperform the percutaneous transluminal angioplasty (PTA) control arm in freedom from clinically-driven target lesion revascularisation (CD-TLR) over the five-year follow-up period. The Kaplan-Meier estimate was 74.5% in the DCB group versus 65.3% in the PTA group (log-rank p= 0.0196). The data also showed the long-term safety benefits of IN.PACT Admiral, with low rates of major target limb amputation (0.5%) and thrombosis (2.2%) in the IN.PACT Admiral DCB arm, and no device or procedure-related deaths through five years in both the IN.PACT Admiral DCB and PTA arms.
“With the data presented today at VIVA, we continue to see sustained clinical benefit of IN.PACT Admiral with three quarters of DCB patients in the study not requiring a reintervention through five years,” said Laird. “This is truly remarkable considering the complexity and progressive nature of PAD. For these patients, it means we are providing them with a long-term, durable solution that reduces the need for frequent reinterventions, leading to a potential improvement in their quality of life.”
Total IN.PACT Pooled Analysis: All-Subjects
Mehdi Shishehbor, director of the Heart and Vascular Institute, University Hospitals Cleveland Medical Center, presented one-year all-subjects data from the Total IN.PACT Pooled Analysis-the largest collective, independently adjudicated DCB series to-date. The data showed that IN.PACT Admiral DCB demonstrated consistently superior safety and freedom from clinically-driven target lesion revascularisation (CD-TLR) compared to standard PTA alone.
The all-subjects analysis evaluated all 1,837 DCB and 143 PTA patients from across IN.PACT Admiral clinical programmes, including IN.PACT SFA, IN.PACT Global, IN.PACT SFA Japan, and IN.PACT SFA China studies. Results showed that IN.PACT Admiral DCB outperformed the PTA control arm in freedom from CD-TLR with a Kaplan-Meier estimate of 93.8% in the DCB group versus 80.2% in the PTA group (log-rank p<0.001). Additional safety and effectiveness outcomes from the DCB arm also included low rates of thrombosis (2.5%), major target limb amputation (0.2%), and all-cause mortality (3.1%) through one-year in a large PAD patient population.
“With Total IN.PACT, we are able to show that IN.PACT Admiral is the first DCB to demonstrate strong and consistent efficacy in lesions up to 360mm,” said Shishehbor. “The data from the all-subjects analysis also confirm IN.PACT Admiral DCB’s superior safety and freedom from reintervention rate at one year, while offering important information to help enhance treatment decisions. These one-year data, combined with the five-year data also presented today, provide physicians with additional confidence in using IN.PACT Admiral DCB as a primary therapy over PTA.”
