September 22, 2016 — New data presented at the Vascular Interventional Advances (VIVA) conference demonstrated the durability, consistency and safety of Medtronic’s IN.PACT Admiral drug-coated balloon. The presentation included three-year results from the pivotal IN.PACT SFA Trial and one-year, real-world results from the full clinical cohort of the IN.PACT Global Study.
The IN.PACT SFA Trial outcomes were presented by Prakash Krishnan, M.D., assistant professor of medicine and director of endovascular intervention at Mount Sinai Heart in New York. The results demonstrated the sustained, long-term clinical benefits of IN.PACT Admiral DCB compared to plain balloon angioplasty.
"The IN.PACT Admiral is the only DCB to-date with superior performance supported by three-year data," said Krishnan. "In line with the one- and two-year data, we saw a consistently low clinically-driven target lesion revascularization rate and high patency rate. These durable, long-term outcomes reinforce the shift we are seeing in adoption of In.Pact Admiral DCB as the primary treatment option for SFA treatment."
The IN.PACT SFA Trial enrolled 331 patients at 57 sites across Europe and the United States who were randomized to treatment with either the IN.PACT Admiral DCB or plain balloon angioplasty (percutaneous transluminal angioplasty, or PTA). The data demonstrate strong durability through three years with superior performance in both primary patency (69.5 percent compared to 45.1 percent in the PTA group (p<0.001)) and clinically-driven target lesion revascularization (CD-TLR) (15.2 percent compared to 31.1 percent in the PTA group (p=0.002)).
Additionally, of the patients who received a repeat procedure within three years, those in the IN.PACT Admiral DCB group did not require a second procedure as soon as those in the PTA group (542.9 days for IN.PACT Admiral DCB on average versus 302.9 days for PTA, p<0.001). The data also continue to demonstrate the long-term safety benefits of the IN.PACT Admiral DCB, with no major target limb amputations in the IN.PACT Admiral DCB group.
In a separate session, Michael R. Jaff, D.O., medical director, Mass General Vascular Center at the Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston, presented new one-year results from the full clinical cohort of the IN.PACT Global Study.
The IN.PACT Global Study is the largest and most rigorous post-market evaluation of any peripheral artery intervention ever undertaken, according to Medtronic. It has enrolled over 1,500 patients across 27 countries, including the 1,406 patients in the full clinical cohort presented at VIVA, to characterize the performance of the IN.PACT Admiral DCB in treating real-world patients with challenging and complex lesions. The study included external monitoring and adjudication of events by an independent clinical events committee. Additionally, it included core lab evaluations for pre-specified imaging subsets for subjects with long lesions (>=15 cm) (n=157), chronic total occlusions (CTO) (>= 5 cm) (n=126) and in-stent restenosis (ISR) lesions (n=131), as recently presented at international conferences.
"Despite the complexity of these challenging lesions and patients, the outcomes were consistent across all patients, including the imaging subsets," said Jaff. "Complex lesion types, including long lesions, chronic total occlusions and ISR, remain challenging to treat with no clearly superior treatment options. These results demonstrate the effectiveness of the IN.PACT Admiral DCB as a primary therapy in treating these challenging patients who we routinely see in clinical practice."
The one-year data demonstrated a low CD-TLR rate of 7.5 percent in a population with a mean lesion length of 12.09 cm, 18 percent in-stent restenosis lesions and 35.5 percent occluded lesions. Additional safety and efficacy outcomes also included low rates of thrombosis (2.9 percent), occurrences of major target limb amputation (0.2 percent), and clinically-driven target vessel revascularization (8.1 percent) within one year.
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