New data, presented in a series of late-breaking clinical trial presentations at the Vascular Interventional Advances (VIVA) 2016 conference in Las Vegas, USA, have shown Medtronic’s In.Pact Admiral drug-coated balloon to offer durability, consistency and safety. The data 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 three-year outcomes from the IN.PACT SFA (superficial femoral artery) Trial were presented by Prakash Krishnan, assistant professor of medicine and director of endovascular intervention at Mount Sinai Heart in New York, USA. The results demonstrated the sustained, long-term clinical benefits of Medtronic’s device in comparison to plain balloon angioplasty.
“The In.Pact Admiral is the only drug-coated balloon to-date with superior performance supported by three-year data,” says Krishnan. “In line with the one- and two-year data, we saw a consistently low clinically-driven target lesion revascularisation rate and high patency rate.”
The IN.PACT SFA Trial enrolled 331 patients at 57 sites across Europe and the USA who were randomised to treatment with either the In.Pact Admiral drug-coated balloon or plain balloon angioplasty. The data demonstrate strong durability through three years with superior performance in both primary patency (69.5% compared to 45.1% in the percutaneous transluminal angioplasty group (p<0.001)) and clinically-driven target lesion revascularisation (CD-TLR) (15.2% compared to 31.1% in the percutaneous transluminal angioplasty group (p=0.002)).
Additionally, of the patients who received a repeat procedure within three years, those in the In.Pact group did not require a second procedure as soon as those in the percutaneous transluminal angioplasty group (542.9 days for In.Pact Admiral on average vs 302.9 days for percutaneous transluminal angioplasty, p<0.001). No major target limb amputations were recorded in the In.Pact Admiral drug-coated balloon group.
In a separate session, Michael R Jaff, medical director, Massachusetts General Vascular Center at the Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston, USA, presented new one-year results from the full clinical cohort of the IN.PACT Global Study.
According to a company release, the IN.PACT Global Study is the largest and most rigorous post-market evaluation of any peripheral artery intervention ever undertaken. It has enrolled over 1,500 patients across 27 countries, including the 1,406 patients in the full clinical cohort presented today, to characterise the performance of the drug-coated balloon 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 (≥15cm) (n=157), chronic total occlusions (>= 5 cm) (n=126) and in-stent restenosis 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 in-stent restenosis, remain challenging to treat with no clearly superior treatment options.
These results demonstrate the effectiveness of the In.Pact Admiral drug-coated balloon 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% in a population with a mean lesion length of 12.09cm, 18% in-stent restenosis lesions, and 35.5% occluded lesions. Additional safety and efficacy outcomes also included low rates of thrombosis (2.9%), occurrences of major target limb amputation (0.2%), and clinically-driven target vessel revascularisation (8.1%) within one year.
Additionally, Antonio Micari of Maria Eleonora Hospital in Palermo, Italy has performed an independent study evaluating treatment of long lesion lengths with the device. His data is to be presented in the late-breaking clinical trial session at VIVA on Tuesday, September 20, 2016.