Medtronic has announced with several new presentations that showed durable and consistent clinical outcomes in the most challenging patients with peripheral artery disease. The new data, presented at the 2016 Charing Cross Symposium (26–29 April, London, UK), included the one-year results from the chronic total occlusion imaging cohort from the IN.PACT Global Study and the two-year gender and diabetic subgroup analyses from the pivotal IN.PACT SFA Trial.
“The IN.PACT Admiral drug-coated balloon’s unique coating delivers paclitaxel in a solid state which results in durable tissue levels of drug leading to prolonged anti-restenotic effect. We have first-of-its-kind data that shows it continues to do so even in the more challenging cases and patient populations,” said Peter Schneider, Kaiser Medical Center, Honolulu, USA, and a principal investigator of the IN.PACT SFA Trial. “These data continue to position the IN.PACT Admiral drug- coated balloon as a durable treatment option for femoropopliteal interventions.”
Chronic total occlusions
New data from the chronic total occlusion imaging cohort of the real-world, IN.PACT Global Study were presented at Charing Cross by Gunnar Tepe, chief of radiology at RoMed Klinikum in Rosenheim, Germany.
As part of the 1,535 patients enrolled across 27 countries in the rigorous, first-of-its-kind IN.PACT Global Study, 126 patients with an average lesion length of 22.9cm were included in the pure chronic total occlusion imaging cohort analysis. The primary patency rate was 84.4% and the clinically-driven target lesion revascularisation (CD-TLR) rate was 12.2% at one year. Additional safety and efficacy outcomes included low rates of all-cause mortality (4.3%), thrombosis (4.3%) and no occurrences of major target limb amputation (0%). Previous reports from the IN.PACT Global Study demonstrated effectiveness in complex in-stent restenosis lesions and long lesions in the superficial femoral artery through one year.
“Despite the complexity of these challenging and complex long chronic total occlusion lesions, the outcomes were excellent and remarkably consistent to that of the overall cohort. These results show the effectiveness of the IN.PACT Admiral drug-coated balloon as a primary treatment in this complex lesion subset,” concluded Tepe.
Gender and diabetes
IN.PACT SFA Trial investigators sought to better understand the treatment effect of the IN.PACT Admiral drug-coated balloon compared to balloon angioplasty in females and patients with diabetes, patient populations whose outcomes have historically not fared as well as males and non-diabetic patients, respectively. Schneider presented outcomes from the IN.PACT SFA Trial gender and diabetes subgroups, which showed superior and durable outcomes for the IN.PACT Admiral drug-coated balloon compared with balloon angioplasty across both subgroups at two years.
The IN.PACT SFA Trial enrolled 331 patients, 113 of which were female, at 57 sites across Europe and the USA. At two years, females who were treated with the IN.PACT Admiral demonstrated a higher primary patency rate compared to balloon angioplasty arm (76.7% versus 42.3%, p<0.001). Similarly, females in the IN.PACT Admiral arm had a lower CD-TLR rate compared to the balloon angioplasty arm (13.2% versus 38.2%, p=0.005). The beneficial treatment effect seen in female patients who were treated with the IN.PACT Admiral was consistent with the male population, who had a primary patency rate of 80.2% in the IN.PACT Admiral arm, compared to 53.7% in the balloon angioplasty arm (p<0.001), and a 6.9% CD-TLR rate versus 23.6% (p=0.002), respectively. These positive drug-coated balloon outcomes in the female population are “unique to IN.PACT Admiral”, according to a Medtronic press release.
In a separate evaluation of patients with or without diabetes, the IN.PACT Admiral group demonstrated consistently favourable results at two years regardless of whether a patient had diabetes. Among patients with diabetes, those treated with an IN.PACT Admiral had significantly higher rates of primary patency (73.3% vs 45.8%, p<0.001) and CD-TLR (10.7% vs 29.4%, p=0.010) compared to balloon angioplasty. Similarly, in the non-diabetes subgroup, the IN.PACT Admiral arm showed consistent and significant improvements in primary patency (82.5% vs 54.5%, p<0.001) and CD-TLR (8.1% vs 27.3%, p=0.002).
These sustained and consistent results across complex anatomy and patient subsets may be partly attributed to IN.PACT Admiral’s unique coating. New pre-clinical data presented at Charing Cross by Renu Virmani, a cardiovascular pathologist and president of CVPATH Institute in Gaithersburg, USA, demonstrated that IN.PACT Admiral’s proprietary coating demonstrates sustained paclitaxel in tissue over time, facilitating an extended retention of drug in tissue available for a sustained anti-restenotic effect.