Safety trial of IN.PACT Admiral drug-coated balloon shows no link to mortality in peripheral artery disease.- Medtronic

Medtronic announced new data shared on the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) in the superficial femoral (SFA) and popliteal arteries. Outcomes from the IN.PACT DCB Paclitaxel Safety Analysis, an independent, patient-level survival analysis inclusive of all IN.PACT DCB clinical programs show that at five years there was no statistically significant difference in all-cause mortality between the DCB and plain balloon angioplasty (PTA) arms (9.3 percent versus 11.2 percent respectively, p=0.399). In addition, the data found no correlation between paclitaxel dose and long-term survival. Patients treated in the DCB arm were classified by upper, mid, and lower dose ranges. Freedom from all-cause mortality based on Kaplan-Meier estimates was 91.7 percent in the upper range, 90.6 in the mid-range, and 90.0 percent in the lower range (p=0.700). Upon review of other endovascular therapies in published literature, it was found that the mortality rates across IN.PACT DCB studies are comparable to or lower than what would be expected in similar patient populations.

Data also demonstrated no difference in mean nominal dose of paclitaxel between overall survival in patients treated with DCB (n=1,696) and those who died (n=140). Mean nominal paclitaxel doses were 11,829.8ug +/- 7,347.6ug and 11,419.6ug +/- 7,414.8ug respectively (p=0.529). Data were presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany. A manuscript detailing outcomes from the IN.PACT DCB Paclitaxel Safety analysis was also accepted and is in press with the Journal of the American College of Cardiology (JACC).

New data from the IN.PACT SFA Japan Study were also presented. The data demonstrated continued safety, durability, and efficacy compared to PTA at three years. The study enrolled 100 patients across 11 sites in Japan and randomized treatment to either DCB (n=68) PTA (n=32). Results showed a consistently low clinically-driven target lesion revascularization (CD-TLR) rate and high patency rate. IN.PACT SFA Japan demonstrated a 68.9 percent primary patency in the DCB group compared to 46.9 percent in the PTA group at three years based on Kaplan-Meier estimates (p=0.001). The three-year freedom from CD-TLR rates based on Kaplan-Meier estimates were 84.4 percent in the DCB group compared to 81.3 percent in the PTA group (p=0.451). In IN.PACT SFA Japan, major adverse events were also lower in the DCB group at three years with a rate of 20.9 percent compared to 31.0 percent in the PTA group (p=0.306), with no major target limb amputations in either study arm. The mortality rate was also lower in the DCB arm at 6.0 percent, versus 6.9 percent in the PTA group.