Medtronic's Drug-Coated Balloon Evaluated in the IN.PACT SFA Japan Trial
February 9, 2017—Medtronic announced that the 1-year clinical outcomes from the MDT-2113 IN.PACT SFA Japan trial were presented by Osamu Iida, MD, at LINC 2017, the Leipzig Interventional Course, which was held January 24–27 in Leipzig, Germany. Medtronic's drug-coated balloon (DCB) is an investigational device in Japan and not available for sale.
The IN.PACT SFA Japan trial enrolled 100 patients at 11 sites in Japan who were randomized to treatment with either the DCB (n = 68) or plain balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 32). Per protocol, primary patency rates were assessed at 12-month follow-up.
According to Medtronic, 12-month primary patency rates were 89.2% for the DCB group and 48.4% for the PTA group (P < .001). Primary patency at 360 days was also calculated by Kaplan-Meier survival estimates; at this specific time point, it was 93.9% for the DCB group and 49.9% for the PTA group (P < .001). Clinically driven target lesion revascularization was 2.9% for the DCB group, compared to 18.8% in the PTA group (P = .012). The data also showed lower major adverse events for the DCB at 1 year (4.4% vs 18.8% in the PTA group; P = .028), with no major target limb amputations.
The company advised that these results are consistent with previous findings from the pivotal IN.PACT SFA trial 1-year outcomes, and further reinforce the real-world results from the full clinical cohort of the IN.PACT Global Study.
In Medtronic's announcement, Dr. Iida commented, "This study builds on the previous Medtronic DCB clinical studies, reinforcing the consistent clinical performance in terms of primary patency and reintervention rates of this device across patient populations. We are pleased to see such substantive DCB clinical data from a patient cohort in Japan."