Data Presented for Medtronic's In.Pact Admiral DCB
September 12, 2017—Medtronic announced that the 2-year, real-world results from the full clinical cohort of the IN.PACT Global study and 4-year results from the pivotal IN.PACT SFA study were presented in two late-breaking clinical trial presentations at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada. The data demonstrated the durability and safety of the In.Pact Admiral drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD), stated the company.
The IN.PACT Global study has enrolled more than 1,500 patients in 24 countries, including the 1,406 patients in the full clinical cohort presented at VIVA 17. The study is designed to characterize the performance of the In.Pact Admiral DCB in treating real-world patients with challenging and complex lesions. The study included adjudication of events by an independent clinical events committee.
The new, 2-year fully adjudicated results from the full clinical cohort of the global study of the company's In.Pact Admiral DCB were presented at VIVA by Professor Thomas Zeller, MD.
According to the company, the data showed consistent performance in both safety and efficacy for In.Pact Admiral DCB. The data were calculated using Kaplan-Meier survival estimates and revealed a freedom from clinically driven target lesion revascularization (CD-TLR) rate of 83.3% in a real-world patient cohort with a mean lesion length of 12.09 ± 9.54 cm that included 18% in-stent restenosis lesions, 35.5% occluded lesions, and 39.9% of patients with diabetes. Additional safety and effectiveness outcomes included low rates of thrombosis (4.5%), occurrences of major target limb amputation (0.7%), and CD-TLR (16.9%) within 2 years.
In Medtronic's announcement, Prof. Zeller commented, "At 2 years, the In.Pact Admiral DCB continues to confirm positive outcomes from the IN.PACT randomized trials, demonstrating efficacy, safety, and durability, despite the complexity of these lesions. These results also highlight the clinical utility of the In.Pact Admiral DCB as a primary therapy in treating patients with some of the most challenging PAD cases."
Also at VIVA, Peter Schneider, MD, presented 4-year outcomes from the IN.PACT SFA trial for the In.Pact Admiral DCB that further demonstrated the safety and efficacy of the device in patients with PAD. The study enrolled 331 patients at 57 sites in Europe and the United States who were randomized to treatment with either the In.Pact Admiral DCB or percutaneous transluminal angioplasty (PTA). The 4-year data included a total of 284 patients (184 DCB and 103 PTA).
Of the patients who received a repeat procedure within 4 years, those in the In.Pact Admiral DCB group showed that the average time to reintervention was approximately double that of those in the PTA group (739.2 ± 384 days vs 302.9 ± 213 days; P < .001).
Using Kaplan-Meier survival rate estimates, the In.Pact Admiral DCB continued to outperform in freedom from CD-TLR compared to PTA (76.8% vs 70.4%; P = .0399). The data also showed the long-term safety benefits of the In.Pact Admiral DCB, with no major target limb amputations, a low rate of thrombosis, and no major adverse events from years 3 to 4 in the In.Pact Admiral DCB group.
Dr. Schneider commented in the company's press release, "With the In.Pact Admiral DCB, preclinical studies have demonstrated that the drug remains in the tissue for approximately 6 months. Therefore, at 4 years, we would expect to see some catch-up effect and at least some late progression of atherosclerosis. However, in the 4-year data from IN.PACT SFA, we are still seeing sustained durability and clinical benefit. For patients suffering with this chronic condition, these findings are not only encouraging from a therapeutic perspective, but are also suggestive of improved quality of life, with patients requiring fewer reinterventions over time compared to PTA and leaving future treatment options open."