Medtronic's In.Pact Admiral DCB Shows Favorable Outcomes in Challenging Peripheral Cases

April 26, 2016—Medtronic plc announced that clinical data supporting the company’s In.Pact Admiral drug-coated balloon (DCB) were presented at the 2016 Charing Cross Symposium in London, United Kingdom. The data showed durable and consistent clinical outcomes in the most challenging patients with peripheral artery disease (PAD). The new data included the 1-year results from the chronic total occlusion (CTO) imaging cohort from the IN.PACT Global study and the 2-year sex and diabetic subgroup analyses from the pivotal IN.PACT SFA trial. 

At Charing Cross, Gunnar Tepe, MD, presented the new data from the CTO imaging cohort of the real-world IN.PACT Global study. Dr. Tepe is Chief of Radiology at RoMed Klinikum in Rosenheim, Germany.

As summarized by Medtronic, the pure CTO imaging cohort analysis of the IN.PACT Global study included 126 patients with an average lesion length of 22.9 cm. Overall, the global study enrolled 1,535 patients in 27 countries.

The primary patency rate was 84.4%, and the clinically driven target lesion revascularization (CD-TLR) rate was 12.2% at 1 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 SFA through 1 year.

“Despite the complexity of these challenging and complex long CTO lesions, the outcomes were excellent and remarkably consistent to that of the overall cohort. These results show the effectiveness of the In.Pact Admiral DCB as a primary treatment in this complex lesion subset,” concluded Dr. Tepe in Medtronic’s announcement.

In the sex and diabetes analysis, the IN.PACT SFA trial investigators sought to better understand the treatment effect of the In.Pact Admiral DCB compared to balloon angioplasty in women and patients with diabetes. These patient population outcomes have historically not fared as well as in men and nondiabetic patients, noted Medtronic.

Principal Investigator Peter Schneider, MD, presented outcomes from the IN.PACT SFA trial’s sex and diabetes subgroups. The data showed superior and durable outcomes for the In.Pact Admiral DCB compared to balloon angioplasty across both subgroups at 2 years.

The IN.PACT SFA trial enrolled 331 patients, 113 of which were women, at 57 sites across Europe and the United States. At 2 years, women who were treated with the In.Pact Admiral DCB demonstrated a higher primary patency rate compared to the balloon angioplasty arm (76.7% vs 42.3%). Similarly, women in the In.Pact Admiral DCB arm had a lower CD-TLR rate compared to the balloon angioplasty arm (13.2% vs 38.2%).

The beneficial treatment effect seen in women who were treated with the In.Pact Admiral DCB was consistent with the male population, who had a primary patency rate of 80.2% in the In.Pact Admiral DCB arm compared to 53.7% in the balloon angioplasty arm, as well as a 6.9% CD-TLR rate versus 23.6%, respectively. These positive DCB outcomes in the female population are unique to the In.Pact Admiral DCB, stated Medtronic.

In the evaluation of patients with or without diabetes, the In.Pact Admiral DCB group continued to demonstrate consistently favorable results at 2 years regardless of whether a patient had diabetes. Among patients with diabetes, those treated with an In.Pact Admiral DCB had significantly higher rates of primary patency (73.3% vs 45.8%) and CD-TLR (10.7% vs 29.4%) compared to balloon angioplasty. Similarly, in the nondiabetes subgroup, the In.Pact Admiral DCB arm showed consistent and significant improvements in primary patency (82.5% vs 54.5%) and CD-TLR (8.1% vs 27.3%).

In the company’s press release, IN.PACT SFA trial Principal Investigator Peter Schneider, MD, commented, “The In.Pact Admiral DCB’s unique coating delivers paclitaxel in a solid state which results in durable tissue levels of drug leading to prolonged antirestenotic effect. We have first-of-its-kind data that shows it continues to do so even in the more challenging cases and patient populations. These data continue to position the In.Pact Admiral DCB as a durable treatment option for femoropopliteal interventions.” Dr. Schneider is with Kaiser Medical Center in Honolulu, Hawaii.

According to Medtronic, these sustained and consistent results across complex anatomy and patient subsets may be partly attributed to In.Pact Admiral DCB’s coating. Renu Virmani, MD, presented new preclinical data presented at Charing Cross that demonstrated that Medtronic’s coating on the In.Pact Admiral DCB demonstrated sustained paclitaxel in tissue over time, facilitating an extended retention of drug in tissue available for a sustained antirestenotic effect. Dr. Virmani is a cardiovascular pathologist and President of CVPATH Institute in Gaithersburg, Maryland. 

Medtronic advised that the In.Pact Admiral DCB received European CE Mark in 2009 to treat PAD and was approved by the US Food and Drug Administration in December 2014 to treat superficial femoral and popliteal arteries. In 2016, the CE Mark indication was expanded for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.