Diabetes Subgroup Analysis from Medtronic's IN.PACT SFA Trial Presented

November 4, 2014––Medtronic, Inc. announced that the company’s In.Pact Admiral drug-coated balloon (DCB) demonstrated consistently favorable results in patients with diabetes being treated for peripheral artery disease in above-the-knee leg arteries in the company’s landmark IN.PACT SFA trial study. The In.Pact Admiral DCB is an investigational medical device under review for approval by the US Food and Drug Administration.

The findings from a prespecified subgroup analysis of patients with diabetes in the IN.PACT SFA trial were presented by principal investigator Peter Schneider, MD, during a late-breaking clinical trials session at the VIVA 2014: Vascular Interventional Advances meeting in Las Vegas, Nevada. The IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the United States. All study patients were randomized to treatment with the DCB or percutaneous transluminal angioplasty (PTA).

Dr. Schneider commented in Medtronic’s press release, “Peripheral artery disease in patients with diabetes tends to be more advanced and complex and, as a result, more challenging to treat than it is in patients without diabetes. While that tendency held true in this study, diabetes did not negate the magnitude of the difference in treatment effect. The patency rates were statistically significantly higher, by more than 20%, for all patients in the DCB arm and for its diabetic patient subset.” Dr. Schneider is Chief of Vascular Surgery at Kaiser Foundation Hospital in Honolulu, Hawaii.

Medtronic summarized the 12-month outcomes of the IN.PACT SFA trial’s diabetes subgroup analysis. Primary patency rates at 360 days by Kaplan-Meier survival estimates were 82.7% in diabetic patients treated with DCB (n = 89) versus 62.3% in patients treated with PTA (n = 54) (P = .015). In all patients, the primary patency rates were 89.8% (DCB; n = 220) versus 66.8% (PTA, n = 111) (P = .001).

In April 2014, Medtronic announced the first presentation of outcomes from all patients in the IN.PACT SFA trial at the Charing Cross International Symposium in London, United Kingdom. Principal investigator Gunnar Tepe, MD, presented the data showing that patients with peripheral artery disease in the SFA who were treated with the In.Pact Admiral device experienced significantly better outcomes at 12 months after treatment compared to those treated with PTA. Those findings will soon be published in a peer-reviewed medical journal.