Subgroup analysis shows IN.PACT Admiral drug-coated balloon is effective in females and diabetics

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Medtronic released results of a few studies involving its IN.PACT Admiral drug-coated balloon in patients with peripheral artery disease.

The findings were presented at the Charing Cross Symposium in London.

In January 2015, the FDA approved the IN.PACT Admiral for peripheral artery disease. The Centers for Medicare & Medicaid Services also announced last June that it would reimburse the cost of drug-coated balloons for outpatient treatment of Medicare patients with peripheral artery disease.

At Charing Cross, Medtronic released data on 126 patients with an average lesion length of 22.9 cm who were part of the pure chronic total occlusion imaging cohort of the IN.PACT global study. At one year, the primary patency rate was 84.4 percent and the clinically-driven target lesion revascularization rate (CD-TLR) was 12.2 percent. Meanwhile, there was a 4.3 percent mortality rate, 4.3 percent thrombosis rate and no occurrences of major target limb amputation.

Medtronic also released data on females and patients with diabetes who were part of the IN.PACT SFA trial. After two years, females who were treated with the IN.PACT Admiral had a 76.7 percent primary patency rate compared with 42.3 percent for females in the balloon angioplasty group. Males had a primary patency rate of 80.2 percent and 53.7 percent, respectively.

Females treated with the IN.PACT Admiral had a 13.2 percent CD-TLR rate compared with 38.2 percent for females in the balloon angioplasty group. Males had a CD-TLR rate of 6.9 percent and 23.6 percent, respectively.

Of the patients with diabetes, those who were treated with the IN.PACT Admiral had a 73.7 percent primary patency rate compared with 45.8 percent for females in the balloon angioplasty group. The CD-TLR rates were 10.7 percent and 29.4 percent, respectively.

Of the patients without diabetes, those who were treated with the IN.PACT Admiral had an 82.5 percent primary patency rate compared with 54.5 percent for females in the balloon angioplasty group. The CD-TLR rates were 8.1 percent and 27.3 percent, respectively.