12-Month DANCE Pilot Study Results Presented

October 10, 2013—Christopher Owens, MD, presented the 12-month results of the DANCE pilot study at the VIVA 2013: Vascular Interventional Advances conference on October 8–11 in Las Vegas, Nevada.

It has been long established that atherosclerosis is, in part, an inflammatory disease of the blood vessels, noted Dr. Owens. Treatment of occlusive atherosclerosis is primarily mechanical in nature, which imparts an injury on an already damaged artery. Therefore, the investigators hypothesized that a rational treatment approach would involve an anti-inflammatory solution. Dexamethasone is a very powerful anti-inflammatory drug that is 25 times more potent than cortisol, and it inhibits many of the mediators of inflammation in doses that can be achieved in the blood vessel. Dexamethasone treatment could inhibit the natural injury response signals that eventually lead to intimal hyperplasia and fibrosis.

Dexamethasone was delivered directly into the artery wall with a microinfusion catheter that is designed to penetrate the external elastic lamina to target the adventitia. This established a gradient whereby the maximal concentration of the drug is in the adventitia and outer media, with the lowest concentration at the endothelial cell layer. The drug delivery was confirmed fluoroscopically by mixing the dexamethasone with dilute contrast.

The DANCE pilot results support that this strategy is safe and feasible in human femoral and popliteal arteries. While the study was not designed to assess efficacy, 12-month results suggest that this treatment may be a durable solution to restenosis. Based on these results, Mercator MedSystems, Inc. (San Leandro, CA) is launching a 300-patient multicenter trial to determine if dexamethasone infusion can mitigate restenosis following balloon angioplasty or atherectomy.