DANCE Trial Investigates Dexamethasone Infusion to Enhance Femoropopliteal Revascularization

May 11, 2017—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that Ehrin J. Armstrong, MD, presented results from an analysis of inflammatory biomarkers in patient subgroups of the DANCE trial of dexamethasone infusion to the adventitia to enhance clinical efficacy after femoropopliteal revascularization through either percutaneous transluminal angioplasty (PTA) or atherectomy.

The DANCE trial analysis showed that peripheral artery disease (PAD) patients who were treated with an anti-inflammatory steroid injected directly into the tissue surrounding their leg artery showed a significant reduction in inflammatory biomarkers. The findings were presented as a late-breaking clinical trial at SCAI's 2017 scientific session in New Orleans, Louisiana.

In the SCAI announcement, Dr. Armstrong commented, “This is a novel approach to treating the diseased artery by administering a steroid to the tissue that surrounds it. By injecting an anti-inflammatory drug directly into the artery wall and the adjacent tissue, as opposed to inside the artery where much of the drug could be washed away by blood flow, the drug is precisely targeted to the site of the inflammatory signals. Thus, the cycle of inflammation that can lead to repeat blockages is controlled, and the healing process is potentially improved.” Dr. Armstrong is Director of the VA Eastern Colorado Healthcare System in Denver, Colorado, and associate professor of medicine at the University of Colorado School of Medicine in Aurora, Colorado.

As summarized by SCAI, the DANCE trial investigators measured the inflammatory biomarkers in a patient subgroup (PTA, n = 52; atherectomy, n = 42) before and after using the Bullfrog microinfusion device (Mercator MedSystems, Inc.) to locally deliver dexamethasone (1.6 mg per cm of treated artery) after their angioplasty or atherectomy, versus a control group (PTA, n = 12; atherectomy, n = 16) that did not receive the steroid following the same techniques. Both groups had blood drawn before the interventions, at 24 hours, and at 4 weeks after the procedure.

The investigators found that patients treated with the Bullfrog microinfusion device and dexamethasone experienced a significant reduction of two key inflammatory biomarkers that have been linked to restenosis in balloon angioplasty interventions: high-sensitivity C-reactive protein (hsCRP) and monocyte chemoattractive protein-1 (MCP-1).

In the control group, the average 24-hour increase in hsCRP was 280% for PTA and 138% for atherectomy. In the dexamethasone-treated group, the increase was 55% for PTA and 14% for atherectomy in treated patients (P = NS). Additionally, a 24-hour mean rise in MCP-1 of 19% for PTA and 14% for atherectomy was seen in the nontreated group, while treated patients experienced a reduction of 39% for PTA (P < .003) and 52% for atherectomy (P < .00005).

Dr. Armstrong noted, “The way we address a blockage in the leg artery now is to initially restore blood flow and any limitation to the blood flow dynamics using a balloon or stent to mechanically open the artery back up. The idea behind the addition of a steroid to the procedure is to change the underlying biology associated with these techniques so that the intervention is more durable over time." He continued, "The DANCE study has provided insight that the measurement of the levels of the inflammatory biomarkers for individual patients may be a beneficial strategy in predicting outcomes and lead to improvement by personalizing our therapy for each PAD patient.”

In February, the company announced that the DANCE trial's comprehensive 13-month data were presented by the national Co-Principal Investigators, Mahmood Razavi, MD, at ISET 2017, the International Symposium on Endovascular Therapy in Hollywood, Florida, and George Adams, MD, at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany. In September 2016, Chris Owens, MD, first presented 12-month findings from the DANCE study at VIVA 16, the 14th annual Vascular InterVentional Advances meeting in Las Vegas, Nevada. The 12-month and 13-month data from DANCE comparing the method of revascularization—with atherectomy performed in 157 limbs, and angioplasty without atherectomy performed in 124 limbs—showed that the safety and efficacy outcomes were similar in the two groups.