News | Peripheral Artery Disease (PAD) | May 12, 2017

Interrupting Inflammatory Signals Decreases Repeat Artery Blockage in DANCE Trial

Novel delivery method improves treatment outcomes for patients with peripheral artery disease

Interrupting Inflammatory Signals Decreases Repeat Artery Blockage

May 12, 2017 — 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, according to new data from the DANCE trial. Results from the trial were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions, May 10-13 in New Orleans.

Current treatments for PAD include percutaneous transluminal angioplasty angioplasty (PTA) and atherectomy (ATX). While these treatments can be effective in the short term, they have limitations over time. Both of these approaches treat the blockage from the inside of the artery and can trigger a cycle of inflammation that may contribute to restenosis.  Over the course of 6-12 months, a meaningful percentage of patients experience a repeat blockage due to restenosis that was initiated by inflammation resulting from the PTA or ATX.

Researchers in the DANCE (Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy after Femoropopliteal Revascularization) trial measured the inflammatory biomarkers in a patient subgroup (n=52 PTA and n=42 ATX) before and after using the Bullfrog Micro-Infusion Device to locally deliverdexamethasone (1.6 mg per cm of treated artery) after their angioplasty or atherectomy, and a control group (n=12 PTA and n=16 ATX) that did not receive the steroid following the same techniques. Both groups had blood drawn prior to intervention, at 24-hours and at four weeks post-procedure. Patients treated with the Bullfrog Micro-Infusion 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).

“This is a novel approach to treating the diseased artery by administering a steroid to the tissue that surrounds it,” said one of the study’s leading investigators Ehrin J. Armstrong, M.D., MSc, FSCAI, director, VA Eastern Colorado Healthcare System and associate professor of medicine, University of Colorado School of Medicine. “By injecting 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.”

In the control group, the average 24-hour increase in hsCRP was 280 percent (PTA) or 138 percent (ATX) as compared to 55 percent (PTA) or 14 percent (ATX) in treated patients (P=NS). Additionally, a 24-hour mean rise in MCP-1 of 19 percent (PTA) or 14 percent (ATX) was seen in the non-treated group, while treated patients experienced a reduction of 39 percent (PTA, P<0.003) or 52 percent (ATX, P<0.00005).

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. 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.”

Armstrong reported no relevant disclosures.

For more information: www.scaiscientificsessions.org

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Overlay Init