麻豆传媒

NEW ORLEANS -- The usual cycle of inflammation triggered by percutaneous transluminal angioplasty and atherectomy for peripheral artery disease (PAD) may be broken with local injection of a corticosteroid, an observational analysis suggested.

Injecting dexamethasone into the arterial wall right after either procedure was tied to reductions of two inflammatory biomarkers, reported Ehrin J. Armstrong, MD, MSc, director of Interventional Cardiology at the VA Eastern Colorado Healthcare System in Denver.

Twenty-four hours after atherectomy and angioplasty, high-sensitivity C-reactive protein climbed only 14% and 55%, respectively (compared with 138% and 208% for controls who did not receive the corticosteroid). Similarly, monocyte chemoattractive protein-1 (MCP-1) levels fell by 52% and 39% (as opposed to gains of 16% and 17% in controls).

Armstrong presented the late-breaking secondary analysis of the DANCE (Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy after Femoropopliteal Revascularization) study at the annual meeting here.

"Adventitial infusion and targeting of inflammation represent an appropriate and compelling challenge to established treatments," he told the audience.

"Painted" into the arterial wall by the Bullfrog Micro-Infusion device, dexamethasone is thought to cut down on the inflammation that is often blamed for restenosis, he explained. Indeed, top-line results of the multicenter DANCE study -- reported at the 2016 Vascular Interventional Advances (VIVA) meeting -- showed that the drug was associated with >80% rates of primary patency at 1 year, with freedom from target lesion revascularization approaching 90% to boot.

In the present analysis, Armstrong took a look at recipients of angioplasty (n=52) and atherectomy (n=42) who had blood drawn at baseline, at 24 hours, and at the 4-week mark.

"The elephant in the room is when will there be a trial to adequately prove this is true?" asked the session's co-moderator, Gregg W. Stone, MD, director of Cardiovascular Research and Education at Columbia University Medical Center/New York-Presbyterian Hospital in New York City. Stone pointed out that he himself had led a small steroid trial almost 3 decades ago that failed to find a reduction of restenosis in coronary arteries.

Coupled with the paucity of randomized data on PAD is the "difficulty that legs don't work the same way as coronaries," Armstrong suggested, given the differences in mechanics and torsion strength.

"We will have some additional randomized data, especially for below the knee." He noted that Mercator MedSystems, the maker of the Bullfrog device, is currently enrolling critical limb ischemia patients for the small randomized . This time, the drug in question is temsirolimus (Torisel).

Similarly, Proteon Therapeutics is investigating the effect of recombinant human elastase in a small phase I trial, Armstrong added.

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