No convincing data vessel preparation enhances peripheral interventions

CHICAGO — Vessel preparation is common practice because of biological plausibility and successful case histories, but there are no convincing data that it confers superior outcomes in endovascular procedures to treat peripheral artery disease, according to an expert.

“We share a collective belief that debulking with atherectomy and aggressive vessel preparation leads to some magical chain of events, including lumen gain, a raw and uniform surface or uptake, deeper penetration and less dissection,” James D. Joye, DO, FACC, from El Camino Hospital in Mountain View, California, said in a presentation at AMP: The Amputation Prevention Symposium.

Although acute results of debulking plus use of a drug-coated balloon are “more appealing to the eye” vs. DCB use alone, “the question remains, is it durable or superior?” Joye said. “What is the inflammatory cost of plaque removal? How effective are current devices at lumen gain? What does history tell us about atherectomy outcomes?”

The problem is that not enough research has been done to definitively address those issues, he said.

“It seems inherently logical that starting with a better lumen would improve outcomes with a variety of final treatment options, but does it?” Joye said. “Are we doing the right studies? Our biases make it hard to believe that reducing plaque burden as a prelude to final therapies is not the right thing to do. Bigger [lumen] is better, at least we’ve all been taught that. Deeper penetration of the drug must be better. Mechanical sequelae of atherectomy can be overcome by the soothing effects of things like DCBs. But the current literature doesn’t tell us that is true.”

Fortunately, he said, “we’re now getting to the point where we’re starting to do meaningful trials to push for finality.”

DEFINITIVE AR “was essentially designed to pilot this concept” and demonstrated safety and feasibility of plaque removal with directional atherectomy before use of a DCB, Joye said. Other studies evaluating use of atherectomy and a DCB in the same procedure include OPTIMIZE BTK and REALITY, he added.

“At present, there are not convincing data that vessel prep enhances the outcomes of endovascular therapies,” Joye said. “Until we fully evaluate multi-device therapy, we will not know if the expense attached to what we believe must be true is realized in long-term patency.” – by Erik Swain

Reference:

Joye JD. Is there convincing evidence for aggressive vessel prep prior to some of the final treatment options? Presented at: AMP: The Amputation Prevention Symposium; Aug. 10-13, 2016; Chicago.

Disclosure: Joye reports founding NuCryo and holding equity in NuCryo and PQ Bypass.