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REACH PVI Clinical Trial Update

Debra L. Beck, MSc

“We've always wondered if we can successfully perform radial artery access to do peripheral interventions,” started Ankur Lohda, MD, from the Cardiovascular Institute of the South in Lafayette, LA. His AMP 2020 Virtual talk provided attendees with an update on radial artery access for peripheral intervention, reporting data from the REACH PVI trial.

 “Radial artery access for peripheral intervention has gained a lot of attention because of the success we’ve seen with coronary intervention using radial access,” explained Dr. Lohda. Among the many factors that can complicate femoral access, bilateral hostile groins (from previous surgery or obesity), infrainguinal lesions, and the presence of kissing iliac stents or bifurcated aortic grafts count among the worse.

Radial artery access also provides several unique benefits, said Dr. Lohda. These include a reduced incidence of access site complications, avoidance of difficult sheath placement, and quicker ambulation and shorter discharge time.

It also eliminates the need for compression of the femoral artery (and a closure device) and is preferred by patients.

“Historically, the use of radial access for peripheral interventions has been limited primarily due to a lack of dedicated extended-length equipment,” said Dr. Lohda. “However, now we have an extended length peripheral orbital atherectomy [OA] catheter from CSI [Cardiovascular Systems, Inc], which is 180 to 200 centimeters long.”

“It comes in various sizes and can easily go from an intervention of the SFA and into the infrapopliteal vessels using radial artery access,” said Dr. Lohda.

REACH PVI

The Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI (REACH PVI) observational, post-market trial included 50 patients enrolled at 6 clinical sites.

This single-arm study used the Diamondback 360 Extended Length Orbital Atherectomy System and enrolled patients with Rutherford class 2 to 5 lesions and a positive Allen’s test.

More than half (62%) of patients were Rutherford class 3 and 86% were current or previous smokers.

The most common target lesion was the superficial femoral artery (68%) with 78% of patients having severe calcification (PARC criteria).

The primary outcome of procedural success, defined as completion of the OA treatment of target lesion via transradial access without serious transradial access-related events, was seen in 100% of patients with final residual stenosis of a mean of 7.6%. There was no serious access site bleeding or hematoma.

Treatment success (final residual stenosis <50% without stent placement or <30% residual stenosis with stent placement and without significant angiographic complications) was seen in 98%. There was one dissection.

Overall, length of stay was 7.2 hours from admission to discharge. “It is fair to assume” that the length of stay will go down further as these centers get more experience, to around 2 to 4 hours, said Dr. Lohda.

“I would say that this study has demonstrated that orbital atherectomy can be utilized via transradial access,” with this extended-length catheter. There appear to be clear clinical and economic benefits to transradial access peripheral intervention, he concluded.

FOR FULL ACCESS TO THIS PRESENTATION PLEASE VISIT THE AMP 2020 VIRTUAL EVENT PAGE AND REGISTER AT:

https://www.ampclivirtual.com/login

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