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VISION: OCT-guided directional atherectomy safe, effective for patients with PAD
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LAS VEGAS — An OCT-guided directional atherectomy system was safe and effective at 6 months in patients with peripheral artery disease, according to results from the VISION investigational device exemption trial.
The system (Pantheris, Avinger) has OCT embedded approximately 1 mm behind the atherectomy blade’s edge, can be used with 8F or 7F catheters for lesions up to 130 cm (for 8F) or 110 cm (for 7F), and is compatible with .014-inch guidewires, Arne Schwindt, MD, from St. Franziskus Hospital in Münster, Germany, said during a presentation at VIVA 15.
The FDA approved the device in October based on the results of this trial, he said.
“The device visualizes the vessel wall in very high-resolution, histology-like pictures,” Schwindt said. “You can differentiate the layers of the vessel wall … and you can very accurately point the cutter toward plaque and remove it without injury to the deep-wall components. The amount of adventitial tissue in the overall study cohort was below 1%, based on histological area calculation.”
The prospective, single-arm study enrolled 130 patients (mean age, 67 years; 55% men) with 164 lesions in the superficial femoral artery and/or popliteal artery, of which 125 patients were available for analysis at 6 months.
The primary efficacy endpoint was postprocedure reduction of stenosis to less than 50% after atherectomy. The primary safety endpoints were freedom from acute device-related events such as pseudoaneurysm or clinically significant perforation, dissection or embolus and freedom from major adverse events, including CV death, unplanned limb amputation, MI and clinically driven target lesion revascularization, at 6 months.
The primary efficacy endpoint was achieved in 96.3% of lesions, with the lower bound 95% CI of 93.1% exceeding the performance goal of 87%, Schwindt said.
At 6 months, the rate of major adverse events was 17.6%, with the upper bound 95% CI of 23.9% exceeding the performance goal of 43.2%, he said.
The major adverse event rates broke down as follows: TLR 8%, CV death 3.2%, MI 2.4%, amputation 0% and device-related events 4%. The device-related events were three emboli related to the system, all of which did not require open surgery to address, and one dissection and one pseudoaneurysm related to the occlusion sheath.
The length of treated lesions turned out to be longer than the estimates based on fluoroscopy (P < .0001).
“This doesn’t surprise me because PAD is not a binary disease,” Schwindt said. “Plaque shifts in and out, so the average lesion length estimated by OCT was 2 cm longer than the radiographic image length.”
The rate of freedom from bailout stenting was 96%, including 97% in those with chronic total occlusions.
At 6 months, the cohort improved in ankle-brachial index (baseline, 0.76; 6 months, 0.85; P < .001) and in Rutherford class (P < .001).
“There was a five- to 10-case learning curve that leads to longer lesions treated, reduced adventitial injury and improved freedom from TLR,” he said. – by Erik Swain
Reference:
Schwindt A, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: Schwindt reports receiving honoraria from Abbott Vascular, Avinger, Cordis, Covidien, Medtronic and Terumo; receiving research funding from Avinger, Jotec and Viviasure; and serving as a consultant for Avinger.
Perspective
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Douglas E. Drachman, MD
The VISION trial confirmed the safety and efficacy of the Pantheris atherectomy catheter, guided by forward-facing OCT in the treatment of patients with femoropopliteal PAD. Of the 164 lesions treated in the study, 56% were successfully treated with Pantheris alone, 40% were treated with Pantheris and percutaneous transluminal angioplasty, and 4% were treated with bailout stenting. The 6-month TLR rate was 8%. The use of OCT facilitated the application of atherectomy selectively to the areas of plaque, with no evidence of dissection, perforation or late aneurysm formation. Clinically significant distal embolus was noted in 2.4%, which resolved with manual thrombectomy.
The opportunity to use intravascular imaging to direct therapy selectively to the areas of need is inherently appealing, as is the potential to reduce the need for fluoroscopy during treatment. Larger studies will help define whether this novel device and strategy provides greater efficacy and durability compared with conventional treatment paradigms in femoropopliteal PAD.
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