OCT-guided directional atherectomy system confers positive outcomes in PAD

A system combining directional atherectomy with OCT was safe and effective at 24 months in patients with peripheral artery disease, according to findings presented at the Leipzig Interventional Course.

Ian M. Cawich, MD, from Arkansas Heart Hospital, Little Rock, presented interim results of 55 of 158 patients (mean age, 67 years; 55% men) who completed 24-month follow-up of the VISION study evaluating safety and efficacy of the directional atherectomy system (Pantheris, Avinger) used in concert with real-time IVUS (Lumivascular, Avinger).

Study results were used to gain FDA clearance for the system in 2016, according to a press release issued by Avinger.

All patients were aged at least 18 years, were candidates for percutaneous intervention for PAD, had Rutherford classification 2 to 5 and had one or two de novo target lesions with stenosis 70%, Cawich said during a presentation.

The primary efficacy outcome was 50% residual stenosis after directional atherectomy. The primary safety outcomes were acute device-related events and freedom from major adverse events, defined as CV death, unplanned major index limb amputation, clinically driven target lesion revascularization and MI, at 6 months.

According to the release, most lesions were treated with OCT-guided directional atherectomy alone, with 9.6% of patients also receiving a drug-coated balloon and 5% of patients also receiving a stent.

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At 6 months, the overall rate of major adverse events was 16.6%, including 2.6% with CV death, 7.9% with TLR, 2% with MI and 4% with device-related events, Cawich said.

Among the 55 patients with 24-month follow-up, 85% were free from TLR, similar to the 88% freedom from TLR rate at 12 months, according to Cawich, who said there were no amputations at 24 months.

At 24 months, 54.2% of patients were Rutherford class 0 and 18.8% were Rutherford class 1, compared with none at baseline (P = .001), Cawich said.

Ankle-brachial index improved from 0.77 at baseline to 0.9 at 24 months (P = .0056), he said.

“These 24-month results demonstrate a stable, consistent and high-functioning patient population through 2 years — impressive results for a study of mostly stand-alone, drug-free atherectomy cases,” Cawich said in the release. “The findings are particularly striking considering that all data generation and outcomes were in the setting of a first-generation clinical trial device and brand-new users.” – by Erik Swain

Reference:

Cawich IM, et al. Update on peripheral clinical trials and new data – claudication/femoropopliteal. Presented at: Leipzig Interventional Course; Jan. 24-27, 2017; Leipzig, Germany.

Disclosure : The study was funded by Avinger. Cawich reports no relevant financial disclosures.