DETOUR I: Percutaneous bypass procedure successful in long peripheral lesions
A novel percutaneous bypass system using the femoral vein as a pathway conferred a high rate of patency with no effect on venous health in patients with very long superficial femoral artery lesions, according to data from VIVA 17.
Sean P. Lyden, MD, professor and chairman of the department of vascular surgery, Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic and chief medical officer for Excelerate Strategic Health Sourcing, presented a subanalysis of 50 patients (mean age, 65 years; 84% men) with lesions longer than 25 cm from the DETOUR I trial of the PQ Detour procedure (PQ Bypass), a percutaneous technique in which revascularization is performed via modular stent graft bypass using the femoral vein as a conduit.
In patients requiring long-segment femoropopliteal treatment, surgical bypass is associated with a longer length of stay, higher odds of wound complications and long rehabilitation and higher risk for readmission, whereas endovascular procedures confer low patency rates, high procedure times and use of multiple devices per procedure, Lyden said during a presentation.
“If you are treating patients with life-limiting claudication or critical limb ischemia, they typically have lesions longer than 15 cm,” Lyden told Cardiology Today’s Intervention. “We know that lesion length is directly proportional to patency. Despite whatever stents were placed, the longer the lesion, the worse they did. Atherectomy has worked about as well as stents in short lesions but not in long lesions. That leaves us with suboptimal treatments for patients with long-segment disease. This is one reason why there has been such an aggressive uptake of drug-coated balloons, but nothing is approved on-label that works well in these lesions. The Detour procedure can treat patients with severely calcified or long-segment disease. It’s essentially a femoropopliteal bypass with polytetrafluoroethylene (PTFE), but done percutaneously.”
For the present analysis, the primary safety endpoint was major adverse events, defined as death, target vessel revascularization or target limb amputation, at 30 days. The primary efficacy endpoint was primary patency at 6 months.
Mean lesion length was 33.8 cm and 96% of patients had total occlusions.
The device was delivered successfully in all procedures. Procedural success, defined as successful delivery and removal of the delivery system without in-hospital major adverse events, occurred in 98.1% of patients, and clinical success, defined as a 6-month improvement of at least 1 in Rutherford class, occurred in 94%, Lyden said.
The rate of major adverse events at 30 days was 2%, as one patient required TVR, he said.
At 6 months, primary patency was 76.9%, primary-assisted patency was 84.6% and secondary patency was 94.1%, according to the researchers. However, Lyden said, when excluding procedures where positioning of the system was suboptimal, those rates improved to 88.9% for primary patency, 91.1% primary-assisted patency and 95.6% for secondary patency.
There were no cases of deep vein thrombosis in the bypass segment at 6 months, and two metrics of venous function did not indicate significant changes between baseline and 6 months, Lyden said.
Rutherford class improved by at least 2 in 92% of patients from baseline to 6 months, according to the researchers. Also during that time, ankle-brachial index improved from 0.64 to 0.92 (P < .001).
“This procedure allows us a new way of treating patients in whom we can’t cross their lesions, we can’t get them open with a stent and we can’t atherectomize them without embolizing them,” Lyden told Cardiology Today’s Intervention. “The study showed an amazing patency rate in very difficult lesions.”
A U.S. pivotal trial for the system is expected to begin in 2018, he said, noting it does not yet have a CPT code, but professional societies are working to establish one before an FDA approval decision.
“We’ve argued that the work product is similar to what you’d have for a PTFE femoropopliteal bypass, with the advantage that it could potentially be done in an outpatient setting,” he said. – by Erik Swain
Lyden SP, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
Disclosure: The study was funded by PQ Bypass. Lyden reports he receives honoraria from Endologix; consults for Biomet, Endologix, PQ Bypass and Spectranetics; receives research funding from Bard Peripheral Vascular, Biomet, Bolton Medical, Boston Scientific, Cook Medical, Cordis, Endologix, the NIH, Spectranetics and W.L. Gore and Associates; and serves as treasurer of VIVA Physicians.