Percutaneous Bypass for Long, Complex SFA Lesions Holds Up Well to 6 Months: DETOUR I Study
The novel therapy improved symptoms and achieved a primary patency rate of 84.7% at 6 months, researchers reported at ISET 2017.
HOLLYWOOD, FL—Percutaneous bypass may be a path toward better long-term patency in long, complex superficial femoral artery (SFA) lesions by virtue of combining the best of both surgical and endovascular methods, according to data from the DETOUR I trial. At 6 months, the primary patency rate in the study was 84.7%.
Presenting his findings at the International Symposium on Endovascular Therapy (ISET) 2017 earlier this week, investigator Sean P. Lyden, MD (Cleveland Clinic, OH), explained: “Really the thought is, can you do this percutaneously? Provide the durability [of surgery] with the reduced morbidity and mortality [of] less invasive endovascular techniques?”
The technology being studied, PQ Detour (PQ Bypass), “is designed to achieve the same end result as open bypass surgery,” he said.
During the percutaneous bypass, “fluoroscopic guidance is used to deploy a series of proprietary PQ Bypass Stent Grafts from the popliteal artery into the femoral vein, and from the femoral vein into the [SFA] in a continuous, overlapping fashion through two independent anastomoses,” the company explained in a recent press release. “The final result is a large lumen, endograft bypass that delivers unobstructed, pulsatile flow from the SFA ostium to the popliteal artery and restores blood flow to the lower extremities.”
Barry Katzen, MD (Miami Cardiac and Vascular Institute, FL), discussing the results with TCTMD, said the technology shows potential for treating long-segment occlusions. “It’s a group of patients that haven’t been included in any clinical trials [of endovascular therapy and] have always been considered to be traditional bypass patients, so that’s the exciting thing about it.”
Explaining the approach, Katzen said, “The vein and the artery run adjacent to each other. And what it does is it uses the vein as a space in which to put the endograft. The conduit actually goes in the vein and then it reinters the artery . . . on the other side of the occlusion.”
Deep vein thrombosis (DVT) would be the “biggest concern,” he continued, “because how is it going to affect the venous return of the lower leg? Because now there’s an endograft in it.” Reassuringly, there was no evidence of this in the trial, Katzen said.
Results of DETOUR I were first announced late last month at the Leipzig Interventional Course (LINC).
Exceeded Performance Goal
For the study, Lyden et al enrolled 60 patients (59 were treated) at 7 sites. Mean lesion length was 28.6 cm (range 13.4-43.2 cm), with 96.7% of lesions being chronic total occlusions and 93.3% classified as TASC II D. One-third of the patients had previously undergone peripheral artery revascularization or surgery. Procedural and technical success were achieved in more than 95% of patients, Lyden noted.
The primary safety endpoint of 30-day major adverse events (MAE; defined as death, TVR, and target limb amputation) was 3.4% based on the occurrence of 2 TVRs. There were no instances of DVT within 30 days. The primary efficacy endpoint of 6-month primary patency was 84.7%, exceeding the study’s performance goal of 70%.
By 6 months, the MAE rate was 10.2% due to 6 total cases of TVR. There were no deaths or major amputations. Nor were significant changes in venous function based on either the Villata or VCSS scale. Most patients (94%) had improved by at least one Rutherford class by 6 months after treatment (P < 0.0001). Mean ankle-brachial index rose from 0.65 at baseline to 0.92 at 6 months (P < 0.0001).
“Percutaneous bypass using the femoral vein as a conduit may prove to be an important step forward in the treatment of long SFA occlusions,” Lyden concluded. This spring, he said, 12-month data from DETOUR I will be presented and the DETOUR II study will begin.
Lyden S. Results of the DETOUR I trial: percutaneous bypass for long-segment SFA occlusions. Presented at: ISET 2017. February 7, 2017. Hollywood, FL.
PQ Bypass. PQ Bypass announces positive results from DETOUR I Study at LINC 2017. http://www.businesswire.com/news/home/20170124006013/en/PQ-Bypass-Announces-Positive-Results-DETOUR-Study. Published on: January 24, 2017. Accessed on: February 7, 2017.
- Lyden reports serving as a consultant to Endologix, Spectranetics, and TVA Medical and as a board member of VIVA.
- Katzen reports serving on an advisory board for PQ Bypass but not being involved in the DETOUR I study.