A study of a novel percutaneous technique for treating long, complex occlusions of the superficial femoral artery met its primary safety and efficacy endpoints, according to findings presented at the Leipzig Interventional Course.
The DETOUR I study evaluated 30-day and 6-month results 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, Dierk Scheinert, MD, chairman of the division of interventional angiology, University Hospital Leipzig, Germany, said during a presentation.
“Percutaneous bypass may provide the durability associated with open surgery while reducing morbidity and mortality associated with more invasive interventions,” he said.
Scheinert and colleagues enrolled 60 patients (mean age, 64 years; 83% men) with long-segment superficial femoral artery (SFA) occlusions of at least 10 cm (mean, 28.6 cm; 96.7% total occlusions; 93.3% TASC-II type D lesion type).
The primary safety endpoint was 30-day major adverse events, defined as death, target vessel revascularization or target limb amputation. The primary efficacy endpoint was 6-month primary patency, defined as no evidence of stenosis 50% within or near the treated arterial segment according to duplex ultrasound.
Technical success was 98.3%, procedural success was 96.7% and clinical success, defined as improvement of at least one grade in Rutherford class at 6 months, was 94.7% (P < .0001), according to the researchers.
At 30 days, two patients had TVR and none died or had target limb amputation, for a major adverse event rate of 3.4%, Scheinert reported. At 6 months, 10.2% had TVR and none died or had target limb amputation, he said.
The 6-month rate of primary patency was 84.7%, beating the performance goal of 70%, and there were no changes in venous function scores according to the Villalta and venous clinical severity score (VCSS) scales, Scheinert said.
“The data from this study strongly suggest that the PQ Detour procedure provides a viable option for revascularization via modular stent graft bypass, a much-needed treatment option for patients with long-segment occlusive disease,” Scheinert said in a press release. “The clinical performance in severe lesions demonstrates the potential for this novel therapy for complex patients who are otherwise left without a durable endovascular option. The results warrant further evaluation as percutaneous bypass using the femoral vein as a conduit may prove to be an important step forward in the treatment of extremely long SFA occlusions.” – by Erik Swain
Scheinert D, et al. The Last Frontiers: New concepts for calcified lesions. Presented at: Leipzig Interventional Course; Jan. 24-27, 2017; Leipzig, Germany.
Scheinert reports no relevant financial disclosures.