One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass

J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8.

Abstract

Objective: The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.

Methods: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR.

Results: During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism.

Conclusions: The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions.

Trial registration: ClinicalTrials.gov NCT02471638.

Keywords: Bypass; Claudication; Endovascular; Femoropopliteal artery disease.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amputation / statistics & numerical data
  • Arterial Occlusive Diseases / complications
  • Arterial Occlusive Diseases / mortality
  • Arterial Occlusive Diseases / surgery*
  • Endovascular Procedures / adverse effects*
  • Endovascular Procedures / instrumentation
  • Female
  • Femoral Artery / surgery
  • Humans
  • Intermittent Claudication / etiology
  • Intermittent Claudication / mortality
  • Intermittent Claudication / surgery*
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / complications
  • Peripheral Arterial Disease / mortality
  • Peripheral Arterial Disease / surgery*
  • Popliteal Artery / surgery
  • Postoperative Complications / epidemiology*
  • Postoperative Complications / etiology
  • Prospective Studies
  • Stents / adverse effects
  • Treatment Outcome
  • Vascular Patency
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT02471638