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

Simple item page
dc.contributor.authorKrievins, Dainis K.
dc.contributor.authorHalena, Grzegorz
dc.contributor.authorScheinert, Dierk
dc.contributor.authorSavlovskis, Janis
dc.contributor.authorSzopinski, Piotr
dc.contributor.authorKraemer, Albrecht
dc.contributor.authorOuriel, Kenneth
dc.contributor.authorNair, Kasthuri
dc.contributor.authorHolden, Andrew
dc.contributor.authorSchmidt, Andrej
dc.date.accessioned2025-01-23T19:46:05Z
dc.date.available2025-01-23T19:46:05Z
dc.date.issued2020
dc.description.abstractObjective: 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.
dc.description.abstractMethods: 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.
dc.description.abstractResults: During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 +/- 55mm; 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-yearKaplan-Meier primary, assisted primary, and secondary patency rates were 81% 64%, 82% 64%, and 90% 63%, respectively. Theankle-brachial index increased anaverage 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% 64%, 85% 64%, and 84% 64%, 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.
dc.description.abstractConclusions: 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.
dc.description.funderPQ Bypass
dc.fuente.origenWOS
dc.identifier.doi10.1016/j.jvs.2020.02.043
dc.identifier.issn0741-5214
dc.identifier.urihttps://doi.org/10.1016/j.jvs.2020.02.043
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/100261
dc.identifier.wosidWOS:000580652000019
dc.issue.numero5
dc.language.isoen
dc.pagina.final+
dc.pagina.inicio1648
dc.revistaJournal of vascular surgery
dc.rightsacceso restringido
dc.subjectFemoropopliteal artery disease
dc.subjectBypass
dc.subjectEndovascular
dc.subjectClaudication
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleOne-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass
dc.typeartículo
dc.volumen72
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
Files
Collections
Artículos de revistas