دورية أكاديمية
أعرض في EDS

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

التفاصيل البيبلوغرافية
العنوان: Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.
المؤلفون: van Walraven LA; Department of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands; Multi-Modality Medical Imaging Group, University of Twente, Enschede, The Netherlands., Kalil VM; Albert Einstein Hospital College, Faculdade Israelita de Ciências da Saúde Albert Einstein, São Paulo, Brazil., van der Veen D; Department of Surgery, Rijnstate, Arnhem, The Netherlands., Bosiers MJ; Department of Vascular Surgery, St. Franziskus-Hospital, Munster, Germany; Department of Vascular Surgery, University Hospital Bern, University of Bern, Bern, Switzerland., Deloose K; Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium., Holewijn S; Department of Surgery, Rijnstate, Arnhem, The Netherlands., Zeebregts CJ; Department of Surgery (Division of Vascular Surgery), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Reijnen MMPJ; Multi-Modality Medical Imaging Group, University of Twente, Enschede, The Netherlands; Department of Surgery, Rijnstate, Arnhem, The Netherlands. Electronic address: mmpj.reijnen@gmail.com.
المصدر: Journal of vascular surgery [J Vasc Surg] 2024 Aug; Vol. 80 (2), pp. 505-514.e2. Date of Electronic Publication: 2024 Apr 09.
نوع المنشور: Journal Article; Comparative Study
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 8407742 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6809 (Electronic) Linking ISSN: 07415214 NLM ISO Abbreviation: J Vasc Surg Subsets: MEDLINE
أسماء مطبوعة: Publication: <2008-> : New York, NY : Elsevier
Original Publication: St. Louis, Mo. : Mosby, [c1984-
مواضيع طبية MeSH: Femoral Artery*/physiopathology , Femoral Artery*/diagnostic imaging , Peripheral Arterial Disease*/therapy , Peripheral Arterial Disease*/physiopathology , Peripheral Arterial Disease*/diagnostic imaging , Peripheral Arterial Disease*/mortality , Vascular Patency* , Drug-Eluting Stents* , Limb Salvage* , Endovascular Procedures*/adverse effects , Endovascular Procedures*/instrumentation , Endovascular Procedures*/mortality, Humans ; Male ; Female ; Aged ; Time Factors ; Treatment Outcome ; Coated Materials, Biocompatible ; Heparin/administration & dosage ; Middle Aged ; Risk Factors ; Prosthesis Design ; Amputation, Surgical ; Anticoagulants/therapeutic use ; Aged, 80 and over ; Databases, Factual ; Stents ; Randomized Controlled Trials as Topic
مستخلص: Objective: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up.
Methods: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality.
Results: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR.
Conclusions: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.
Competing Interests: Disclosures L.v.W. received speaker fees from W.L. Gore & Associates. M.B. reports consulting for Cook Medical. K.D. reports consulting for W.L. Gore & Associates and Cook Medical. C.J.Z. reports research support, honoraria, and travel support from W.L. Gore & Associates and Cook Medical. M.R. reports consulting for W.L. Gore & Associates.
(Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
فهرسة مساهمة: Keywords: Covered stents; Drug eluting stents; SFA
المشرفين على المادة: 0 (Coated Materials, Biocompatible)
9005-49-6 (Heparin)
0 (Anticoagulants)
تواريخ الأحداث: Date Created: 20240411 Date Completed: 20240720 Latest Revision: 20240720
رمز التحديث: 20240722
DOI: 10.1016/j.jvs.2024.03.449
PMID: 38604319
قاعدة البيانات: MEDLINE
الوصف
تدمد:1097-6809
DOI:10.1016/j.jvs.2024.03.449