Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry.

Published on May 31, 2021in Radiologia Medica2
· DOI :10.1007/S11547-021-01373-5
Maria Antonella Ruffino6
Estimated H-index: 6
,
Marco Fronda3
Estimated H-index: 3
+ 18 AuthorsPaolo Fonio23
Estimated H-index: 23
Sources
Abstract
PURPOSE To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. METHODS Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. RESULTS The primary patency rate was 99(95%CI 98-100)% at 1 month, 86(80-92)% at 6 months and 81(74-88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86-96)% at 6 months and 88(82-94)% at 12 months and a secondary patency of 94(90-98)% at 6 months and 90(84-95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. CONCLUSIONS The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.
References17
Newest
#1Jun Shu (Albert Einstein College of Medicine)H-Index: 6
#2Gaetano Santulli (Albert Einstein College of Medicine)H-Index: 52
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#1Pierleone Lucatelli (UNISI: University of Siena)H-Index: 18
#2Marco Cini (UNISI: University of Siena)H-Index: 5
Last. Carmelo Ricci (UNISI: University of Siena)H-Index: 8
view all 8 authors...
Abstract Purpose To prospectively evaluate the safety and efficacy of using the Tigris vascular stent (Gore, Flagstaff, Arizona) alone or in combination with the Viabahn stent (Gore) for revascularizing femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) type B–D lesions with varying degrees of calcification. Materials and Methods Patients with Rutherford stage ≥ 3 and TASC type ≥ B were included in the study. From January 2015 to April 2017, 31 segments in 31 patients (21 men, ovarall ...
3 CitationsSource
#1John R. Laird (UC Davis: University of California, Davis)H-Index: 31
#2Thomas ZellerH-Index: 74
Last. Michael R. Jaff (Harvard University)H-Index: 89
view all 12 authors...
Purpose: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA). Methods: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was ...
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#1Maxime SibéH-Index: 1
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Abstract Background Preliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease. Methods This retrospective, single-arm, multicenter cohort study ...
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#1Aneeta Parthipun (HealthPartners)H-Index: 4
#2Athanasios Diamantopoulos (HealthPartners)H-Index: 19
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#1M PiorkowskiH-Index: 2
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The aim of this paper was to report the continued mid-term follow-up of the first patients world-wide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Sten...
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#1F. Gerald R. Fowkes (Edin.: University of Edinburgh)H-Index: 46
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Summary Background Lower extremity peripheral artery disease is the third leading cause of atherosclerotic cardiovascular morbidity, following coronary artery disease and stroke. This study provides the first comparison of the prevalence of peripheral artery disease between high-income countries (HIC) and low-income or middle-income countries (LMIC), establishes the primary risk factors for peripheral artery disease in these settings, and estimates the number of people living with peripheral art...
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Background—It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal lesions, also reduces angiographic restenosis. Methods and Results—The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred pa...
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#1John R. LairdH-Index: 31
#2Barry T. KatzenH-Index: 53
Last. Michael R. Jaff (Harvard University)H-Index: 89
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PurposeTo evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty.MethodsTwo hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for...
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#1Christos Kasapis (UM: University of Michigan)H-Index: 5
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Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis affecting 5 million adults in the United States, with an age-adjusted prevalence of 4% to 15% and increasing up to 30% with age and the presence of cardiovascular risk factors. In this article we focus on lower extremity PAD and specifically on the superficial femoral and proximal popliteal artery (SFPA), which are the most common anatomic locations of lower extremity atherosclerosis. We summarize current evidence and...
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