One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients

Taeymans, Kim; Bosiers, Marc; Deloose, Koen; Callaert, Joren; Keirse, Koen; Verbist, Jürgen; Eynde, Wouter Van den; Torsello, Giovanni; Wauters, Jeroen

doi:10.23736/s0021-9509.19.10830-0

Cited by 3 publications

(6 citation statements)

References 12 publications

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“…Despite the greater complexity of our patient cohort in terms of comorbidities, clinical presentation, and lesion characteristics, the early and midterm outcomes in our study were respectable compared with the other published series of infrapopliteal BVS and metallic DES. 14–17 Our 86% 12-month patency rate was somewhat inferior to patency rates noted in the existing BVS studies (92%–96%), 14–16 which could be explained by a more complex group of patients in the current study. The presence of diabetes, calcification, and associated lesion complexity is known to adversely affect the outcomes in patients with PAD 18,19 and could have been contributing factors.…”

Section: Discussioncontrasting

confidence: 89%

“…13,20 Despite these limitations, our patients experienced patency rates in the range reported for metallic DES (80%-86%). 17,21 The lower 12-month patency rate in our study did not translate to a significant need for CD-TLR. Freedom from CD-TLR at 12 months in our study was 93% vs 96% in a previous study on Absorb BVS with a relatively high 96% 12-month patency rate.…”

Section: Discussionmentioning

confidence: 52%

“…13,20 Despite these limitations, our patients experienced patency rates in the range reported for metallic DES (80%–86%). 17,21…”

Section: Discussionmentioning

confidence: 99%

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Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

et al. 2020

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Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR ( Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

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Section: Discussioncontrasting

confidence: 89%

Section: Discussionmentioning

confidence: 52%

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Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

et al. 2020

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“…The efficacy of other -limus (sirolimus, everolimus) eluting stents for the treatment of infrapopliteal arterial disease has been analyzed in systematic reviews, prospective and retrospective cohort studies [ 43 , 44 , 45 , 46 , 47 ]. In a meta-analysis by Fong [ 43 ], individual patient data meta-analysis of 282 patients who underwent infrapopliteal stenting with sirolimus eluting stents yielded primary patency rates of 95.2% and 82.8% at 6 and 12 months respectively, whereas pooled six-month primary patency (339 patients) was 87.3%.…”

Section: Discussionmentioning

confidence: 99%

“…The results were not satisfactory and were inferior to previously reported outcomes with primary patency reaching 57% at one year [ 45 ]. The PREVENT study was a prospective, multicenter, non-randomized study that evaluated the everolimus eluting stent “Promus Element and Promus Element Plus stents” (Boston Scientific, Marlborough, MA, USA) [ 46 ]. Primary patency was 86.2% and freedom from TLR was 93% at 1 year.…”

Section: Discussionmentioning

confidence: 99%

Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium

et al. 2022

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Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5–6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.

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Below-the-Knee Stents and Scaffolds: A Comprehensive Review

Dadrass

Raja

Lookstein

2023

Semin intervent Radiol

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Below-the-knee intervention of chronic limb-threatening ischemia is an area of increasing interest. Due to lower morbidity and possibly better clinical outcomes, endovascular techniques have become increasingly important in this patient population many of who have limited surgical options. This article serves as a review of existing stent and scaffolding devices utilized for infrapopliteal disease. The authors will additionally discuss current indications and review studies that are investigating novel materials used in treating infrapopliteal arterial disease.

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One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients

Cited by 3 publications

References 12 publications

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium

Below-the-Knee Stents and Scaffolds: A Comprehensive Review

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