Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

Varcoe, Ramon L.; Thomas, Shannon D.; Lennox, Andrew

doi:10.1177/1526602818799736

Cited by 28 publications

(42 citation statements)

References 51 publications

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“…Despite lack of superior outcomes in the coronary arteries, a recent trial demonstrated the short‐term safety of an Absorb BVS in simple lesions below the knee, reporting excellent 12‐month vessel patency rates and most recently at 36 months . The aim of our study was to assess the safety and efficacy of the Absorb BVS in complex, infrapopliteal lesions for the management of chronic limb ischemia.…”

Section: Introductionmentioning

confidence: 99%

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease

Dia

Venturini

Kalathiya

et al. 2019

Cathet Cardio Intervent

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Objectives To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. Background The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug‐eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long‐term inflammation. BVSs are biodegradable scaffolds that provide short‐term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12‐month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. Methods This single‐center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly‐L‐lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD‐TVF) at 12 months. Results Thirty‐one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80–100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD‐TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford–Becker classification. Conclusions At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD‐TVF.

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Section: Introductionmentioning

confidence: 99%

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease

Dia

Venturini

Kalathiya

et al. 2019

Cathet Cardio Intervent

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“…Initial experiences with non‐drug eluting BRS yielded comparable immediate angiographic results to metal stents, but improvements of mechanical characteristics and addition of an antiproliferative drug appeared necessary to reduce the restenosis rate during the resorption period . A more refined drug‐eluting BRS technology in the form of coronary ABSORB BVS was used in the below the knee territory with sustained good results out to 3 years . The only dedicated BRS for peripheral use demonstrated favorable results out to 2 years in a first‐in‐human study, 9 but overall progress has been slow, proving that a quick transformation of technically viable coronary BRS technology into peripheral application is not warranted.…”

Section: Discussionmentioning

confidence: 99%

“…Although the long‐term outcomes of BRS in the coronary setting have been disappointing in comparison to metallic DES, peripheral arteries have a different pathological (diffuse atherosclerosis with higher occurrence of chronic occlusions) and physiological (different healing and restenotic response) profile . Hence, some of the presumed benefits of BRS like the restoration of artery plasticity and the capacity to improve lumen patency over time may still be attainable in PAD at a more favorable risk‐to‐benefit ratio than in the coronary arteries; however, there have been very few reports on peripheral use of BRS to date . We conducted a preclinical pilot study evaluating operational performance, pharmacokinetics, and long‐term durability and biocompatibility of a novel sirolimus‐eluting balloon‐expandable BRS (Credence BRS, Meril Life Sciences, Gujarat, India).…”

Section: Introductionmentioning

confidence: 99%

Long‐term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three‐year pilot study in Yucatan miniswine

Melnick

Ferrone

Cheng

et al. 2020

Cathet Cardio Intervent

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Aims Peripheral arteries are constantly exposed to deformation (elongation, twisting, shortening, compression) making bioresorbable scaffolds (BRS) a potentially attractive therapeutic alternative to metallic stents. We conducted a long‐term pilot preclinical study of a novel sirolimus‐eluting BRS in peripheral arteries. Methods and results Fourteen BRS were deployed in iliofemoral arteries of seven healthy Yucatan miniswine and examined with imaging, pharmacokinetic, histopathologic, and polymer degradation techniques at 0, 30, 90, 180 days, 1, 2, and 3.3 years. Angiographic late luminal loss remained unchanged at 30 and 180 days but significantly decreased from 1 to 3.3 years. optical coherence tomography (OCT) showed late increase in lumen area (1 year: 14.70 ± 3.58 mm2, 2 years 22.04 ± 3.81 mm2, and 3.3 years 23.45 ± 7.07 mm2; p < .05) primarily due to scaffold area enlargement between 1 and 3.3 years, while there was no difference in the percent area stenosis at all time points. Histologic evidence of scaffold degradation was observed starting at 2 years, with minimal inflammatory reaction. At 3.3 years, BRS struts were rarely discernible by OCT, confirmed by a nearly complete polymer degradation by molecular weight analysis. Conclusions In this pilot study, novel sirolimus‐eluting BRS showed promising acute and chronic performance in the iliofemoral arteries of Yucatan miniswine.

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“…12 Contrarily, early and midterm results of BVS implantation in infrapopliteal arteries were encouraging. [13][14][15] The current report presents the early and midterm experience with the Absorb BVS in a cohort of patients with CLTI from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry.…”

Section: Introductionmentioning

confidence: 99%

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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Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

Abstract: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

Cited by 28 publications

References 51 publications

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease

Long‐term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three‐year pilot study in Yucatan miniswine

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

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