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
Kum, Steven; Ipema, Jetty; Chun-yin, Derek Ho; Lim, Darryl M.; Tan, Yih Kai; Varcoe, Ramon L.; Hazenberg, Constantijn E.V.B.; Ünlü, Çağdaş
(2020) Journal of Endovascular Therapy, volume 27, issue 4, pp. 616 - 622
(Article)
Abstract
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;
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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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Keywords: Absorbable Implants, Aged, Amputation, Asians, Cardiovascular Agents/administration & dosage, Chronic Disease, Endovascular Procedures/adverse effects, Everolimus/administration & dosage, Female, Humans, Ischemia/diagnostic imaging, Limb Salvage, Male, Middle Aged, Peripheral Arterial Disease/diagnostic imaging, Popliteal Artery/diagnostic imaging, Prosthesis Design, Registries, Retrospective Studies, Risk Factors, Singapore, Time Factors, Treatment Outcome, Vascular Patency, Wound Healing, Journal Article, Observational Study
ISSN: 1526-6028
Publisher: International Society of Endovascular Specialists
Note: Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by the National Medical Research Council of Singapore (NMRC Grant no. CG12Aug02-09). Abbott Vascular provided an educational grant but had no role in the reporting of results or drafting of the manuscript. Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by the National Medical Research Council of Singapore (NMRC Grant no. CG12Aug02-09). Abbott Vascular provided an educational grant but had no role in the reporting of results or drafting of the manuscript. Publisher Copyright: © The Author(s) 2020.
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