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Expanded clinical use of everolimus eluting bioresorbable vascular scaffolds for treatment of coronary artery disease


Diletti, Roberto; Ishibashi, Yuki; Felix, Cordula; Onuma, Yoshinobu; Nakatani, Shimpei; van Mieghem, Nicolas M; Regar, Eveliyn; Valgimigli, Marco; de Jaegere, Peter P; van Ditzhuijzen, Nienke; Fam, Jiang Ming; Ligthart, Jurgen M R; Lenzen, Mattie J; Serruys, Patrick W; Zijlstra, Felix; Jan van Geuns, Robert (2017). Expanded clinical use of everolimus eluting bioresorbable vascular scaffolds for treatment of coronary artery disease. Catheterization and Cardiovascular Interventions, 90(1):58-69.

Abstract

BACKGROUND: Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice.
METHODS: This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported.
RESULTS: A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%.
CONCLUSIONS: The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.

Abstract

BACKGROUND: Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice.
METHODS: This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported.
RESULTS: A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%.
CONCLUSIONS: The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Uncontrolled Keywords:Bioabsorbable devices/polymers, , Coronary artery disease, , Interventional devices/innovation
Language:English
Date:July 2017
Deposited On:01 Feb 2018 17:13
Last Modified:19 Feb 2018 10:42
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:1522-1946
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/ccd.26832
PubMed ID:27896897

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