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Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice

BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receivi...

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Autores principales: Lee, Joo Myung, Joh, Hyun Sung, Choi, Ki Hong, Hong, David, Park, Taek Kyu, Yang, Jeong Hoon, Song, Young Bin, Choi, Jin-Ho, Choi, Seung-Hyuk, Jeong, Jin-Ok, Lee, Jong-Young, Choi, Young Jin, Chae, Jei-Keon, Hur, Seung-Ho, Bae, Jang-Whan, Oh, Ju-Hyeon, Chun, Kook-Jin, Kim, Hyun-Joong, Cho, Byung Ryul, Shin, Doosup, Lee, Seung Hun, Hwang, Doyeon, Lee, Hyun-Jong, Jang, Ho-Jun, Kim, Hyun Kuk, Ha, Sang Jin, Shin, Eun-Seok, Doh, Joon-Hyung, Hahn, Joo-Yong, Gwon, Hyeon-Cheol
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Medical Sciences 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9902667/
https://www.ncbi.nlm.nih.gov/pubmed/36747363
http://dx.doi.org/10.3346/jkms.2023.38.e34
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author Lee, Joo Myung
Joh, Hyun Sung
Choi, Ki Hong
Hong, David
Park, Taek Kyu
Yang, Jeong Hoon
Song, Young Bin
Choi, Jin-Ho
Choi, Seung-Hyuk
Jeong, Jin-Ok
Lee, Jong-Young
Choi, Young Jin
Chae, Jei-Keon
Hur, Seung-Ho
Bae, Jang-Whan
Oh, Ju-Hyeon
Chun, Kook-Jin
Kim, Hyun-Joong
Cho, Byung Ryul
Shin, Doosup
Lee, Seung Hun
Hwang, Doyeon
Lee, Hyun-Jong
Jang, Ho-Jun
Kim, Hyun Kuk
Ha, Sang Jin
Shin, Eun-Seok
Doh, Joon-Hyung
Hahn, Joo-Yong
Gwon, Hyeon-Cheol
author_facet Lee, Joo Myung
Joh, Hyun Sung
Choi, Ki Hong
Hong, David
Park, Taek Kyu
Yang, Jeong Hoon
Song, Young Bin
Choi, Jin-Ho
Choi, Seung-Hyuk
Jeong, Jin-Ok
Lee, Jong-Young
Choi, Young Jin
Chae, Jei-Keon
Hur, Seung-Ho
Bae, Jang-Whan
Oh, Ju-Hyeon
Chun, Kook-Jin
Kim, Hyun-Joong
Cho, Byung Ryul
Shin, Doosup
Lee, Seung Hun
Hwang, Doyeon
Lee, Hyun-Jong
Jang, Ho-Jun
Kim, Hyun Kuk
Ha, Sang Jin
Shin, Eun-Seok
Doh, Joon-Hyung
Hahn, Joo-Yong
Gwon, Hyeon-Cheol
author_sort Lee, Joo Myung
collection PubMed
description BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS: The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS: Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487–3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663–3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION: With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02601404, NCT04265443
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spelling pubmed-99026672023-02-08 Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice Lee, Joo Myung Joh, Hyun Sung Choi, Ki Hong Hong, David Park, Taek Kyu Yang, Jeong Hoon Song, Young Bin Choi, Jin-Ho Choi, Seung-Hyuk Jeong, Jin-Ok Lee, Jong-Young Choi, Young Jin Chae, Jei-Keon Hur, Seung-Ho Bae, Jang-Whan Oh, Ju-Hyeon Chun, Kook-Jin Kim, Hyun-Joong Cho, Byung Ryul Shin, Doosup Lee, Seung Hun Hwang, Doyeon Lee, Hyun-Jong Jang, Ho-Jun Kim, Hyun Kuk Ha, Sang Jin Shin, Eun-Seok Doh, Joon-Hyung Hahn, Joo-Yong Gwon, Hyeon-Cheol J Korean Med Sci Original Article BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS: The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS: Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487–3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663–3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION: With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02601404, NCT04265443 The Korean Academy of Medical Sciences 2023-01-13 /pmc/articles/PMC9902667/ /pubmed/36747363 http://dx.doi.org/10.3346/jkms.2023.38.e34 Text en © 2023 The Korean Academy of Medical Sciences. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Lee, Joo Myung
Joh, Hyun Sung
Choi, Ki Hong
Hong, David
Park, Taek Kyu
Yang, Jeong Hoon
Song, Young Bin
Choi, Jin-Ho
Choi, Seung-Hyuk
Jeong, Jin-Ok
Lee, Jong-Young
Choi, Young Jin
Chae, Jei-Keon
Hur, Seung-Ho
Bae, Jang-Whan
Oh, Ju-Hyeon
Chun, Kook-Jin
Kim, Hyun-Joong
Cho, Byung Ryul
Shin, Doosup
Lee, Seung Hun
Hwang, Doyeon
Lee, Hyun-Jong
Jang, Ho-Jun
Kim, Hyun Kuk
Ha, Sang Jin
Shin, Eun-Seok
Doh, Joon-Hyung
Hahn, Joo-Yong
Gwon, Hyeon-Cheol
Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
title Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
title_full Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
title_fullStr Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
title_full_unstemmed Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
title_short Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
title_sort safety and efficacy of everolimus-eluting bioresorbable vascular scaffold versus second-generation drug-eluting stents in real-world practice
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9902667/
https://www.ncbi.nlm.nih.gov/pubmed/36747363
http://dx.doi.org/10.3346/jkms.2023.38.e34
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