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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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Detalles Bibliográficos
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
Descripción
Sumario: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