KMID : 0191120230380050034
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Journal of Korean Medical Science 2023 Volume.38 No. 5 p.34 ~ p.34
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Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
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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 Doo-Sup Lee Seung-Hun Hwang Do-Yeon Lee Hyun-Jong Jang Ho-Jun Kim Hyun-Kuk Ha Sang-Jin Shin Eun-Seok Doh Joon-Hyung Hahn Joo-Yong Gwon Hyeon-Cheol
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Abstract
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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 ¡¾ 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.
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KEYWORD
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Bioresorbable Vascular Scaffold (BVS), Drug-Eluting Stent (DES), Safety, Efficacy
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