Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
- Author(s)
- Joo Myung Lee; Hyun Sung Joh; Ki Hong Choi; David Hong; Taek Kyu Park; Jeong Hoon Yang; Young Bin Song; Jin-Ho Choi; Seung-Hyuk Choi; Jin-Ok Jeong; Jong-Young Lee; Young Jin Choi; Jei-Keon Chae; Seung-Ho Hur; Jang-Whan Bae; Ju-Hyeon Oh; Kook-Jin Chun; Hyun-Joong Kim; Byung Ryul Cho; Doosup Shin; Seung Hun Lee; Doyeon Hwang; Hyun-Jong Lee; Ho-Jun Jang; Hyun Kuk Kim; Sang Jin Ha; Eun-Seok Shin; Joon-Hyung Doh; Joo-Yong Hahn; Hyeon-Cheol Gwon
- Keimyung Author(s)
- Hur, Seung Ho
- Department
- Dept. of Internal Medicine (내과학)
- Journal Title
- J Korean Med Sci
- Issued Date
- 2023
- Volume
- 38
- Issue
- 5
- Keyword
- Bioresorbable Vascular Scaffold (BVS); Drug-Eluting Stent (DES); Efficacy; Safety
- Abstract
- 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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