Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
- Author:
Joo Myung LEE
1
;
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
;
On behalf of the SMART-REWARD Investigators
Author Information
- Publication Type:Original Article
- From:Journal of Korean Medical Science 2023;38(5):e34-
- CountryRepublic of Korea
- Language:English
-
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 patientoriented 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.
