J Korean Med Sci.  2023 Feb;38(5):e34. 10.3346/jkms.2023.38.e34.

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

• Lee JM
• Joh HS
• Choi KH
• Hong D
• Park TK
• Yang JH
• Song YB
• Choi JH
• Choi SH
• Jeong JO
• Lee JY
• Choi YJ
• Chae JK
• Hur SH
• Bae JW
• Oh JH
• Chun KJ
• Kim HJ
• Cho BR
• Shin D
• Lee SH
• Hwang D
• Lee HJ
• Jang HJ
• Kim HK
• Ha SJ
• Shin ES
• Doh JH
• Hahn JY
• Gwon HC
• on behalf of the SMART-REWARD Investigators

• KMID: 2539198
• DOI: http://doi.org/10.3346/jkms.2023.38.e34

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.

Keyword

Bioresorbable Vascular Scaffold (BVS); Drug-Eluting Stent (DES); Safety; Efficacy

Figure

• 

  Fig. 1 Study flow. Study flow is presented. Two independent registries were used in current study. Among the population of the SMART-REWARD registry (390 patients), patients with unavailable follow-up data were excluded, leaving 377 patients with BVS implantation. Among the population of the PERSPECTIVE-PCI registry (675 patients), overlapped patients with SMART-REWARD registry and patients with DCB angioplasty and POBA were excluded, leaving 626 patients with 2nd generation DES implantation. A total 1,003 patients with clinical outcomes of 2 years of follow-up were pooled for analysis.BVS = bioresorbable vascular scaffold, DCB = drug coated balloon, DES = drug-eluting stent, FFR = fractional flow reserve, MI = myocardial infarction, NHPR = non-hyperemic pressure ratio, PCI = percutaneous coronary intervention, POBA = plain old balloon angioplasty.

• 

  Fig. 2 Comparison of primary and major secondary outcomes between BVS and DES. Kaplan-Meier curve is presented for 2-year cumulative incidence of (A) TVF and (B) POCO between BVS group and DES group. Multivariable Cox proportional hazard regression was used to calculate adjusted HR and 95% CI. The adjusted covariables were age, hypertension, diabetes mellitus, chronic kidney disease, previous MI, acute coronary syndrome, multivessel disease, left main disease, target vessel location, ACC/AHA lesion class B2 and C, multivessel PCI.BVS = bioresorbable vascular scaffold, CI = confidence interval, DES = drug-eluting stent, HR = hazard ratio, MI = myocardial infarction, PCI = percutaneous coronary intervention, POCO = patient-oriented composite outcome, TVF = target vessel failure, ACC/AHA = American College of Cardiology/American Heart Association.

• 

  Fig. 3 Comparison of 2-year risk of target vessel failure between BVS and DES according to subgroups. Cumulative incidence of target vessel failure at 2 years is compared between BVS group and DES group according to subgroup. The interaction P value represents the likelihood of interaction between the variable and the relative treatment effect.ACS = acute coronary syndrome, BVS = bioresorbable vascular scaffold, CI = confidence interval, DES = drug-eluting stent, HR = hazard ratio, IHD = ischemic heart disease, MI = myocardial infarction, PCI = percutaneous coronary intervention.

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