Thirty-Day and One-Year Clinical Outcomes of Bioresorbable Vascular Scaffold Implantation: A Single-Center Experience

Abstract

Background: Available data on the use of the Bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) in real-world patients is limited, particularly in Asian populations. The aim of this study was to assess clinical outcomes of patients treated with a BVS in real-world practice in Taiwan.

Methods: This study focused on 156 patients with coronary artery disease and a total of 249 lesions who received BVS implantation from October 2012 to October 2015. The study's primary endpoint was major adverse cardiac event (MACE), such as a myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), definite or possible scaffold thrombosis, cardiovascular death, and all-cause mortality during the thirty-day follow-up period. The secondary endpoint was MACE during the one-year follow-up period. Additionally, the composite clinical secondary endpoint was target lesion failure (TLF), which was called device-oriented composite endpoint.

Results: The average age of the patients was 60.34 ± 10.15 years, and 81.4% were male. The average of Syntax score was 12.42 ± 8.77 points. 44.2 % lesions were type B2 or C. At 31 days, one patient experienced a MACE (1/156) the composite of two TLF (2/249) with ST elevation MI, which was related to scaffold thrombosis. At one-year, 5.1 % (8/156) of the patients experienced a MACE and 3.6% (9/249) of the lesions experienced a TLF. There was no cardiovascular or all-cause mortality in the 30-day follow-up. The one-year cardiovascular and all-cause mortality rates were each 1.3%, respectively. Diabetes, ostial lesion, bifurcation lesion, and non-standard dual anti-platelet therapy (DAPT) were the strong associations of one-year TLF.

Conclusions: Even with difficult and complex lesions of patients in this study, acceptable outcomes were achieved with low definite or possible scaffold thrombosis rates after BVS implantation. And despite anatomical issues, it is important to complete standard DAPT.

Keywords: Bioresorbable vascular scaffold; Clinical outcomes; Single center experience.

Figure 1

A: Coronary angiography (CAG) of the left coronary artery (LCA): Proximal to mid segment of left anterior descending artery (LAD) showed diffuse diseased lesions (white arrows); B: CAG of LCA: 3.5-year follow-up CAG showed fair coronary flow without stenosis; (C, D, and E) Optical coherence tomography (OCT) of LAD showed complete neointimal coverage of the residual bioresorbable vascular scaffold (BVS) struts (black boxes) from proximal to mid LAD (C-E). D: The overlap site showed two layers of BVS struts (white arrows).

Figure 2

(A) Coronary angiography (CAG) of right coronary artery (RCA): 70~80% stenosis at proximal RCA (white arrow); (B) optical coherence tomography (OCT): good apposition of scaffold; (C) 1-year follow-up CAG of RCA presented no restenosis; (D) 1-year follow-up OCT of RCA: complete neointimal coverage of the residual bioresorbable vascular scaffold (BVS) struts.

Figure 3

(A) Coronary angiography (CAG) of left coronary artery (LCA): one new lesion with critical stenosis of proximal left circumflex artery (LCX) was noted (white arrow); (B) CAG of LCA: fair coronary flow of LCX after bioresorbable vascular scaffold (BVS) deployment; (C) Intravascular ultrasound (IVUS) of LCX; Double layer struct was BVS struct, but IVUS could not evaluate the condition of BVS clearly; (D) Optical coherence tomography (OCT) of LCX: good apposition of BVS.