Bioresorbable Vascular Scaffolds Studied for Very Late Scaffold Thrombosis
January 13, 2017—Toshiaki Toyota, MD, et al conducted a study that sought to compare the 2-year outcomes between bioresorbable vascular scaffolds (BVS) and metallic everolimus-eluting stents (EES) because of the increased concern of the occurrence of very late stent/scaffold thrombosis (VLST) of BVS beyond 1 year after implantation. The study showed that BVS compared to EES was associated with a higher risk for VLST between 1 and 2 years and stent/scaffold thrombosis (ST) through 2 years. The investigators published their findings in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:27–37).
As summarized in JACC: Cardiovascular Interventions, this meta-analysis of 24 studies (BVS, n = 2,567; EES, n = 19,806) reporting the 2-year outcomes of BVS and/or EES compared the risk of BVS versus EES for ST and target lesion failure (TLF) in seven comparative studies (three randomized and four observational) and estimated the pooled incidence rates of ST and TLF, including an additional 17 single-arm studies.
The investigators found that in the seven comparative studies, the risk for VLST between 1 and 2 years was numerically higher in BVS than in EES (odds ratio [OR], 2.03; 95% confidence interval [CI], 0.62–6.71).
The excess risk of BVS relative to EES for ST through 2 years was significant (OR, 2.08; 95% CI, 1.02–4.26). The risk for TLF was neutral between BVS and EES.
In the 24 studies, the pooled estimated incidence rates of VLST and ST through 2 years were higher in BVS than in EES: 0.24% (95% CI, 0.022%–0.608%) vs 0.003% (95% CI, 0%–0.028%) and 1.43% (95% CI, 0.67%–2.41%) vs 0.56% (95% CI, 0.43%–0.7%), respectively.
The corresponding rates for TLF were comparable between BVS and EES: 1.88% (95% CI, 1.3%–2.55%), 1.78% (95% CI, 1.17%–2.49%), 7.9% (95% CI, 6.26%–9.69%), and 7.49% (95% CI, 5.86%–9.29%), respectively, reported the investigators in JACC: Cardiovascular Interventions.