Toshiaki Toyota1, Takeshi Morimoto2, Hiroki Shiomi1, Yusuke Yoshikawa1, Hidenori Yaku1, Yugo Yamashita1, Takeshi Kimura3. 1. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 2. Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan. 3. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.
Abstract
OBJECTIVES: This study sought to compare the 2-year outcomes between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic drug-eluting stent (EES). BACKGROUND: The occurrence of very late stent/scaffold thrombosis (VLST) of BVS beyond 1 year after implantation is an increasing concern. METHODS: We conducted a meta-analysis of 24 studies (BVS: n = 2,567 and EES: n = 19,806) reporting the 2-year outcomes of BVS and/or EES to compare the risk of BVS versus EES for stent/scaffold thrombosis (ST) and target lesion failure (TLF) in 7 comparative studies (3 randomized and 4 observational), and to estimate the pooled incidence rates of ST and TLF including additional 17 single-arm studies. RESULTS: In the 7 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 to 6.71]). The excess risk of BVS relative to EES for ST through 2 years was significant (OR: 2.08 [95% CI: 1.02 to 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 (0.240 [95% CI: 0.022 to 0.608]% vs. 0.003 [95% CI: 0.000 to 0.028]%, and 1.43 [95% CI: 0.67 to 2.41]% vs. 0.56 [95% CI: 0.43 to 0.70]%, respectively). The corresponding rates for TLF were comparable between BVS and EES (1.88 [95% CI: 1.30 to 2.55]% and 1.78 [95% CI: 1.17 to 2.49]% and 7.90 [95% CI: 6.26 to 9.69]% and 7.49 [95% CI: 5.86 to 9.29]%, respectively). CONCLUSIONS: In this meta-analysis, BVS as compared with EES was associated with higher risk for VLST between 1 and 2 years and ST through 2 years.
OBJECTIVES: This study sought to compare the 2-year outcomes between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic drug-eluting stent (EES). BACKGROUND: The occurrence of very late stent/scaffold thrombosis (VLST) of BVS beyond 1 year after implantation is an increasing concern. METHODS: We conducted a meta-analysis of 24 studies (BVS: n = 2,567 and EES: n = 19,806) reporting the 2-year outcomes of BVS and/or EES to compare the risk of BVS versus EES for stent/scaffold thrombosis (ST) and target lesion failure (TLF) in 7 comparative studies (3 randomized and 4 observational), and to estimate the pooled incidence rates of ST and TLF including additional 17 single-arm studies. RESULTS: In the 7 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 to 6.71]). The excess risk of BVS relative to EES for ST through 2 years was significant (OR: 2.08 [95% CI: 1.02 to 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 (0.240 [95% CI: 0.022 to 0.608]% vs. 0.003 [95% CI: 0.000 to 0.028]%, and 1.43 [95% CI: 0.67 to 2.41]% vs. 0.56 [95% CI: 0.43 to 0.70]%, respectively). The corresponding rates for TLF were comparable between BVS and EES (1.88 [95% CI: 1.30 to 2.55]% and 1.78 [95% CI: 1.17 to 2.49]% and 7.90 [95% CI: 6.26 to 9.69]% and 7.49 [95% CI: 5.86 to 9.29]%, respectively). CONCLUSIONS: In this meta-analysis, BVS as compared with EES was associated with higher risk for VLST between 1 and 2 years and ST through 2 years.
Authors: Cordula M Felix; Victor J van den Berg; Sanne E Hoeks; Jiang Ming Fam; Mattie Lenzen; Eric Boersma; Peter C Smits; Patrick W Serruys; Yoshinobu Onuma; Robert Jan M van Geuns Journal: PLoS One Date: 2018-05-09 Impact factor: 3.240