Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Drug-Eluting Stents: A Meta-Analysis

Abstract

BackgroundsDrug-eluting stents (DES) with biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation DES. We aimed to determine the efficacy and safety of biodegradable polymer biolimus-eluting stents (BES) versus durable polymer DES.MethodsSystematic database searches of MEDLINE (1950 to June 2013), EMBASE (1966 to June 2013), the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013), and a review of related literature were conducted. All randomized controlled trials comparing biodegradable polymer BES versus durable polymer DES were included.ResultsEight randomized controlled trials investigating 11,015 patients undergoing percutaneous coronary interventions were included in the meta-analysis. The risk of major adverse cardiac events did not differ significantly between the patients treated with the biodegradable polymer BES and the durable polymer DES (Relative risk [RR], 0.970; 95% CI, 0.848–1.111; p = 0.662). However, biodegradable polymer BES was associated with reduced risk of very late ST compared with the durable polymer DES, while the risk of early or late ST was similar (RR for early or late ST, 1.167; 95% CI 0.755–1.802; p = 0.487; RR 0.273; 95% CI 0.115–0.652; p = 0.003; p for interaction = 0.003).ConclusionsIn this meta-analysis of randomized controlled trials, treatments with biodegradable polymer BES did not significantly reduce the risk of major adverse cardiac events, but demonstrated a significantly lower risk of very late ST when compared to durable polymer DES. This conclusion requires confirmation by further studies with long-term follow-up.PROSPERO register number http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004364#.UnM2lfmsj6J

Safety and efficacy profile of bioresorbable‐polylactide‐polymer‐biolimus‐A9‐eluting stents versus durable‐polymer‐everolimus‐ and zotarolimus‐eluting stents in patients with acute coronary syndrome

“…Interestingly, BES versus second‐generation DES showed higher rates of definite ST than CoCr‐EES . On the other hand, the beneficial outcomes regarding late lumen loss and late ST after biodegradable‐polymer‐DES versus durable‐polymer‐DES have been documented in the meta‐analysis made by Lupi et al Significantly lower risk of very late ST in biodegradable‐polymer‐BES versus durable polymer DES has been reported by Ye and Niu X et al . In both studies, heterogenous‐DES‐comparators were used in different patient subsets, which could fundamentally influence safety and efficacy results .…”

“…On the other hand, the beneficial outcomes regarding late lumen loss and late ST after biodegradable‐polymer‐DES versus durable‐polymer‐DES have been documented in the meta‐analysis made by Lupi et al Significantly lower risk of very late ST in biodegradable‐polymer‐BES versus durable polymer DES has been reported by Ye and Niu X et al . In both studies, heterogenous‐DES‐comparators were used in different patient subsets, which could fundamentally influence safety and efficacy results . Furthermore, the previously cited data derived from randomized controlled trials (RCTs), are mainly limited in everyday clinical practice by inclusion criteria, excluding high‐risk patients including those with ACS.…”

A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: A systematic review and meta-analysis

“…Comparisons between BP-BES and DP-DES in terms of prognosis after PCI have attracted a great deal of attention. Many studies have been performed at different time points based on six outcomes (MACE, death, MI, TVR, TLR, ST), especially at one year 21 – 24 or three years 25 of follow-up. However, no significant evidence from one or three years of follow-up have supported the superiority of BP-BES or DP-DES.…”

Novel Fabrication of MicroRNA Nanoparticle-Coated Coronary Stent for Prevention of Post-Angioplasty Restenosis

“…Cytotoxic drugs or Cytostatics that inhibit SMC growth in the lumen, are used for clinically approved restenosis inhibition therapies. Stents eluting these drugs are effective in cell proliferation inhibition, 18) but they do not promote re-endothelilization of the vessel, which is crucial in the long-term treatment of restenosis. 19) 20) …”