Clinical outcomes of patients treated with Nobori biolimus-eluting stent: Meta-analysis of randomized trials

Abstract

Backgrounds: The Nobori is a new-generation, biodegradable-polymer coated, biolimus-eluting stent (BES) that has recently been investigated in several randomized trials with inconsistent results. The aim of this study was to assess the efficacy and safety of Nobori BES versus other drug-eluting stents (DES) in patients treated with percutaneous coronary intervention (PCI).

Methods: We undertook a meta-analysis of randomized trials investigating Nobori BES versus other DES. Primary efficacy and safety outcomes were target lesion revascularization (TLR) and definite/probable stent thrombosis (ST), respectively. Secondary outcomes were the composite of cardiac death/myocardial infarction (MI)/target vessel revascularization (TVR), MI and death.

Results: A total of 9114 PCI-patients randomly received Nobori BES (n=5080) or other DES (n=4034). This latter group comprised patients receiving everolimus- (n=2533), sirolimus- (n=1376) or paclitaxel-eluting stents (n=125). Median follow-up was 11 months [interquartile range 9-12]. The Nobori BES versus other DES showed comparable risk of TLR (odds ratio [95% confidence interval]=0.91 [0.57-1.46], p=0.71). There was significant heterogeneity across trials due to significant lower TLR risk with Nobori BES versus paclitaxel-eluting stent (0.32 [0.10-0.98], p=0.046; p for interaction=0.009). Nobori BES versus other DES showed comparable risk of definite/probable ST (1.40 [0.66-2.97], p=0.39), cardiac death/MI/TVR (1.05 [0.88-1.25], p=0.59), MI (1.13 [0.87-1.48], p=0.37) and death (1.09 [0.81-1.48], p=0.56).

Conclusions: Nobori BES has comparable efficacy with other limus-eluting stents at 1-year follow-up. There is no difference in terms of safety profile between these stent platforms.

Keywords: Biolimus-eluting stent; Drug-eluting stent; Meta-analysis; Percutaneous coronary intervention.