Key result
The Nobori biolimus-eluting stent demonstrated a comparable risk of target lesion revascularization (OR 0.94) and other clinical outcomes compared to permanent polymer drug-eluting stents at 1-year follow-up.
Why the study?
Does the Nobori biolimus-eluting stent improve clinical outcomes compared to permanent polymer drug-eluting stents in patients undergoing percutaneous coronary intervention?
Meta-Analysis (n=12,090)
Yes
Does the Nobori biolimus-eluting stent improve clinical outcomes compared to permanent polymer drug-eluting stents in patients undergoing percutaneous coronary intervention?
Odds Ratio: 0.94 (95% CI 0.66–1.34)
Absolute Event Rate: 3.2% vs 3.3%
p-value: p=0.74
The Nobori biolimus-eluting stent with a biodegradable polymer demonstrates similar 1-year safety and efficacy to permanent polymer drug-eluting stents, with superior efficacy in reducing target lesion revascularization compared to paclitaxel-eluting stents.
Supports use of Nobori biolimus-eluting stent as alternative to permanent polymer DES; confirms 1-year equivalence in meta-analysis of PCI outcomes.
BACKGROUND: Permanent polymer coatings on drug-eluting stents (DES) surface have been identified as triggers of adverse events following percutaneous coronary intervention (PCI). However, efficacy and safety data for the Nobori biolimus-eluting stent (BES), a biodegradable polymer DES, are limited, so the aim of this study was to evaluate clinical outcomes associated with the Nobori BES compared with permanent polymer DES in patients undergoing PCI. METHODS AND RESULTS: Randomized trials comparing Nobori BES vs. other DES were included in the meta-analysis. The 12-month clinical endpoints were: target lesion revascularization (TLR), all-cause mortality, myocardial infarction (MI) and stent thrombosis (ST). Seven trials totaling 12,090 PCI patients met the inclusion criteria. Nobori BES vs. other DES had a comparable risk of TLR (odds ratio [OR] 0.94; 95% confidence interval [CI], 0.66-1.34; P=0.74), mortality (OR 1.00; 95% CI, 0.78-1.28; P=0.98), MI (OR 1.10; 95% CI, 0.87-1.40; P=0.42) and definite/probable ST (OR 1.01; 95% CI, 0.45-2.25; P=0.99). Despite Nobori BES showing similar clinical results to sirolimus-, everolimus- and zotarolimus-eluting stents, it was superior to paclitaxel-eluting stents in reducing the risk of TLR (OR 0.31; 95% CI, 0.10-0.90; P=0.03)CONCLUSIONS:Nobori BES use is associated with a similar safety and efficacy as permanent polymer DES at 1-year follow-up, albeit it is superior to paclitaxel-eluting stents in terms of TLR. Long-term follow-up data are needed in order to establish whether polymer degradation related to Nobori BES implantation improves clinical outcomes.
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Danzi et al. (2014) conducted a meta-analysis in Patients undergoing percutaneous coronary intervention (PCI) (n=12,090). Nobori biolimus-eluting stent (BES) vs. Permanent polymer drug-eluting stents (DES) was evaluated on Target lesion revascularization (TLR) at 12 months (OR 0.94, 95% CI 0.66-1.34, p=0.74). The Nobori biolimus-eluting stent demonstrated a comparable risk of target lesion revascularization (OR 0.94) and other clinical outcomes compared to permanent polymer drug-eluting stents at 1-year follow-up.
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