OBJECTIVE: To evaluate the long-term follow-up of the unrestricted use of a biodegradable polymer-coated drug-eluting stent in patients undergoing percutaneous coronary intervention (PCI). METHODS: The Nobori 2 study was a prospective, multicentre, observational registry evaluating the safety and the efficacy of the biodegradable polymer biolimus-eluting stent (BP-BES) among 3067 patients recruited at 125 international sites. The primary combined endpoint was a composite of cardiac death, myocardial infarction and target-lesion revascularisation (TLR). RESULTS: Five-year follow-up was available in 2738 (89.3%) patients. The combined endpoint occurred in 268 patients (10%, 95% CIs 8.9% to 11.3%) at 5 years, with 3.9% of events during the first year and 6.2% during years 1-5 of follow-up. Cumulative rates of TLR and definite/probable stent thrombosis were 5.3% (95% CI 4.5% to 6.3%) and 1.1% (95% CI 0.8% to 1.6%), respectively. Between 1 and 5 years, TLR and very late stent thrombosis rates were 3.5% (95% CI 2.8% to 4.4%) and 0.6% (95% CI 0.3% to 1.1%), respectively. Previous PCI (HR, 2.05, 95% CI 1.68 to 2.50), moderate-to-severe renal disease (HR, 1.89, 95% CI 1.30 to 2.74) and peripheral vascular disease (HR, 1.86, 95% CI 1.38 to 2.52) were the three most powerful independent predictors of the combined endpoint at 5 years. CONCLUSIONS: The final 5-year follow-up of the Nobori 2 registry demonstrates the safety and effectiveness of the BP-BES in an unselected, broadly inclusive cohort of PCI patients, highlighting the excellent performance of this coronary stent technology after polymer biodegradation. TRIAL REGISTRATION NUMBER: ISRCTN81649913; Results.
- MeSH
- imunosupresiva aplikace a dávkování MeSH
- Kaplanův-Meierův odhad MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení metody MeSH
- koronární trombóza epidemiologie etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- nemoci ledvin epidemiologie etiologie MeSH
- onemocnění periferních cév epidemiologie etiologie MeSH
- opakovaná terapie statistika a číselné údaje MeSH
- polymery MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- registrace MeSH
- senioři MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- stenty uvolňující léky * škodlivé účinky MeSH
- vstřebatelné implantáty * škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH