Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem
PubMed
27511446
DOI
10.1136/heartjnl-2016-309283
PII: heartjnl-2016-309283
Knihovny.cz E-zdroje
- 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
- práce podpořená grantem MeSH
- Názvy látek
- imunosupresiva MeSH
- polymery MeSH
- sirolimus MeSH
- umirolimus MeSH Prohlížeč
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.
A R N A S Ospedale Civico Palermo Italy
Bern University Hospital Bern Switzerland
Cardiovascular Research Center OLV Hospital Aalst Belgium
Centre Hospitalier Universitaire Rangueil Toulouse France
Department of Cardiology and Intensive Care Medicine Johannes Wesling Hospital Minden Minden Germany
Division of Cardiology Ospedale Santa Corona Pietra Ligure Italy
Herz und Diabeteszentrum North Rhine Westphalia Bad Oeynhausen Germany
Hôpital de la Tour Geneva Switzerland
Hospital de la Sta Creu i St Pau Barcelona Spain
Hospital Puerta de Hierro Madrid Spain
Institut Cardiovasculaire Paris Sud Massy Quincy France
Institute for Cardiovascular Disease Dedinje Belgrade Serbia
Klinikum Fulda AG Fulda Germany
North Estonia Regional Hospital Tallinn Estonia
Citace poskytuje Crossref.org
ISRCTN
ISRCTN81649913
