@article {Danzi111, author = {Gian Battista Danzi and Raffaele Piccolo and Bernard Chevalier and Philip Urban and Farzin Fath-Ordoubadi and Didier Carrie and Marcus Wiemer and Antonio Serra and William Wijns and Petr Kala and Amerigo Stabile and Javier Goicolea Ruigomez and Dragan Sagic and Peep Laanmets and Gerhard Strupp and Nick West}, title = {Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients}, volume = {103}, number = {2}, pages = {111--116}, year = {2017}, doi = {10.1136/heartjnl-2016-309283}, publisher = {BMJ Publishing Group Ltd}, abstract = {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{\textendash}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.}, issn = {1355-6037}, URL = {https://heart.bmj.com/content/103/2/111}, eprint = {https://heart.bmj.com/content/103/2/111.full.pdf}, journal = {Heart} }