TY - JOUR T1 - Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients JF - Heart JO - Heart SP - 111 LP - 116 DO - 10.1136/heartjnl-2016-309283 VL - 103 IS - 2 AU - Gian Battista Danzi AU - Raffaele Piccolo AU - Bernard Chevalier AU - Philip Urban AU - Farzin Fath-Ordoubadi AU - Didier Carrie AU - Marcus Wiemer AU - Antonio Serra AU - William Wijns AU - Petr Kala AU - Amerigo Stabile AU - Javier Goicolea Ruigomez AU - Dragan Sagic AU - Peep Laanmets AU - Gerhard Strupp AU - Nick West Y1 - 2017/01/15 UR - http://heart.bmj.com/content/103/2/111.abstract N2 - 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. ER -