title: Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients.
abstract: 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).
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  ISRCTN81649913; Results.
authors: Division of Cardiology, Ospedale Santa Corona, Pietra Ligure, Italy.
authors: Gian Battista
authors: GB
authors: Danzi
authors: Division of Cardiology, Ospedale Santa Corona, Pietra Ligure, Italy.|Bern University Hospital, Bern, Switzerland.
authors: Raffaele
authors: R
authors: Piccolo
authors: Institut Cardiovasculaire Paris Sud, Massy/Quincy, France.
authors: Bernard
authors: B
authors: Chevalier
authors: Hôpital de la Tour, Geneva, Switzerland.
authors: Philip
authors: P
authors: Urban
authors: Royal Infirmary, Manchester, UK.
authors: Farzin
authors: F
authors: Fath-Ordoubadi
authors: Centre Hospitalier Universitaire Rangueil, Toulouse, France.
authors: Didier
authors: D
authors: Carrie
authors: Herz-und Diabeteszentrum North-Rhine Westphalia, Bad Oeynhausen, Germany.|Department of Cardiology and Intensive Care Medicine, Johannes Wesling Hospital Minden, Minden, Germany.
authors: Marcus
authors: M
authors: Wiemer
authors: Hospital de la Sta. Creu i St. Pau, Barcelona, Spain.
authors: Antonio
authors: A
authors: Serra
authors: Cardiovascular Research Center OLV Hospital, Aalst, Belgium.
authors: William
authors: W
authors: Wijns
authors: University Hospital Brno, Brno, Czech Republic.
authors: Petr
authors: P
authors: Kala
authors: A.R.N.A.S. Ospedale Civico, Palermo, Italy.
authors: Amerigo
authors: A
authors: Stabile
authors: Hospital Puerta de Hierro, Madrid, Spain.
authors: Javier
authors: J
authors: Goicolea Ruigomez
authors: Institute for Cardiovascular Disease Dedinje, Belgrade, Serbia.
authors: Dragan
authors: D
authors: Sagic
authors: North-Estonia Regional Hospital, Tallinn, Estonia.
authors: Peep
authors: P
authors: Laanmets
authors: Klinikum Fulda AG, Fulda, Germany.
authors: Gerhard
authors: G
authors: Strupp
authors: Papworth Hospital, Cambridge, UK.
authors: Nick
authors: N
authors: West
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000368:Aged; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D007674:Kidney Diseases / Q000453:epidemiology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D016491:Peripheral Vascular Diseases / Q000453:epidemiology / Q000209:etiology; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D019233:Retreatment / Q000706:statistics & numerical data; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus