title: Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.
abstract: OBJECTIVE
  To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice.
  
  
  BACKGROUND
  The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent.
  
  
  METHODS
  5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years.
  
  
  RESULTS
  Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST.
  
  
  CONCLUSIONS
  This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.
authors: Department of Cardiovascular, Hôpital De La Tour, Geneva, Switzerland.
authors: Philip
authors: P
authors: Urban
authors: Hospital Universitario Virgen De La Arrixaca, Murcia, Spain.
authors: Mariano
authors: M
authors: Valdés
authors: Department of Cardiology, Craigavon Cardiovascular Centre, Craigavon, United Kingdom.
authors: Ian
authors: I
authors: Menown
authors: Stadtspital Triemli, Zurich, Switzerland.
authors: Franz
authors: F
authors: Eberli
authors: The Cardiovascular Center, Jordan Hospital, Amman, Jordan.
authors: Imad
authors: I
authors: Alhaddad
authors: Brighton and Sussex Hospital, Brighton, United Kingdom.
authors: David
authors: D
authors: Hildick-Smith
authors: Moscow City Center of Interventional Cardioangiology, Moscow, Russian Federation.
authors: David
authors: D
authors: Iosseliani
authors: Hôpitaux Universitaires De Genève, Geneva, Switzerland.
authors: Marco
authors: M
authors: Roffi
authors: Golden Jubilee National Hospital, Glasgow, United Kingdom.
authors: Keith
authors: K
authors: Oldroyd
authors: Biosensors Europe, Morges, Switzerland.
authors: Erifyli
authors: E
authors: Kalloudi
authors: Biosensors Europe, Morges, Switzerland.
authors: Pedro
authors: P
authors: Eerdmans
authors: Department of Cardiology, Clinique Saint-Hilaire, Rouen, France.
authors: Jacques
authors: J
authors: Berland
authors: Cardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine, Berlin, Germany.
authors: Franz Xaver
authors: FX
authors: Kleber
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; C518022:umirolimus; D020123:Sirolimus
keywords: bleeding; drug eluting stent; dual antiplatelet therapy; stent thrombosis