title: Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study.
abstract: Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients.
  
  
  
  Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005).
  
  
  
  We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication.
authors.affiliation: Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klara-Kopp-Weg 1, 45138 Essen, Germany.
authors.forename: Christoph K
authors.initials: CK
authors.lastname: Naber
authors.affiliation: Hôpital de la Tour, Geneva, Switzerland.
authors.forename: Philip
authors.initials: P
authors.lastname: Urban
authors.affiliation: Tan Tock Seng Hospital, Singapore.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Ong
authors.affiliation: Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
authors.forename: Mariano
authors.initials: M
authors.lastname: Valdes-Chavarri
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Alexandre A
authors.initials: AA
authors.lastname: Abizaid
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.affiliation: Centro Cardiologico Monzino, Milan, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Fabbiocchi
authors.affiliation: Department of Cardiovascular Medicine, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
authors.forename: Christophe
authors.initials: C
authors.lastname: Dubois
authors.affiliation: Biosensors Europe, Morges, Switzerland.
authors.forename: Samuel
authors.initials: S
authors.lastname: Copt
authors.affiliation: Biosensors Europe, Morges, Switzerland.
authors.forename: Samantha
authors.initials: S
authors.lastname: Greene
authors.affiliation: Cardiovascular European Research Center (CERC), Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
mesh_terms: D054058:Acute Coronary Syndrome / Q000601:surgery; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006470:Hemorrhage / Q000209:etiology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D000072658:Non-ST Elevated Myocardial Infarction / Q000188:drug therapy / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000188:drug therapy / Q000601:surgery*; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; C518022:umirolimus; D020123:Sirolimus
keywords: Acute coronary syndrome; Bare-metal stent; Drug-coated stent; High bleeding risk; Percutaneous coronary intervention