title: Early Clinical Experience with a Polymer-Free Biolimus A9 Drug-Coated Stent in DES-Type Patients Who Are Poor Candidates for Prolonged Dual Anti-Platelet Therapy.
abstract: BACKGROUND
  Prolonged dual anti-platelet therapy (DAPT) may cause excess bleeding in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. Data were gathered on the early experience implanting this stent in drug-eluting stent eligible patients deemed to be at high risk of bleeding.
  
  
  METHODS
  The demographics, procedural data and clinical outcomes were gathered prospectively for 249 patients treated with a BA9-DCS stent at 2 UK centres, and compared to a cohort of patients treated in the same period with drug-eluting stents (PCI-DES).
  
  
  RESULTS
  Operator-defined BA9-DCS indications included warfarin therapy, age, and anaemia. Patients receiving a BA9-DCS were older (71.6±11.8 vs. 64.8±11.6yrs, p<0.001), more often female (38.2 vs. 26.8%, P<0.001), and more likely to have comorbidity including chronic kidney disease or poor LV function than PCI-DES patients. The baseline Mehran bleed risk score was also significantly higher in the BA9-DCS group (19.4±8.7 vs. 13.1±5.8, p<0.001). Of the BA9-DCS cohort, 95.5% of patients demonstrated disease fitting NICE criteria for DES placement. The number of lesions treated (1.81±1.1 vs. 1.58±0.92, p = 0.003), total lesion length (32.1±21.7 vs. 26.1±17.6mm, p<0.001), number of stents used (1.93±1.11 vs. 1.65±1.4, p = 0.007) and total stent length (37.5±20.8 vs. 32.4±20.3, p<0.01) were greater for BA9-DCS patients. DAPT was prescribed for 3.3±3.9 months for BA9-DCS patients and 11.3±2.4 months for PCI-DES patients (p<0.001). At follow up of 392±124 days despite the abbreviated DAPT course stent related event were infrequent with ischemia-driven restenosis PCI (2.8 vs. 3.4%, p = 0.838), and stent thrombosis (1.6 vs. 2.1%, p = 0.265) rates similar between the BA9-DCS ad PCI-DES groups. After propensity scoring all clinical end-points were similar between both cohorts.
  
  
  CONCLUSIONS
  This early experience using polymer-free BA9 drug-coated stents in drug-eluting stent type patients at risk of bleeding are encouraging. Further studies are warranted.
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Tim
authors.initials: T
authors.lastname: Kinnaird
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Mehmood
authors.initials: M
authors.lastname: Butt
authors.affiliation: Department of Cardiology Morriston Cardiac Centre, Swansea, United Kingdom.
authors.forename: Fairoz
authors.initials: F
authors.lastname: Abdul
authors.affiliation: Department of Cardiology Morriston Cardiac Centre, Swansea, United Kingdom.
authors.forename: Khaled
authors.initials: K
authors.lastname: Yazji
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Hailan
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Sean
authors.initials: S
authors.lastname: Gallagher
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Ossei-Gerning
authors.affiliation: Department of Cardiology Morriston Cardiac Centre, Swansea, United Kingdom.
authors.forename: Alexander
authors.initials: A
authors.lastname: Chase
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Anirban
authors.initials: A
authors.lastname: Choudhury
authors.affiliation: Department of Cardiology Morriston Cardiac Centre, Swansea, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Smith
authors.affiliation: Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Anderson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000601:surgery*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D057216:Propensity Score; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin; C518022:umirolimus; D020123:Sirolimus