title: Effect of bivalirudin on aortic valve intervention outcomes study: a two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty.
abstract: OBJECTIVE
  We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin.
  
  
  RESULTS
  We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08).
  
  
  CONCLUSIONS
  In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.
authors.affiliation: Mount Sinai Medical Center, New York, NY, USA.
authors.forename: Annapoorna
authors.initials: A
authors.lastname: Kini
authors.forename: Jennifer
authors.initials: J
authors.lastname: Yu
authors.forename: Mauricio G
authors.initials: MG
authors.lastname: Cohen
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Usman
authors.initials: U
authors.lastname: Baber
authors.forename: Samantha
authors.initials: S
authors.lastname: Sartori
authors.forename: Georgios J
authors.initials: GJ
authors.lastname: Vlachojannis
authors.forename: Jason C
authors.initials: JC
authors.lastname: Kovacic
authors.forename: Robert
authors.initials: R
authors.lastname: Pyo
authors.forename: Brian
authors.initials: B
authors.lastname: O'Neill
authors.forename: Vikas
authors.initials: V
authors.lastname: Singh
authors.forename: Evan
authors.initials: E
authors.lastname: Jacobs
authors.forename: Shyam
authors.initials: S
authors.lastname: Poludasu
authors.forename: Pedro
authors.initials: P
authors.lastname: Moreno
authors.forename: Michael C
authors.initials: MC
authors.lastname: Kim
authors.forename: Prakash
authors.initials: P
authors.lastname: Krishnan
authors.forename: Samin K
authors.initials: SK
authors.lastname: Sharma
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D005260:Female; D005431:Florida; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D061847:Hospitals, High-Volume; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D009519:New York City; D016017:Odds Ratio; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D057216:Propensity Score; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin