title: Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding.
abstract: To evaluate the clinical benefit of pre-procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI).
  
  
  
  OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI is a prospective, multicentre, observational cohort registry, enrolling 749 patients who underwent TAVI from October 2013 to August 2015 in Japan. We identified 540 patients (median age 85 years, 68.1% female) undergoing TF-TAVI; of these, 80 had no pre-procedural antiplatelet therapy and 460 had antiplatelet therapy. The endpoints were any bleeding (life-threatening, major, and minor bleeding) and thrombotic events (stroke, myocardial infarction, and valve thrombosis) during hospitalisation.
  
  
  
  Patients with dual antiplatelet therapy (DAPT) had a significantly higher incidence of any bleeding than those with single antiplatelet therapy (SAPT) (36.5% vs 27.5%, p=0.049) and no antiplatelet therapy (36.5% vs 21.3%, p=0.010). Patients without pre-procedural antiplatelet therapy did not experience an increased risk of thrombotic events. In multivariable logistic regression analysis, DAPT before TF-TAVI significantly increased any bleeding compared with SAPT (OR 2.05, 95% CI 1.16 to 3.65) and no antiplatelet therapy (OR 2.30, 95% CI 1.08 to 4.90).
  
  
  
  The current study demonstrated that DAPT before TF-TAVI increased the risk of bleeding compared with single or no antiplatelet therapy. Lower intensity antiplatelet therapy was not associated with thrombotic events. In modern practice, it might be reasonable to perform TAVI using single or no pre-procedural antiplatelet therapy with an expectation of no increase of adverse events.
  
  
  
  UMIN-ID; 000020423; Results.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Hioki
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Watanabe
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Yugo
authors.initials: Y
authors.lastname: Nara
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Kawashima
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Akihisa
authors.initials: A
authors.lastname: Kataoka
authors.affiliation: Division of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Takagi
authors.affiliation: Department of Cardiovascular Medicine, Yokohama City Eastern Hospital, Kanagawa, Japan.
authors.forename: Motoharu
authors.initials: M
authors.lastname: Araki
authors.affiliation: Department of Cardiovascular Center, Sendai Kosei Hospital, Miyagi, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Tada
authors.affiliation: Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Shirai
authors.affiliation: Department of Cardiovascular Medicine, Shonan Kamakura General Hospital, Kanagawa, Japan.
authors.forename: Futoshi
authors.initials: F
authors.lastname: Yamanaka
authors.affiliation: Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Hayashida
mesh_terms: D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D019106:Postoperative Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors