ORIGINAL ARTICLE Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding Hirofumi Hioki, 1 Yusuke Watanabe, 1 Ken Kozuma, 1 Yugo Nara, 1 Hideyuki Kawashima, 1 Akihisa Kataoka, 1 Masanori Yamamoto, 2 Kensuke Takagi, 3 Motoharu Araki, 4 Norio Tada, 5 Shinichi Shirai, 6 Futoshi Yamanaka, 7 Kentaro Hayashida, 8 And on behalf of OCEAN-TAVI investigators ABSTRACT Objective To evaluate the clinical benefit of pre- procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI). Methods 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. Results 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). Conclusions 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. Trial registration number UMIN-ID; 000020423; Results. INTRODUCTION Transcatheter aortic valve implantation (TAVI) is becoming the mainstream treatment for severe aortic valve stenosis. 12 Before TAVI, dual antiplate- let therapy (DAPT) including aspirin (75–100 mg/ day) and clopidogrel (75 mg/day after a loading dose of 300 mg) is initiated empirically, based on the experience of percutaneous coronary interven- tion (PCI). 3 4 However, compared to coronary intervention, TAVI is associated with a higher inci- dence of bleeding and has the risk of emergent open heart surgery during the procedure. 5 Because almost all candidates for TAVI have advanced age, frailty, and several comorbidities, DAPT before TAVI has been associated with a high incidence of bleeding or vascular complications. 6 Moreover, the benefit of DAPT over single antiplatelet therapy (SAPT) or no pre-procedural antiplatelet therapy has not been well studied. The aim of this study was to evaluate the incidence of adverse events according to pre-procedural antiplatelet therapy in patients from a multicentre cohort who underwent TAVI. METHODS Study population This retrospective study used data for the period from October 2013 to July 2015, obtained from the OCEAN (Optimized transCathEter vAlvular interveNtion) TAVI registry. The OCEAN-TAVI is a prospective, multicentre, observational registry of symptomatic patients with severe aortic valve sten- osis (AS), undergoing TAVI using the Edwards Sapien XT prosthesis (Edwards Lifesciences) at nine collaborating hospitals located in Japan. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry, as accepted by the International Committee of Medical Journal Editors (UMIN-ID; 000020423). Inclusion criteria were: (1) the pres- ence of symptoms; (2) degenerative AS with New York Heart Association class ≥II; (3) a mean gradient >40 mm Hg or a jet velocity >4.0 m/s; or (4) an aortic valve area <1.0 cm 2 (or an effective orifice area index <0.6 cm 2 /m 2 ). Indication for TAVI was determined based on the clinical consen- sus of a multidisciplinary team including cardiac surgeons, interventional cardiologists, anaesthetists, and imaging specialists. Exclusion criteria were: (1) bicuspid or non-calcified aortic valve; (2) failed sur- gical bioprosthesis implantation; (3) severe aortic regurgitation; or (4) patients on dialysis. The study protocol was developed in accordance with the Declaration of Helsinki and was approved by the ethics committee of each participating hospital. All patients gave written informed consent before par- ticipating in this study. To cite: Hioki H, Watanabe Y, Kozuma K, et al. Heart 2017;103:361–367. 1 Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan 2 Division of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan 3 Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan 4 Department of Cardiovascular Medicine, Yokohama City Eastern Hospital, Kanagawa, Japan 5 Department of Cardiovascular Center, Sendai Kosei Hospital, Miyagi, Japan 6 Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan 7 Department of Cardiovascular Medicine, Shonan Kamakura General Hospital, Kanagawa, Japan 8 Department of Cardiology, Keio University School of Medicine, Tokyo, Japan Correspondence to Dr Hirofumi Hioki, Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003, Japan; hhioki@shinshu-u.ac.jp Received 1 April 2016 Revised 19 July 2016 Accepted 30 July 2016 Published Online First 18 August 2016 Valvular heart disease Hioki H, et al. Heart 2017;103:361–367. doi:10.1136/heartjnl-2016-309735 361