title: Comparison of dual antiplatelet therapy prescribed as one-pill versus two-pill regimen. A pooled analysis of individual patient data from the three MR-CAPCIS trials.
abstract: Fixed-dose combination (FDC) drugs can simplify the medication regimen and potentially improve adherence. However, evidence is lacking about the efficacy and safety of FDC drugs of clopidogrel plus aspirin. Individual data from the three independent MR-CAPCIS trials were pooled and analysed. In those trials, subjects who had been treated with either dual antiplatelet therapy (DAPT) or aspirin alone after drug-eluting stent (DES) implantation were randomly assigned to one-pill or to two-pill DAPT group. Platelet reactivity was measured with VerifyNow-P2Y12 and aspirin point-of-care assays at baseline and eight weeks after treatment. In the present study, primary efficacy endpoint was changes in platelet reactivity unit (PRU) between baseline and eight weeks. A total of 965 subjects were analysed. In prior clopidogrel and aspirin users, PRU was well maintained regardless of switching to either one-pill or two-pill DAPT (ΔPRU=0.4 vs 0.0, p=0.939). In prior aspirin users, PRU was decreased by 73.7 in one-pill DAPT and 77.5 in two-pill DAPT group, with no differences between them (p=0.499). The incidence of high on-treatment platelet reactivity at eight weeks, defined as PRU≥235 in Western people, was 34.8 % in one-pill DAPT group and 37.6 % in two-pill DAPT group (p=0.380), and that defined as PRU ≥275 in Oriental people was 17.7 vs 21.7 % (p=0.129). Independent predictors of high platelet reactivity on clopidogrel were female gender, increasing age, and diabetes. Study drugs were well tolerated. In conclusion, FDC one-pill DAPT showed similar efficacy to two-pill DAPT in terms of platelet reactivity in patients receiving DES in Korea.
authors.forename: Woo-Hyun
authors.initials: WH
authors.lastname: Lim
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.forename: Chang-Hwan
authors.initials: CH
authors.lastname: Yoon
authors.forename: Dong-Ju
authors.initials: DJ
authors.lastname: Choi
authors.forename: Sang Wook
authors.initials: SW
authors.lastname: Lim
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Park
authors.forename: Joon-Hyung
authors.initials: JH
authors.lastname: Doh
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Myung-A
authors.initials: MA
authors.lastname: Kim
authors.forename: Seung-Hwan
authors.initials: SH
authors.lastname: Lee
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Yoon
authors.forename: Young Keun
authors.initials: YK
authors.lastname: Ahn
authors.forename: Min-Su
authors.initials: MS
authors.lastname: Hyon
authors.forename: Ki Seok
authors.initials: KS
authors.lastname: Kim
authors.forename: Young Kwon
authors.initials: YK
authors.lastname: Kim
authors.forename: Han Cheol
authors.initials: HC
authors.lastname: Lee
authors.forename: Sang-Hoon
authors.initials: SH
authors.lastname: Seol
authors.forename: Kyung-Kuk
authors.initials: KK
authors.lastname: Hwang
authors.forename: Si-Wan
authors.initials: SW
authors.lastname: Choi
authors.forename: Kyoo-Rok
authors.initials: KR
authors.lastname: Han
authors.forename: Eun-Seok
authors.initials: ES
authors.lastname: Shin
authors.forename: Sang-Wook
authors.initials: SW
authors.lastname: Kim
authors.forename: Byoung Kwon
authors.initials: BK
authors.lastname: Lee
authors.affiliation: Hyo-Soo Kim, MD, PhD, Professor, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 110-744, Korea, Tel.: +82 2 2072 2226, Fax: +82 2 766 8904, E-mail : usahyosoo@gmail.com, hyosoo@snu.ac.kr.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000097:blood / Q000188:drug therapy / Q000601:surgery; D004338:Drug Combinations; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D010979:Platelet Function Tests; D056910:Republic of Korea; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D004338:Drug Combinations; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: Aspirin; clopidogrel; dual antiplatelet therapy; fixed-dose combination