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

Woo Hyun Lim, In Ho Chae, Chang Hwan Yoon, Dong Ju Choi, Sang Wook Lim, Woo Jung Park, Joon Hyung Doh, Sang Hyun Kim, Myung A. Kim, Seunghwan Lee, Junghan Yoon, Young Keun Ahn, Min Su Hyon, Ki Seok Kim, Young Kwon Kim, Han Cheol Lee, Sang Hoon Seol, Kyung Kuk Hwang, Si Wan Choi, Kyoo Rok HanEun Seok Shin, Sang Wook Kim, Byoung Kwon Lee, Hyo Soo Kim

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)78-86
Number of pages9
JournalThrombosis and Haemostasis
Volume116
Issue number1
DOIs
Publication statusPublished - 2016 Jul 1

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Blood Platelets
clopidogrel
Aspirin
Group Psychotherapy
Drug-Eluting Stents
Therapeutics
Drug Combinations
Point-of-Care Systems
Korea
Safety
Incidence
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Lim, Woo Hyun ; Chae, In Ho ; Yoon, Chang Hwan ; Choi, Dong Ju ; Lim, Sang Wook ; Park, Woo Jung ; Doh, Joon Hyung ; Kim, Sang Hyun ; Kim, Myung A. ; Lee, Seunghwan ; Yoon, Junghan ; Ahn, Young Keun ; Hyon, Min Su ; Kim, Ki Seok ; Kim, Young Kwon ; Lee, Han Cheol ; Seol, Sang Hoon ; Hwang, Kyung Kuk ; Choi, Si Wan ; Han, Kyoo Rok ; Shin, Eun Seok ; Kim, Sang Wook ; Lee, Byoung Kwon ; Kim, Hyo Soo. / 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. In: Thrombosis and Haemostasis. 2016 ; Vol. 116, No. 1. pp. 78-86.
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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.",
author = "Lim, {Woo Hyun} and Chae, {In Ho} and Yoon, {Chang Hwan} and Choi, {Dong Ju} and Lim, {Sang Wook} and Park, {Woo Jung} and Doh, {Joon Hyung} and Kim, {Sang Hyun} and Kim, {Myung A.} and Seunghwan Lee and Junghan Yoon and Ahn, {Young Keun} and Hyon, {Min Su} and Kim, {Ki Seok} and Kim, {Young Kwon} and Lee, {Han Cheol} and Seol, {Sang Hoon} and Hwang, {Kyung Kuk} and Choi, {Si Wan} and Han, {Kyoo Rok} and Shin, {Eun Seok} and Kim, {Sang Wook} and Lee, {Byoung Kwon} and Kim, {Hyo Soo}",
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Lim, WH, Chae, IH, Yoon, CH, Choi, DJ, Lim, SW, Park, WJ, Doh, JH, Kim, SH, Kim, MA, Lee, S, Yoon, J, Ahn, YK, Hyon, MS, Kim, KS, Kim, YK, Lee, HC, Seol, SH, Hwang, KK, Choi, SW, Han, KR, Shin, ES, Kim, SW, Lee, BK & Kim, HS 2016, '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', Thrombosis and Haemostasis, vol. 116, no. 1, pp. 78-86. https://doi.org/10.1160/TH15-12-0931

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. / Lim, Woo Hyun; Chae, In Ho; Yoon, Chang Hwan; Choi, Dong Ju; Lim, Sang Wook; Park, Woo Jung; Doh, Joon Hyung; Kim, Sang Hyun; Kim, Myung A.; Lee, Seunghwan; Yoon, Junghan; Ahn, Young Keun; Hyon, Min Su; Kim, Ki Seok; Kim, Young Kwon; Lee, Han Cheol; Seol, Sang Hoon; Hwang, Kyung Kuk; Choi, Si Wan; Han, Kyoo Rok; Shin, Eun Seok; Kim, Sang Wook; Lee, Byoung Kwon; Kim, Hyo Soo.

In: Thrombosis and Haemostasis, Vol. 116, No. 1, 01.07.2016, p. 78-86.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of dual antiplatelet therapy prescribed as one-pill versus two-pill regimen

T2 - A pooled analysis of individual patient data from the three MR-CAPCIS trials

AU - Lim, Woo Hyun

AU - Chae, In Ho

AU - Yoon, Chang Hwan

AU - Choi, Dong Ju

AU - Lim, Sang Wook

AU - Park, Woo Jung

AU - Doh, Joon Hyung

AU - Kim, Sang Hyun

AU - Kim, Myung A.

AU - Lee, Seunghwan

AU - Yoon, Junghan

AU - Ahn, Young Keun

AU - Hyon, Min Su

AU - Kim, Ki Seok

AU - Kim, Young Kwon

AU - Lee, Han Cheol

AU - Seol, Sang Hoon

AU - Hwang, Kyung Kuk

AU - Choi, Si Wan

AU - Han, Kyoo Rok

AU - Shin, Eun Seok

AU - Kim, Sang Wook

AU - Lee, Byoung Kwon

AU - Kim, Hyo Soo

PY - 2016/7/1

Y1 - 2016/7/1

N2 - 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.

AB - 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.

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