TY - JOUR
T1 - Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients
T2 - an analysis of safety and efficacy
AU - Liu, Ping Yen
AU - Su, Cheng Huang
AU - Kuo, Feng Yu
AU - Lee, Wen Lieng
AU - Wang, Yi Chih
AU - Lin, Wei Shiang
AU - Chu, Pao Hsien
AU - Lu, Tse Min
AU - Lo, Ping Han
AU - Lee, Cheng Han
AU - Lan, Wei Ren
AU - Huang, Chien Lung
AU - Tsukiyama, Shuji
AU - Yang, Wei Chen
AU - Cheng, Li Chung
AU - Rafael, Virginia
AU - Nikolajsen, Christian
AU - Yin, Wei Hsian
N1 - Funding Information:
The Switch Study protocol was approved by the institutional ethics committees of each study site prior to study initiation. This study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice, the local laws and regulations of Taiwan, and the Declaration of Helsinki. The study was sponsored by Daiichi Sankyo Co., Ltd., and registered on http://www.clinicaltrials.gov (Registration Number: NCT03672097).
Funding Information:
We would like to thank the participating patients, the supporting staff, and the investigators of all study sites. (Study sites listed in alphabetical order: Chang Gung Memorial Hospital, Cheng Hsin General Hospital, China Medical University Hospital, Kaohsiung Veterans General Hospital, Mackay Memorial Hospital, National Cheng Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, and Tri-service General Hospital.) We would like to further acknowledge Linical Co., Ltd. and MIMS Pte. Ltd. for their assistance in performing statistical analysis and preparing the manuscript, respectively.
Publisher Copyright:
© 2021, The Author(s).
PY - 2022/4
Y1 - 2022/4
N2 - The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg as part of dual antiplatelet therapy (DAPT) for the prevention of recurrent ischemia and stent thrombosis in acute coronary syndrome (ACS). This modified dosage regimen has been established in studies conducted in Japan; however, the efficacy and safety of switching from clopidogrel to prasugrel DAPT among Taiwanese patients remain to be explored. In this phase IV, multicenter, single-arm, open-label study, we evaluated the 4-week pharmacodynamic response, and the 48-week safety outcomes of prasugrel 3.75 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5, p < 0.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU > 208) dropped from 23.5 to 10% (p < 0.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age ≥ 65 years, and body mass index ≥ 25 best predicted HPR at Week 4. Throughout the 48-week treatment with prasugrel, the incidences of MACE (1.0%) and TIMI major bleeding (2.0%) were rather low, accompanying an acceptable safety profile of TIMI minor (6.4%) and non-major, non-minor clinically relevant bleeding (3.0%). Overall, switching to the maintenance dose of prasugrel (3.75 mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.
AB - The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg as part of dual antiplatelet therapy (DAPT) for the prevention of recurrent ischemia and stent thrombosis in acute coronary syndrome (ACS). This modified dosage regimen has been established in studies conducted in Japan; however, the efficacy and safety of switching from clopidogrel to prasugrel DAPT among Taiwanese patients remain to be explored. In this phase IV, multicenter, single-arm, open-label study, we evaluated the 4-week pharmacodynamic response, and the 48-week safety outcomes of prasugrel 3.75 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5, p < 0.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU > 208) dropped from 23.5 to 10% (p < 0.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age ≥ 65 years, and body mass index ≥ 25 best predicted HPR at Week 4. Throughout the 48-week treatment with prasugrel, the incidences of MACE (1.0%) and TIMI major bleeding (2.0%) were rather low, accompanying an acceptable safety profile of TIMI minor (6.4%) and non-major, non-minor clinically relevant bleeding (3.0%). Overall, switching to the maintenance dose of prasugrel (3.75 mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.
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U2 - 10.1007/s12928-021-00771-w
DO - 10.1007/s12928-021-00771-w
M3 - Article
C2 - 33813727
AN - SCOPUS:85103668069
SN - 1868-4300
VL - 37
SP - 269
EP - 278
JO - Cardiovascular Intervention and Therapeutics
JF - Cardiovascular Intervention and Therapeutics
IS - 2
ER -