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Antiplatelet Efficacy of Fixed-Dose Aspirin–Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation

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Abstract

Background and Objectives

A fixed-dose combination (FDC) of aspirin and clopidogrel bisulfate may improve medication adherence. However, the absence of data on the relative antiplatelet efficacy of FDC and separate dual pills (SDP) of aspirin and clopidogrel in real-world patients with stable coronary artery disease is a major factor retarding clinical introduction of such an FDC.

Methods

This was a single-centre, randomized, open-label, parallel-group, non-inferiority trial. Patients who maintained a regimen of separate aspirin and clopidogrel pills for at least 1 year after drug-eluting stent implantation without adverse events were enrolled. Patients were randomly assigned to either the FDC group or the SDP group. Antiplatelet efficacy and tolerability were assessed at baseline and at 4 weeks.

Results

Of the 93 enrolled patients, 83 (FDC group: n = 42; SDP group: n = 41) completed the study. The difference in the changes in P2Y12 percentage inhibition did not exceed the predetermined value for inferiority [mean difference −1.7; 95 % confidence interval (CI) −6.9 to 4.5, p < 0.001 for non-inferiority]. The changes from baseline to 4 weeks in P2Y12 reaction units (PRU) (mean difference 9.7 PRU, p = 0.46), maximal platelet aggregation (mean difference 2.0 %, p = 0.44) and aspirin reaction units (ARU) (mean difference −2.3 ARU, p = 0.88) did not differ significantly between the treatment groups. The tolerability of the FDC formulation was similar to that of SDP therapy (p = 0.68).

Conclusion

In patients with prior percutaneous coronary intervention, the antiplatelet efficacy of the aspirin/clopidogrel FDC was non-inferior to that of SDP and the tolerability of the two regimens was similar after 4 weeks of treatment.

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Acknowledgments

The authors acknowledge the cooperation of all investigators and their staff who contributed to the trial.

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Authors and Affiliations

  1. Division of Cardiology, Department of Internal Medicine, College of Medicine, Bucheon St. Mary’s Hospital, The Catholic University of Korea, Bucheon, Republic of Korea

    Sungmin Lim & Hee-Yeol Kim

  2. Cardiovascular Center and Cardiology Division, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 137-701, Republic of Korea

    Pum Joon Kim, Chunyeong Baek, Tae-Hoon Kim, Yoon Seok Koh, Hun-Jun Park, Kiyuk Chang, Wook Sung Chung & Ki-Bae Seung

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  1. Sungmin Lim
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Corresponding author

Correspondence to Pum Joon Kim.

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Funding

This study was funded by a grant from CJ Healthcare Co., Ltd., Seoul, Republic of Korea. The study was designed and conducted by an investigator. The sponsor had no role in the collection, analysis and interpretation of the data and no role in the drafting and revision of the manuscript.

Conflicts of interest

All authors declare that they have no conflict of interest.

Ethical approval

All procedures in this study were performed in accordance with the 1964 Helsinki Declaration, and this study was approved by the institutional review boards of the Catholic University of Korea Catholic Medical Center.

Informed consent

Written informed consent was obtained from all enrolled patients.

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Lim, S., Kim, P.J., Baek, C. et al. Antiplatelet Efficacy of Fixed-Dose Aspirin–Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation. Clin Drug Investig 35, 833–842 (2015). https://doi.org/10.1007/s40261-015-0350-2

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  • DOI: https://doi.org/10.1007/s40261-015-0350-2

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