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Comparison of Clinical Efficacy and Safety of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients Undergoing Percutaneous Coronary Intervention

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An Erratum to this article was published on 31 August 2013

Abstract

Objective

A new polymeric salt form of clopidogrel, clopidogrel resinate (CR), is a resinate complex of the (+)-clopidogrel optical isomer wherein the (+)-clopidogrel isomer binds to a water-soluble cation exchange resin via sulfonic acid groups. CR was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available regarding its impact on adverse clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).

Methods

Clopidogrel bisulfate (CB) was used exclusively from January 2004 through April 2010, after which CR was exclusively administered from May 2010 through September 2011, in 8 centers. We categorized the overall population (N = 10,487) into two groups according to the prescribed clopidogrel type: CB (n = 9,127) or CR (n = 1,360). To minimize the covariate imbalance and confounding in comparing CB and CR, we used a multivariable Cox proportional hazard regression model and the propensity score (PS) method to identify a 1:1 matched cohort (n = 2,470). We compared cumulative adverse outcomes during a 1-year follow-up after PCI in the overall population and in the PS-matched cohort.

Results

In the overall population, there is no difference in the 1-year cumulative event rates between the two groups (CB : CR) : composite of any death, nonfatal myocardial infarction or stroke (6.0 % vs. 6.0 %, adjusted HR, 0.82; 95 % CI, 0.61–1.11, p = 0.57), stent thrombosis (0.4 % vs. 0.2 %; adjusted HR, 0.40; 95 % CI, 0.09–1.72, p = 0.31), and bleeding (0.9 % vs. 0.6 %; adjusted HR, 0.67; 95 % CI, 0.28–1.58, p = 0.22). In the PS-matched cohort, the overall findings were consistent.

Conclusions

In this large real-world PCI population, CR was as effective and as safe as CB in preventing adverse clinical outcomes.

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Authors and Affiliations

  1. The Catholic University of Korea, Daejeon St. Mary’s Hospital, Daejeon, Republic of Korea

    Mahn-Won Park, Sung Ho Her, Jung Sun Cho & Chan Joon Kim

  2. Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Seung Hee Jeong & Hyeon-Woo Yim

  3. Clinical Research Coordinating Center of Catholic Medical Center, Seoul, Republic of Korea

    Seung Hee Jeong & Hyeon-Woo Yim

  4. The Catholic University of Korea, Seoul St. Mary’s Hospital, 505 Banpo-Dong, Seocho-Gu, Seoul, 137-040, Republic of Korea

    Pum-Joon Kim, Wook-Sung Chung, Ki-Bae Seung & Kiyuk Chang

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  1. Mahn-Won Park
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Correspondence to Kiyuk Chang.

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Park, MW., Jeong, S.H., Her, S.H. et al. Comparison of Clinical Efficacy and Safety of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients Undergoing Percutaneous Coronary Intervention. Cardiovasc Drugs Ther 27, 441–449 (2013). https://doi.org/10.1007/s10557-013-6466-9

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  • DOI: https://doi.org/10.1007/s10557-013-6466-9

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