title: Comparison of clinical efficacy and safety of clopidogrel resinate with clopidogrel bisulfate in patients undergoing percutaneous coronary intervention.
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.
authors.affiliation: The Catholic University of Korea, Daejeon St. Mary's Hospital, Daejeon, Republic of Korea.
authors.forename: Mahn-Won
authors.initials: MW
authors.lastname: Park
authors.forename: Seung Hee
authors.initials: SH
authors.lastname: Jeong
authors.forename: Sung Ho
authors.initials: SH
authors.lastname: Her
authors.forename: Pum-Joon
authors.initials: PJ
authors.lastname: Kim
authors.forename: Jung Sun
authors.initials: JS
authors.lastname: Cho
authors.forename: Chan Joon
authors.initials: CJ
authors.lastname: Kim
authors.forename: Wook-Sung
authors.initials: WS
authors.lastname: Chung
authors.forename: Ki-Bae
authors.initials: KB
authors.lastname: Seung
authors.forename: Hyeon-Woo
authors.initials: HW
authors.lastname: Yim
authors.forename: Kiyuk
authors.initials: K
authors.lastname: Chang
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control; D002561:Cerebrovascular Disorders / Q000517:prevention & control; D000077144:Clopidogrel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D013927:Thrombosis / Q000517:prevention & control; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; C528439:clopidogrel resinate; D000077144:Clopidogrel; D013988:Ticlopidine