Abstract 17185: Comparison of Clinical efficacy and Safety of Clopidogrel Resinate (Pregrel®) With Clopidogrel Bisulfate (Plavix®) in Patients Undergoing Percutaneous Coronary Intervention
Introduction While clopidogrel bisulfate (Plavix®) is very susceptible to degradation or chiral inversion by moisture including acidic or alkaline conditions as well as dry heat, clopidogrel resinate (Pregrel®), a new salt form of clopidogrel, is very stable in the physicochemical stability and the gastrointestinal stability tests as well as was highly safe in toxicity studies compared to conventional clopidogrel bisulfate. In 2007, clopidogrel resinate was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available on the comparison of impact of the two drugs on adverse clinical outcomes.
Methods Plavix was used exclusively from January 2004 through April 2010 and then Pregrel was used exclusively from May 2010 through September 2011. We dichotomized the overall population into two groups according to prescribed type of clopidogrel: Plavix (n= 9,127) and Pregrel (n= 1,360) group. We compared adverse outcomes with the use of propensity-score matching in overall cohort during 6 months after PCI (matched cohort; Plavix group, n=1238, Pregrel group, n=1238).
Results In the overall matched cohort, there was no significant difference between Pregrel and Plavix groups in the 6-month cumulative event rate of BARC bleeding ≥ type 2 (Pregrel vs. Plavix: 0.3% vs. 1%; HR, 0.53; 95% CI, 0.13-2.14, p=0.3)or stent thrombosis (definite +probable) (Pregrel vs. Plavix: 0.3% vs. 0.7%; HR; 0.25, 95% CI; 0.05-1.17,p=0.08). The rate of composite of any death, nonfatal myocardial infarction and stroke were significantly lower in Pregrel group (Pregrel vs. Plavix: 3.2% vs. 5.3%; HR; 0.58, 95% CI; 0.37-0.91, p=0.02), which might be explained partly by exclusive use of second generation DES and intensive statin therapy.
Conclusions In conclusion, clopidogrel resinate, a new salt form of clopidogrel, was as efficacious and as safe as conventional clopidogrel resinate to prevent adverse clinical outcomes after PCI.
- © 2012 by American Heart Association, Inc.