Equivalence comparison between domestic and imported clopidogrel for percutaneous coronary interventions in 1 798 cases / 中国组织工程研究

ABSTRACT

BACKGROUND:A few of studies have showed similar efficacy and safety between domestic clopidogrel (Talcom?) and imported clopidogrel (Plavix?) in patients after percutaneous coronary intervention, but there is lack of large-scale, large sample, and prospective clinical comparative study in China. OBJECTIVE:To compare the efficacy and safety of Talcom?and Plavix?on percutaneous coronary intervention. METHODS:Total y 1 798 patients with Coronary atherosclerotic heart disease who received percutaneous coronary interventions were divided to two groupsTalcom?group (n=1 104) and Plavix?group (n=694). 300 mg clopidogrel was administrated oral y before percutaneous coronary intervention fol owed by 75 mg/d clopidogrel sequential y for 1 year. Al the patients were fol owed for 3-28 months to observe the incidence rate of stent thrombosis at acute, subacute, late, and very late stage, major adverse cardiac events of combination end point (including myocardial infarction, cardiac death, and stroke), and correlated adverse reactions, such as bleeding. RESULTS AND CONCLUSION:There were no significant differences in the incidence of stent thrombosis, target vessel revascularization, cardiac death, bleeding, major bleeding and major adverse cardiac events of combination end point between Talcom?group and Plavix?group. In addition, event-free survival also showed no difference between the two groups. After treatment, white blood cellcount, erythrocyte count, hemoglobin, hematocrit, platelet count were significantly decreased in both the two groups (P<0.05). Hemoglobin level in the Talcom?group was fewer than that in the Plavix?group (P<0.05). The results suggest that effects and safety of Talcom?are similar to those of Plavix?for percutaneous coronary interventions.