Equivalence comparison between domestic and imported clopidogrel for percutaneous coronary interventions in 1 798 cases

doi:10.3969/j.issn.2095-4344.2013.47.006

Abstract

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: Totally 1 798 patients with Coronary atherosclerotic heart disease who received percutaneous coronary interventions were divided to two groups: Talcom™ group (n=1 104) and Plavix™ group (n=694). 300 mg clopidogrel was administrated orally before percutaneous coronary intervention followed by 75 mg/d clopidogrel sequentially for 1 year. All the patients were followed 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 cell count, 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.

Key words: biocompatible materials, stents, coronary vessels, comparative effectiveness research

CLC Number:

R318

Yang Yu-heng, Sun Zhong-hua, Mi Jie, Zhong Ming-hui, Zhang Jian, Wang Yong-de, Chen Tao, Tian Gang, Zang Xi-wen, Xiong Guo-jun, Luo Huan, Qi Xiang-qian. Equivalence comparison between domestic and imported clopidogrel for percutaneous coronary interventions in 1 798 cases[J]. Chinese Journal of Tissue Engineering Research, 2013, 17(47): 8175-8181.

Figures/Tables 4

References

[1] CAPRIE Steering Committee. A randomized, blinded, trial of clopidogrel versus aspirin in patients at risk of ishaemic events (CAPRIE).Lancet. 1996;348(9038): 1329-1339.
[2] Yusuf S,Mehta SR,Zhao F,et al.Early and late effects of clopidogrel in patients with acute coronary syndromes. Circulation.2003;107(7): 966-972.
[3] Chen ZM,Jiang LX,Chen YP,et al.Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial.Lancet.2005;366(9497): 1607-1621.
[4] Sabatine MS,Cannon CP,Gibson CM,et al.Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation.N Engl J Med.2005; 352(12): 1179-1189.
[5] Sabatine MS,Cannon CP,Gibson CM,et al.Effet of clopidogrel pretreatment before percutaneous coronary intervention in patients with ST-elevation myocardial infarction treated with fibrinolytics: the PCI-CLARITY study. JAMA.2005;294(10): 1224-1232.
[6] Verheugt FW,Montalescot G,Sabatine MS,et al.Prehospital fibrinolysis with dual antiplatelet therapy in ST-elevation acute myocardial infarction: a substudy of the randomized double blind CLARITY-TIMI 28 trial.J Thromb Thrombolysis.2007; 23(3):173-179.
[7] Bertrand ME,Rupprecht HJ,Urban P,et al.Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting : the clopidogrel aspirin stent international cooperative study (CLASSICS).Circulation.2000;102(6): 624-629.
[8] Mehta SR,Yusuf S,Peters RJ,et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet.2001;358(9281): 527-533.
[9] Steinhubl SR,Berger PB,Mann JT 3rd,et al.Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA.2002;288 (19): 2411-2420.
[10] Mehta SR,Bassand JP,Chrolavicius S,et al.CURRENT-OASIS 7 Investigators. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med.2010;363(10): 930-942
[11] 中华医学会心血管病学分会/中华心血管病杂志编辑委员会. 经皮冠状动脉介入治疗指南2009[J].中华心血管病杂志,2009, 37(1): 4-25.
[12] 柏瑾,李志善,戚文航,等.国产硫酸氯吡格雷片降低血小板聚集率的临床观察[J].中国临床药学杂志2001,10(2): 67-69.
[13] 陈凌,李志善,戚文航,等.硫酸氯吡格雷的抗血小板聚集临床研究[J].中国新药杂志2000,9(10): 715-717.
[14] Kushner FG,Hand M,Smith SC Jr,et al.2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction.Circulation.2009;120(22): 2271-2306.
[15] Silber S,Albertsson P,Avilés FF,et al.Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions.Eur Heart J.2005;26(8):804-847.
[16] Anderson JL,Adams CD,Antman EM,et al.ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction.Circulation. 2007;116(7): e148-304.
[17] Holmes DR,Kereiakes DJ,Kleiman NS,et al.Combining antiplatelet and anticoagulant therapies.J Am Coll Cardiol. 2009;54(2): 95-109.
[18] 李志娟,董平栓,杨旭明,等.国产和进口氯吡格雷对经皮冠状动脉介入术后血小板功能的影响[J].中国介入心脏病学杂志,2006, 14(4):208-210.
[19] 顾俊,胡伟,肖红兵,等.国产和进口氯吡格雷对PCI近中期预后的影响[J].上海交通大学学报:医学版,2008,28(5): 608-609.
[20] 卢春山,周志强,柳景华,等.冠状动脉支架术后进口氯吡格雷(波立维)与国产氯吡格雷(泰嘉)抗血小板治疗的对照研究[J].中国介入心脏病学杂志,2009,17(2): 67-70.
[21] 李鹏,王文红,刘勇.国产氯吡格雷(泰嘉)与进口氯吡格雷(波立维)PCI术后应用的有效性和安全性对照研究[J].中国心血管病研究,2010,8(7): 506-508.
[22] 阴赪茜,李志忠,张京梅,等.国产与进口氯吡格雷在冠状动脉介入治疗中的疗效对比分析[J].中国新药杂志,2010,19(10): 849-852.
[23] Meng K, Lü SZ, Zhu HG,et al.Use of tailored loading-dose clopidogrel in patients undergoing selected percutaneous coronary intervention based on adenosine diphosphate-mediated platelet aggregation. Chin Med J. 2010;123(24): 3578-3582.
[24] 孙裕华,陶秀彬,倪芳,等.国产氯吡格雷治疗冠心病疗效及安全性的Meta分析[J].中国循证心血管医学杂志,2010,2(4): 214-218.