Benefit of addition of clopidogrel in addition to aspirin and fibrinolytic therapy in STEMI: an Indian data
Keywords:
STEMI, Aspirin, Clopidogrel, Primary end points, Secondary end pointsAbstract
Background: The study was designed to find out whether the addition of clopidogrel for patients with ST- elevation myocardial infarction [STEMI] who are receiving a standard fibrinolytic therapy, including aspirin, reduce the incidence of primary and secondary end points like recurrent ischemia, re-infarction, need for urgent Target Vessel Revascularisation [TVR], mortality & bleeding.
Methods: The patients were randomly assigned to receive the study medication. The patients were divided into two groups. Those receiving fibrinolytic therapy & aspirin were included in Group A. Those receiving the study drug in addition to aspirin & fibrinolytic agent were included in Group B. The study drug was given daily upto 1 month. These patients were assessed during their hospital stay & followed up for a period of 30 days for end points like recurrent ischemia, re-infarction, need for urgent TVR, bleeding episodes & mortality.
Results: There was reduction in primary endpoints in group B compared to group A of which only reduction of recurrent ischemia was statistically significant (26% vs 2%). The same pattern of benefit was seen with secondary end points with significant reduction in recurrent ischemia in group B (28% vs 2%). Safety end points showed some increased bleeding in group B patients which was statistically insignificant (4% vs 0).
Conclusion: Addition of Clopidogrel to aspirin and fibrinolytic therapy in ST-elevation MI showed a significant reduction in recurrent ischemia during in hospital stay and during the first 30 days. The patients received clopidogrel had less mortality compared to aspirin group. There were only minor bleeding episodes reported with use of clopidogrel.
References
Sabatine MS, Cannon CP, Gibson CM, López-Sendón JL, Montalescot G, Theroux P, et al. Addition of Clopidogrel to Aspirin & Fibrinolytic therapy for Myocardial Infarction with ST-segment elevation. N Engl J Med 2005;352:1179-89.
Cannon C. Perspective on COMMIT/CCS-2 Trial of Clopidogrel in STEMI. Available at www.clintrialresults.org/Slides/COMMITClopidogrel%20LBCT%20Comments%20-%20ACC%202005.ppt. Accessed 15 March 2013.
Pedersen AK, Fitzgerald GA. Dose-related kinetics of aspirin. Presystemic acetylation of platelet cyclooxygenase. N Engl J Med 1984;311:1206-11.
Lewis HD, Davis JW, Archibald DG, et al. Protective effects of aspirin against acute myocardial infarction and death in men with unstable angina. N Engl J Med 1983;309:396-403.
Cairns JA, Gent M, Singer J, et al. Aspirin, sulfinpyrazone, or both in unstable angina. N Engl J Med 1985;313:1369-75.
ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomized trial of intravenous streptokinase, oral aspirin, both, or, neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988;2(8607):349-60.
Theroux P, Ouimet H, McCans J, et al. Aspirin, heparin, or both to treat acute unstable angina. N Engl J Med 1988;319:1105-11.
The RISC Group. Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease. Lancet 1990;336:827-30.
Heras M, Chesebro J, Penny WJ, et al. Effects of thrombin inhibition on the development of acute platelet-thrombus deposition during angioplasty in pigs. Circulation 1989;79:657-65.
Ridker PM, Cushman M, Stampfer M, et al. Inflammation, aspirin and the risk of cardiovascular disease in apparently healthy men. N Engl J Med 1997;336:973-9.
The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001;345:494-502.