Circulation. 2005;111:2099-2106
Published online before print March 6, 2005, doi: 10.1161/01.CIR.0000161383.06692.D4
Published online before print March 6, 2005, doi: 10.1161/01.CIR.0000161383.06692.D4
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(Circulation. 2005;111:2099-2106.)
© 2005 American Heart Association, Inc.
Interventional Cardiology |
Randomized Trial of High Loading Dose of Clopidogrel for Reduction of Periprocedural Myocardial Infarction in Patients Undergoing Coronary Intervention
Results From the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) Study*
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (G.P., L.L.P., G.D.S.); Interventional Cardiology Unit, Vito Fazzi Hospital, Lecce, Italy (G.C., A.M.); and Interventional Cardiology Unit, San Filippo Neri Hospital, Rome, Italy (V.P.).
Correspondence to Prof Germano Di Sciascio, MD, Department of Cardiovascular Sciences, Campus Bio-Medico University, Via E. Longoni, 83, 00155 Rome, Italy. E-mail g.disciascio{at}unicampus.it
Received December 23, 2004; revision received February 21, 2005; accepted February 22, 2005.
Background— Aggressive platelet inhibition is crucial to reduce myocardial injury and early cardiac events after coronary intervention. Although observational data have suggested that pretreatment with a high loading dose of clopidogrel may be more effective than a conventional dose, this hypothesis has never been tested in a randomized trial.
Methods and Results— A total of 255 patients scheduled to undergo percutaneous coronary intervention were randomized to a 600-mg (n=126) or 300-mg (n=129) loading regimen of clopidogrel given 4 to 8 hours before the procedure. Creatine kinase MB, troponin I, and myoglobin levels were measured at baseline and at 8 and 24 hours after intervention. The primary end point was the 30-day occurrence of death, myocardial infarction (MI), or target vessel revascularization. The primary end point occurred in 4% of patients in the high loading dose versus 12% of those in the conventional loading dose group (P=0.041) and was due entirely to periprocedural MI. Peak values of all markers were significantly lower in patients treated with the 600-mg regimen (P
0.038). Safety end points were similar in the 2 arms. At multivariable analysis, the high loading regimen was associated with a 50% risk reduction of MI (OR 0.48, 95% CI 0.15 to 0.97, P=0.044). An incremental benefit was observed in patients randomized to the 600-mg dose who were receiving statins, with an 80% risk reduction.
Conclusions— Pretreatment with a 600-mg loading dose of clopidogrel 4 to 8 hours before the procedure is safe and, as compared with the conventional 300-mg dose, significantly reduced periprocedural MI in patients undergoing percutaneous coronary intervention. These results may influence practice patterns with regard to antiplatelet therapy before percutaneous revascularization.
Key Words: angioplasty • trials • myocardial infarction • stents • clopidogrel
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G. Patti, M. Chello, D. Candura, V. Pasceri, A. D'Ambrosio, E. Covino, and G. Di Sciascio Randomized Trial of Atorvastatin for Reduction of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: Results of the ARMYDA-3 (Atorvastatin for Reduction of MYocardial Dysrhythmia After cardiac surgery) Study Circulation, October 3, 2006; 114(14): 1455 - 1461. [Abstract] [Full Text] [PDF]
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B. Ibanez, G. Vilahur, and J. J. Badimon Pharmacology of thienopyridines: rationale for dual pathway inhibition Eur. Heart J. Suppl., October 1, 2006; 8(suppl_G): G3 - G9. [Abstract] [Full Text] [PDF]
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H. Hamdalla and S. R. Steinhubl Clinical efficacy of clopidogrel across the whole spectrum of indications: percutaneous coronary intervention Eur. Heart J. Suppl., October 1, 2006; 8(suppl_G): G20 - G24. [Abstract] [Full Text] [PDF]
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S. R. Mehta Clopidogrel in non-ST-segment elevation acute coronary syndromes Eur. Heart J. Suppl., October 1, 2006; 8(suppl_G): G25 - G30. [Abstract] [Full Text] [PDF]
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A. D. Michelson, A. L. Frelinger, and M. I. Furman Resistance to antiplatelet drugs Eur. Heart J. Suppl., October 1, 2006; 8(suppl_G): G53 - G58. [Abstract] [Full Text] [PDF]
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D. J. Kereiakes and E. M. Antman Clinical Guidelines and Practice: In Search of the Truth J. Am. Coll. Cardiol., September 19, 2006; 48(6): 1129 - 1135. [Abstract] [Full Text] [PDF]
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G. Montalescot, G. Sideris, C. Meuleman, C. Bal-dit-Sollier, N. Lellouche, Ph. G. Steg, M. Slama, O. Milleron, J.-P. Collet, P. Henry, et al. A Randomized Comparison of High Clopidogrel Loading Doses in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes: The ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) Trial J. Am. Coll. Cardiol., September 5, 2006; 48(5): 931 - 938. [Abstract] [Full Text] [PDF]
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R. P. Giugliano and E. Braunwald The Year in Non-ST-Segment Elevation Acute Coronary Syndromes J. Am. Coll. Cardiol., July 18, 2006; 48(2): 386 - 395. [Full Text] [PDF]
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S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., April 18, 2006; 47(8): 1689 - 1706. [Full Text] [PDF]
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N. G. Vallurupalli and S. Z. Goldhaber Gastrointestinal Complications of Dual Antiplatelet Therapy Circulation, March 28, 2006; 113(12): e655 - e658. [Full Text] [PDF]
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S. R. Steinhubl, P. B. Berger, D. M. Brennan, E. J. Topol, and for the CREDO Investigators Optimal Timing for the Initiation of Pre-Treatment With 300 mg Clopidogrel Before Percutaneous Coronary Intervention J. Am. Coll. Cardiol., March 7, 2006; 47(5): 939 - 943. [Abstract] [Full Text] [PDF]
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T. H. Wang, D. L. Bhatt, and E. J. Topol Aspirin and clopidogrel resistance: an emerging clinical entity Eur. Heart J., March 2, 2006; 27(6): 647 - 654. [Abstract] [Full Text] [PDF]
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A. Colombo and G. Stankovic The Value of Selectivity J. Am. Coll. Cardiol., February 21, 2006; 47(4): 719 - 720. [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) J. Am. Coll. Cardiol., January 3, 2006; 47(1): 216 - 235. [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) Circulation, January 3, 2006; 113(1): 156 - 175. [Full Text] [PDF]
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