(Circulation. 2001;103:1727.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Trial of Aspirin, Sibrafiban, or Both for Secondary Prevention After Acute Coronary Syndromes
Correspondence to L. Kristin Newby, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715-7969. E-mail newby001{at}mc.duke.edu
Background—The first Sibrafiban Versus Aspirin to Yield Maximum Protection From Ischemic Heart Events Post–Acute Coronary Syndromes (SYMPHONY) trial showed no benefit of 2 doses of sibrafiban over aspirin for secondary prevention after acute coronary syndromes. In 2nd SYMPHONY, we compared low-dose sibrafiban plus aspirin (LDS+A), high-dose sibrafiban (HDS), and aspirin alone.
Methods and Results—When the first SYMPHONY results became known, enrollment in 2nd SYMPHONY was stopped prematurely at 6671 patients who had been treated for a median of 90 days. The primary end point of death, myocardial (re)infarction (MI), or severe recurrent ischemia did not differ significantly between aspirin (9.3%) and LDS+A (9.2%; OR, 0.98; 95% CI, 0.80 to 1.20) or HDS (10.5%; OR, 1.14; 95% CI, 0.9 to 1.39) patients. Secondary end points did not differ significantly between aspirin and LDS+A patients. Death or MI occurred significantly more often with HDS (OR, 1.43; 95% CI, 1.14 to 1.80), as did mortality alone (OR, 1.83; 95% CI, 1.17 to 2.88) and MI (OR, 1.32; 95% CI, 1.03 to 1.69). Major bleeding was significantly more frequent in LDS+A patients (5.7%) versus aspirin alone (4.0%) but not in HDS patients (4.6%).
Conclusions—Combining aspirin with LDS did not improve outcomes after acute coronary syndromes and caused more bleeding compared with aspirin alone. There was a trend toward increased mortality in this group and a significant increase in the high-dose arm.
Key Words: coronary disease • platelets • prognosis • treatment
This article has been cited by other articles:
 |
|
 |
|
  T. A. Meadows and D. L. Bhatt Clinical Aspects of Platelet Inhibitors and Thrombus Formation Circ. Res., May 11, 2007; 100(9): 1261 - 1275. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 V. J. Dzau, E. M. Antman, H. R. Black, D. L. Hayes, J. E. Manson, J. Plutzky, J. J. Popma, and W. Stevenson The Cardiovascular Disease Continuum Validated: Clinical Evidence of Improved Patient Outcomes: Part II: Clinical Trial Evidence (Acute Coronary Syndromes Through Renal Disease) and Future Directions Circulation, December 19, 2006; 114(25): 2871 - 2891. [Full Text] [PDF]
|
|
|
|
 |
|
 K. P. Alexander, L. K. Newby, M. V. Bhapkar, H. D. White, J. S. Hochman, M. E. Pfisterer, D. J. Moliterno, E. D. Peterson, F. Van de Werf, P. W. Armstrong, et al. International variation in invasive care of the elderly with acute coronary syndromes Eur. Heart J., July 1, 2006; 27(13): 1558 - 1564. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. D. Bushnell, J. Griffin, L. K. Newby, L. B. Goldstein, K. W. Mahaffey, C. A. Graffagnino, R. A. Harrington, H. D. White, R. J. Simes, R. M. Califf, et al. Statin Use and Sex-Specific Stroke Outcomes in Patients With Vascular Disease Stroke, June 1, 2006; 37(6): 1427 - 1431. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Additional Information JAMA, March 15, 2006; 295(11): E1 - E6. [Full Text] [PDF]
|
|
|
|
 |
|
 D. N. Reddan, L. Szczech, M. V. Bhapkar, D. J. Moliterno, R. M. Califf, E. M. Ohman, P. B. Berger, J. S. Hochman, F. Van de Werf, R. A. Harrington, et al. Renal function, concomitant medication use and outcomes following acute coronary syndromes Nephrol. Dial. Transplant., October 1, 2005; 20(10): 2105 - 2112. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. W. Armstrong, L. K. Newby, C. B. Granger, K. L. Lee, R. J. Simes, F. Van de Werf, H. D. White, R. M. Califf, and for the Virtual Coordinating Centre for Global Col Lessons Learned From a Clinical Trial Circulation, December 7, 2004; 110(23): 3610 - 3614. [Full Text] [PDF]
|
|
|
|
 |
|
 C. Patrono, B. Coller, G. A. FitzGerald, J. Hirsh, and G. Roth Platelet-Active Drugs: The Relationships Among Dose, Effectiveness, and Side Effects: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy Chest, September 1, 2004; 126(3_suppl): 234S - 264S. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. F Viles-Gonzalez, V. Fuster, and J. J Badimon Atherothrombosis: A widespread disease with unpredictable and life-threatening consequences Eur. Heart J., July 2, 2004; 25(14): 1197 - 1207. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. M Kramer, L.K. Newby, W.-C. Chang, R.J. Simes, F. Van de Werf, C. B Granger, K. L Lee, H. D White, L. S Piegas, E. J Topol, et al. International variation in the use of evidence-based medicines for acute coronary syndromes Eur. Heart J., December 1, 2003; 24(23): 2133 - 2141. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. J Knight Antiplatelet treatment in stable coronary artery disease Heart, October 1, 2003; 89(10): 1273 - 1278. [Full Text] [PDF]
|
|
|
|
|
|
E. J. Topol, D. Easton, R. A. Harrington, P. Amarenco, R. M. Califf, C. Graffagnino, S. Davis, H.-C. Diener, J. Ferguson, D. Fitzgerald, et al. Randomized, Double-Blind, Placebo-Controlled, International Trial of the Oral IIb/IIIa Antagonist Lotrafiban in Coronary and Cerebrovascular Disease Circulation, July 29, 2003; 108(4): 399 - 406. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 U. N. Khot and S. E. Nissen Statistical versus clinical significance of the CURE study in acute coronary syndromes: Reply J. Am. Coll. Cardiol., April 2, 2003; 41(7): 1234 - 1235. [Full Text] [PDF]
|
|
|
|
|
|
S. R. Mehta and S. Yusuf Short- and long-term oral antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention J. Am. Coll. Cardiol., February 19, 2003; 41(4_Suppl_S): 79S - 88S. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L.K Newby, M.V Bhapkar, H.D White, E.J Topol, F.C Dougherty, R.A Harrington, M.C Smith, L.F Asarch, R.M Califf, and for the SYMPHONY and 2nd SYMPHONY Investigators Predictors of 90-day outcome in patients stabilized after acute coronary syndromes Eur. Heart J., January 2, 2003; 24(2): 172 - 181. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. J. Quinn, E. F. Plow, and E. J. Topol Platelet Glycoprotein IIb/IIIa Inhibitors: Recognition of a Two-Edged Sword? Circulation, July 16, 2002; 106(3): 379 - 385. [Full Text] [PDF]
|
|
|
|
|
|
L. K. Newby, A. Kristinsson, M. V. Bhapkar, P. E. Aylward, A. P. Dimas, W. W. Klein, D. K. McGuire, D. J. Moliterno, F. W. A. Verheugt, W. D. Weaver, et al. Early Statin Initiation and Outcomes in Patients With Acute Coronary Syndromes JAMA, June 19, 2002; 287(23): 3087 - 3095. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. B. Michels and E. Braunwald Estimating Treatment Effects From Observational Data: Dissonant and Resonant Notes From the SYMPHONY Trials JAMA, June 19, 2002; 287(23): 3130 - 3132. [Full Text] [PDF]
|
|
|
|
|
|
W. J. Cantor, L. K. Newby, R. H. Christenson, R. H. Tuttle, V. Hasselblad, P. W. Armstrong, D. J. Moliterno, R. M. Califf, E. J. Topol, E. M. Ohman, et al. Prognostic significance of elevated troponin i after percutaneous coronary intervention J. Am. Coll. Cardiol., June 5, 2002; 39(11): 1738 - 1744. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. F. O'Connor, D. C. Shields, A. Fitzgerald, C. P. Cannon, E. Braunwald, and D. J. Fitzgerald Genetic variation in glycoprotein IIb/IIIa (GPIIb/IIIa) as a determinant of the responses to an oral GPIIb/IIIa antagonist in patients with unstable coronary syndromes Blood, December 1, 2001; 98(12): 3256 - 3260. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. Agnelli Rationale for the use of platelet aggregation inhibitors in PAD patients Vascular Medicine, February 1, 2001; 6(1_suppl): 13 - 15. [Abstract] [PDF]
|
|