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Original Article
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Volume 353:1095-1104 September 15, 2005 Number 11
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Early Invasive versus Selectively Invasive Management for Acute Coronary Syndromes
Robbert J. de Winter, M.D., Ph.D., Fons Windhausen, M.D., Jan Hein Cornel, M.D., Ph.D., Peter H.J.M. Dunselman, M.D., Ph.D., Charles L. Janus, M.D., Peter E.F. Bendermacher, M.D., H. Rolf Michels, M.D., Ph.D., Gerard T. Sanders, Ph.D., Jan G.P. Tijssen, Ph.D., Freek W.A. Verheugt, M.D., Ph.D., for the Invasive versus Conservative Treatment in Unstable Coronary Syndromes (ICTUS) Investigators

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ABSTRACT

Background Current guidelines recommend an early invasive strategy for patients who have acute coronary syndromes without ST-segment elevation and with an elevated cardiac troponin T level. However, randomized trials have not shown an overall reduction in mortality, and the reduction in the rate of myocardial infarction in previous trials has varied depending on the definition of myocardial infarction.

Methods We randomly assigned 1200 patients with acute coronary syndrome without ST-segment elevation who had chest pain, an elevated cardiac troponin T level (≥0.03 µg per liter), and either electrocardiographic evidence of ischemia at admission or a documented history of coronary disease to an early invasive strategy or to a more conservative (selectively invasive) strategy. Patients received aspirin daily, enoxaparin for 48 hours, and abciximab at the time of percutaneous coronary intervention. The use of clopidogrel and intensive lipid-lowering therapy was recommended. The primary end point was a composite of death, nonfatal myocardial infarction, or rehospitalization for anginal symptoms within one year after randomization.

Results The estimated cumulative rate of the primary end point was 22.7 percent in the group assigned to early invasive management and 21.2 percent in the group assigned to selectively invasive management (relative risk, 1.07; 95 percent confidence interval, 0.87 to 1.33; P=0.33). The mortality rate was the same in the two groups (2.5 percent). Myocardial infarction was significantly more frequent in the group assigned to early invasive management (15.0 percent vs. 10.0 percent, P=0.005), but rehospitalization was less frequent in that group (7.4 percent vs. 10.9 percent, P=0.04).

Conclusions We could not demonstrate that, given optimized medical therapy, an early invasive strategy was superior to a selectively invasive strategy in patients with acute coronary syndromes without ST-segment elevation and with an elevated cardiac troponin T level.


Source Information

From the Academisch Medisch Centrum, Amsterdam (R.J.W., F.W., G.T.S., J.G.P.T.); Medisch Centrum Alkmaar, Alkmaar (J.H.C.); Amphia Ziekenhuizen, Breda (P.H.J.M.D.); WestFriesGasthuis, Hoorn (C.L.J.); Elkerliek Ziekenhuis, Helmond (P.E.F.B.); Catharina Ziekenhuis, Eindhoven (H.R.M.); and Universitair Medisch Centrum St. Radboud, Nijmegen (F.W.A.V.) — all in the Netherlands.

Address reprint requests to Dr. de Winter at the Department of Cardiology, B2-137, Academic Medical Center, Meibergdreef 9, P.O. Box 22660, 1100 DD Amsterdam, the Netherlands, or at r.j.dewinter{at}amc.uva.nl.

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Related Letters:

Management of Acute Coronary Syndromes
Tarantini G., Ramondo A., Iliceto S., Newby D. E., Fox K. A., Ionescu A., Garg A., Spaulding C., Varenne O., Weber S., Costantino G., Raggi F., Montano N., Garcia-Pavia P., Aguiar-Souto P., Silva-Melchor L., de Winter R. J., Windhausen F., Tijssen J. G.P., Boden W. E.
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N Engl J Med 2005; 353:2714-2718, Dec 22, 2005. Correspondence

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