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
Background Current guidelines recommend an early invasive strategyfor patients who have acute coronary syndromes without ST-segmentelevation 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 previoustrials has varied depending on the definition of myocardialinfarction.
Methods We randomly assigned 1200 patients with acute coronarysyndrome without ST-segment elevation who had chest pain, anelevated cardiac troponin T level (0.03 µg per liter),and either electrocardiographic evidence of ischemia at admissionor a documented history of coronary disease to an early invasivestrategy or to a more conservative (selectively invasive) strategy.Patients received aspirin daily, enoxaparin for 48 hours, andabciximab at the time of percutaneous coronary intervention.The use of clopidogrel and intensive lipid-lowering therapywas recommended. The primary end point was a composite of death,nonfatal myocardial infarction, or rehospitalization for anginalsymptoms within one year after randomization.
Results The estimated cumulative rate of the primary end pointwas 22.7 percent in the group assigned to early invasive managementand 21.2 percent in the group assigned to selectively invasivemanagement (relative risk, 1.07; 95 percent confidence interval,0.87 to 1.33; P=0.33). The mortality rate was the same in thetwo groups (2.5 percent). Myocardial infarction was significantlymore frequent in the group assigned to early invasive management(15.0 percent vs. 10.0 percent, P=0.005), but rehospitalizationwas less frequent in that group (7.4 percent vs. 10.9 percent,P=0.04).
Conclusions We could not demonstrate that, given optimized medicaltherapy, an early invasive strategy was superior to a selectivelyinvasive strategy in patients with acute coronary syndromeswithout ST-segment elevation and with an elevated cardiac troponinT 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.
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.
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