ICTUS, 2007 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of routine invasive strategy versus concervative strategy in patients with non–ST-segment elevation acutec oronary syndrome and elevated cardiac troponin T

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ISRCTN82153174    N Engl J Med 2005;353:1095-104
 



Studied treatment early invasive strategy
early invasive strategy including early routine catheterisation and revascularisation where appropriate
Control treatment selective invasive treatment strategy
more selective invasive strategy where catheterisation was done if the patient had refractory angina or recurrent ischaemia
Female (%) 27%
Age 62
GpIIb/IIIa inhibitors, % 93%/0%
Time to cardiac catheterization, median (h) 23/283
Revascularization during initial hopsitalization (routine/selective) % 76%/40%
revascularization at end of follow up (routine/selective) % 79%/54%
PCI with stent (%) 88/88
Inductible ischemia in conservative strategy Exercise stress test before discharge
Thienopyridine with PCI, % 100%
Statin at follow-up, % 92%



Patients patients with non–ST-segment elevation acutec oronary syndrome and elevated cardiac troponin T
Group sizes604 / 596
history of MI 23%
diabetes 14%



Blindness open Inclusion period 2001–2003
Follow-up duration 12 mo (4y) Centers 42
Lost to FU geographical localisation Netherlands
Primary endpoint death, MI, rehospitalization Design Parallel groups
PeriodeInclusion2001–2003
HypotheseSuperiority



EndpointX1N1X0N0TE95% CI Death, myocardial infarction, or strokeg - 604 - 596 no data Repeat intervention - 604 - 596 no data 5-year CV death 38 604 40 596 0,94[0,59; 1,48] 5-year CV death or MI 78 604 78 596 0,99[0,70; 1,38] Death, MI, stroke, refractory ischemia - 604 - 596 no data Stroke - 604 - 596 no data 5-year death - 604 - 596 no data 5-year MI 50 604 54 596 0,91[0,61; 1,37] Myocardial infarction - 604 - 596 no data 5 year all cause death 67 604 59 596 1,12[0,77; 1,62] 5-year death or MI 105 604 95 596 1,09[0,80; 1,48] In hospital death 5 604 5 596 0,99[0,28; 3,43] No nagina at 6-wk - 604 - 596 no data In hospital non fatal MI 70 604 33 596 Out of scale2,09[1,36; 3,22] Composite endpoint - 604 - 596 no data Positive 6-wk ETT - 604 - 596 no data In hospital death or MI 75 604 38 596 1,95[1,30; 2,93] CCS class III-IV angina - 604 - 596 no data 1-year death or MI - 604 - 596 no data Non fatal MI 90 604 59 596 1,51[1,06; 2,14] rehospitalization 44 604 64 596 0,68[0,45; 1,01] 1-year non fatal death - 604 - 596 no data Death or MI 139 604 91 596 1,51[1,12; 2,02] death, MI, rehospitalization 137 604 126 596 1,07[0,82; 1,41] 1-year death - 604 - 596 no data Death 15 604 15 596 0,99[0,48; 2,04] Adverse events - 604 - 596 no data Major bleeding - 604 - 596 no data0,22,01,0

Hirsch A, Windhausen F, Tijssen JG, Verheugt FW, Cornel JH, de Winter RJ Long-term outcome after an early invasive versus selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome and elevated cardiac troponin T (the ICTUS trial): a follow-up study. Lancet 2007;369:827-35     [PMID: 17350451]   link to pdf   add to Mendeley  

de Winter RJ, Windhausen F, Cornel JH, Dunselman PH, Janus CL, Bendermacher PE, Michels HR, Sanders GT, Tijssen JG, Verheugt FW Early invasive versus selectively invasive management for acute coronary syndromes. N Engl J Med 2005;353:1095-104     [PMID: 16162880]   link to pdf   add to Mendeley  

ClinicalTrial.gov record ISRCTN82153174



Registering number ISRCTN82153174 (see trial on clinicaltrials.gov)
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All trials of routine invasive strategy

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