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

Alexander Hirsch, Fons Windhausen, Jan GP Tijssen, Freek W.A. Verheugt, The Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) investigators, Jan Hein Cornel, Robbert J. de Winter*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background The ICTUS trial was a study that compared an early invasive with a selective invasive treatment strategy
in patients with non-ST-elevation acute coronary syndrome (nSTE-ACS). The study reported no diff erence between
the strategies for frequency of death, myocardial infarction, or rehospitalisation after 1 year. We did a follow-up study
to assess the eff ects of these treatment strategies after 4 years.
Methods 1200 patients with nSTE-ACS and an elevated cardiac troponin were enrolled from 42 hospitals in the
Netherlands. Patients were randomly assigned either to an early invasive strategy, including early routine catheterisation
and revascularisation where appropriate, or to a more selective invasive strategy, where catheterisation was done if the
patient had refractory angina or recurrent ischaemia. The main endpoints for the current follow-up study were death,
recurrent myocardial infarction, or rehospitalisation for anginal symptoms within 3 years after randomisation, and
cardiovascular mortality and all-cause mortality within 4 years. Analysis was by intention-to-treat. This study is
registered as an International Standard Randomised Controlled Trial, number ISRCTN82153174.
Findings The in-hospital revascularisation rate was 76% in the early invasive group and 40% in the selective invasive
group. After 3 years, the cumulative rate for the combined endpoint was 30·0% in the early invasive group compared
with 26·0% in the selective invasive group (hazard ratio 1·21; 95% CI 0·97–1·50; p=0·09). Myocardial infarction was
more frequent in the early invasive strategy group (106 [18·3%] vs 69 [12·3%]; HR 1·61; 1·19–2·18; p=0·002). Rates of
death or spontaneous myocardial infarction were not diff erent (76 [14·3%] patients in the early invasive and
63 [11·2%] patients in the selective invasive strategy [HR 1·19; 0·86–1·67; p=0·30]). No diff erence in all-cause mortality
(7·9% vs 7·7%; p=0·62) or cardiovascular mortality (4·5% vs 5·0%; p=0·97) was seen within 4 years.
Interpretation Long-term follow-up of the ICTUS trial suggests that an early invasive strategy might not be better
than a more selective invasive strategy in patients with nSTE-ACS and an elevated cardiac troponin, and implementation
of either strategy might be acceptable in these patients.
Original languageEnglish
Pages (from-to)827-835
JournalThe Lancet
Volume369
Issue number9564
DOIs
Publication statusPublished - 10 Mar 2007
Externally publishedYes

Bibliographical note

© 2007 Elsevier Ltd. All rights reserved.

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