European Heart Journal Advance Access published online on September 29, 2008
European Heart Journal, doi:10.1093/eurheartj/ehn438
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Diverging associations of an intended early invasive strategy compared with actual revascularization, and outcome in patients with non-ST-segment elevation acute coronary syndrome: the problem of treatment selection bias
1 Department of Cardiology, B2-137, Academic Medical Center, Meibergdreef 9, PO Box 22660, 1100 DD Amsterdam, The Netherlands
2 Department of Cardiology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
3 Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands
4 Department of Cardiology, Medical Center Alkmaar, Alkmaar, The Netherlands
5 Department of Cardiology, University Medical Center St Radboud, Nijmegen, The Netherlands
Received 4 May 2008; revised 24 August 2008; accepted 12 September 2008.
* Corresponding author. Tel: +31 20 5669111, Fax: +31 20 6962609, Email: r.j.dewinter{at}amc.uva.nl
Aims: In several observational studies, revascularization is associated with substantial reduction in mortality in patients with non-ST-segment elevation acute coronary syndrome (nSTE-ACS). This has strengthened the belief that routine early angiography would lead to a reduction in mortality. We investigated the association between actual in-hospital revascularization and long-term outcome in patients with nSTE-ACS included in the ICTUS trial.
Methods and results: The study population of the present analysis consists of ICTUS participants who were discharged alive after initial hospitalization. The ICTUS trial was a randomized, controlled trial in which 1200 patients were randomized to an early invasive or selective invasive strategy. The endpoints were death from hospital discharge until 4 year follow-up and death or spontaneous myocardial infarction (MI) until 3 years. Among 1189 patients discharged alive, 691 (58%) underwent revascularization during initial hospitalization. In multivariable Cox regression analyses, in-hospital revascularization was independently associated with a reduction in 4 year mortality and 3 year event rate of death or spontaneous MI: hazard ratio (HR) 0.59 [95% confidence interval (CI) 0.37–0.96] and 0.46 (95% CI 0.31–0.68). However, when intention-to-treat analysis was performed, no differences in cumulative event rates were observed between the early invasive and selective invasive strategies: HR 1.10 (95% CI 0.70–1.74) for death and 1.27 (95% CI 0.88–1.85) for death or spontaneous MI.
Conclusion: The ICTUS trial did not show that an early invasive strategy resulted in a better outcome than a selective invasive strategy in patients with nSTE-ACS. However, similar to retrospective analyses from observational studies, actual revascularization was associated with lower mortality and fewer MI. Whether an early invasive strategy leads to a better outcome than a selective invasive strategy cannot be inferred from the observation that revascularized patients have a better prognosis in non-randomized studies.
Key Words: Unstable angina • Treatment strategy • Revascularization • Prognosis
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