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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.
Eur Heart J. 2009 Mar; 30(6):645-54.EH

Abstract

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.

Authors+Show Affiliations

Department of Cardiology, B2-137, Academic Medical Center, Meibergdreef 9, PO Box 22660, 1100 DD Amsterdam, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18824461

Citation

Hirsch, Alexander, et al. "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." European Heart Journal, vol. 30, no. 6, 2009, pp. 645-54.
Hirsch A, Windhausen F, Tijssen JG, et al. 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. Eur Heart J. 2009;30(6):645-54.
Hirsch, A., Windhausen, F., Tijssen, J. G., Oude Ophuis, A. J., van der Giessen, W. J., van der Zee, P. M., Cornel, J. H., Verheugt, F. W., & de Winter, R. J. (2009). 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. European Heart Journal, 30(6), 645-54. https://doi.org/10.1093/eurheartj/ehn438
Hirsch A, et al. 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. Eur Heart J. 2009;30(6):645-54. PubMed PMID: 18824461.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hirsch,Alexander, AU - Windhausen,Fons, AU - Tijssen,Jan G P, AU - Oude Ophuis,Anthonius J M, AU - van der Giessen,Willem J, AU - van der Zee,P Marc, AU - Cornel,Jan Hein, AU - Verheugt,Freek W A, AU - de Winter,Robbert J, AU - ,, Y1 - 2008/09/29/ PY - 2008/10/1/pubmed PY - 2009/5/15/medline PY - 2008/10/1/entrez SP - 645 EP - 54 JF - European heart journal JO - Eur Heart J VL - 30 IS - 6 N2 - 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. SN - 1522-9645 UR - https://www.unboundmedicine.com/medline/citation/18824461/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_ L2 - https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehn438 DB - PRIME DP - Unbound Medicine ER -