Safety and clinical outcome of erythropoiesis-stimulating agents in patients with ST-elevation myocardial infarction: A meta-analysis of individual patient data

Marieke L. Fokkema, Peter Van Der Meer, Sunil V. Rao, Anne M. Belonje, Maurizio Ferrario, Hans L. Hillege, Stuart D. Katz, Erik Lipšic, Andrew J. Ludman, Ilka Ott, Fabrice Prunier, Dong Ju Choi, Ken Toba, Dirk J. Van Veldhuisen, Adriaan A. Voors

Research output: Contribution to journalArticle

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Abstract

Background Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events. Methods A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with ≥ 30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality. Results Individual patient data were obtained from 10 of 11 trials, including 97.3% (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (±131) days. The primary end point occurred in 3.5% (20/577) in the control group and in 2.1% (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95% CI [0.31-1.27]; P =.20). Mortality occurred in 13 (2.3%) in the control group and 5 (0.8%) in the ESA group (hazard ratio for ESAs, 0.38; 95% CI [0.13-1.06]; P =.06). Conclusions Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients.

Original languageEnglish
JournalAmerican Heart Journal
Volume168
Issue number3
DOIs
Publication statusPublished - 2014

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Hematinics
Meta-Analysis
Safety
Percutaneous Coronary Intervention
Mortality
ST Elevation Myocardial Infarction
Control Groups
Left Ventricular Function
MEDLINE
Stents
Thrombosis
Randomized Controlled Trials
Myocardial Infarction
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Safety and clinical outcome of erythropoiesis-stimulating agents in patients with ST-elevation myocardial infarction : A meta-analysis of individual patient data. / Fokkema, Marieke L.; Van Der Meer, Peter; Rao, Sunil V.; Belonje, Anne M.; Ferrario, Maurizio; Hillege, Hans L.; Katz, Stuart D.; Lipšic, Erik; Ludman, Andrew J.; Ott, Ilka; Prunier, Fabrice; Choi, Dong Ju; Toba, Ken; Van Veldhuisen, Dirk J.; Voors, Adriaan A.

In: American Heart Journal, Vol. 168, No. 3, 2014.

Research output: Contribution to journalArticle

Fokkema, ML, Van Der Meer, P, Rao, SV, Belonje, AM, Ferrario, M, Hillege, HL, Katz, SD, Lipšic, E, Ludman, AJ, Ott, I, Prunier, F, Choi, DJ, Toba, K, Van Veldhuisen, DJ & Voors, AA 2014, 'Safety and clinical outcome of erythropoiesis-stimulating agents in patients with ST-elevation myocardial infarction: A meta-analysis of individual patient data', American Heart Journal, vol. 168, no. 3. https://doi.org/10.1016/j.ahj.2014.04.020
Fokkema, Marieke L. ; Van Der Meer, Peter ; Rao, Sunil V. ; Belonje, Anne M. ; Ferrario, Maurizio ; Hillege, Hans L. ; Katz, Stuart D. ; Lipšic, Erik ; Ludman, Andrew J. ; Ott, Ilka ; Prunier, Fabrice ; Choi, Dong Ju ; Toba, Ken ; Van Veldhuisen, Dirk J. ; Voors, Adriaan A. / Safety and clinical outcome of erythropoiesis-stimulating agents in patients with ST-elevation myocardial infarction : A meta-analysis of individual patient data. In: American Heart Journal. 2014 ; Vol. 168, No. 3.
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abstract = "Background Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events. Methods A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with {\^a}‰¥ 30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality. Results Individual patient data were obtained from 10 of 11 trials, including 97.3{\%} (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (±131) days. The primary end point occurred in 3.5{\%} (20/577) in the control group and in 2.1{\%} (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95{\%} CI [0.31-1.27]; P =.20). Mortality occurred in 13 (2.3{\%}) in the control group and 5 (0.8{\%}) in the ESA group (hazard ratio for ESAs, 0.38; 95{\%} CI [0.13-1.06]; P =.06). Conclusions Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients.",
author = "Fokkema, {Marieke L.} and {Van Der Meer}, Peter and Rao, {Sunil V.} and Belonje, {Anne M.} and Maurizio Ferrario and Hillege, {Hans L.} and Katz, {Stuart D.} and Erik Lipšic and Ludman, {Andrew J.} and Ilka Ott and Fabrice Prunier and Choi, {Dong Ju} and Ken Toba and {Van Veldhuisen}, {Dirk J.} and Voors, {Adriaan A.}",
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T1 - Safety and clinical outcome of erythropoiesis-stimulating agents in patients with ST-elevation myocardial infarction

T2 - A meta-analysis of individual patient data

AU - Fokkema, Marieke L.

AU - Van Der Meer, Peter

AU - Rao, Sunil V.

AU - Belonje, Anne M.

AU - Ferrario, Maurizio

AU - Hillege, Hans L.

AU - Katz, Stuart D.

AU - Lipšic, Erik

AU - Ludman, Andrew J.

AU - Ott, Ilka

AU - Prunier, Fabrice

AU - Choi, Dong Ju

AU - Toba, Ken

AU - Van Veldhuisen, Dirk J.

AU - Voors, Adriaan A.

PY - 2014

Y1 - 2014

N2 - Background Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events. Methods A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with ≥ 30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality. Results Individual patient data were obtained from 10 of 11 trials, including 97.3% (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (±131) days. The primary end point occurred in 3.5% (20/577) in the control group and in 2.1% (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95% CI [0.31-1.27]; P =.20). Mortality occurred in 13 (2.3%) in the control group and 5 (0.8%) in the ESA group (hazard ratio for ESAs, 0.38; 95% CI [0.13-1.06]; P =.06). Conclusions Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients.

AB - Background Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events. Methods A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with ≥ 30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality. Results Individual patient data were obtained from 10 of 11 trials, including 97.3% (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (±131) days. The primary end point occurred in 3.5% (20/577) in the control group and in 2.1% (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95% CI [0.31-1.27]; P =.20). Mortality occurred in 13 (2.3%) in the control group and 5 (0.8%) in the ESA group (hazard ratio for ESAs, 0.38; 95% CI [0.13-1.06]; P =.06). Conclusions Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients.

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