Low-dose erythropoietin in patients with ST-segment elevation myocardial infarction (EPO-AMI-II): ― A randomized controlled clinical trial ―

EPO-AMI-II Investigators

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Erythropoietin (EPO) has antiapoptotic and tissue-protective effects, but previous clinical studies using high-dose EPO have not shown cardioprotective effects, probably because of platelet activation and a lack of knowledge regarding the optimal dose. In contrast, a small pilot study using low-dose EPO has shown improvement in left ventricular function without adverse cardiovascular events. Methods and Results: We performed a multicenter (25 hospitals), prospective, randomized, double-blind, placebo-controlled, dose-finding study to clarify the efficacy and safety of low-dose EPO in patients with ST-segment elevation myocardial infarction (STEMI) under the Evaluation System of Investigational Medical Care of the Ministry of Health, Labor and Welfare of Japan. In total, 198 STEMI patients with low left ventricular ejection fraction (LVEF <50%) were randomly assigned to receive intravenous administration of EPO (6,000 or 12,000 IU) or placebo within 6 h of successful percutaneous coronary intervention. At 6 months, there was no significant dose-response relationship in LVEF improvement among the 3 groups tested (EPO 12,000 IU: 5.4±9.3%, EPO 6,000 IU: 7.3±7.7%, Placebo: 8.1±8.3%, P=0.862). Low-dose EPO also did not improve cardiac function, as evaluated by99 mTc-MIBI SPECT or NT-proBNP at 6 months and did not increase adverse events. Conclusions: Administration of low-dose EPO did not improve LVEF at 6 months in STEMI patients (UMIN000005721).

Original languageEnglish
Pages (from-to)1083-1091
Number of pages9
JournalCirculation Journal
Volume82
Issue number4
DOIs
Publication statusPublished - Jan 1 2018

Fingerprint

Erythropoietin
Randomized Controlled Trials
Placebos
Myocardial Infarction
ST Elevation Myocardial Infarction
Platelet Activation
Percutaneous Coronary Intervention
Single-Photon Emission-Computed Tomography
Left Ventricular Function
Intravenous Administration
Stroke Volume
Japan
Delivery of Health Care
Safety

Keywords

  • Acute myocardial infarction
  • Erythropoietin
  • Left ventricular ejection fraction

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Low-dose erythropoietin in patients with ST-segment elevation myocardial infarction (EPO-AMI-II) : ― A randomized controlled clinical trial ―. / EPO-AMI-II Investigators.

In: Circulation Journal, Vol. 82, No. 4, 01.01.2018, p. 1083-1091.

Research output: Contribution to journalArticle

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title = "Low-dose erythropoietin in patients with ST-segment elevation myocardial infarction (EPO-AMI-II): ― A randomized controlled clinical trial ―",
abstract = "Background: Erythropoietin (EPO) has antiapoptotic and tissue-protective effects, but previous clinical studies using high-dose EPO have not shown cardioprotective effects, probably because of platelet activation and a lack of knowledge regarding the optimal dose. In contrast, a small pilot study using low-dose EPO has shown improvement in left ventricular function without adverse cardiovascular events. Methods and Results: We performed a multicenter (25 hospitals), prospective, randomized, double-blind, placebo-controlled, dose-finding study to clarify the efficacy and safety of low-dose EPO in patients with ST-segment elevation myocardial infarction (STEMI) under the Evaluation System of Investigational Medical Care of the Ministry of Health, Labor and Welfare of Japan. In total, 198 STEMI patients with low left ventricular ejection fraction (LVEF <50{\%}) were randomly assigned to receive intravenous administration of EPO (6,000 or 12,000 IU) or placebo within 6 h of successful percutaneous coronary intervention. At 6 months, there was no significant dose-response relationship in LVEF improvement among the 3 groups tested (EPO 12,000 IU: 5.4±9.3{\%}, EPO 6,000 IU: 7.3±7.7{\%}, Placebo: 8.1±8.3{\%}, P=0.862). Low-dose EPO also did not improve cardiac function, as evaluated by99 mTc-MIBI SPECT or NT-proBNP at 6 months and did not increase adverse events. Conclusions: Administration of low-dose EPO did not improve LVEF at 6 months in STEMI patients (UMIN000005721).",
keywords = "Acute myocardial infarction, Erythropoietin, Left ventricular ejection fraction",
author = "{EPO-AMI-II Investigators} and Tetsuo Minamino and Shuichiro Higo and Ryo Araki and Shungo Hikoso and Daisaku Nakatani and Hiroshi Suzuki and Takahisa Yamada and Masaaki Okutsu and Kouji Yamamoto and Yasushi Fujio and Yoshio Ishida and Takuya Ozawa and Kiminori Kato and Ken Toba and Yoshifusa Aizawa and Issei Komuro and T. Toba and T. Ishimitsu and S. Higo and Y. Yasumura and T. Yamada and Y. Ueda and M. Nishino and Hiroshi Itoh and H. Suzuki and A. Namiki and T. Tobaru and K. Ando and S. Yasuda and Y. Doi and S. Koba and M. Yasutake and Y. Akashi and S. Saito and M. Okutsu and Y. Kijima and T. Yoshida and N. Sato and Y. Sakai and Y. Ohira",
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T1 - Low-dose erythropoietin in patients with ST-segment elevation myocardial infarction (EPO-AMI-II)

T2 - ― A randomized controlled clinical trial ―

AU - EPO-AMI-II Investigators

AU - Minamino, Tetsuo

AU - Higo, Shuichiro

AU - Araki, Ryo

AU - Hikoso, Shungo

AU - Nakatani, Daisaku

AU - Suzuki, Hiroshi

AU - Yamada, Takahisa

AU - Okutsu, Masaaki

AU - Yamamoto, Kouji

AU - Fujio, Yasushi

AU - Ishida, Yoshio

AU - Ozawa, Takuya

AU - Kato, Kiminori

AU - Toba, Ken

AU - Aizawa, Yoshifusa

AU - Komuro, Issei

AU - Toba, T.

AU - Ishimitsu, T.

AU - Higo, S.

AU - Yasumura, Y.

AU - Yamada, T.

AU - Ueda, Y.

AU - Nishino, M.

AU - Itoh, Hiroshi

AU - Suzuki, H.

AU - Namiki, A.

AU - Tobaru, T.

AU - Ando, K.

AU - Yasuda, S.

AU - Doi, Y.

AU - Koba, S.

AU - Yasutake, M.

AU - Akashi, Y.

AU - Saito, S.

AU - Okutsu, M.

AU - Kijima, Y.

AU - Yoshida, T.

AU - Sato, N.

AU - Sakai, Y.

AU - Ohira, Y.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Erythropoietin (EPO) has antiapoptotic and tissue-protective effects, but previous clinical studies using high-dose EPO have not shown cardioprotective effects, probably because of platelet activation and a lack of knowledge regarding the optimal dose. In contrast, a small pilot study using low-dose EPO has shown improvement in left ventricular function without adverse cardiovascular events. Methods and Results: We performed a multicenter (25 hospitals), prospective, randomized, double-blind, placebo-controlled, dose-finding study to clarify the efficacy and safety of low-dose EPO in patients with ST-segment elevation myocardial infarction (STEMI) under the Evaluation System of Investigational Medical Care of the Ministry of Health, Labor and Welfare of Japan. In total, 198 STEMI patients with low left ventricular ejection fraction (LVEF <50%) were randomly assigned to receive intravenous administration of EPO (6,000 or 12,000 IU) or placebo within 6 h of successful percutaneous coronary intervention. At 6 months, there was no significant dose-response relationship in LVEF improvement among the 3 groups tested (EPO 12,000 IU: 5.4±9.3%, EPO 6,000 IU: 7.3±7.7%, Placebo: 8.1±8.3%, P=0.862). Low-dose EPO also did not improve cardiac function, as evaluated by99 mTc-MIBI SPECT or NT-proBNP at 6 months and did not increase adverse events. Conclusions: Administration of low-dose EPO did not improve LVEF at 6 months in STEMI patients (UMIN000005721).

AB - Background: Erythropoietin (EPO) has antiapoptotic and tissue-protective effects, but previous clinical studies using high-dose EPO have not shown cardioprotective effects, probably because of platelet activation and a lack of knowledge regarding the optimal dose. In contrast, a small pilot study using low-dose EPO has shown improvement in left ventricular function without adverse cardiovascular events. Methods and Results: We performed a multicenter (25 hospitals), prospective, randomized, double-blind, placebo-controlled, dose-finding study to clarify the efficacy and safety of low-dose EPO in patients with ST-segment elevation myocardial infarction (STEMI) under the Evaluation System of Investigational Medical Care of the Ministry of Health, Labor and Welfare of Japan. In total, 198 STEMI patients with low left ventricular ejection fraction (LVEF <50%) were randomly assigned to receive intravenous administration of EPO (6,000 or 12,000 IU) or placebo within 6 h of successful percutaneous coronary intervention. At 6 months, there was no significant dose-response relationship in LVEF improvement among the 3 groups tested (EPO 12,000 IU: 5.4±9.3%, EPO 6,000 IU: 7.3±7.7%, Placebo: 8.1±8.3%, P=0.862). Low-dose EPO also did not improve cardiac function, as evaluated by99 mTc-MIBI SPECT or NT-proBNP at 6 months and did not increase adverse events. Conclusions: Administration of low-dose EPO did not improve LVEF at 6 months in STEMI patients (UMIN000005721).

KW - Acute myocardial infarction

KW - Erythropoietin

KW - Left ventricular ejection fraction

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U2 - 10.1253/circj.CJ-17-0889

DO - 10.1253/circj.CJ-17-0889

M3 - Article

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VL - 82

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JO - Circulation Journal

JF - Circulation Journal

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