Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study

Kaiyue Diao; Duolao Wang; Zhongxiu Chen; Xi Wu; Min Ma; Ye Zhu; Li Zhang; Hua Wang; Mian Wang; Sen He; Chen Li; Qiao Deng; Ting Yan; Tao Wu; Lu Tang; Baotao Huang; Jiayu Sun; Yong He

doi:10.1002/clc.23744

Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study

Kaiyue Diao, Duolao Wang, Zhongxiu Chen, Xi Wu, Min Ma, Ye Zhu, Li Zhang, Hua Wang, Mian Wang, Sen He, Chen Li, Qiao Deng, Ting Yan, Tao Wu, Lu Tang, Baotao Huang, Jiayu Sun, Yong He

Clinical Sciences

Sichuan University

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

Background

Angiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan has been recommended as one of the first-line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST-segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.

Hypothesis

We hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6-month follow-up.

Methods

PERI-STEMI is an investigator-initiated, prospective, multi-center, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 376 first-time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril-valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post-PPCI. The primary endpoint is the change of indexed LV mass at the 6-month follow-up CMR.

Results

Enrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.

Conclusions

The results of the PERI-STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR-based risk stratification and therapy selection for these patients. PERI-STEMI is registered at ClinicalTrials.gov (NCT04912167).

Original language	English
Pages (from-to)	1709-1717
Number of pages	9
Journal	Clinical Cardiology
Volume	44
Issue number	12
Early online date	20 Oct 2021
DOIs	https://doi.org/10.1002/clc.23744
Publication status	Published - 1 Dec 2021

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Diao, K., Wang, D., Chen, Z., Wu, X., Ma, M., Zhu, Y., Zhang, L., Wang, H., Wang, M., He, S., Li, C., Deng, Q., Yan, T., Wu, T., Tang, L., Huang, B., Sun, J., & He, Y. (2021). Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study. Clinical Cardiology, 44(12), 1709-1717. https://doi.org/10.1002/clc.23744

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title = "Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study",

abstract = "BackgroundAngiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan has been recommended as one of the first-line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST-segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.HypothesisWe hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6-month follow-up.MethodsPERI-STEMI is an investigator-initiated, prospective, multi-center, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 376 first-time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril-valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post-PPCI. The primary endpoint is the change of indexed LV mass at the 6-month follow-up CMR.ResultsEnrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.ConclusionsThe results of the PERI-STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR-based risk stratification and therapy selection for these patients. PERI-STEMI is registered at ClinicalTrials.gov (NCT04912167).",

author = "Kaiyue Diao and Duolao Wang and Zhongxiu Chen and Xi Wu and Min Ma and Ye Zhu and Li Zhang and Hua Wang and Mian Wang and Sen He and Chen Li and Qiao Deng and Ting Yan and Tao Wu and Lu Tang and Baotao Huang and Jiayu Sun and Yong He",

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Diao, K, Wang, D, Chen, Z, Wu, X, Ma, M, Zhu, Y, Zhang, L, Wang, H, Wang, M, He, S, Li, C, Deng, Q, Yan, T, Wu, T, Tang, L, Huang, B, Sun, J & He, Y 2021, 'Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study', Clinical Cardiology, vol. 44, no. 12, pp. 1709-1717. https://doi.org/10.1002/clc.23744

Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study. / Diao, Kaiyue; Wang, Duolao; Chen, Zhongxiu et al.
In: Clinical Cardiology, Vol. 44, No. 12, 01.12.2021, p. 1709-1717.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study

AU - Diao, Kaiyue

AU - Wang, Duolao

AU - Chen, Zhongxiu

AU - Wu, Xi

AU - Ma, Min

AU - Zhu, Ye

AU - Zhang, Li

AU - Wang, Hua

AU - Wang, Mian

AU - He, Sen

AU - Li, Chen

AU - Deng, Qiao

AU - Yan, Ting

AU - Wu, Tao

AU - Tang, Lu

AU - Huang, Baotao

AU - Sun, Jiayu

AU - He, Yong

PY - 2021/12/1

Y1 - 2021/12/1

N2 - BackgroundAngiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan has been recommended as one of the first-line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST-segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.HypothesisWe hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6-month follow-up.MethodsPERI-STEMI is an investigator-initiated, prospective, multi-center, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 376 first-time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril-valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post-PPCI. The primary endpoint is the change of indexed LV mass at the 6-month follow-up CMR.ResultsEnrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.ConclusionsThe results of the PERI-STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR-based risk stratification and therapy selection for these patients. PERI-STEMI is registered at ClinicalTrials.gov (NCT04912167).

AB - BackgroundAngiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan has been recommended as one of the first-line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST-segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.HypothesisWe hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6-month follow-up.MethodsPERI-STEMI is an investigator-initiated, prospective, multi-center, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 376 first-time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril-valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post-PPCI. The primary endpoint is the change of indexed LV mass at the 6-month follow-up CMR.ResultsEnrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.ConclusionsThe results of the PERI-STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR-based risk stratification and therapy selection for these patients. PERI-STEMI is registered at ClinicalTrials.gov (NCT04912167).

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DO - 10.1002/clc.23744

M3 - Article

SN - 0160-9289

VL - 44

SP - 1709

EP - 1717

JO - Clinical Cardiology

JF - Clinical Cardiology

IS - 12

ER -

Diao K, Wang D, Chen Z, Wu X, Ma M, Zhu Y et al. Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study. Clinical Cardiology. 2021 Dec 1;44(12):1709-1717. Epub 2021 Oct 20. doi: 10.1002/clc.23744