Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial - 07/06/24

Doi : 10.1016/j.ahj.2024.03.017

Min Chul Kim, MD, PhD ^a, Joon Ho Ahn, MD, PhD ^a, Dae Young Hyun, MD, PhD ^a, Yongwhan Lim, MD ^a, Seung Hun Lee, MD, PhD ^a, Seok Oh, MD ^a, Kyung Hoon Cho, MD, PhD ^a, Doo Sun Sim, MD, PhD ^a, Young Joon Hong, MD, PhD ^a, Ju Han Kim, MD, PhD ^a, Myung Ho Jeong, MD, PhD ^a, Jang Hyun Cho, MD, PhD ^b, Sang-Rok Lee, MD, PhD ^c, Dong Oh Kang, MD, PhD ^d, Jin-Yong Hwang, MD, PhD ^e, Young Jin Youn, MD, PhD ^f, Young-Hoon Jeong, MD, PhD ^g, Yongwhi Park, MD, PhD ^h, Dong-Bin Kim, MD, PhD ⁱ, Eun-Ho Choo, MD, PhD ^j, Chan Joon Kim, MD, PhD ^k, Weon Kim, MD, PhD ^l, Jay Young Rhew, MD, PhD ^m, Jung-Hee Lee, MD, PhD ⁿ, Sang-Yong Yoo, MD, PhD ^o, Youngkeun Ahn, MD, PhD ^a,^⁎
on behalf of the
OPTION-STEMI Investigators
^a Division of Cardiology, Department of Internal Medicine, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, Korea
^b St Carollo General Hospital, Suncheon, Korea
^c Division of Cardiology, Department of Internal Medicine, Jeonbuk National University Medical School, Jeonbuk National University Hospital, Jeonju, Korea
^d Cardiovascular Center, Department of Internal Medicine, Korea University College of Medicine, Korea University Guro Hospital, Seoul, Korea
^e Division of Cardiology, Department of Internal Medicine, Gyeongsang National University College of Medicine, Gyeongsang National University Hospital, Jinju, Korea
^f Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Korea
^g CAU Thrombosis and Biomarker Center, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea and Division of Cardiology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
^h Division of Cardiology, Department of Internal Medicine, Gyeongsang National University College of Medicine, Gyeongsang National University Changwon Hospital, Changwon, Korea
ⁱ Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea
^j Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea
^k Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Uijeongbu, Korea
^l Division of Cardiology, Department of Internal Medicine, Kyung Hee University College of Medicine, Kyung Hee University Medical Center, Seoul, Korea
^m Presbyterian Medical Center, Jeonju, Korea
ⁿ Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Korea and Division of Cardiology, Yeungnam University College of Medicine, Yeungnam University Medical Center, Daegu, Korea
^o Good Morning Hospital, Pyeongtaek, Korea and Division of Cardiology, Department of Internal Medicine, University of Ulsan College of Medicine, Gangneung Asan Hospital, Gangneung, Korea

^⁎Reprint requests: Youngkeun Ahn, MD, PhD, Division of Cardiology, Department of Internal Medicine, Chonnam National University Medical School, Chonnam National University Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Republic of Korea.Division of CardiologyDepartment of Internal MedicineChonnam National University Medical School, Chonnam National University Hospital42 Jebong-roDong-guGwangju61469Republic of Korea

ABSTRACT

Background

Current guidelines recommend complete revascularization (CR) in hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD). With regard to the timing of percutaneous coronary intervention (PCI) for non-infarct-related artery (non-IRA), recent randomized clinical trials have revealed that immediate CR was non-inferior to staged CR. However, the optimal timing of CR remains uncertain. The OPTION-STEMI trial compared immediate CR and in-hospital staged CR guided by fractional flow reserve (FFR) for intermediate stenosis of the non-IRA.

Methods

The OPTION-STEMI is a multicenter, investigator-initiated, prospective, open-label, non-inferiority randomized clinical trial. The study included patients with at least 1 non-IRA lesion with ≥50% stenosis by visual estimation. Patients fulfilling the inclusion criteria were randomized into 2 groups at a 1:1 ratio: immediate CR (i.e., PCI for the non-IRA performed during primary angioplasty) or in-hospital staged CR. In the in-hospital staged CR group, PCI for non-IRA lesions was performed on another day during the index hospitalization. Non-IRA lesions with 50%−69% stenosis by visual estimation were evaluated by FFR, whereas those with ≥70% stenosis was revascularized without FFR. The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, and all unplanned revascularization at 1 year after randomization. Enrolment began in December 2019 and was completed in January 2024. The follow-up for the primary endpoint will be completed in January 2025, and primary results will be available in the middle of 2025.

Conclusions

The OPTION-STEMI is a multicenter, non-inferiority, randomized trial that evaluated the timing of in-hospital CR with the aid of FFR in patients with STEMI and MVD.

Trial Registration

URL: www.clinicaltrials.gov. Unique identifier: NCT04626882; and URL: cris.nih.go.kr. Unique identifier: KCT0004457.

Le texte complet de cet article est disponible en PDF.

Plan

Randomization and study intervention

Current status of the trial

Discussion

Timing of staged PCI of the non-IRA: Performed in-hospital or electively after discharge

FFR guidance for non-IRA lesions before PCI

Issues concerning immediate CR

Summary

CRediT authorship contribution statement

Export

Vol 273

P. 35-43 - juillet 2024 Retour au numéro

Article précédent

Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial
Yujian Wu, Lin Hu, Xiaofei Xie, Wei Li, Yanfei Wang, Li Zhang, Ping Huang, Fengxiang Li, Jianbin Li, Shuliang Xia, Jia Yuan, Ming Li, Zhouping Wang, Xu Zhang

| Article suivant

Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: Rationale and design of the SUPER LIPID program
Alexander C. Fanaroff, Qian Huang, Kayla Clark, Laurie A. Norton, Wendell E. Kellum, Dwight Eichelberger, John C. Wood, Zachary Bricker, Andrea G. Dooley Wood, Greta Kemmer, Jennifer I. Smith, Srinath Adusumalli, Mary Putt, Kevin G.M. Volpp

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

connectez-vous ou créez un compte

Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial - 07/06/24

ABSTRACT

Background

Methods

Conclusions

Trial Registration

Plan

Export citations

Fichier

Contenu

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL