Observational Study for Left Main Disease Treatment

Официальное название

A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT

Обзор

The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.

Подробное описание

This study is a multicenter, large clinical registry to evaluate comparative outcomes of medical therapy, PCI with DES, or CABG for patients with unprotected LMCA stenosis in the Asia-Pacific, as recorded in the MAIN-IRIS Registry. Data will be prospectively collected on approximately 5000 subjects who diagnosed LM disease (\>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region. Brief study design is as depicted in the following figure

Первичные конечные точки

• Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event [Срок оценки: 2-year]

Вторичные конечные точки (9)

• Death [Срок оценки: 10-year]
• Cardiac death [Срок оценки: 10-year]
• Myocardial infarction [Срок оценки: 10-year]
• Cerebrovascular event [Срок оценки: 10-year]
• Target vessel revascularization [Срок оценки: 10-year]
• Target lesion revascularization [Срок оценки: 10-year]
• Stent thrombosis [Срок оценки: 10-year]
• Binary restenosis and late luminal loss in both in-stent and in-segment [Срок оценки: 9-month]
• Rehospitalization [Срок оценки: 10-year]

Критерии участия

Критерии включения

• Significant unprotected left main stenosis (>50% by visual estimation)

• The LMCA is considered unprotected if there are no patent coronary artery bypass grafts to the left anterior descending artery or the left circumflex artery.
• No limitation of clinical or lesion characteristics
• Age >18 years
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Критерии исключения

• Protected left main stenosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 38 центров

• Hallym University medical center — Anyang
• Soonchunhyang University Hospital, Buchen — Bucheon-si
• The Catholic University of Korea, Bucheon ST.Mary's Hospital — Bucheon-si
• Inje University Busan Paik Hospital — Busan
• Soonchunhyang University Hospital, Cheonan — Cheonan
• St.Mary's Catholic Medical Center — Cheongju-si
• Daegu Catholic University Medical Center — Daegu
• Keimyung University Dongsan Medical Center — Daegu
• … и ещё 30 центров

Китай · 1 центр

• Zhongshan Hospital — Шанхай

Малайзия · 1 центр

• Sarawak General Hospital — Kuching

Тайвань · 1 центр

• Shin Kong Hospital — Taipei

Таиланд · 1 центр

• Siriraj Hospital — Bangkok

Публикации

• Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068. PMID 38199751
• Cho S, Kang DY, Kim JS, Park DW, Kim IS, Kang TS, Ahn JM, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK, Park SJ. Dual antiplatelet therapy after percutaneous coronary intervention for left main coronary artery disease. Rev Esp Cardiol (Engl Ed). 2023 Apr;76(4):245-252. doi: 10.1016/j.rec.2022.07.007. Epub 2022 Jul 27. English, Sp PMID 35907438
• Park S, Ahn JM, Park H, Kang DY, Lee PH, Kim TO, Lee J, Kim JH, Yang Y, Jeong YJ, Hyun J, Kim AR, Kim T, Oh HJ, Lee YJ, Lee JH, Jang M, Park DW, Park SJ; IRIS-MAIN Registry Investigators. Comparison of Long-Term Outcomes Following Coronary Revascularization in Men-vs-Women with Unprotected Left Main Disease. Am J Cardiol. 2021 Aug 15;153:9-19. doi: 10.1016/j.amjcard.2021.05.016. Epub 2021 Jul 4. PMID 34233836
• Park S, Ahn JM, Kim TO, Park H, Kang DY, Lee PH, Jeong YJ, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Park SJ, Park DW; IRIS-MAIN Registry Investigators. Revascularization in Patients With Left Main Coronary Artery Disease and Left Ventricular Dysfunction. J Am Coll Cardiol. 2020 Sep 22;76(12):1395-1406. doi: 10.1016/j.jacc.2020.07.047. PMID 32943156
• Kang SH, Ahn JM, Lee CH, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Differential Event Rates and Independent Predictors of Long-Term Major Cardiovascular Events and Death in 5795 Patients With Unprotected Left Main Coronary Artery Disease Treated With Stents, Bypass Surgery, or Medication: Insights From a Large International Multicenter Registry. Circ Cardiovasc Interv. 20 PMID 28701487

Идентификаторы

NCT: NCT01341327 · CVRF2010-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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