Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Официальное название

A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

Обзор

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Подробное описание

COMPLETE-2 STUDY OBJECTIVES

1. To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR). 2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Вмешательства

• Процедура Physiology-guided NCL PCI
  For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80.
• Процедура Angiography-guided NCL PCI
  PCI will be performed as per local practice

Первичные конечные точки

• Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR [Срок оценки: at study completion, a minimum of 2 years]
• Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury. [Срок оценки: at study completion, a minimum of 2 years]

Вторичные конечные точки (2)

• Time to first occurrence of the composite of CV death or new MI. [Срок оценки: at study completion, a minimum of 2 years]
• Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury. [Срок оценки: at study completion, a minimum of 2 years]

Критерии участия

Критерии включения

• Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
• Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:

• Amenable to successful treatment with PCI
• At least 50% diameter stenosis by visual estimation
• At least 2.5 mm in diameter
• Planned complete revascularization strategy for qualifying MI

Критерии исключения

• Planned or prior coronary artery bypass graft (CABG) surgery
• Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
• Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
• Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
• Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
• Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
• The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
• Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
• Non-cardiovascular co-morbidity with expected life expectancy <2 years
• Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 24 центра

• McGill University Health Centre (MUHC) — Montreal
• William Osler Health System — Brampton
• University of Alberta Hospital, Mazankowski Heart — Edmonton
• Hamilton Health Sciences — Hamilton
• Kingston Health Sciences Centre — Kingston
• St. Mary's General Hospital — Kitchener
• London Health Sciences Centre — London
• Centre Hospitalier de l'Universite de Montreal — Montreal
• … и ещё 16 центров

Великобритания · 19 центров

Список центров уточняется — проверьте первичный протокол.

США · 13 центров

• UCLA — Los Angeles
• University of California, San Francisco — San Francisco
• Cardiovascular Research Institute of Kansas — Wichita
• The Johns Hopkins University School of Medicine — Baltimore
• University of Michigan — Ann Arbor
• Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI) — Coon Rapids
• RWJ Barnabas Health — Jersey City
• Bassett Medical Center — Cooperstown
• … и ещё 5 центров

Индия · 10 центров

• Lisie Hospital — Ernākulam
• Meditrina Hospital — Kollam
• Caritas Hospital Trust — Kottayam
• Apollo Rajshree Hospitals — Indore
• Rukmani Birla Hospital — Jaipur
• Apollo Hospital — Chennai
• The Madras Medical Mission — Chennai
• Meenakshi Mission Hospital and Research Center — Madurai
• … и ещё 2 центра

Германия · 7 центров

• St. Vinzenz-Hospital — Cologne
• Helios Amper-Klinikum — Dachau
• Universitatsklinikum Frankfurt — Frankfurt
• Marienkrankenhaus — Hamburg
• Schoen Klink Hamburg — Hamburg
• University Heart & Vascular Center Hamburg — Hamburg
• WKK Heide — Heide

Испания · 7 центров

Список центров уточняется — проверьте первичный протокол.

Швеция · 7 центров

Список центров уточняется — проверьте первичный протокол.

Италия · 6 центров

• Azienda USL Toscana Sud Est — Arezzo
• UOC Cardiologia - Ospedale Maggiore — Bologna
• Azienda Ospedaliero - Universitaria di Ferrara — Ferrara
• Misericordia Hospital — Grosseto
• Azienda USL-IRCCS di Reggio Emilia, Reggio — Reggio Emilia
• Sant Andrea Hospital - Sapienza University — Rome

Норвегия · 4 центра

• Sorlandet Hospital Arendal — Kristiansand
• Oslo University Hospital Ulleval — Oslo
• Stavanger University Hospital — Stavanger
• University Hospital Tromso — Tromsø

Дания · 3 центра

• Aalborg University Hospital — Aalborg
• Aarhus University Hospital — Aarhus
• Rigshospitalet - Copenhagen University Hospital — Copenhagen

Финляндия · 3 центра

• Helsinki University Hospital — Helsinki
• TAYS Sydankeskus Oy — Tampere
• Turku University Hospital — Turku

Польша · 3 центра

• Provincial Specialized Hospital — Legnica
• Miedziowym Centrum Zdrowia S.A. w Lubinie — Lubin
• Medical University of Warsaw — Warsaw

Венгрия · 2 центра

• Gottsegen National Cardiovascular Center — Budapest
• University of Szeged — Szeged

Сербия · 2 центра

• Institute for Cardiovascular Diseases Dedinje — Belgrade
• University Clinical Center of Serbia — Belgrade

Австралия · 1 центр

• Westmead Hospital — Westmead

Австрия · 1 центр

• Klinik Floridsdorf — Vienna

Чехия · 1 центр

• St. Anne's University Hospital — Brno

Идентификаторы

NCT: NCT05701358 · COMPLETE-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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