The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

Официальное название

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial

Обзор

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF). The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD). Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization. The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.

Подробное описание

The evidence comparing PCI and CABG with medical therapy in patients with iLVSD has been the subject of multiple systematic reviews/meta-analyses of observational studies with inconsistent results. There is a current lack of evidence from properly powered randomized trials comparing contemporary state-of-the-art PCI vs. CABG to guide the clinical management in the vulnerable population of patients with iLVSD. Understanding the relative impact of both revascularization strategies on clinical outcomes in this prevalent population would have important clinical implications.

The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/left main (LM) CAD and iLVSD.

Participants will be allocated in a 1:1 ratio to either study arm using permuted block randomization stratified for study center and acute coronary syndrome (ACS) presentation through a centrally controlled, automated, web system. Eligible patients who provide informed consent can be enrolled. It is expected that initial revascularization will take place within 2 weeks of randomization. Staged PCI is expected to take place within 90 days of randomization. The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years.

Вмешательства

• Процедура Revascularization by PCI
  Contemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access
• Процедура Revascularization by CABG
  The surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of

Первичные конечные точки

• The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission. [Срок оценки: Median follow-up of 5 years.]

Вторичные конечные точки (12)

• Death [Срок оценки: At 30 days , 90 days and through study completion with a median follow-up of 5 years.]
• Myocardial Infarction (MI) [Срок оценки: At 30 days and through study completion with a median follow-up of 5 years.]
• Number of participants with Stroke [Срок оценки: At 30 days , 90 days and through study completion with a median follow-up of 5 years.]
• Repeat Revascularization (RR) [Срок оценки: At 30 days , 90 days and through study completion with a median follow-up of 5 years.]
• Hospitalizations [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Composite of death/stroke/spontaneous MI [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Composite of death/stroke/spontaneous MI/RR [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Composite of death or cardiac hospitalization [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Coronary composite endpoint [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Heart Failure endpoint [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Hierarchal Heart Failure outcome [Срок оценки: Through study completion with a median follow-up of 5 years.]
• Number of participants with advanced Heart failure therapies [Срок оценки: Through study completion with a median follow-up of 5 years.]

Критерии участия

Критерии включения

• Age >18 years;
• LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
• Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as >50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
• The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization;
• Signed informed consent.

Критерии исключения

• Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
• Recent (<4 weeks) ST-elevation MI;
• Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
• Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
• Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
• Prior cardiac surgery;
• Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
• Circumstances likely to lead to poor treatment adherence;
• Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
• Current pregnancy;
• Patient not amenable to both CABG or PCI according to the Heart Team;
• Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.

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 · 17 центров

• University of Calgary; Libin Cardiovascular Institute — Calgary
• Mackenzie Health Sciences Center — Edmonton
• Fraser Health; Royal Columbian Hospital — New Westminster
• Providence Health — Vancouver
• The University of Manitoba and St. Boniface Hospital Inc. — Winnipeg
• Queen Elizabeth II Hospital — Halifax
• Hamilton General Hospital — Hamilton
• London Health Sciences Center, University Hospital — London
• … и ещё 9 центров

США · 6 центров

• Cedars-Sinai — Los Angeles
• Yale University — New Haven
• UofL Health, Inc — Louisville
• John Hopkins Hospital — Baltimore
• Mayo Clinic — Rochester
• University Hospitals Cleveland Medical Center — Cleveland

Испания · 4 центра

• Hospital Clinic de Barcelona (ICCV) — Barcelona
• Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar
• Hospital del Vinalopó — Alicante
• Hospital Universitario de Navarra — Pamplona

Китай · 2 центра

• Jilin Heart Hospital — Jilin City
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Германия · 2 центра

• University Hospital Dusseldorf — Düsseldorf
• Leipzig Heart Center — Leipzig

Польша · 2 центра

• Medical University Bialystok — Bialystok
• Medical University of Silesia — Katowice

Португалия · 2 центра

• Unidade Local de Saude Lisboa Ocidental (ULSLO) — Lisbon
• Centro Hospitalar e Universitário Sao João — Porto

Австрия · 1 центр

• Medical University of Vienna — Vienna

Бразилия · 1 центр

• Heart Institute, Medical School of the University of Sao Paulo_INCOR — São Paulo

Хорватия · 1 центр

• Clinical Hospital Dubrava — Sušak

Египет · 1 центр

• Al Nas Hospital — Cairo

Индия · 1 центр

• G Kuppuswamy Naidu Memorial Hospital (GKNM) — Palayam

Италия · 1 центр

• European Hospital, Via Portuense — Roma

Мексика · 1 центр

• Instituto Mexicano del Seguro Social (IMSS) — Mexico City

Сербия · 1 центр

• Dedinje Cardiovascular Institute — Belgrade

Публикации

• Fremes SE, Marquis-Gravel G, Gaudino MFL, Jolicoeur EM, Bedard S, Masterson Creber R, Ruel M, Vervoort D, Wijeysundera HC, Farkouh ME, Rouleau JL; STICH3C Study Investigators. STICH3C: Rationale and Study Protocol. Circ Cardiovasc Interv. 2023 Aug;16(8):e012527. doi: 10.1161/CIRCINTERVENTIONS.122.012527. Epub 2023 Aug 15. PMID 37582169

Идентификаторы

NCT: NCT05427370 · v.1.6; August 22, 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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