Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion

Официальное название

Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion (CROSS-COBIS)

Обзор

Hypothesis: Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion. A total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled. Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio. Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.

Подробное описание

Despite advances in stenting techniques and devices, percutaneous coronary intervention (PCI) for bifurcation lesions remains one of the most challenging and complex procedures. Current guidelines recommend 1-stenting with provisional side branch (SB) approach should be an initial treatment strategy for the bifurcation lesions, based on the previous results of several randomized trials. However, the standardization of the provisional strategy is limited. In particular, there is a recommendation on the treatment technique for SB when SB intervention is required, but It has not been decided in which cases SB treatment is necessary, in the latest European Bifurcation Club (EBC) consensus document.16 In previous studies, the criteria for performing SB opening after MV stent intervention in the 1-stenting with provisional SB approach were varied. In the DK-CUSH II (Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions) or CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) trials, SB intervention was performed when the SB diameter stenosis more than 50%, grade B or higher dissection, or blood flow disturbance (TIMI flow 2 or less) after MV stent insertion. On the other hand, in the Nordic trial, the authors applied strict criteria for SB intervention after MV stent insertion (TIMI flow 2 or less only). Furthermore, there have been conflicting results regarding the clinical and angiographic outcomes of the jailed SB opening strategy after the main vessel (MV) stenting, compared with the simple crossover strategy for non-left main bifurcation lesion.

On this background, this trial aims to compare the clinical outcomes between simple crossover and side branch opening strategies in patients with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion.

Вмешательства

• Процедура Simple Crossover
  Regardless of allocated arms, stent implantation in the MV (selected 1:1 according to the distal MV size) followed by systematic proximal optimization technique (POT, post-dilatation of the stent at the level of proximal MV with a balloon diameter sized 1:1 according to the proximal MV) or POT like procedure is strongly recommended.
• Процедура Side branch opening
  According to the latest European Bifurcation Club (EBC) consensus document, distal SB rewiring followed by kissing balloon inflation (eventually conducted with short non-compliant balloons) and repeat POT procedures are highly recommended. An additional stent will be allowed if major dissection or decreased TIMI flow of SB occurs during SB treatment.

Первичные конечные точки

• Target-lesion failure [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]

Вторичные конечные точки (12)

• All-cause death [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Cardiac death [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Myocardial infarction [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Target-vessel myocardial infarction [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Target-lesion revascularization [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Target-vessel revascularization [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Any revascularization [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Stent thrombosis [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Bleeding [Срок оценки: up to 2 years of median follow-up (till 1 year after the last patient enrollment)]
• Total procedure time [Срок оценки: at 1 day]
• Total amount of contrast use [Срок оценки: at 1 day]
• Incidence of contrast induced nephropathy [Срок оценки: 72 hours after the index procedure]

Критерии участия

Критерии включения

• (1) Subject must be at least 19 years of age
• (2) Patients with non-left main bifurcation lesion (SB diameter ≥2.3 mm)
• (3) Target lesions amenable for 1-stenting with provisional SB approach by operators' decision
• (4) Angiographically compromised SB (visual SB stenosis ≥50%) after provisional MV stenting

Критерии исключения

• (1) Target lesions requiring elective 2-stenting technique by operators' decision (Observation Group 1)\*
• (2) Patients who inevitably require SB intervention after MV stenting, as follows. (Observation Group 2)\*

• Reduced SB TIMI flow (≤2) after MV stenting
• SB dissection after MV stenting (≥ Type C)
• (3) Patients without SB compromise after MV stenting (visually SB stenosis <50%) (Observation Group 3)\*
• (4) Cardiogenic shock (Killip class IV) at presentation
• (5) Patients with significant valvular heart disease or severe left ventricular systolic dysfunction (ejection fraction <35%)
• (6) Pregnancy or breast feeding
• (7) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
• (8) Unwillingness or inability to comply with the procedures described in this protocol

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05705362 · CROSS-COBIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗