Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Total procedure time
研究概览
简要总结
The ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Beyond the patient-oriented outcomes, the influence of the studied CTO PCI strategies on the stress levels among interventional cardiologists will be explored.
The main questions it aims to answer are as follows:
- What is the difference between ADR versus retrograde strategy with regard to total procedure time, the rates of successful guidewire crossing and periprocedural complications as well as stress levels experienced by interventional cardiologists?
- Is retrograde approach associated with higher rates of myocardial injury/infarction based on cardiac troponin/cardiac magnetic resonance (CMR) as compared with ADR?
Participants will undergo pre- and postprocedural laboratory testing (cardiac troponin, CK-MB), CMR for late gadolinium enhancement and health status assessment. Subjects undergoing successful CTO PCI using antegrade wiring strategy will be included in the observational arm.
详细描述
The ADRENALINE trial is planned as a multicenter, prospective randomized research experiment in patients with clinical indication for PCI of CTO. The target population will comprise patients with at least difficult CTO (J-CTO score ≥2) and angiographic equipoise for either ADR or the retrograde CTO recanalization strategy as evaluated by 2 independent CTO PCI operators. The pre-procedural assessment will comprise cardiac magnetic resonance (CMR) for late gadolinium enhancement, laboratory testing (cardiac troponin, creatine kinase-MB) and health status assessed by the Seattle angina questionnaire (SAQ) and the Rose Dyspnea Scale. Subsequently patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or the retrograde CTO crossing strategy (n=74), while subjects undergoing successful antegrade wiring will be included in the observational arm (n=47). After CTO PCI, the cardiac troponin and creatine kinase-MB will be measured at 12 hours intervals (at least up to 24 hours), while CMR with late gadolinium enhancement will be repeated within 5 days post-procedure (including the observational arm). The health status of the study participants (SAQ and the Rose Dyspnea Scale) will be re-assessed at 3-months post-CTO PCI. In addition, to investigate the effect of the studied CTO PCI strategies on the occupational hazard of interventional cardiologists, the physical and mental stress levels experienced by CTO operators will be continuously monitored during the procedure. The co-primary endpoint is defined as: 1) total procedure time and 2) successful guidewire crossing through CTO. The secondary endpoints include: time of successful guidewire crossing through CTO, final technical success of CTO PCI, radiation dose, contrast volume, equipment cost, procedural complications, rate of periprocedural myocardial injury, rate of new myocardial infarction on CMR, quality of life, target lesion failure (cardiac death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization) at 3 months follow-up, and stress indices experienced by physicians during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- •at least difficult native CTO lesion with J-CTO difficulty score ≥2 points on invasive angiography
- •angiographic suitability for both ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators
- •informed consent for participation in the study
排除标准
- •<18 years of age
- •acute myocardial infarction
- •cardiogenic shock
- •severe valvular disease
- •estimated life expectancy <1 year
- •contraindication to PCI
- •contrast allergy
- •positive pregnancy test or breast-feeding
- •native CTO lesion with easy or intermediate difficulty score on invasive angiography (J-CTO score <2 points)
- •lack of angiographic equipoise between the ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators
研究组 & 干预措施
ADR strategy
Patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The ADR, as part of the antegrade approach, involves extraplaque crossing of the occluded coronary artery with subsequent reentry into the distal true lumen using dedicated reentry systems or knuckle wire techniques.
干预措施: CTO PCI using ADR strategy (Procedure)
Retrograde strategy
Patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The retrograde technique, planned as the comparator to the ADR strategy, relies on crossing the occluded coronary artery from the distal vessel (i.e. against the original direction of blood flow). Retrograde CTO crossing is attempted either with retrograde intraplaque wiring or more frequently using the retrograde dissection and reentry techniques.
干预措施: CTO PCI using retrograde strategy (Procedure)
结局指标
主要结局
Total procedure time
时间窗: procedural (1 day)
Total procedure time in minutes.
Successful guidewire crossing through CTO
时间窗: procedural (1 day)
Rate of successful guidewire crossing through CTO.
次要结局
- Periprocedural myocardial injury(in-hospital (2-5 days))
- Periprocedural myocardial infarction(in-hospital (2-5 days))
- All-cause death(3-months)
- Cardiac death(3-months)
- Target vessel-related myocardial infarction(3-months)
- Fluoroscopy time(procedural (1 day))
- Technical success(procedural (1 day))
- Radiation dose(procedural (1 day))
- Time of successful guidewire crossing(procedural (1 day))
- Target lesion failure(3-months)
- Cost of CTO PCI(procedural (1 day))
- Myocardial infarction on CMR(in-hospital (2-5 days))
- Contrast volume(procedural (1 day))
- Number and type of procedural complications(procedural (1 day))
- Clinically-driven target lesion revascularization(3-months)
- CCS class(3-months)
- SAQ score(3-months)
- Dyspnea severity on the Rose Dyspnea Scale(3-months)
- Heart rate(operator-related (1 day))
- Mean arterial pressure(operator-related (1 day))
- Systolic blood pressure(operator-related (1 day))
- Diastolic blood pressure(operator-related (1 day))
- Blood glucose concentration(operator-related (1 day))
- Brain activity monitoring(operator-related (1 day))
- Salivary cortisol concentration(operator-related (1 day))
- High-sensitivity cardiac troponin concentration(operator-related (1 day))
- Perceived Stress Scale score(operator-related (1 day))