Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * \<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