Antegrade dissection and re-entry vs retrograde strategy in chronic total occlusion percutaneous coronary intervention: Rationale and design of the ADRENALINE randomized study - 20/08/26
, Mateusz Spiewak, MD, PhD b, Filip Machaj, MD c, Hubert Borzuta, MD a, d, Grzegorz Sobieszek, MD, PhD e, Jakub Drozd, MD, PhD f, Filip Kiljanski, MD a, Pavlo Matsko, MD a, Mariusz Klopotowski, MD, PhD a, Bartosz Zieba, MD, PhD e, Wojciech Kula, MD, PhD f, Magdalena Marczak, MD, PhD b, Artur Debski, MD, PhD a, Adam Witkowski, MD, PhD a, Paul Knaapen, MD, PhD g, Gregor Leibundgut, MD, PhD h, Claudiu Ungureanu, MD, PhD i, Stéphane Rinfret, MD, PhD j, Emmanouil S. Brilakis, MD, PhD kHighlights |
• | Antegrade wiring strategy is often unsuccessful in difficult CTO referred for PCI. |
• | ADRENALINE is the first RCT of ADR vs retrograde strategy in patients with CTO. |
• | The primary endpoints are total procedure time and successful guidewire crossing. |
• | A secondary endpoint is the new myocardial infarction on serial CMR with LGE. |
• | Another secondary endpoint is stress level of CTO operators. |
ABSTRACT |
Rationale |
While antegrade wiring (AW) is the most common initial strategy for chronic total occlusion (CTO) percutaneous coronary intervention (PCI), difficult CTO lesions frequently require either antegrade dissection and re-entry (ADR) or a retrograde strategy. Comparative data between ADR and the retrograde approach remain limited.
Design |
The Antegrade Dissection vs Retrograde re-ENtry And Load of Interventionalist Effort (ADRENALINE) is a prospective, multicenter randomized study with a superiority design. It is planned to enroll 121 patients with difficult coronary CTO (J-CTO score ≥2) referred for CTO-PCI in accordance with the hybrid algorithm. Subjects undergoing successful AW will be included in the observational arm. Patients with failed or unattempted AW will be randomized 1:1 to ADR or retrograde CTO crossing strategy ( n = 74). All patients will undergo pre- and postprocedural laboratory testing (including cardiac troponin T and creatine kinase-MB), cardiac magnetic resonance (CMR) for late gadolinium enhancement, and health status assessment by the Seattle Angina Questionnaire and the Rose Dyspnea Scale. The co-primary endpoints are total procedure time and successful guidewire crossing. Additionally, the relationship between different recanalization strategies and stress among interventional cardiologists will be explored.
Conclusion |
ADRENALINE is the first randomized study of ADR vs retrograde strategy for difficult CTO PCI, assessing procedural outcomes, CMR-detected myocardial infarction, and 3-month quality of life.
Enrolment status |
The first patient was enrolled on July 29, 2025. As of June 14, 2026, 45 patients (26 randomized, 19 observational) of the planned 121 patients have been enrolled.
Trials registration |
Clinicaltrials.gov : Identifier, NCT06878729.
Il testo completo di questo articolo è disponibile in PDF.Graphical abstract |
Overview of the ADRENALINE randomized study. CTO, chronic total occlusion; J-CTO, Multicenter CTO Registry of Japan; PCI, percutaneous coronary intervention.
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Articolo 107538- novembre 2026 Ritorno al numeroBenvenuto su EM|consulte, il riferimento dei professionisti della salute.
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