International randomized trial on the effect of revascularization or optimal medical therapy of chronic total coronary occlusions with myocardial ischemia - ISCHEMIA-CTO trial - rationale and design.

Autor: Råmunddal T; Sahlgrenska University Hospital, Gothenburg, Sweden., Holck EN; Dept. Cardiology Aarhus University Hospital, Skejby, Denmark. Electronic address: eh@clin.au.dk., Karim S; Dept. Cardiology Aarhus University Hospital, Skejby, Denmark., Eftekhari A; Dept. of Cardiology, Aalborg University Hospital, Aalborg, Denmark., Escaned J; Hospital Universitario Clíníco San Carlos, Madrid, Spain., Ioanes D; Sahlgrenska University Hospital, Gothenburg, Sweden., Walsh S; Cardiology Department, Belfast Health & Social Care Trust Belfast, Northern Ireland, United Kingdom., Spratt J; Edinburgh Royal Infirmary, Edinburgh, United Kingdom., Veien K; Odense University Hospital, Odense, Denmark., Jensen LO; Odense University Hospital, Odense, Denmark., Tilsted HH; Rigshospitalet, Copenhagen, Denmark., Terkelsen CJ; Dept. Cardiology Aarhus University Hospital, Skejby, Denmark., Havndrup O; Zealand University Hospital, Roskilde, Denmark., Olsen NT; Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark., Kajander OA; Tays Heart Hospital and Tampere University, Tampere, Finland., Faurie B; Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France., Lanematt P; North-Estonia Medical Centre, Tallinn, Estonia., Jakobsen L; Dept. Cardiology Aarhus University Hospital, Skejby, Denmark., Christiansen EH; Dept. Cardiology Aarhus University Hospital, Skejby, Denmark.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2023 Mar; Vol. 257, pp. 41-50. Date of Electronic Publication: 2022 Nov 21.
DOI: 10.1016/j.ahj.2022.11.016
Abstrakt: Background: Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone.
Methods: This trial aims to evaluate the effect of CTO PCI in patients with a CTO lesion and target vessel diameter ≥ 2.5 mm, and myocardial ischemia in the relevant territory. First, all patients are subjected to optimal medical therapy (OMT) for at least for 3 months and non-CTO lesions are managed according to guidelines. Subsequently, prior to randomization myocardial ischemia and quality of life (Seattle Questionnaire (SAQ)) is assessed. Patients are divided into two cohorts based on their SAQ score and randomized to either OMT alone or OMT and CTO-PCI. Cohort A is defined as Low- or asymptomatic patients with a quality-of-life score > 60 and/or CCS class < 2, and more than 10 % ischemia in the left ventricle (LV). Cohort B is symptomatic patients with a quality-of-life score < 60 or CCS class angina > 1 and at least ischemia in 5% of the LV. The primary end-point in cohort A is a composite of major adverse cardiac and cerebral events, hospitalization for heart failure and malignant ventricular arrhythmias. The primary endpoint in cohort B is difference in quality of life 6 months after randomization.
Implications: This trial is designed to investigate if CTO-PCI improves QoL and MACCE. Both positive and negative outcome of the trial will affect future guidelines and recommendations on how to treat patients with CTO.
(Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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