Råmunddal, T;
Holck, EN;
Karim, S;
Eftekhari, A;
Escaned, J;
Ioanes, D;
Walsh, S;
Spratt, J;
Veien, K;
Jensen, LO;
et al.
Råmunddal, T; Holck, EN; Karim, S; Eftekhari, A; Escaned, J; Ioanes, D; Walsh, S; Spratt, J; Veien, K; Jensen, LO; Tilsted, H-H; Terkelsen, CJ; Havndrup, O; Olsen, NT; Kajander, OA; Faurie, B; Lanematt, P; Jakobsen, L; Christiansen, EH
(2023)
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.
Am Heart J, 257.
pp. 41-50.
ISSN 1097-6744
https://doi.org/10.1016/j.ahj.2022.11.016
SGUL Authors: Spratt, James
Abstract
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.
Item Type: |
Article
|
Additional Information: |
© 2022 The Author(s). Published by Elsevier Inc.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) |
Keywords: |
Humans, Coronary Occlusion, Coronary Artery Disease, Quality of Life, Percutaneous Coronary Intervention, Angina Pectoris, Chronic Disease, Treatment Outcome, Humans, Angina Pectoris, Chronic Disease, Treatment Outcome, Quality of Life, Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention, 1102 Cardiorespiratory Medicine and Haematology, 1117 Public Health and Health Services, Cardiovascular System & Hematology |
Journal or Publication Title: |
Am Heart J |
ISSN: |
1097-6744 |
Language: |
eng |
Dates: |
Date | Event |
---|
March 2023 | Published | 21 November 2022 | Published Online | 15 November 2022 | Accepted |
|
Publisher License: |
Creative Commons: Attribution 4.0 |
Projects: |
Project ID | Funder | Funder ID |
---|
19-R133-A9089_22145 | Danish Heart Foundation | UNSPECIFIED | UNSPECIFIED | The Swedish Heart Foundation | UNSPECIFIED | UNSPECIFIED | Asahi Corp | UNSPECIFIED | UNSPECIFIED | Philips Corp | UNSPECIFIED | UNSPECIFIED | Orbus Neich Corp | UNSPECIFIED |
|
PubMed ID: |
36423733 |
Web of Science ID: |
WOS:000908812900001 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/116519 |
Publisher's version: |
https://doi.org/10.1016/j.ahj.2022.11.016 |
Statistics
Item downloaded times since 29 May 2024.
Actions (login required)
![Edit Item](/style/images/action_view.png) |
Edit Item |