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

Truls Råmunddal; Emil Nielsen Holck; Salma Karim; Ashkan Eftekhari; Javier Escaned; Dan Ioanes; Simon Walsh; James Spratt; Karsten Veien; Lisette Okkels Jensen; Hans-Henrik Tilsted; Christian Juhl Terkelsen; Ole Havndrup; Niels Thue Olsen; Olli Kajander; Benjamin Faurie; Peep Lanematt; Lars Jakobsen; Evald Høj Christiansen

doi:10.1016/j.ahj.2022.11.016

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

Truls Råmunddal, Emil Nielsen Holck^*, Salma Karim, Ashkan Eftekhari, Javier Escaned, Dan Ioanes, Simon Walsh, James Spratt, Karsten Veien, Lisette Okkels Jensen, Hans-Henrik Tilsted, Christian Juhl Terkelsen, Ole Havndrup, Niels Thue Olsen, Olli Kajander, Benjamin Faurie, Peep Lanematt, Lars Jakobsen, Evald Høj Christiansen

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin - Hjertesygdomme

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

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 AND DESIGN: 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.

Originalsprog	Engelsk
Tidsskrift	American Heart Journal
Vol/bind	257
Sider (fra-til)	41-50
Antal sider	10
ISSN	0002-8703
DOI	https://doi.org/10.1016/j.ahj.2022.11.016
Status	Udgivet - mar. 2023

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10.1016/j.ahj.2022.11.016Licens: CC BY

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Råmunddal, T., Holck, E. N., Karim, S., Eftekhari, A., Escaned, J., Ioanes, D., Walsh, S., Spratt, J., Veien, K., Jensen, L. O., Tilsted, H.-H., Terkelsen, C. J., Havndrup, O., Olsen, N. T., Kajander, O., Faurie, B., Lanematt, P., Jakobsen, L., & Christiansen, E. H. (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. American Heart Journal, 257, 41-50. https://doi.org/10.1016/j.ahj.2022.11.016

@article{c37fccd1cf484df597c28a9ebcebb866,

title = "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",

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 AND DESIGN: 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.",

author = "Truls R{\aa}munddal and Holck, {Emil Nielsen} and Salma Karim and Ashkan Eftekhari and Javier Escaned and Dan Ioanes and Simon Walsh and James Spratt and Karsten Veien and Jensen, {Lisette Okkels} and Hans-Henrik Tilsted and Terkelsen, {Christian Juhl} and Ole Havndrup and Olsen, {Niels Thue} and Olli Kajander and Benjamin Faurie and Peep Lanematt and Lars Jakobsen and Christiansen, {Evald H{\o}j}",

year = "2023",

month = mar,

doi = "10.1016/j.ahj.2022.11.016",

language = "English",

volume = "257",

pages = "41--50",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby, Inc",

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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, O, 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', American Heart Journal, bind 257, s. 41-50. https://doi.org/10.1016/j.ahj.2022.11.016

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. / Råmunddal, Truls; Holck, Emil Nielsen ; Karim, Salma et al.
I: American Heart Journal, Bind 257, 03.2023, s. 41-50.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - 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

AU - Råmunddal, Truls

AU - Holck, Emil Nielsen

AU - Karim, Salma

AU - Eftekhari, Ashkan

AU - Escaned, Javier

AU - Ioanes, Dan

AU - Walsh, Simon

AU - Spratt, James

AU - Veien, Karsten

AU - Jensen, Lisette Okkels

AU - Tilsted, Hans-Henrik

AU - Terkelsen, Christian Juhl

AU - Havndrup, Ole

AU - Olsen, Niels Thue

AU - Kajander, Olli

AU - Faurie, Benjamin

AU - Lanematt, Peep

AU - Jakobsen, Lars

AU - Christiansen, Evald Høj

PY - 2023/3

Y1 - 2023/3

N2 - 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 AND DESIGN: 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.

AB - 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 AND DESIGN: 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.

UR - http://www.scopus.com/inward/record.url?scp=85144407339&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2022.11.016

DO - 10.1016/j.ahj.2022.11.016

M3 - Journal article

C2 - 36423733

SN - 0002-8703

VL - 257

SP - 41

EP - 50

JO - American Heart Journal

JF - American Heart Journal

ER -

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

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