External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI

SYNTAX, BEST, and FREEDOM Trial investigators

doi:10.1016/j.jacc.2022.01.049

External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI

SYNTAX, BEST, and FREEDOM Trial investigators

Medicine

University of Amsterdam
Icahn School of Medicine at Mount Sinai
Centro Nacional de Investigaciones Cardiovasculares Carlos III
University of Toronto
Saint Luke's Mid America Heart Institute
University of Missouri-Kansas City
Cardiovascular Research Foundation
The Heart Center
Asan Medical Center
Tufts Medical Center
Leiden University Medical Center
Erasmus MC

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

11 Citations (Scopus)

Abstract

Background: Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction. Objectives: This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. Methods: This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed. Results: Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (P_interaction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: −0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: −0.53). The FREEDOM score showed some heterogeneity of treatment benefit. Conclusions: The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD.

Original language	English
Pages (from-to)	1458-1473
Number of pages	16
Journal	Journal of the American College of Cardiology
Volume	79
Issue number	15
DOIs	https://doi.org/10.1016/j.jacc.2022.01.049
Publication status	Published - 19 Apr 2022

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

coronary artery bypass grafting
diabetes
FREEDOM score
heterogeneity of treatment effect
multivessel coronary artery disease
percutaneous coronary intervention

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10.1016/j.jacc.2022.01.049

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@article{2feb8c31e066483c92b65484ec115525,

title = "External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI",

abstract = "Background: Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction. Objectives: This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. Methods: This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed. Results: Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4\% vs 20.3\%; log-rank P = 0.021) irrespective of a history of smoking (Pinteraction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: −0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: −0.53). The FREEDOM score showed some heterogeneity of treatment benefit. Conclusions: The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD.",

keywords = "coronary artery bypass grafting, diabetes, FREEDOM score, heterogeneity of treatment effect, multivessel coronary artery disease, percutaneous coronary intervention",

author = "\{SYNTAX, BEST, and FREEDOM Trial investigators\} and Kuniaki Takahashi and Serruys, \{Patrick W.\} and Valentin Fuster and Farkouh, \{Michael E.\} and Spertus, \{John A.\} and Cohen, \{David J.\} and Park, \{Seung Jung\} and Park, \{Duk Woo\} and Ahn, \{Jung Min\} and Yoshinobu Onuma and Kent, \{David M.\} and Steyerberg, \{Ewout W.\} and \{van Klaveren\}, David",

note = "Publisher Copyright: {\textcopyright} 2022 American College of Cardiology Foundation",

year = "2022",

month = apr,

day = "19",

doi = "10.1016/j.jacc.2022.01.049",

language = "English",

volume = "79",

pages = "1458--1473",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "15",

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TY - JOUR

T1 - External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI

AU - SYNTAX, BEST, and FREEDOM Trial investigators

AU - Takahashi, Kuniaki

AU - Serruys, Patrick W.

AU - Fuster, Valentin

AU - Farkouh, Michael E.

AU - Spertus, John A.

AU - Cohen, David J.

AU - Park, Seung Jung

AU - Park, Duk Woo

AU - Ahn, Jung Min

AU - Onuma, Yoshinobu

AU - Kent, David M.

AU - Steyerberg, Ewout W.

AU - van Klaveren, David

PY - 2022/4/19

Y1 - 2022/4/19

N2 - Background: Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction. Objectives: This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. Methods: This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed. Results: Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (Pinteraction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: −0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: −0.53). The FREEDOM score showed some heterogeneity of treatment benefit. Conclusions: The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD.

AB - Background: Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction. Objectives: This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. Methods: This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed. Results: Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (Pinteraction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: −0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: −0.53). The FREEDOM score showed some heterogeneity of treatment benefit. Conclusions: The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD.

KW - coronary artery bypass grafting

KW - diabetes

KW - FREEDOM score

KW - heterogeneity of treatment effect

KW - multivessel coronary artery disease

KW - percutaneous coronary intervention

UR - https://www.scopus.com/pages/publications/85127534389

U2 - 10.1016/j.jacc.2022.01.049

DO - 10.1016/j.jacc.2022.01.049

M3 - Article

C2 - 35422242

AN - SCOPUS:85127534389

SN - 0735-1097

VL - 79

SP - 1458

EP - 1473

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 15

ER -

External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI

Abstract

UN SDGs

Keywords

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