External Validation of the OAC3-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease

Marie Ørskov; Flemming Skjøth; Christian Alexander Behrendt; Chalotte W. Nicolajsen; Nikolaj Eldrup; Mette Søgaard

doi:10.1016/j.ejvs.2023.12.001

External Validation of the OAC³-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease

Marie Ørskov^*, Flemming Skjøth, Christian Alexander Behrendt, Chalotte W. Nicolajsen, Nikolaj Eldrup, Mette Søgaard

^*Corresponding author for this work

Department of Clinical Medicine - Karkirurgi, Viborg

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

Abstract

Objective: The OAC³-PAD score was developed to predict bleeding risk in patients with lower extremity peripheral arterial disease (PAD), but its performance in concomitant international cohorts is largely unknown. This study aimed to validate the OAC³-PAD score in an unselected nationwide population of patients undergoing invasive treatment for symptomatic PAD. Methods: This was a nationwide cohort study including all patients who underwent a first revascularisation procedure or major amputation for symptomatic PAD in Denmark from 2000 – 2021. The study population was stratified based on OAC³-PAD score, and the one year risk of major bleeding was assessed, accounting for the competing risk of death. The score performance was evaluated using calibration plots, C statistic, Brier score, and the index of prediction accuracy (IPA). Results: A total of 52 016 patients were included (mean age 71 years, 43.8% female). The one year risk of major bleeding increased with higher OAC³-PAD score, ranging from 1.6% (95% confidence interval [CI] 1.4 – 1.8%) to 2.3% (95% CI 2.0 – 2.5%), 3.5% (95% CI 3.2 – 3.8%), and 5.2% (95% CI 4.8 – 5.6%) for patients with low, low moderate, moderate high, and high score, respectively. Using patients with low risk as reference, the OAC³-PAD score effectively categorised patients, demonstrating statistically significant differences in bleeding risk across strata. However, the score showed modest discriminative performance, with a C statistic of 65% (95% CI 63 – 66%) and a Brier score of 2.6% (95% CI 2.5 – 2.7%). Nevertheless, it performed significantly better than the null model, as indicated by an IPA of 3.1%. Conclusion: Among patients who underwent invasive treatment for symptomatic PAD in routine care, the OAC³-PAD score was associated with greater risk of major bleeding with increasing score level. However, its discriminatory ability was modest, and the clinical utility remains to be determined.

Original language	English
Journal	European Journal of Vascular and Endovascular Surgery
Volume	67
Issue	4
Pages (from-to)	621-629
Number of pages	9
ISSN	1078-5884
DOIs	https://doi.org/10.1016/j.ejvs.2023.12.001
Publication status	Published - Apr 2024

Keywords

Major bleeding
Peripheral arterial disease
Prediction model
Validation
Humans
Risk Factors
Male
Hemorrhage/epidemiology
Peripheral Arterial Disease/diagnosis
Female
Vascular Surgical Procedures
Aged
Cohort Studies

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@article{39ea3a08fc714af493a33279604771a8,

title = "External Validation of the OAC3-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease",

abstract = "Objective: The OAC3-PAD score was developed to predict bleeding risk in patients with lower extremity peripheral arterial disease (PAD), but its performance in concomitant international cohorts is largely unknown. This study aimed to validate the OAC3-PAD score in an unselected nationwide population of patients undergoing invasive treatment for symptomatic PAD. Methods: This was a nationwide cohort study including all patients who underwent a first revascularisation procedure or major amputation for symptomatic PAD in Denmark from 2000 – 2021. The study population was stratified based on OAC3-PAD score, and the one year risk of major bleeding was assessed, accounting for the competing risk of death. The score performance was evaluated using calibration plots, C statistic, Brier score, and the index of prediction accuracy (IPA). Results: A total of 52 016 patients were included (mean age 71 years, 43.8% female). The one year risk of major bleeding increased with higher OAC3-PAD score, ranging from 1.6% (95% confidence interval [CI] 1.4 – 1.8%) to 2.3% (95% CI 2.0 – 2.5%), 3.5% (95% CI 3.2 – 3.8%), and 5.2% (95% CI 4.8 – 5.6%) for patients with low, low moderate, moderate high, and high score, respectively. Using patients with low risk as reference, the OAC3-PAD score effectively categorised patients, demonstrating statistically significant differences in bleeding risk across strata. However, the score showed modest discriminative performance, with a C statistic of 65% (95% CI 63 – 66%) and a Brier score of 2.6% (95% CI 2.5 – 2.7%). Nevertheless, it performed significantly better than the null model, as indicated by an IPA of 3.1%. Conclusion: Among patients who underwent invasive treatment for symptomatic PAD in routine care, the OAC3-PAD score was associated with greater risk of major bleeding with increasing score level. However, its discriminatory ability was modest, and the clinical utility remains to be determined.",

keywords = "Major bleeding, Peripheral arterial disease, Prediction model, Validation, Humans, Risk Factors, Male, Hemorrhage/epidemiology, Peripheral Arterial Disease/diagnosis, Female, Vascular Surgical Procedures, Aged, Cohort Studies",

author = "Marie {\O}rskov and Flemming Skj{\o}th and Behrendt, {Christian Alexander} and Nicolajsen, {Chalotte W.} and Nikolaj Eldrup and Mette S{\o}gaard",

year = "2024",

month = apr,

doi = "10.1016/j.ejvs.2023.12.001",

language = "English",

volume = "67",

pages = "621--629",

journal = "European Journal of Vascular and Endovascular Surgery",

issn = "1078-5884",

publisher = "Elsevier Ltd",

number = "4",

}

External Validation of the OAC³-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease. / Ørskov, Marie; Skjøth, Flemming; Behrendt, Christian Alexander et al.
In: European Journal of Vascular and Endovascular Surgery, Vol. 67, No. 4, 04.2024, p. 621-629.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - External Validation of the OAC3-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease

AU - Ørskov, Marie

AU - Skjøth, Flemming

AU - Behrendt, Christian Alexander

AU - Nicolajsen, Chalotte W.

AU - Eldrup, Nikolaj

AU - Søgaard, Mette

PY - 2024/4

Y1 - 2024/4

N2 - Objective: The OAC3-PAD score was developed to predict bleeding risk in patients with lower extremity peripheral arterial disease (PAD), but its performance in concomitant international cohorts is largely unknown. This study aimed to validate the OAC3-PAD score in an unselected nationwide population of patients undergoing invasive treatment for symptomatic PAD. Methods: This was a nationwide cohort study including all patients who underwent a first revascularisation procedure or major amputation for symptomatic PAD in Denmark from 2000 – 2021. The study population was stratified based on OAC3-PAD score, and the one year risk of major bleeding was assessed, accounting for the competing risk of death. The score performance was evaluated using calibration plots, C statistic, Brier score, and the index of prediction accuracy (IPA). Results: A total of 52 016 patients were included (mean age 71 years, 43.8% female). The one year risk of major bleeding increased with higher OAC3-PAD score, ranging from 1.6% (95% confidence interval [CI] 1.4 – 1.8%) to 2.3% (95% CI 2.0 – 2.5%), 3.5% (95% CI 3.2 – 3.8%), and 5.2% (95% CI 4.8 – 5.6%) for patients with low, low moderate, moderate high, and high score, respectively. Using patients with low risk as reference, the OAC3-PAD score effectively categorised patients, demonstrating statistically significant differences in bleeding risk across strata. However, the score showed modest discriminative performance, with a C statistic of 65% (95% CI 63 – 66%) and a Brier score of 2.6% (95% CI 2.5 – 2.7%). Nevertheless, it performed significantly better than the null model, as indicated by an IPA of 3.1%. Conclusion: Among patients who underwent invasive treatment for symptomatic PAD in routine care, the OAC3-PAD score was associated with greater risk of major bleeding with increasing score level. However, its discriminatory ability was modest, and the clinical utility remains to be determined.

AB - Objective: The OAC3-PAD score was developed to predict bleeding risk in patients with lower extremity peripheral arterial disease (PAD), but its performance in concomitant international cohorts is largely unknown. This study aimed to validate the OAC3-PAD score in an unselected nationwide population of patients undergoing invasive treatment for symptomatic PAD. Methods: This was a nationwide cohort study including all patients who underwent a first revascularisation procedure or major amputation for symptomatic PAD in Denmark from 2000 – 2021. The study population was stratified based on OAC3-PAD score, and the one year risk of major bleeding was assessed, accounting for the competing risk of death. The score performance was evaluated using calibration plots, C statistic, Brier score, and the index of prediction accuracy (IPA). Results: A total of 52 016 patients were included (mean age 71 years, 43.8% female). The one year risk of major bleeding increased with higher OAC3-PAD score, ranging from 1.6% (95% confidence interval [CI] 1.4 – 1.8%) to 2.3% (95% CI 2.0 – 2.5%), 3.5% (95% CI 3.2 – 3.8%), and 5.2% (95% CI 4.8 – 5.6%) for patients with low, low moderate, moderate high, and high score, respectively. Using patients with low risk as reference, the OAC3-PAD score effectively categorised patients, demonstrating statistically significant differences in bleeding risk across strata. However, the score showed modest discriminative performance, with a C statistic of 65% (95% CI 63 – 66%) and a Brier score of 2.6% (95% CI 2.5 – 2.7%). Nevertheless, it performed significantly better than the null model, as indicated by an IPA of 3.1%. Conclusion: Among patients who underwent invasive treatment for symptomatic PAD in routine care, the OAC3-PAD score was associated with greater risk of major bleeding with increasing score level. However, its discriminatory ability was modest, and the clinical utility remains to be determined.

KW - Major bleeding

KW - Peripheral arterial disease

KW - Prediction model

KW - Validation

KW - Humans

KW - Risk Factors

KW - Male

KW - Hemorrhage/epidemiology

KW - Peripheral Arterial Disease/diagnosis

KW - Female

KW - Vascular Surgical Procedures

KW - Aged

KW - Cohort Studies

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U2 - 10.1016/j.ejvs.2023.12.001

DO - 10.1016/j.ejvs.2023.12.001

M3 - Journal article

C2 - 38056523

AN - SCOPUS:85184040392

SN - 1078-5884

VL - 67

SP - 621

EP - 629

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

IS - 4

ER -

External Validation of the OAC³-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease

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