Villiger, Rahel; Méan, Marie; Stalder, Odile; Limacher, Andreas; Rodondi, Nicolas; Righini, Marc; Aujesky, Drahomir (2023). Prediction of very early major bleeding risk in acute pulmonary embolism: an independent external validation of the PE-SARD Bleeding Score. Journal of thrombosis and haemostasis, 21(10), pp. 2884-2893. Elsevier 10.1016/j.jtha.2023.04.025
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Villiger_JThrombHaemost_2023.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (596kB) | Request a copy |
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1-s2.0-S1538783623003471-main.pdf - Accepted Version Restricted to registered users only Available under License Publisher holds Copyright. Download (1MB) | Request a copy |
BACKGROUND
The PE-SARD Bleeding Score was derived to predict very early major bleeding (MB) in patients with acute pulmonary embolism (PE). Before adoption into practice the score requires external validation in different populations.
OBJECTIVE
We independently validated the PE-SARD in a prospective multicenter Swiss cohort of 687 patients aged ≥65 years with acute PE.
METHODS
The PE-SARD uses 3 variables (syncope, anemia, renal dysfunction) to classify patients into 3 categories of increasing bleeding risk. The outcomes were very early MB at 7 days (primary) and MB at later time points (secondary). We calculated the PE-SARD for each patient and the proportion of patients classified as low, intermediate, and high risk. To assess discrimination and calibration, we calculated the area under the receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow goodness-of-fit test, respectively.
RESULTS
The prevalence of MB was 2.0% (14/687) at 7 days and 14.0% (96/687) after a median follow-up of 30 months. The PE-SARD classified 40.2%, 42.2%, and 17.6% of patients as low, intermediate, and high risk for MB, respectively. The frequency of observed very early MB at 7 days was 1.8% in low-, 2.1% in intermediate-, and 2.5% in high-risk patients. The area under the ROC curve was 0.52 (95%CI 0.48-0.56) at 7 days and increased to 0.60 (95%CI 0.56-0.64) at the end of follow-up. Score calibration was adequate (P>0.05) over the entire follow-up.
CONCLUSION
In our independent validation, the PE-SARD did not accurately predict very early MB and may not be transportable to older patients with PE.
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