Prediction of very early major bleeding risk in acute pulmonary embolism: an independent external validation of the Pulmonary Embolism-Syncope, Anemia, and Renal Dysfunction (PE-SARD) bleeding score.

BACKGROUND: The Pulmonary Embolism-Syncope, Anemia, and Renal Dysfunction (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.

OBJECTIVES: We independently validated the PE-SARD score in a prospective multicenter Swiss cohort of 687 patients aged ≥65 years with acute PE.

METHODS: The PE-SARD score uses 3 variables (syncope, anemia, and 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 score for each patient and classified the proportion of patients as being at low, intermediate, and high risk. To assess discrimination and calibration, we calculated the area under the receiver operating characteristic 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 score 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 receiver operating characteristic 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 > .05) over the entire follow-up.

CONCLUSION: In our independent validation, the PE-SARD score did not accurately predict very early MB and may not be transportable to older patients with PE.