Luspatercept and thrombotic events in patients with myelodysplastic syndrome: a target trial emulation framework using TriNetX database.

Myelodysplastic syndrome (MDS) is an identified risk for both venous and arterial thromboembolism (ATE). The thrombotic risk of drugs used in MDS, such as Luspatercept and Erythropoietin-stimulating agents (ESAs), has yielded conflicting results. Therefore, knowing the thrombotic risk of these agents in the real-world setting is of paramount importance. In our analysis, the incidence of VTE was 34.9 events per 1000 patient-years among patients receiving Luspatercept versus 46.8 events per 1000 patient-years receiving ESAs (Hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.55-1.08; log-rank test, p = 0.13). The incidence of DVT, PE, and stroke was also not statistically significant between the cohorts. In contrast, the incidence of acute myocardial infarction was significantly lower in the Luspatercept cohort (42.6/1000PY vs 65.7/1000 PY; HR (95% CI): 0.67 (0.49-0.91)). In this study, the use of Luspatercept did not increase the risk of VTE as compared to ESAs. These findings reinforce the thrombotic safety of luspatercept.