4. Discussion
bleeding, TPO-RAs, thrombocytopenia, cirrhosis, TEAEs, CLD
THROMBOCYTOPENIA, BLEEDING, CIRRHOSIS, CLD
The objective of this phase 4 study was to collect real-world data on the ability of avatrombopag to increase platelet counts and reduce the need for platelet transfusions or rescue procedures for bleeding in patients with CLD scheduled to undergo a procedure. Avatrombopag was effective and well tolerated by all patients, with the mean platelet count nearly doubling by procedure day and only 1 patient (2%) requiring a platelet transfusion.The progression of CLD frequently results in cirrhosis,The advent of TPO-RAs has resulted in a new treatment management strategy to allow procedures that carry a risk of periprocedural bleeding to be managed safely in this vulnerable patient population.In this study, avatrombopag consistently increased platelet counts in patients with CLD and thrombocytopenia. The mean (SD) baseline platelet count in this study was 46.9 × 10Avatrombopag was also found to reduce the need for platelet transfusions in this patient population. Forty-nine out of 50 enrolled patients did not require a platelet transfusion after the baseline visit and up to 7 days following procedure day (98%; 95% CI: 89.4%–99.9%), and no patients required a rescue procedure for bleeding during the study period. Although direct comparisons cannot be made due to the heterogeneity of patient populations and study designs, the proportion of patients not requiring a platelet transfusion was higher than that in the phase 3 ADAPT studies,Similar efficacy results were recently reported in a real-world retrospective study of avatrombopag in patients with CLD scheduled to undergo a procedure (n = 29), which had similar patient population demographics and in which the most common procedure was upper GI endoscopy with planned esophageal band ligation (86%).Our study provides limited initial data on the safety and effectiveness of avatrombopag in patients with baseline platelet counts greater than those previously evaluated in the phase 3 ADAPT studies. Increasing platelet counts in patients with baseline platelet counts ≥ 50 × 10The use of avatrombopag could facilitate invasive procedures that would otherwise be postponed or not performed due to the severity of the patient’s thrombocytopenia. In the real-world setting, patients with CLD require diverse interventions and severe thrombocytopenia can exclude these patients from life-saving procedures such as percutaneous radio-frequency ablation in malignant lesions.The safety profile observed in this study is comparable to the pooled phase 3 ADAPT data and similar to the reported safety of lusutrombopag.The TEAEs identified in this study were similar for all doses of avatrombopag taken and do not suggest any new or unexpected safety concerns compared to the 2 large, multicenter, phase 3 ADAPT studies. The safety and effectiveness profiles did not differ in the 2 patients who received 2 subsequent courses of treatment with avatrombopag for separate procedures, in line with data published for lusutrombopag,