Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia

Terrault, Norah A.; Chen, Yi-Cheng; Izumi, Namiki; Kayali, Zeid; Mitruţ, Paul; Tak, Won Young; Allen, Lee F.; Hassanein, Tarek

doi:10.1053/j.gastro.2018.05.025

Cited by 164 publications

(234 citation statements)

References 39 publications

(55 reference statements)

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“…It is common practice to transfuse to a platelet threshold of 50 × 10 9 /L in the event of a bleed or invasive procedure based on evidence from in vitro and retrospective studies . Preprocedural administration of TPO receptor agonists has shown promise in increasing platelet levels and reducing platelet transfusions . In regards to other threshold‐based transfusion strategies, the INR as a marker for coagulopathy has fallen out of favor in cirrhotic patients .…”

Section: Resultsmentioning

confidence: 99%

“…In ADAPT‐1 and ADAPT‐2, the Avatrombopag groups compared to the placebo groups had a significant reduction in the studies' primary endpoint of platelet transfusions or rescue procedures for bleeding . Lusutrombopag was studied in thrombocytopenic patients with child‐Pugh Class A or Class B cirrhosis expecting to undergo a non‐emergency invasive procedure.…”

Section: Thrombocytopenia and Thrombopoietin Receptor Agonistsmentioning

confidence: 99%

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Transfusion strategies in patients with cirrhosis

Liu

Hum

Jou

et al. 2019

European J of Haematology

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Bleeding related to portal hypertension and coagulopathy is a common complication in patients with cirrhosis. Complications and management of bleeding is a significant source of healthcare cost and utilization, as well as morbidity and mortality. Due to the scarcity of evidence surrounding transfusion strategies and hemostatic interventions in patients with cirrhosis, there has been significant debate regarding the best practice. Emerging data suggest that evidence supporting transfusion of packed red blood cells to a hemoglobin threshold of 7‐8 g/dL is strong. thrombopoietin (TPO) receptor agonists have shown promise in increasing platelet levels and reducing transfusions preprocedurally, although have not specifically been found to reduce bleeding risk. Data for viscoelastic testing (VET)‐guided transfusions appear favorable for reducing blood transfusion requirements prior to minor procedures and during orthotopic liver transplantation. Hemostatic agents such as recombinant factor VIIa, prothrombin complex concentrates, and tranexamic acid have been examined but their role in cirrhotic patients is unclear. Other areas of growing interest include balanced ratio and whole blood transfusion. In the following manuscript, we summarize the most up to date evidence for threshold‐guided, VET‐guided, balanced‐ratio, and whole blood transfusions as well as the use of hemostatic agents in cirrhotic patients to provide practice guidance to clinicians.

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Section: Resultsmentioning

confidence: 99%

Section: Thrombocytopenia and Thrombopoietin Receptor Agonistsmentioning

confidence: 99%

Transfusion strategies in patients with cirrhosis

Liu

Hum

Jou

et al. 2019

European J of Haematology

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“…Lusutrombopag is currently the only thrombopoietin receptor agonist with available postmarketing surveillance data for treatment of patients with CLD and thrombocytopenia undergoing invasive procedures. Another agent, avatrombopag, was approved in the USA in May 2018, but no real‐world surveillance data have yet been reported …”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

Sasaki

Shiino

Imawari

et al. 2019

Hepatology Research

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Aim Lusutrombopag is approved for the treatment of thrombocytopenia in chronic liver disease patients undergoing invasive procedures. This real‐world surveillance assesses the safety and effectiveness of lusutrombopag in Japan. Methods This ongoing, multicenter, prospective, real‐world surveillance is collecting data from case report forms between October 2016 and May 2021. Interim data up to September 2018 were used to evaluate safety (adverse events and adverse drug reactions [ADRs]) and effectiveness (proportion of patients avoiding preoperative platelet transfusion and change in platelet count from baseline). Results The safety analysis set included 331 patients. The mean baseline platelet count was 46.2 ± 13.7 × 109/L. Of 377 invasive procedures, radiofrequency ablation (110 procedures, 29.2%) was the most frequent. The mean time from starting lusutrombopag treatment to invasive procedure was 12.3 days. Incidences of serious adverse events and ADRs were 8.76% and 3.32%, respectively. Six cases (1.81%) of portal vein thrombosis were considered serious adverse events; of these, four cases (1.21%) were classified as serious ADRs. Of 300 patients who underwent an invasive procedure (excluding those with platelet transfusion refractoriness), 282 (94.0%) avoided preoperative platelet transfusion. In patients with platelet measurements before and after lusutrombopag administration who did not undergo platelet transfusion, the mean maximum change in platelet count from baseline was 41.7 ± 31.4 × 109/L (range, −6 to 276; n = 286). All patients receiving second (n = 20) and third (n = 1) treatments avoided preoperative platelet transfusion without developing any ADRs. Conclusions This real‐world surveillance further supports the safety and effectiveness of lusutrombopag in patients with chronic liver disease undergoing invasive procedures.

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“…However, two nonpeptide TPO agonists, avatrombopag and lusutrombopag, were recently approved for use in patients with advanced liver disease and thrombocytopenia who undergo elective procedures. Avatrombopag (Doptelet) was approved in the United States in May 2018 . In the global, multicenter, combined ADAPT‐1 and ADAPT‐2 phase III, randomized, double‐blind, placebo‐controlled clinical trials, avatrombopag given at 40 or 60 mg daily (based on initial platelet counts) for 5 days before an elective procedure increased the platelet count and reduced platelet transfusion requirements .…”

Section: Current Tpo Receptor Agonistsmentioning

confidence: 99%

Thrombocytopenia and Procedural Prophylaxis in the Era of Thrombopoietin Receptor Agonists

Caldwell

Flamm²

2019

Hepatol Commun

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Thrombocytopenia is common in patients with advanced liver disease. These patients frequently require invasive diagnostic or therapeutic procedures in the setting of thrombocytopenia. A common platelet goal before such procedures is ≥50,000/μL, but target levels vary by provider and the procedure. Platelet transfusion has disadvantages, including safety and cost. No other short‐term options for ameliorating thrombocytopenia before procedures were available until the thrombopoietin receptor agonists were recently approved. Avatrombopag and lusutrombopag can be used in certain patients with thrombocytopenia due to advanced liver disease undergoing elective invasive procedures; these new agents are highly effective in carefully selected patients, and real world data of safety and efficacy are awaited.

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Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia

Abstract: In 2 phase 3 randomized trials, avatrombopag was superior to placebo in reducing the need for platelet transfusions or rescue procedures for bleeding in patients with thrombocytopenia and CLD undergoing a scheduled procedure. ClinicalTrials.gov nos.: NCT01972529 and NCT01976104.

Cited by 164 publications

References 39 publications

Transfusion strategies in patients with cirrhosis

Transfusion strategies in patients with cirrhosis

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

Thrombocytopenia and Procedural Prophylaxis in the Era of Thrombopoietin Receptor Agonists

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