Abstract: TH-PO1131
Hemodialysis Vascular Access Complications: Insights from the ASCEND-D Trial
Session Information
- Late-Breaking Posters
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 803 Dialysis: Vascular Access
Authors
- Lopes, Renato D., Duke University Medical Center, Durham, North Carolina, United States
- Cases, Aleix, Hospital Clinic of Barcelona, Barcelona, Spain
- Claggett, Brian, Brigham and Women's Hospital, Boston, Massachusetts, United States
- Dember, Laura M., University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Bhatt, Nisha, GSK, Collegeville, Pennsylvania, United States
- Jones-Leone, Angela Renne, GSK, Collegeville, Pennsylvania, United States
- Meadowcroft, Amy M., GSK, Collegeville, Pennsylvania, United States
- Muoneke, Mary O., GSK, Collegeville, Pennsylvania, United States
- Ranganathan, Prerna, GSK, Collegeville, Pennsylvania, United States
- Taft, Lin, GSK, Collegeville, Pennsylvania, United States
- Singh, Ajay K., Brigham and Women's Hospital, Boston, Massachusetts, United States
Background
Daprodustat (Dapro) is a hypoxia-inducible factor–prolyl hydroxylase inhibitor (HIF-PHI) approved in the United States for treating anemia of chronic kidney disease (CKD) in adult patients (pts) receiving dialysis for at least 4 months. Dapro provides an oral alternative to erythropoiesis-stimulating agent (ESA) therapy. There are concerns that increasing hemoglobin in the dialysis population, such as with ESAs and HIF-PHIs, may cause thromboembolic events (TEEs). In the phase 3 ASCEND-D study, which randomized (1:1) 2964 pts with CKD undergoing dialysis and receiving ESAs to receive Dapro or ESA (NCT02879305; N Engl J Med. 2021;385:2325–2335), a trend toward a lower incidence of first occurrence of TEEs was observed with Dapro (185/1487 [12.4%]) compared with ESA (215/1477 [14.6%]). Here, we examine the occurrence of vascular access thrombosis (VAT), the most frequent type of TEE in the ASCEND-D study.
Methods
Adjudicated TEEs (including VAT) were a component of a prespecified principal secondary outcome. VAT was predefined as the absence of bruit or thrill and/or an inability to successfully initiate dialysis via the arteriovenous access after initial successful use. All suspected TEEs were adjudicated by the blinded Clinical Events Committee (CEC) according to predefined criteria. Post hoc analyses of time to first occurrence of VAT and recurrent events of VAT were performed.
Results
The CEC adjudicated 1088 potential TEEs, including VAT. First occurrence of adjudicated VAT occurred in 164/1487 (11.0%) and 201/1477 (13.6%) pts in the Dapro and ESA groups, respectively; hazard ratio 0.80 (95% CI: 0.65–0.98; P=0.015; Figure). Based on a recurrent events analysis of VAT using the negative binomial model, the rate ratio was 0.80 (95% CI: 0.63–1.01).
Conclusion
In the ASCEND-D study, there was a reduced incidence of VAT events with Dapro compared with ESAs.
Funding
- Commercial Support – The study and this analysis were funded by GSK.