A randomized controlled trial evaluated the efficacy and safety of apixaban for prevention of recurrent thrombosis after thrombectomy of hemodialysis vascular access

Tsung-Yu Ko; Chih-Cheng Wu; Mu-Yang Hsieh; Chung-Wei Yang; Chi-Hung Cheng; Chun-Kai Chen; Hsien-Li Kao

doi:10.1016/j.kint.2024.10.023

A randomized controlled trial evaluated the efficacy and safety of apixaban for prevention of recurrent thrombosis after thrombectomy of hemodialysis vascular access

Kidney Int. 2024 Nov 16:S0085-2538(24)00792-0. doi: 10.1016/j.kint.2024.10.023. Online ahead of print.

Authors

Tsung-Yu Ko¹, Chih-Cheng Wu², Mu-Yang Hsieh³, Chung-Wei Yang⁴, Chi-Hung Cheng⁵, Chun-Kai Chen⁶, Hsien-Li Kao⁷

Affiliations

¹ Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University, Taipei, Taiwan.
² Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan; Center of Quality Management, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; Institute of Biomedical Engineering, National Tsing-Hua University, Hsinchu, Taiwan; Institute of Cellular and System Medicine, National Health Research Institutes, Zhunan, Taiwan. Electronic address: chihchengwumd@gmail.com.
³ Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: drake1128@gmail.com.
⁴ College of Medicine, National Taiwan University, Taipei, Taiwan; Hemodialysis Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.
⁵ Ansn Clinic, Hsinchu, Taiwan.
⁶ Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.
⁷ Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.

PMID: 39551132
DOI: 10.1016/j.kint.2024.10.023

Abstract

Dialysis vascular access thrombosis poses a substantial challenge for individuals undergoing hemodialysis. The efficacy and safety of apixaban, a direct oral coagulation factor Xa inhibitor, in preventing recurrent access thrombosis have yet to be explored. Here, a multicenter randomized control study (NCT04489849) enrolled hemodialysis patients to evaluate this who underwent successful endovascular thrombectomy within 48 hours. Participants were assigned to standard care or standard care plus apixaban, 2.5 mg twice daily for three months. The trial design involved open-label administration, with independent adjudication of endpoints. The primary efficacy endpoint was recurrent access thrombosis within three months after thrombectomy. A total of 186 patients with well-balanced baseline characteristics were enrolled, 93 randomized to the apixaban group and 93 to the control group. The apixaban group demonstrated a significantly lower rate of access thrombosis at three months than the control group (24.0% vs. 40.8%; hazard ratio, 0.52 [95% confidence interval 0.31-0.88]), along with a significantly better primary patency failure rate (32.2% vs. 49.5%, 0.57 [0.36-0.91]). Safety outcomes showed comparable death rates and major bleeding incidents but significantly higher incidence of minor bleeding in the apixaban group (22.6% vs. 7.5%). The effect of apixaban did not show interaction in subgroups of different access types, antiplatelet usage, severity of comorbidities, or history of thrombosis. Thus, apixaban effectively reduced the risk of recurrent thrombosis in hemodialysis vascular access post-thrombectomy. Despite a minor increase in bleeding adverse effects, the net clinical benefit favors the use of apixaban in this context.

Keywords: anticoagulation, apixaban, hemodialysis, thrombectomy, thrombosis, vascular access.