OC 74.1 - REDUCED DOSE OF RIVAROXABAN/APIXABAN Vs VITAMIN K ANTAGONISTS FOR SECONDARY PREVENTION OF VENOUS THROMBOEMBOLISM: A REAL-WORLD COMPARATIVE STUDY

Wednesday, June 26, 2024

10:15 – 10:30 ICT

Room: 110 A-C

Co-Author(s)

Pável E. Olivera Sumire, Sr.

Head of Thrombosis and Hemostasis Unit
Department of Hematology, Hospital Universitari Vall d'Hebron Vall d' Hebron Institut of Oncology (VHIO)
Barcelona, Catalonia, Spain

Presenting Author(s)

SC

Sergi Camarillas, Sr., MD

Medical Resident
Department of Hematology, Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain

Co-Author(s)

GA

Gonzalo Artaza

Hematologist
Department of Hematology, Hospital Universitari Vall d'Hebron Vall d' Hebron Institut of Oncology (VHIO)
Barcelona, Catalonia, Spain
DC

Desirée Campoy

Hematologist
Department of Hematology, Hospital Universitari Vall d'Hebron Vall d' Hebron Institut of Oncology (VHIO)
Barcelona, Catalonia, Spain
SM

Sofia Muzio

Resident of Hematology
Department of Hematology, Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
MS

Marina Serra Carrera

Resident of Hematology
Department of Hematology, Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
OB

Olga Benítez

Hematologist
Department of Hematology, Hospital Universitari Vall d'Hebron Vall d' Hebron Institut of Oncology (VHIO)
Barcelona, Catalonia, Spain

Background: In venous thromboembolism (VTE), secondary prevention (SP) with reduced-dose (RD) Rivaroxaban and Apixaban has demonstrated both efficacy and safety in preventing VTE recurrence, without a notable increase in bleeding risk. However, constrained funding in Spain often leads to vitamin K antagonists (VKAs) [INR:2-3] being the primary choice for SP

Aims: To assess the effectiveness and safety of RD Rivaroxaban and Apixaban compared to a cohort of VKA-treated patients for the SP of VTE

Methods: Between 2018 and 2022, we consecutively enrolled patients over 18 years with venous thrombosis (DVT or PE) who completed standard-dose Rivaroxaban or Apixaban treatment (3-6 months) and transitioned to SP with RD. The follow-up period, spanning at least 12 months, included assessments of recurrent VTE, major bleeding, and non-major but clinically relevant bleeding (NMCR).

Results: Among 798 patients (54.8% women, mean age 53.6±19.1 years), 268 initiated SP with VKA (INR: 2-3, average TRT: 56%). Out of 530 patients on Rivaroxaban (10 mg OD) and Apixaban (2.5 mg BD) (58% women), 55.6% received Rivaroxaban, and 44.4% received Apixaban. The mean follow-up from SP initiation to the last visit was 45 ± 14.5 months. A significant proportion (87%) had unprovoked VTE. Patients treated with VKA showed a comparable rate of VTE recurrences (0.9% vs. 1.0%) but a higher rate of major bleeding (4.9% vs.1.5%; P < .001) compared to those on RD of Rivaroxaban and Apixaban. Multivariable analysis adjusted for competing risks revealed that patients with VKA had an increased risk of major bleeding (subhazard ratio, 1.55; 95% CI, 1.026-1.947).

Conclusion(s): Our real-world clinical data indicate that secondary prevention with RD of Rivaroxaban and Apixaban was associated with a comparable risk of VTE recurrence and significantly fewer bleeding events compared to VKAs. These findings provide valuable insights and can inform discussions about the financing of these drugs within the Spanish healthcare system.