Evaluating the efficacy and safety of rivaroxaban as a warfarin alternative in chronic thromboembolic pulmonary hypertension patients undergoing pulmonary endarterectomy: A randomized clinical trial

Rev Port Cardiol. 2023 Feb;42(2):139-144. doi: 10.1016/j.repc.2021.09.023. Epub 2022 Oct 10.
[Article in English, Portuguese]

Abstract

Background and aim: Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by the obstruction of the main pulmonary artery due to thrombosis and vascular remodeling. Regarding the need for anticoagulant therapy in CTEPH patients, this study aimed to compare rivaroxaban with warfarin in terms of its efficacy and safety in patients undergoing endarterectomy surgery.

Methods: The study was a parallel clinical trial in patients who underwent endarterectomy following CTEPH. A total of 96 patients were randomly selected and assigned to two groups: warfarin-treated (control) and rivaroxaban-treated (intervention). Patients were clinically assessed for re-thrombosis, re-admission, bleeding, and mortality in the first, third, and sixth months after surgery.

Results: There was no significant difference in the occurrence of thrombosis between the two groups within the first, third-, and sixth-months post-surgery (p=0.52, 1, 0.38 respectively). Moreover, the mortality rate (p=0.9), bleeding rate (p=0.06), and re-admission rate (p=0.15) showed no significant differences between the two groups.

Conclusion: Rivaroxaban may be as effective as warfarin in treating CTEPH patients after endarterectomy in the short term and can be used as an anticoagulant in these patients. However, studies with long-term follow-ups are needed to consolidate the strategy of treating these patients with rivaroxaban.

Keywords: Chronic thromboembolic pulmonary hypertension; Cirurgia; Endarterectomia; Endarterectomy; Hipertensão pulmonar tromboembólica crónica; Rivaroxaban; Rivaroxabano; Surgery; Varfarina; Warfarin.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anticoagulants / therapeutic use
  • Chronic Disease
  • Endarterectomy / adverse effects
  • Hemorrhage
  • Humans
  • Hypertension, Pulmonary* / complications
  • Hypertension, Pulmonary* / drug therapy
  • Hypertension, Pulmonary* / surgery
  • Pulmonary Embolism* / complications
  • Pulmonary Embolism* / surgery
  • Rivaroxaban / therapeutic use
  • Thrombosis*
  • Treatment Outcome
  • Warfarin / therapeutic use

Substances

  • Warfarin
  • Rivaroxaban
  • Anticoagulants