Rivaroxaban versus standard anticoagulation for symptomatic venous thromboembolism (REMOTEV observational study): Analysis of 6-month outcomes.
BACKGROUND
This study aimed to provide safety and efficacy data of rivaroxaban in routine patient care in a non-selected symptomatic venous thromboembolism (VTE) population.


RESULTS
REMOTEV is a prospective, non-interventional study of patients with acute symptomatic VTE, treated with oral rivaroxaban, VKA or parenteral heparin/fondaparinux alone for at least 3months and who are followed up for 6months. From Nov. 2013 to July 2015, 499 consecutive patients were retained for baseline analysis and 445 for safety analysis. The mean age was 65.1years, 7.6% had previously known active cancer, 18.6% had creatinine clearance 30≤CrCl<60mL/min, and 87.8% had pulmonary embolism with or without deep venous thrombosis. The major and clinically relevant bleeding rate was 5.4% (15/280) in the rivaroxaban group, 9.4%/(9/96) in the VKA group and 7.2% (5/69) in the heparin/fondaparinux group. The recurrent VTE rate was 1.4% (4/280) in the rivaroxaban group, 3.1% (3/96) in the VKA group and 11.6% (8/69) in the heparin/fondaparinux group. In the propensity score-adjusted samples, major and clinically relevant non-major bleeding (HR 0.37 [95% CI, 0.15 to 0.93], p<0.05), all-cause death (HR 0.21 [95% CI, 0.06 to 0.66], p<0.01) and the composite of recurrent VTE, major and clinically relevant non-major bleeding and all-cause mortality (HR 0.35 [95% CI, 0.17 to 0.71], p<0.01), were significantly lower in the rivaroxaban group compared to the VKA group.


CONCLUSIONS
In REMOTEV 6-month outcomes are consistent with the findings of the phase 3 randomized trials and post-marketing data, with low rates of major bleeding and symptomatic recurrent VTE.
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Sébastien
S
Gaertner
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Elena-Mihaela
EM
Cordeanu
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Salah
S
Nouri
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Alix-Marie
AM
Faller
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Anne-Sophie
AS
Frantz
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Corina
C
Mirea
Emergency Department, Fédération de Médecine Translationnelle, Strasbourg Regional University Hospital, France.
Pascal
P
Bilbault
Department of Cardiology, Strasbourg Regional University Hospital, France.
Patrick
P
Ohlmann
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France.
Isabelle
I
Le Ray
Department of Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg Regional University Hospital, France. Electronic address: dominique.stephan@chru-strasbourg.fr.
Dominique
D
Stephan
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D065427:Factor Xa Inhibitors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D000069552:Rivaroxaban / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology
D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban
Heparin; Propensity score; Registry; Rivaroxaban; Venous thromboembolism; Vitamin K antagonist