RT Journal Article
T1 Rivaroxaban Monotherapy in Patients with Pulmonary Embolism: Off-Label vs. Labeled Therapy.
A1 Di Micco, Pierpaolo
A1 Salazar, Vladimir Rosa
A1 Capitan, Carmen Fernandez
A1 Dentali, Francesco
A1 Cuervo, Covadonga Gomez
A1 Torres, Jose Luis Fernandez
A1 Porras, Jose Antonio
A1 Fidalgo, Angeles
A1 Grandone, Elvira
A1 Meseguer, Manuel Lopez
A1 Monreal, Manuel
A1 The Riete Investigators, 
K1 DOACs
K1 RIETE
K1 oral anticoagulants
K1 rivaroxaban
K1 venpus thromboembolism
AB Background: The use of rivaroxaban in clinical practice often deviates from manufacturer prescribing information. No studies have demonstrated an association between this practice and improved outcomes. Methods: We used the RIETE registry to assess the clinical characteristics of patients with pulmonary embolism (PE) who received off-label rivaroxaban, and to compare their 3-month outcomes with those receiving the labeled therapy. The patients were classified into four subgroups: (1) labeled therapy; (2) delayed start; (3) low doses and (4) both conditions. Results: From May 2013 to May 2022, 2490 patients with PE received rivaroxaban: labeled therapy—1485 (58.6%); delayed start—808 (32.5%); low doses—143 (5.7%); both conditions—54 (2.2%). Patients with a delayed start were more likely to present with syncope, hypotension, raised troponin levels and more severe abnormalities on the echocardiogram than those on labeled therapy. Patients receiving low doses were most likely to have cancer, recent bleeding, anemia, thrombocytopenia or renal insufficiency. During the first 3 months, 3 patients developed PE recurrence, 4 had deep-vein thrombosis, 11 had major bleeding and 16 died. The rates of major bleeding (11 vs. 0; p
SN 2075-1729
YR 2022
FD 2022-07-27
LK http://hdl.handle.net/10668/21400
UL http://hdl.handle.net/10668/21400
LA en
DS RISalud
RD Apr 18, 2025