Rivaroxaban vs standard therapy PE

1. CAT: oral Rivaroxaban vs standard
therapy PE
Rawan Alyemani

2. Clinical scenario
50 year old male present to a emergency department due to shortness of breath for the last 5
days. Also, he noticed a productive cough with blood tinged sputum. He deny any chest pain or
orthopnea or fever. Patient used albuterol inhaler few time but SOB not improved.
Furthermore, patient is known to be asthmatic but it was well control with
fluticasone/salmeterol combination inhaler.
Patient has hypertension, asthma and 3 years ago had DVT that was treated for 6 months.
Moreover, patient has negative family history of PE, DVT or any lung or heart diseases.
Physical exam:
– HR 133/min, BP 150/93, RR 22/min, Po2 89%, temperature 36.2 c
– chest was clear no wheezing or crackles
– Lower extremities: no edema or any abnormalities
Additional tests:
– Chest x-ray was clear
– ECG sinus tachycardia
– Laboratory finding (total blood count and liver function test) was normal
– D-dimer elevated
– CT chest shows a large thrombus in the lung
However, the diagnosis of pulmonary embolism was confirmed.
The next step is to start anticoagulant treatment that will raise a question if the new agent
(Rivaroxaban) is better to treat PE and safer than the standard therapy.

3. Clinical question
To what extent would using oral Rivaroxaban be safer
,within one year, in treating 50 year old male with
shortness of breath, productive cough and history of
hypertension, asthma as well past history with deep
venous thrombosis, Compare with standard therapy?

4. PICOT
Patient problem: 50 year old male diagnosed with pulmonary embolism
Intervention: oral rivaroxaban
Comparison: standard therapy (warfarin)
Outcome: safety
Time: one year

5. Clinical search :
Article chosen:
Number of hits: 25
Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.
EINSTEIN–PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF,
Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD,
Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A.
Therapy MeSH Free text terms
Patient disease and characteristic Pulmonary embolism Pulmonary embolism
Intervention Oral rivaroxaban Oral rivaroxaban
Methodological terms Randomized controlled trial Randomized controlled trial
Control intervention Vitamin K antagonist Vitamin K antagonist
Warfarin
Outcome measure Safety safety

7. Criteria
Criterion 1: The inclusion and exclusion criteria were clearly mentioned in the article
and selection process was mentioned . (++)
Criterion 2: Both intervention and the control treatment have been stated clearly
mentioned in the article. (+ +)
Criterion 3: Randomization was performed with the use of computerized voice-
response. (+)
Criterion 4: Blinding did occur in the article. (+)
Criterion 5: Most important prognostic variables/confounders have been take into
account (+)
Criterion 6: Nothing was mentioned about complication and contamination in the
study, not likely to be occurred. (+)
Criterion 7: Co-interventions was not mentioned in the article. (+)
Criterion 8: The most important outcome measurement have been clearly stated in
the article. (++)
Criterion 9: very small number were lost in the follow up in both group. (+-)
Criterion 10: An intention to treat analysis and pre-protocol analysis was used in the
article, both have quite similar results. (++)

8. Evidence
Rivaroxaban was noninferior to standard therapy.
Nonmajor bleeding episode:
• (10.3%) in the rivaroxaban group
• (11.4%) in the standard-therapy group

9. What should be the appropriate action for this
patient?
Based of the result reported in the study, oral
Rivaroxaban is safe to be used and even without
the need of laboratory monitoring in 50 year old
male with shortness of breath, productive cough
and history of hypertension, asthma as well past
history with deep venous thrombosis.