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The third
Venous most
thrombo common
embolism cause of
vascular death
deep-vein
thrombosis
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The mainstay of treatment is anticoagulation
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Patients with venous thromboembolism
require extended treatment
full-intensity lower-intensity
anticoagulation anticoagulation aspirin
therapy therapy
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METHODS
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Study Design and Oversight
double-
blind
comparing the
efficacy and safety of
two doses of
rivaroxaban with phase 3
randomized
those of aspirin for study
the extended
treatment of venous
thromboembolism
1 year after
the initial 6
to 12
months of
7 therapy
Patients
eligible for
ineligible
inclusion
had a contraindication to continued
18 years of age or older
anticoagulant therapy
had been treated for 6 to 12 months with creatinine clearance of < 30 ml per
an anticoagulant agent minute
had not interrupted therapy for more than hepatic disease associated with a
7 days before randomization coagulopathy
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Randomization
The intended
duration of
administration of
Patients were the study drug was
assigned, in a 1:1:1 12 months
ratio, to receive 20
mg of rivaroxaban,
10 mg of
rivaroxaban, or 100
Patients were mg of aspirin, all
enrolled at least 24 given once daily with
hours after they had food
received the last dose
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of a direct oral
anticoagulant agent
Outcome Measures
efficacy safety
outcome outcome
primary : recurrent fatal or
nonfatal pulmonary
embolism, deep-vein
The principal : major
thrombosis and unexplained
bleeding
death for which pulmonary
embolism could not be
ruled out
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Statistical Analysis
Efficacy and safety outcomes were analyzed with the use of a Cox
proportional hazards model, stratified according to the index
diagnosis (deep-vein thrombosis or pulmonary embolism).
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RESULT
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Study Patients
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s
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DISCUSSION
Clinical strategies for extended anticoagulation in patients with
venous thromboembolism are uncertain
This study shows that as compared with aspirin, both the 20-mg
and 10-mg doses of rivaroxaban reduced the relative risk of
recurrent venous thromboembolism by about 70%
unknown whether the 10-mg additional studies are needed any conclusions with respect
dose of rivaroxaban would be to determine the utility of to this issue are speculative
sufficient to prevent continuing treatment for
recurrence in such patients longer periods
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Rivaroxaban, at both a treatment dose
(20 mg) and a thromboprophylactic
dose (10 mg), was more effective than
aspirin for the prevention of recurrent
venous thromboembolism among
patients who were in equipoise for
continued anticoagulation
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THE QUESTION (PICO) OF THE STUDY
Population/ Patients with venous thromboembolism
Problem
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CRITICAL APPRAISAL
Are the Results Valid? Yes Cant Tell No
Was representative sample of patientsassembled at a
early point in thecourse of their disease?
How likely are the outcome event(s) The risk of a recurrent event was
over a specified period of time? significantly lower with rivaroxaban at
either a treatment dose (20 mg) or a
prophylactic dose (10 mg) than with
aspirin, without a significant increase in
bleeding rates
How precise are the prognostic Hazard ratio for 20 mg of rivaroxaban vs.
estimates? aspirin, 0.34; 95% confidence interval [CI],
0.20 to 0.59;
Hazard ratio for 10 mg of rivaroxaban vs.
aspirin, 0.26; 95% CI, 0.14 to 0.47;
P<0.001 for both comparisons
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Can I apply this valid, important Yes Cant tell No
evidence about prognosis to my
patient?
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