In a recently
publicized study by
Drahomir et al an open-label, randomized non-inferiority trial was
conducted at 19 emergency departments in the USA, Switzerland, France and
Belgium.
Between February, 2007, and June, 2010, 344 eligible
patients with acute, symptomatic pulmonary embolism were enrolled in the study.
The patients were 18 years or older.
The researchers defined
pulmonary embolism as the
acute onset of dyspnea or chest pain,
along with a new contrast filling defect on computed tomography or pulmonary
angiography or a new high-probability ventilation-perfusion lung scan. It may
also be a documentation of a new proximal deep vein thrombosis either by venous
ultrasonography or contrast venography.
The patients
were randomly assigned to
two
categories -
• Initial outpatient treatment (patients were
discharged from hospital ≤24 h after randomization)
• Inpatient treatment with
subcutaneous enoxaparin for approximately 5 days followed by oral
anticoagulation for about 90 days.
The researchers designed the Outpatient
Treatment of Pulmonary Embolism (OTPE) trial to compare and evaluate the safety
and efficiency of outpatient care versus inpatient care for low-risk patients
with acute, symptomatic pulmonary embolism against a validated clinical
prognostic model.
The pulmonary embolism
severity index is a clinical prognostic model that was created and validated in
over 16 000 patients with pulmonary embolism.
Patients with one or more of the following
characteristics were excluded:
• Arterial hypoxemia
• Systolic blood pressure
of less than 100 mm Hg
• Chest pain necessitating
parenteral opioids
• Active bleeding
• Those with high risk of
bleeding (defined as stroke during the preceding 10 days, gastrointestinal
bleeding during the preceding 14 days or fewer than 75 000 platelets per
mm3)
• Severe renal failure (creatinine
clearance of <30 mL per min based on the Cockcroft-Gault equation),
• Extreme obesity (body
mass >150 kg),
• History of
heparin-induced thrombocytopenia or allergy to heparins, therapeutic oral
anticoagulation at the time of diagnosis of pulmonary embolism
• Any barriers to
treatment adherence or follow-up (eg, current alcohol abuse, illicit drug use,
psychosis, dementia, or homelessness),
• Pregnancy
• Imprisonment
• Diagnosis of pulmonary
embolism more than 23 hrs before screening time (to avoid enrolling already
stabilised patients)
• Previous enrolment in
the trial.
In both treatment groups,
early initiation of oral anticoagulation with vitamin K antagonists such as
(warfarin, acenocoumarol, phenprocoumon, or fluidione) was recommended along
with its continuation for a minimum of 90 days.
All patients were contacted every day for the
week after enrolment and at 14, 30, 60, and 90 days and were asked about
symptoms of recurrent venous (VTE) such as dyspnoea, chest pain, leg pain,
swelling, bleeding, and any use of health-care resources. All patients were instructed to report about any new symptoms suggestive of
VTE.
Results & Discussion - In selected low-risk patients with pulmonary
embolism, outpatient care can safely and effectively be used in place of
inpatient care.
The study revealed that
outpatient treatment with low-molecular-weight heparin is not inferior to
inpatient treatment in terms of effectiveness and safety.
The study demonstrated
that out - patient care was well received by patients who were equally
satisfied with their care as were the inpatients.
Another beneficial factor
was that outpatient treatment also reduced hospital time.
Reference :
"Outpatient versus inpatient treatment for patients with acute
pulmonary embolism: an international, open-label, randomised, non-inferiority
trial"
Drahomir et al
The Lancet, Volume
378, Issue 9785, Pages 41 - 48, 2 July 2011
Source: Medindia
