Orlando, Florida (ots/PRNewswire)
- The PREVAIL Study Showed That in Acute Ischemic Stroke Patients
Treated With Clexane(R) / Lovenox(R), the Risk of Having a VTE was
Lowered by a Significant 43% With no Significant Increase in
Clinically Important Bleedings When Compared to UFH
Sanofi-aventis announced today that the results of the PREVAIL
(Prevention of VTE after Acute Ischemic Stroke with LMWH Enoxaparin)
study presented at the 48th American Society of Hematology (ASH)
annual meeting in Orlando demonstrated a significant 43% reduction in
venous thromboembolism (VTE) events with enoxaparin vs.
unfractionated heparin (UFH) in medically-ill patients who suffered
an acute ischemic stroke.
Among medically-ill patients, stroke patients are at an increased
risk for developing VTE. Without VTE prophylaxis, up to 75% of
patients with hemiplegia following stroke develop deep-vein
thrombosis (DVT) and 20% develop pulmonary embolism (PE)[1,2].
The primary efficacy endpoint of the study was the composite of
symptomatic or asymptomatic DVT, and/or symptomatic or fatal PE
during the treatment period.
The significant 43% relative risk reduction in VTE events observed
with enoxaparin vs. UFH for the primary efficacy endpoint (10.2 % vs.
18.1%; p=0.0001) was associated with a consistent reduction in
proximal DVT by 53% (4.5% vs. 9.6%; p=0.0003).
There was no significant difference in clinically important
bleedings (1.3% vs. 0.7%, p=0.20), corresponding to the combination
of both symptomatic intracranial bleeding, the most serious
complication, and major extracranial bleeding.
The reduction in VTE risk was also observed in patients presenting
with different levels of stroke severity, with no significant
difference in clinically important bleedings.
"Balancing the benefits of lowering the risk of VTE while
minimizing the risk of bleeding is a very important element in
choosing prophylactic regimens for this particularly fragile patient
population, as it combines the usual factors of VTE in addition to
the stroke context," said Dr. David Sherman, Professor in the
Division of Neurology in the Department of Medicine at the University
of Texas Health Science Center (UTHSC) in San Antonio, and principal
investigator of the study. "PREVAIL showed that enoxaparin, when
compared to UFH, had a superior efficacy with no significant increase
in clinically important bleedings. These data provide new evidence
that suggests enoxaparin can be used as VTE prophylaxis in this high
About Venous Thromboembolism (VTE)
Venous thromboembolism is a general term used to describe the
formation of a blood clot (thrombus) that blocks a vessel. This may
occur in any part of the venous system, but the most common
manifestations are deep-vein thrombosis (DVT), usually in the leg,
and pulmonary embolism (PE).
VTE is also a common complication among individuals who have
experienced an acute ischemic stroke (AIS).
PREVAIL trial is the first large-scale, multinational,
prospective, randomized study which enrolled 1,762 ischemic stroke
patients (stratified by NIH Stroke Scale Score) in over 15 countries.
Patients confirmed with an acute ischemic stroke, were randomized
within 48 hours of stroke symptoms to receive enoxaparin daily 40 mg
SC or UFH 5000 IU SC Q 12 treatment for 10 days +/- 4 days with a
follow up period of 90 days and stratified by NIH Stroke Scale Score
(severe greater than or equal to 14 and less severe <14).
The primary efficacy endpoint was the composite of symptomatic or
asymptomatic DVT, symptomatic ad / or fatal PE during the treatment
period. The primary safety endpoints included symptomatic
intracranial bleeding, major extracranial bleeding and all-cause
Enoxaparin is an anticoagulant of the low molecular weight heparin
(LMWH) class. Its clinical applications are linked to its
antithrombotic properties. It is used to inhibit clot formation in
venous or arterial vessels to avoid potential acute or chronic
complications of venous or arterial thrombosis such as pulmonary
embolism, myocardial infarction or death of cardiovascular origin. As
with all anticoagulants, the most frequently reported side effect for
enoxaparin is bleeding. Clinical indications for enoxaparin may vary
from one country to another.
Sanofi-aventis is the world's third largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine, and
vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
1. McCarthy ST, Turner J. Low-dose subcutaneous heparin in the
prevention of deep-vein thrombosis and pulmonary emboli following
acute stroke. Age Ageing 1986; 15: 84-8
2. McCarthy ST, Turner JJ, Robertson D, Hawkey CJ, Macey DJ.
Low-dose heparin as a prophylaxis against deep-vein thrombosis after
acute stroke. Lancet 1977: 2: 800-1.
ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.ch
Contact: Salah Mahyaoui +33-6-73-68-78-88