- 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
ORLANDO, Fla., Dec. 13 /Xinhua-PRNewswire/ -- 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 risk population".
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).
About PREVAIL
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 mortality.
About Enoxaparin
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.
About Sanofi-aventis
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).
Notes to Editors
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.
