ATOLL Study Results With Intravenous Enoxaparin in Acute Heart Attack Managed with Urgent Angioplasty
PARIS, August 30, 2010/PRNewswire/ --
- Composite Primary Endpoint: Risk Reduction of 17%
(Non-Statistically Significant ) in Death, Complication of
Myocardial Infraction, Procedure Failure or Major Bleeding
(p=0.07)
- Main Secondary Composite Efficacy Endpoint: 40% Reduction of
Death, Recurrent Acute Coronary Syndrome or Re-Intervention
(p=0.01)
Pitie-Salpetriere Hospital, Paris, France, August 30th 2010. The
international ATOLL study sponsored by the Assistance Publique -
Hopitaux de Paris showed that enoxaparin reduced the composite of
death, complication of myocardial infraction, procedure failure or
major bleeding by 17% in comparison with standard heparin (p=0.07)
in acute heart-attack (STEMI) patients managed with primary
Percutaneous Coronary Intervention (PCI). The pre-specified main
secondary efficacy endpoint showed that treatment with enoxaparin
resulted in a statistically significant 40% reduction of patients'
death, recurrent acute coronary syndrome or urgent
revascularisation. The results of the ATOLL study were presented at
the hotline session of the annual European Cardiology Congress (ESC
2010) in Stockholm, Sweden.
As a result of acute heart attack (STEMI), overall one third of
patient may die in the first 24 hours after the onset of the
ischemic symptoms, making patients' access to appropriate care
units critical. In real life mortality remains high with up to a 10
% death rate at 30 days.
'With all the "hard" pre-specified ischemic and death related
endpoints favoring enoxaparin over UFH, enoxaparin becomes a new
alternative in primary PCI', said Prof. Gilles Montalescot, Head of
Cardiac Care Unit (CCU) at Pitie-Salpetriere Hospital in Paris and
lead investigator of the ATOLL study. 'By allowing maintenance of
the same anticoagulant throughout patient management from the
emergency room or the ambulance to the catheterization laboratory
then to the Cardiac Care Unit, without anticoagulation monitoring,
enoxaparin is securing and simplifying the treatment strategy' he
added.
The international ATOLL study sponsored by the Assistance
Publique - Hopitaux de Paris enrolled 910 patients suffering from
ST-elevated Myocardial Infraction (STEMI), the most severe form of
heart attack. Patients received either intravenous administration
of 0.5 mg/kg enoxaparin (Clexane/Lovenox(R)) without
anticoagulation monitoring/dose adjusted or standard UFH
(unfractionated heparin) prior to primary Percutaneous Coronary
Intervention, a procedure also referred as angioplasty and
stenting.
With regard to major bleeding risk, the main safety endpoint, no
difference was observed in the two treatment groups (respectively
4.9% and 4.5% for UFH and enoxaparin). The same observation was
reported with minor bleeding risk (8.9% with UFH and 7% with
enoxaparin).
About ATOLL
The ATOLL (Acute STEMI Treated with primary angioplasty and
intravenous enoxaparin Or UFH to Lower ischemic and bleeding events
at short and Long-term follow-up) study is the first randomised,
head-to-head comparison between unfractionated heparin (UFH) and
Clexane/Lovenox(R) (enoxaparin) in primary angioplasty in subjects
with ST-segment elevation myocardial infarction (STEMI). The ATOLL
study included 910 subjects from 31 sites in several countries
including Austria, France, Germany and the United States. Patients
were randomized within 24 hours of symptom onset to receive either
UFH IV bolus (ACT-adjusted), 50-70IU with concurrent GP IIb/IIIa
treatment or 70-100IU without GP IIb/IIIa treatment, or
Clexane/Lovenox(R) (enoxaparine) 0.50 mg/kg IV bolus without
monitoring. The ATOLL study is sponsored by AP-HP (Assistance
Publique-Hopitaux de Paris) and received funding from AP-HP, in
addition to an unrestricted research grant from
sanofi-aventis.
About ST-elevation-myocardial infarction (STEMI)
STEMI is one of the most serious and one of the most deadly
types of heart attacks characterized by an abrupt, complete
blockage of a coronary artery. It leads to irreversible myocardial
damage as a result of insufficient blood supply to the heart muscle
(or myocardial ischemia). STEMI is usually recognized by an
elevation of the ST segment on the ECG, indicating that a large
amount of heart muscle damage is occurring.
About primary Percutaneous Coronary Intervention (PCI)
Primary PCI, often referred to as primary angioplasty, involves
opening the artery using a small balloon to clear the blockage.
During the procedure, a catheter is threaded through an artery up
through the blood vessel to the area in the coronary artery that is
blocked. A small balloon at the tip of the catheter is inflated to
widen the blood vessel and restore blood flow to the heart. Often a
small metal mesh tube called a stent is placed in the artery to
keep it open.
Source: Assistance Publique - Hopitaux de Paris
Salah Mahyaoui, +33-6-73-68-78-88
Posted: August 2010
