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Last updated on April 21, 2014 at 1:20 EDT

ATOLL Study Results With Intravenous Enoxaparin in Acute Heart Attack Managed with Urgent Angioplasty

August 30, 2010

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


Source: newswire