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).
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|
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