ATOLL study favors enoxaparin over UFH for primary Percutaneous Coronary Intervention

Aug 30 2010

- Composite Primary Endpoint: Risk Reduction of 17% (Non-Statistically Significant ) in Death, Complication of Myocardial Infraction, Procedure Failure or Major Bleeding

- Main Secondary Composite Efficacy Endpoint: 40% Reduction of Death, Recurrent Acute Coronary Syndrome or Re-Intervention

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 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).