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Prof. Steen Dalby Kristensen,
Prof. Gilles Montalescot,
Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. STEEPLE one year follow-up.
Presenter report: Montalescot, Gilles (France)
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Discussant Report : Kristensen, Steen Dalby (Denmark)
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The STEEPLE Trial (1) evaluated the safety and efficacy of the low molecular-weight heparin, enoxaparin, in 2 doses (0.5 mg per kilogram and 0.75 mg per kilogram bodyweight) versus an intravenous standard dose of unfractionated heparin (UFH) adjusted to appropriate ACT-values, in stable coronary artery disease patients undergoing elective PCI. All PCI's were performed via the femoral artery. Primary endpoint in this trial was the occurrence of non-CABG-related bleedings in the first 48 hours. The incidence of major bleeding was significantly reduced in both enoxaparin groups as compared to the UFH-group (1).
The 1 year follow up data presented by the primary investigator Prof. G. Montalescot showed no statistical significant difference in 1 year mortality between the 3 groups. Looking at individual ischaemic endpoints at 30 days no statistical difference in death, non-fatal MI or urgent target vessel revascularisation was found. Other statistical analysis was performed on the composite of all cause mortality up to 1 year and non-CABG major bleeding up to 48 hours. In the protocol it was prespecified that this analyzis was also performed with the two enoxaparin groups combined. This analysis showed a 4.7% occurrence of this composite endpoint in the UFH group versus 3.3% in the enoxaparin groups combined (P=0.03).
The STEEPLE 1 year results provide interesting information on the predictors of 1 year mortality in a large group of patients undergoing "modern PCI". CKMB release during the intervention was a significant predictor, and also initial ischaemic events (non-fatal MI/urgent targent vessel revascularisation up to day 30) were predictive of 1 year mortality. Importantly, major bleeding within the first 48 hours was a statistically significant predictor of mortality in these patients. Other predictors of mortality were multivessel disease, peripheral arterial disease, age more than 75 years, diabetes and renal insufficiency.
The STEEPLE trial has shown us that intravenous enoxaparin used as anticoagulant during elective PCI with the femoral approach gives rise to fewer bleedings than standard UFH. Although there was no difference in mortality at 1 year between the groups, the study shows that enoxaparin is a an alternative to UFH and should be considered to be implemented in ESC Guidelines and clinical practice.
1) G. Montalescot et al. NEJM 2006;355,1006-17.