Intravenous enoxaparin versus unfractionated heparin in unselected patients undergoing percutaneous coronary interventions: the Zurich enoxaparin versus unfractionated heparin in PCI study (ZEUS).

AIMS: To evaluate the efficacy and safety of intravenous enoxaparin as an alternative to unfractionated heparin (UFH) as antithrombotic therapy in unselected patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: Eight hundred and seventy-six (876) consecutive eligible patients undergoing PCI were prospectively randomised to either intravenous enoxaparin 0.75 mg/kg or dose-adjusted UFH in this open-label study that was prematurely stopped due to slow recruitment. Randomisation was stratified on elective PCI or PCI for acute coronary syndrome (ACS). The primary endpoint was a combination of death, myocardial infarction, unplanned target vessel revascularisation and major bleeding at 30 days. Secondary endpoint was a composite of major and minor bleeding and thrombocytopenia < 50x109. The primary endpoint of intravenous enoxaparin did not differ from those of UFH (5.5% vs. 7.0%, p=ns) whereas safety endpoints were reduced with enoxaparin compared to UFH (9.9% vs. 20.0%, p<0.001). Among 229 (26%) patients presenting with ACS, the incidence of both, the primary and secondary endpoints, was lower with enoxaparin as compared to UFH (1.8% vs. 12.9% and 14.2% vs. 31%, p<0.001 and p=0.003, respectively). CONCLUSIONS: Due to the premature halting of the study and the low event rate, these data are observational only, and no definite conclusion could be made concerning efficacy and safety of intravenous enoxaparin as an alternative to UFH in unselected patients undergoing PCI.

Long-term survival and functional outcome of unselected patients undergoing percutaneous coronary intervention for acute myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) is the most effective reperfusion modality in patients with acute myocardial infarction (MI). Data concerning long-term survival and functional outcome are sparse. METHODS: One thousand consecutive patients treated by emergency PCI were systematically ana-lysed in a single-centre registry. Multivariate predictors of in-hospital mortality, post-discharge mortality and late functional capacity were identified. RESULTS: Follow-up was completed for 978 patients. The median clinical follow-up length was 3.2 years. In-hospital and post-discharge mortality were 7.6% and 7.3%, respectively. Annualised post-discharge mortality remained stable over time at 2% per year. Independent predictors of in-hospital death were cardiogenic shock, TIMI flow <3 after PCI, left ventricular ejection fraction <40%, age and time to patent artery >6 h. Independent predictors of post-discharge mortality were TIMI flow after PCI <3, prior MI, elevated glucose levels at admission, and increasing age. In contrast, cardiogenic shock, time to patent artery and left ventricular ejection fraction <40% were not independently associated with post-hospital death. At late follow-up, 47% of patients had normal functional capacity and 49.1% were in New York Heart Association functional class II. Predictors of impaired functional capacity at follow-up were age, gender, smoking habits and multivessel coronary disease. CONCLUSIONS: Post-discharge mortality after PCI for acute MI was 2% per year. Significant differences exist between predictors of in-hospital and post-discharge mortality. The functional capacity of surviving patients was remarkably good, even when presented in cardiogenic shock.