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Enoxaparin in unstable angina patients who would have been excluded from randomized pivotal trials

Jean-Philippe Collet, MD, PhD^*, Gilles Montalescot, MD, PhD^*,*, Erika Fine, MD^*, Jean-Louis Golmard, MD, PhD, Miles Dalby, MD^*, R.émi Choussat, MD^*, Annick Ankri, MD, Raphaëlle Dumaine, MD^*, Claude Lesty, PhD^*, Nicolas Vignolles, BSc^* and Daniel Thomas, MD^*

^* Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtrière (AP-HP), Paris, France
Department of Biostatistics, Pitié-Salpêtrière Hospital, Paris, France
Hemostasis Laboratory, Pitié-Salpêtrière Hospital, Paris, France

View larger version (31K): [in a new window]   Figure 1 Flow chart of patients in the PARIS registry, including definitions of exclusion criteria and the number of patients in each category. Creat. Clear. = creatinine clearance; Hb = hemoglobin; LBB = left bundle branch block; NSTEMI = non–ST-segment elevation myocardial infarction; UA = unstable angina.

View larger version (27K): [in a new window]   Figure 2 Anti-Xa activity in excluded and non-excluded patients measured after the third injection or just before the coronary angiogram. The distribution of anti-Xa activity matches perfectly in both groups. Nearly all patients (94.4%) had an anti-Xa level above the lower limit of the therapeutic range (0.5 IU/ml), most of them being close to the upper limit (1 IU/ml).

View larger version (28K): [in a new window]   Figure 3 Rates of bleeding events at 30 days in excluded and non-excluded patients. There were no significant differences between the two groups.

View larger version (22K): [in a new window]   Figure 4 Rates of major coronary events at 30 days in excluded and non-excluded patients. **p < 0.001 between the two groups.