Prospective, randomized, preliminary clinical trial with low-molecular-weight heparin or unfractionated heparin as periprocedural anticoagulant during elective percutaneous coronary intervention

Abstract

Background and Objectives: LMWH as a periprocedural anticoagulant during PCI has not yet been extensively studied. The aim of this study is to compare the clinical outcomes of enoxaparin to those of unfractiona ted heparin (UH) during elective PCI. Subjects and Methods: The eligible patients were randomized 1:1 into two treatment arms, either a single IV bolus of enoxaparin (75 IU/kg) or UH (100 IU/kg). The patients who had received any anticoagulants at therapeutic doses were excluded in this study. Data on patient characteristics, angiographic complications, laboratory variables and the in-hospital and 1-month clinical outcomes were compared between the two groups. Results: Of the 139 patients enrolled in this study, 68 received enoxaparin and 71 received UH. The patients' demographic and angiographic characteristics (gender, weight, creatinine and the PCI target vessel) were not different except for age between the groups. Multi-vessel angioplasty was performed in 59 (42.4%) patients. At least one stent was implanted in 130 (93.5%) patients. The sheath was removed immediately after PCI, except for one case, and then a collagen plug was applied in all the cases. There were no significant differences in angiographic complications like no reflow, thrombus at the treated lesion site, occlusion of collateral branches, distal embolism, dissection, coronary rupture or abrupt closure. Cardiac markers including CK (6 [8.8%] in the LMWH group vs 8 [11.3%] in the UH group), CK-MB (6 [8.8%] vs 8 [11.3%], respectively), and troponin-I (6 [8.8%] vs 10 [14.1%], respectively) were slightly increased after PCI compared to the last value obtained before the procedure in both groups, but the differences were not statistically significant. One patient in the enoxaparin arm and 2 patients in the UH arm developed NSTEMI during their admission. Four patients from the UH arm and 3 from the enoxaparin arm experienced hematoma at the puncture site. After discharge, no other events were reported at the 1-month follow-up. Conclusion: The use of enoxaparin (75 IU/kg) during elective PCI was effective and safe as using UH. Enoxaparin could be used like UH as a periprocedural anticoagulant in the elective PCI setting. © 2006, The Korean Society of Circulation.