[A randomized comparative study of using enoxaparin or UFH adjunctive to percutaneous coronary intervention in patients with CHD (ROUTE)].

Objective: To evaluate the efficacy and safety of using Enoxaparin instead of UFH for patients with coronary heart disease (CHD) underwent coronary angiogram with or without percutaneous coronary intervention (PCI).
Methods: From Oct. 2003 to Feb. 2005, 966 patients with CHD underwent coronary angiogram (CAG) were randomized to receive enoxaparin (1 mg/kg subcutaneously, Q12 h, at least twice before CAG and the sheath was withdrawn immediately after the procedure, n = 484) or UFH (25 mg, iv, before CAG with additional 65 mg iv if PCI indicated and the sheath was withdrawn 4 hours after the procedure, n = 482).
Results: (1) PCI was not performed in 511 patients due to mild lesions or patients were suitable for CABG. In 455 patients underwent PCI (227 in enoxaparin and 228 in UFH group), 1 patient in enoxaparin group developed acute thrombosis and resulted in AMI during PCI and underwent successful urgent revascularization. The incidence of in-hospital major adverse cardiac events were 0.44% in the enoxaparin group and 0 in the UFH group. (2) Hematoma at the puncture site happened in 8 patients (3.5%) in enoxaparin group and in 20 patients (8.8%, P < 0.05) in UFH group. (3) One patient had AMI caused by subacute thrombosis in UFH group during 1 month follow-up.
Conclusions: Our results suggest that the effects and safety are comparable for enoxaparin and UFH, it is also safe and efficient to give enoxaparin at least twice before CAG/PCI and the sheath can be withdrawn immediately after PCI. For ACS patients received more than twice enoxaparin and the last dose was given within 8 hours before PCI, PCI could be performed directly without additional UFH.