[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were randomized to receive enoxaparin (1 mg/kg subcutaneously, Q12 h, at least twice before CAG and the sheath was withdrawn immediately after the procedure, n = 484) or UFH (25 mg, iv, before CAG with additional 65 mg iv if PCI indicated and the sheath was withdrawn 4 hours after the procedure, n = 482).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and UFH, it is also safe and efficient to give enoxaparin at least twice before CAG/PCI and the sheath can be withdrawn immediately after PCI.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.
Chen
Ji-lin
JL
Department of Cardiology, Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100037, China. jilin.chen@263.net
Chen
Jue
J
Qiao
Shu-bin
SB
Wu
Yong-jian
YJ
Dai
Jun
J
Yuan
Jin-qing
JQ
Qin
Xue-wen
XW
Yao
Min
M
Yang
Yue-jin
YJ
Gao
Run-lin
RL
D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D003327:Coronary Disease / Q000628:therapy*; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged
D017984:Enoxaparin; D006493:Heparin