Objective: To investigate the efficacy of periprocedural use of
bivalirudin for patients with chronic total occlusion(CTO) lesion undergoing
percutaneous coronary intervention(PCI)
therapy. Methods: In this randomized controlled study, 74 patients with CTO lesions confirmed by coronary angiography or CT angiography, hospitalized in the general hospital of Shenyang military region from September 2015 to December 2016, were randomly divided into
unfractionated heparin(UFH) group (n=38) and
bivalirudin group (n=36) by the random number table.Patients in the UFH group were treated with injection of UFH 5 000 U through the artery sheath
catheter before coronary angiography,and the UFH was intravenously administered at 100 U/kg before PCI. Patients in the
bivalirudin group received
intravenous injection of
bivalirudin (0.75 mg/kg) before coronary angiography, followed by
intravenous infusion of 1.75 mg·kg(-1)·h(-1) until at least 2 hours after the PCI. The values of the activated coagulation time (ACT) were measured,and the value was remained at 250 to 350 seconds during the PCI. The incidence rate of adverse events including
hemorrhage events, no-reflow/slow flow, and contact
thrombus in
perioperative period were observed in all patients. In addition, the incidence rate of the major adverse cardiovascular events (
MACE) including recurrent angina,
heart failure, target vessel revascularization,
cardiac death, non-fatal
myocardial infarction,and
stroke within 1 year follow-up period were also observed in the 2 groups. Results: Baseline clinical and PCI data were similar between the 2 groups (all P>0.05). During the
perioperative period, the incidence of the
bleeding was significantly lower in the
bivalirudin group than in the UFH group(5.6% (2/36) vs. 23.7% (9/38) , P=0.028).The incidence of no-reflow/slow flow was also significantly lower in the
bivalirudin group than in the UFH group(0 vs. 15.8% (6/38) , P=0.025). There was no significant difference in the incidence of contact
thrombosis between
bivalirudin group and UFH group(8.3% (3/36) vs. 0, P=0.110). There was no
cardiac death or non-fatal
myocardial infarction in the 2 groups within 1 year after PCI, and there was no significant difference in the incidence of
MACE in 1 year follow-up after operation between
bivalirudin group and UFH group (11.1% (4/36) vs. 21.1% (8/38) , P=0.246). Conclusion: The application of the
anticoagulant bivalirudin during PCI in patients with CTO lesion can reduce the incidence of perioperative
bleeding and no-reflow/slow flow, and does not increase the risk of
MACE within 1 year after PCI.