Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Bivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries. However, it was not available in China before this clinical trial was designed. This randomized, single-blind and multicenter clinical trial aimed to evaluate the efficacy and the safety of domestic bivalirudin during percutaneous coronary intervention (PCI).</p><p><b>METHODS</b>A randomized, single-blind, multicenter trial was designed. Elective PCI candidates in five centers were randomized into a bivalirudin group and a heparin group, which were treated with domestic bivalirudin and non-fractional heparin during the PCI procedure. The efficacy was evaluated by comparing the activated coagulation time (ACT), the procedural success rate (residual stenosis < 20% in target lesions without any coronary artery related adverse events within 24 hours after PCI), and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups. Safety was evaluated by the major/minor bleeding rate.</p><p><b>RESULTS</b>A total of 218 elective PCI patients were randomized into a bivalirudin group (n = 110) and heparin group (n = 108). Except for two patients needing additional dosing in the heparin group, the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus. Procedural success rates were respectively 100.0% and 98.2% in the bivalirudin group and heparin group (P > 0.05). Survival rates without major adverse cardiac events at 30 days after PCI were 100.0% in the bivalirudin group and 98.2% in the heparin group (P > 0.05). Mild bleeding rates were 0.9% and 6.9% (P < 0.05) at 24 hours, and 1.9% and 8.8% (P < 0.05) at 30 days after PCI in the bivalirudin group and heparin group respectively. There was one severe gastrointestinal bleeding case in the heparin group.</p><p><b>CONCLUSIONS</b>Domestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures. The efficacy is not inferior to heparin, but the safety is superior to heparin.</p>

Predict value of clinical risk score, thrombolysis in myocardial infarction flow grade and combined clinical risk score plus TIMI flow on outcome evaluation of patients with acute coronary syndrome / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the prognostic value of clinical risk score and thrombolysis in myocardial infarction (TIMI) flow grade alone or combined on outcome of acute coronary syndrome (ACS).</p><p><b>METHODS</b>A total of 206 eligible patients [135 males, mean age (67.57 +/- 9.88) years] were enrolled. The primary endpoints included cardiac death and non-cardiac death. The secondary endpoints included non-fatal stroke, reinfarction, heart failure and recurrent angina. Receiver operating characteristic curve (ROC) established by using different endpoints and clinical risk score, TIMI flow grade or combined risk scores. The prognostic value for different endpoint expressed as the area under the curve (AUC).</p><p><b>RESULTS</b>Eleven patients lost during the (11.41 +/- 5.33) months follow up and data were available for 195 patients, 8 patients reached the primary endpoints, and 17 patients reached the secondary end-points at the end of follow up. The AUC was 0.67 (95% CI = 0.557 approximately 0.786), P = 0.006; 0.68 (95% CI = 0.557 approximately 0.786), P = 0.004 and 0.730 (95% CI = 0.691 approximately 0.815), P < 0.001, respectively for clinical risk score, TIMI flow grade and the combined risk score respectively. There were no significant differences among clinical risk score, TIMI flow grade and combined risk score (all P > 0.05) for AUC and for primary end point and the secondary end point.</p><p><b>CONCLUSION</b>The result from this study suggests that the efficacy of predicting the total events based on clinical risk score, TIMI flow grade and combined risk score was similar.</p>