依诺肝素0.75 mg/kg动脉推注在冠状动脉造影和介入术中的应用

目的在中国人群中评价冠状动脉（冠脉）造影和经皮经腔冠脉介入术（PCI）中应用依诺肝素0．75mg／kg经动脉鞘管注射抗凝的安全性及有效性。方法160例择期PCI术患者随机分为两组,依诺肝素组给予依诺肝素0．75mg／kg,手术时间超过90min者再给0．3mg／kg;普通肝素组给予普通肝素100U／kg。结果注射依诺肝素后2h内,患者血浆抗Xa因子水平在0．5IU／ml以上。补充依诺肝素后可使所有患者血浆抗Xa因子水平4h内维持于0．5IU／ml以上。依诺肝素组鞘管内血栓发生率明显高于普通肝素组（26．6％比10．0％,P〈0．001）。两组30d内不良临床事件和出血事件发生率相似。结论择期PGI术中应用依诺肝素0．75mg／kg经动脉鞘管弹丸式注射进行抗凝是安全和有效的,有效抗凝强度至少可维持2h,手术时间超过2h的患者应补充依诺肝素。

The application of a 0.75 mg/kg intra-arterial dose of enoxaparin in coronary angiography and percutaneous coronary intervention

OBJECTIVE: This study was designed to examine the efficacy and safety of a dose of 0.75 mg/kg intra-arterial enoxaparin in elective percutaneous coronary intervention in Chinese population. METHODS: A total of 160 consecutive patients undergoing elective PCI were randomized to either enoxaparin or UFH (80 cases for each) group for procedural anticoagulation. The patients in enoxaparin group were given a bolus of enoxaparin (0.75 mg/kg) intra-arterially before PCI, and a superaddition (0.3 mg/kg) would be administered if the procedural time > 90 minutes. Serial plasma anti-X a factor activities were measured before and after the bolus of enoxaparin. The patients in UFH group were given a bolus of UFH (100 U/kg) intra-arterially before PCI and ACT was controlled between 250 and 300 seconds. Then coronary angiography and PCI was performed immediately. Bleeding complications were classified according to thrombolysis in myocardial infarction (TIMI) criteria. All patients were monitored for thrombosis during PCI and adverse events (i.e. death, myocardial infarction demanding revascularization) 30 days after PCI. RESULTS: 159 patients completed the procedure. Plasma anti-X a factor activities in patients of the enoxaparin group were above 0.5 IU/ml 5 minutes to 2 hours after enoxaparin (0.75 mg/kg) injection and the measurements in 61% of the patients were above 0.5 IU/ml 3 hours after injection. If a supplement of 0.3 mg/kg of enoxaparin was given after 90 minutes, plasma anti-X a factor activities of all the patients were above 0.5 IU/ml within 4 hours after the procedure. As compared with UFH, enoxaparin increased the likelihood of thrombosis significantly in sheath catheter during PCI (26.6% vs 10.0%, P < 0.001). There was no obvious difference in adverse events (2.5% vs. 2.6%, P > 0.05) and bleeding events (2.5% vs 3.8%, P > 0.05) between the two groups. CONCLUSIONS: A 0.75 mg/kg intra-arterial dose of enoxaparin for anticoagulation in patients undergoing elective PCI is safe and effective. Anticoagulation effect can be maintained for at least 2 hours. An additional bolus is proposed when procedure time exceeds 2 hours.