Efficacy and safety of bivalirudin in ST-segment elevation myocardial infarction patients with different bleeding risks during emergency percutaneous coronary intervention
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摘要:目的
比较比伐卢定和普通肝素应用于不同出血风险ST段抬高型心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)围术期的疗效与安全性。
方法选取行急诊PCI的615例STEMI患者作为研究对象，根据CRUSADE出血风险评分将其分为低危出血组患者421例(CRUSADE评分≤30分)和中高危出血组患者194例(CRUSADE评分>30分)，再根据不同抗凝方案将低危出血组患者分为低危普通肝素组患者203例、低危比伐卢定组患者218例，将中高危出血组患者分为中高危普通肝素组患者95例、中高危比伐卢定组患者99例。观察并比较各组患者术后冠状动脉罪犯血管心肌梗死溶栓治疗(TIMI)血流分级、术后30 d内主要心血管不良事件(MACE)和出血事件的发生情况。
结果中高危出血组STEMI患者中，中高危比伐卢定组与中高危普通肝素组的术后TIMI血流分级、MACE发生情况比较，差异均无统计学意义(P>0.05); 中高危比伐卢定组欧美出血学术研究会(BARC)2~5型出血事件发生率、总出血事件发生率分别为13.13%、15.15%, 低于中高危普通肝素组的24.21%、29.47%, 差异有统计学意义(P < 0.05); 中高危比伐卢定组BARC 3~5型出血发生率低于中高危普通肝素组，但差异无统计学意义(P>0.05)。低危出血组STEMI患者中，低危比伐卢定组术后TIMI血流分级、MACE及出血事件发生情况与低危普通肝素组比较，差异均无统计学意义(P>0.05)。
结论相较于普通肝素，中高危出血STEMI患者急诊PCI围术期应用比伐卢定进行抗凝治疗能降低出血风险，但并无包括全因死亡在内的最终获益; 低危出血STEMI患者急诊PCI围术期应用比伐卢定或普通肝素在出血和缺血事件方面比较均无显著差异。STEMI患者PCI术前应接受CRUSADE出血风险评估，并根据出血风险选用合适的抗凝药物。
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关键词:
- 比伐卢定 /
- 普通肝素 /
- ST段抬高型心肌梗死 /
- 经皮冠状动脉介入治疗 /
- CRUSADE出血风险评分
Abstract:ObjectiveTo compare the perioperative efficacy and safety of bivalirudin and unfractionated heparin in ST-segment elevation myocardial infarction (STEMI) patients with different bleeding risks undergoing emergency percutaneous coronary intervention (PCI).
MethodsA total of 615 STEMI patients who underwent emergency PCI were enrolled in the study. According to CRUSADE bleeding risk score, they were divided into low risk bleeding group(CRUSADE score ≤30, 421 patients) and medium and high risk bleeding group(CRUSADE score >30, 194 patients). Patients in the low risk bleeding group were divided into low-risk heparin group(n=203) and low-risk bivalirudin group(n=218)according to the anticoagulant treatment plan, while the patients in the medium and high risk bleeding group were divided into medium and high risk heparin group (n=95) and medium and high risk bivalirudin group (n=99). The blood flow grade, major adverse cardiovascular events (MACE) and occurrence of bleeding events 30 days after operation in patients with thrombolysis in myocardial infarction (TIMI) were observed and compared in different groups.
ResultsOf STEMI patients in moderate and high risk of bleeding group, there were no significant differences in postoperative TIMI blood flow grading and MACE events between the medium and high risk bivalirudin group and the medium and high risk heparin group(P>0.05). The incidence of European and American Hemorrhage Research Committee(BARC)type 2 to 5 bleeding events and total bleeding events in the medium-high risk bivalirudin group were 13.13% and 15.15%, respectively, which were lower than 24.21% and 29.47% in the medium and high risk heparin group (P < 0.05). The incidence of BARC type 3 to 5 bleeding in the medium and high risk bivalirudin group was lower than that in the medium and high risk heparin group, but the difference was not statistically significant (P>0.05). Among STEMI patients in the low risk bleeding group, there were no significant differences in TIMI blood flow grade, MACE and bleeding events between the low risk bivalirudin group and the low risk heparin group (P>0.05).
ConclusionCompared with unfractionated heparin, perioperative application of bivalirudin anticoagulant therapy can reduce the risk of bleeding in STEMI patients with moderate and high risk of bleeding during emergency PCI, but it does not bring the ultimate benefit including all-cause death. In STEMI patients with low risk of bleeding, there are no significant differences in the incidence of bleeding and ischemic events between bivalirudin and unfractionated heparin. Patients with STEMI should undergo CRUSADE bleeding risk assessment before PCI, and select appropriate anticoagulants according to bleeding risk.
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表 1 普通肝素组与比伐卢定组患者一般资料比较(x±s)[n(%)]
指标 分类 普通肝素组(n=298) 比伐卢定组(n=317) 性别 男 243(81.54) 254(80.13) 女 55(18.46) 63(19.87) 年龄/岁 60.86±0.69 63.03±0.68* 体质量指数/(kg/m2) 24.49±0.19 24.62±0.18 合并症 高血压病 172(57.72) 198(62.46) 糖尿病 97(32.55) 108(34.07) 高脂血症 81(27.18) 83(26.18) 既往病史 卒中病史 24(8.05) 30(9.46) 心肌梗死病史 15(5.03) 20(6.31) 吸烟史 177(59.40) 180(56.78) 血小板/(×109/L) 207.08±4.03 204.72±3.65 血红蛋白/(g/L) 114.17±1.04 144.87±1.02 肾小球滤过率/(mL/min) 97.83±2.20 92.55±2.00 丙氨酸氨基转移酶/(U/L) 46.73±2.24 45.83±1.61 心率/(次/min) 75.88±1.10 79.02±1.17 CRUSADE评分 >30分 95(31.88) 99(31.23) ≤30分 203(68.12) 218(68.77) GRACE评分/分 141.91±1.88 143.81±1.92 Killip分级Ⅲ~Ⅳ级 23(7.72) 24(7.57) 治疗药物 阿司匹林 298(100.00) 317(100.00) 氯吡格雷 50(16.78) 51(16.09) 替格瑞洛 248(83.22) 266(83.91) 低分子肝素 290(97.32) 307(96.85) 替罗非班 63(21.14) 49(15.46) GRACE评分: 全球急性冠状动脉事件注册评分。与普通肝素组比较, *P < 0.05。 
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表 2 各组患者术后罪犯血管TIMI血流分级比较[n(%)]
组别 亚组 术后罪犯血管TIMI血流分级 TIMI 0~2级 TIMI 3级 低危出血组(n=421) 低危普通肝素组(n=203) 4(1.97) 199(98.03) 低危比伐卢定组(n=218) 6(2.75) 212(97.25) 中高危出血组(n=194) 中高危普通肝素组(n=95) 3(3.16) 92(96.84) 中高危比伐卢定组(n=99) 4(4.04) 95(95.96) TIMI: 心肌梗死溶栓治疗。
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表 3 各组患者术后30 d内MACE发生情况比较[n(%)]
组别 亚组 MACE 再发心肌梗死 支架内血栓 全因死亡 脑卒中 合计 低危出血组(n=421) 低危普通肝素组(n=203) 2(0.99) 1(0.49) 0 0 3(1.48) 低危比伐卢定组(n=218) 3(1.38) 1(0.46) 2(0.92) 0 6(2.75) 中高危出血组(n=194) 中高危普通肝素组(n=95) 1(1.05) 1(1.05) 8(8.42) 1(1.05) 11(11.58) 中高危比伐卢定组(n=99) 0 1(1.01) 12(12.12) 0 13(13.13) MACE: 主要心血管不良事件。
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表 4 各组患者术后30 d内出血事件发生情况比较[n(%)]
组别 亚组 出血事件 BARC 2~5型出血 BARC 3~5型出血 总出血事件 低危出血组(n=421) 低危普通肝素组(n=203) 13(6.40) 5(2.46) 23(11.33) 低危比伐卢定组(n=218) 11(5.05) 5(2.29) 19(8.72) 中高危出血组(n=194) 中高危普通肝素组(n=95) 23(24.21) 13(13.68) 28(29.47) 中高危比伐卢定组(n=99) 13(13.13)* 6(6.16) 15(15.15)* BARC: 欧美出血学术研究会。与中高危普通肝素组比较, *P < 0.05。
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