PCI围术期比伐芦定抗凝的急性冠脉综合征患者出血事件发生情况及影响因素分析
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摘要
目的探讨PCI围术期静脉注射比伐芦定抗凝的急性冠脉综合征患者1年内出血事件[符合出血学术研究会(BARC)定义的2～5型出血事件标准]发生情况及其影响因素。方法选取PCI围术期静脉注射比伐芦定抗凝的急性冠脉综合征患者706例,收集年龄、性别、既往病史等临床基线资料和药物应用、手术治疗情况等指标。随访1年,统计出血事件发生例数。根据是否出现出血事件将患者分为出血组与无出血组,比较两组上述收集的资料。应用COX回归分析出血事件的影响因素。结果 PCI围术期静脉注射比伐芦定抗凝的急性冠脉综合征患者1年内出血事件发生率为5. 4%。与无出血组比较,出血组高龄、阿司匹林应用、氯吡格雷应用、替格瑞洛应用、CRUSADE评分> 30分、贫血、急诊PCI、有卒中史、e GFR <60 m L/min患者所占比例高(P均<0. 05)。桡动脉入路、ACEI/ARB应用患者比例低(P均<0. 05)。COX回归分析结果显示,急诊PCI(OR:11. 090,95%CI:4. 191～29. 346,P <0. 01)、高龄(OR:1. 065,95%CI:1. 016～1. 116,P=0. 008)、贫血(OR:2. 502,95%CI:1. 224～5. 111,P=0. 012)是PCI围术期静脉注射比伐芦定抗凝的急性冠脉综合征患者1年内出血事件的独立危险因素。桡动脉入路(OR:0. 262,95%CI:0. 111～0. 621,P=0. 002)、术后应用ACEI/ARB类药物(OR:0. 491,95%CI:0. 248～0. 974,P=0. 042)为PCI围术期静脉注射比伐芦定抗凝的急性冠脉综合征患者1年内出血事件的保护因素。结论PCI围术期静脉注射比伐芦定抗凝的急性冠脉综合征患者1年内出血事件发生率高,其独立危险因素为急诊PCI、高龄、贫血,独立保护因素为桡动脉入路、应用ACEI/ARB类药物。
Objective To investigate the occurrence and influencing factors of bleeding events [type 2-5 defined by the bleeding academic research consortium( BARC) ]in patients with acute coronary syndrome( ACS) who received intravenous bivalirudin injection during perioperative period of percutaneous coronary intervention( PCI). Methods Totally 706 patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI were retrospectively enrolled. The clinical baseline data such as age,sex,past medical history,medication and surgical treatment were collected.They were followed up for 1 year,and the number of bleeding incidents was counted. According to the occurrence of bleeding events,patients were divided into the bleeding group and non-bleeding group,and the data collected above were compared between the two groups. COX regression equation was used to analyze the independent influence factors of bleeding events. Results One-year follow-up showed that the incidence of bleeding events in patients with ACS who received bivalirudin during PCI was 5. 4%. Compared with the non-bleeding group,the proportion of the elderly,aspirin,clopidogrel,ticagrelor,CRUSADE score > 30 points,anemia,primary PCI,stroke history,and e GFR < 60 m L/min in the bleeding group was higher( all P < 0. 05). The proportion of patients using radial artery approach and ACEI/ARB was lower in the bleeding group( P < 0. 05). COX regression analysis showed that the primary PCI( OR: 11. 090,95% CI: 4. 191-29. 346,P < 0. 01),the elderly( OR: 1. 065,95% CI: 1. 016-1. 116,P = 0. 008),anemia( OR: 2. 502,95% CI: 1. 224-5. 111,P = 0. 012) were independent risk factors for 1-year bleeding events in patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI. Trans-radial approach( OR: 0. 262,95% CI: 0. 111-0. 621,P = 0. 002)and ACEI/ARB drugs( OR: 0. 491,95% CI: 0. 248-0. 974,P = 0. 042) were protective factors for 1-year bleeding events in patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI. Conclusion The incidence of bleeding events in patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI is high within 1 year,and its independent risk factors are primary PCI,ageing,and anemia; trans-radial approach and ACEI/ARB drugs are independent protective factors.
Objective To investigate the occurrence and influencing factors of bleeding events [type 2-5 defined by the bleeding academic research consortium( BARC) ]in patients with acute coronary syndrome( ACS) who received intravenous bivalirudin injection during perioperative period of percutaneous coronary intervention( PCI). Methods Totally 706 patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI were retrospectively enrolled. The clinical baseline data such as age,sex,past medical history,medication and surgical treatment were collected.They were followed up for 1 year,and the number of bleeding incidents was counted. According to the occurrence of bleeding events,patients were divided into the bleeding group and non-bleeding group,and the data collected above were compared between the two groups. COX regression equation was used to analyze the independent influence factors of bleeding events. Results One-year follow-up showed that the incidence of bleeding events in patients with ACS who received bivalirudin during PCI was 5. 4%. Compared with the non-bleeding group,the proportion of the elderly,aspirin,clopidogrel,ticagrelor,CRUSADE score > 30 points,anemia,primary PCI,stroke history,and e GFR < 60 m L/min in the bleeding group was higher( all P < 0. 05). The proportion of patients using radial artery approach and ACEI/ARB was lower in the bleeding group( P < 0. 05). COX regression analysis showed that the primary PCI( OR: 11. 090,95% CI: 4. 191-29. 346,P < 0. 01),the elderly( OR: 1. 065,95% CI: 1. 016-1. 116,P = 0. 008),anemia( OR: 2. 502,95% CI: 1. 224-5. 111,P = 0. 012) were independent risk factors for 1-year bleeding events in patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI. Trans-radial approach( OR: 0. 262,95% CI: 0. 111-0. 621,P = 0. 002)and ACEI/ARB drugs( OR: 0. 491,95% CI: 0. 248-0. 974,P = 0. 042) were protective factors for 1-year bleeding events in patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI. Conclusion The incidence of bleeding events in patients with ACS who received intravenous bivalirudin injection during perioperative period of PCI is high within 1 year,and its independent risk factors are primary PCI,ageing,and anemia; trans-radial approach and ACEI/ARB drugs are independent protective factors.
引文
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[8]Han Y,Guo J,Zheng Y,et al. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction:the BRIGHT randomized clinical trial[J]. Jama,2015,313(13):1336.
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[12]Sinnaeve PR,Simes J,Yusuf S,et al. Direct thrombin inhibitors in acute coronary syndromes:effect in patients undergoing early percutaneous coronary intervention[J]. Eur Heart J,2005,26(22):2396.
[13]Pham PA,Pham PT,Pham PC,et al. Implications of bleeding in acute coronary syndrome and percutaneous coronary intervention.[J]. Vasc Health Risk Manag,2011,7:551-567.
[14]徐腊生,韩红彦,任勇,等.比较老年冠心病患者行择期PCI与急诊PCI的有效性及安全性[J].中国循证心血管医学杂志,2017,9(3):365-367.
[15]王贺阳,韩雅玲,李毅,等.冠脉介入治疗围手术期应用比伐芦定的中国急性心肌梗死患者临床显著出血事件独立预测因素分析[J].中华医学杂志,2017,97(5):365-369.
[16]抗血小板药物消化道损伤的预防和治疗中国专家共识组.抗血小板药物消化道损伤的预防和治疗中国专家共识(2012更新版)[J].中华内科杂志,2013,52(3):264-270.
[17]海峡两岸医药卫生交流协会老年医学专业委员会. 75岁以上老年抗栓治疗专家共识[J].中国循环杂志,2017,32(6):531-538.
[18] Moscucci M,Fox KA,Cannon CP,et al. Predictors of major bleeding in acute coronary syndromes:the Global Registry of Acute Coronary Events(GRACE)[J]. Eur Heart J,2003,24(20):1815-1823.
[19] Nikolsky E,Aymong ED,Halkin A,et al. Impact of anemia in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention:analysis from the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications(CADILLAC)Trial[J]. J Am Coll Cardiol,2004,44(3):547-553.
[20]Voeltz MD,Patel AD,Feit F,et al. Effect of anemia on hemorrhagic complications and mortality following percutaneous coronary intervention[J]. Am J Cardiol,2007,99(11):1513-1517.
[21]Wang XY,Qiu MH,Qi J,et al. Impact of anemia on long-term ischemic events and bleeding events in patients undergoing percutaneous coronary intervention:a system review and meta-analysis[J]. J Thorac Dis,2015,7(11):2041-2052.
[22]Dündar C,Oduncu V,Erkol A,et al. In-hospital prognostic value of hemoglobin levels on admission in patients with acute ST segment elevation myocardial infarction undergoing primary angioplasty[J]. Clin Res Cardiol,2012,101(1):37-44.
[23] Karrowni W,Vora AN,Dai D,et al. Blood transfusion and the risk of acute kidney injury among patients with acute coronary syndrome undergoing percutaneous coronary intervention[J]. Circ Cardiovasc Interv,2016,9(9):e003279.
[24]Mamas MA,Anderson SG,Ratib K,et al. Arterial access site utilization in cardiogenic shock in the United Kingdom:is radial access feasible[J]. Am Heart J,2014,167(6):900-908. e1.
[25]Neumann FJ,Sousa-Uva M,Ahlsson A,et al. 2018 ESC/EACTS guidelines on myocardial revascularization[J]. Eur Heart J,2019,40(2):87-165.
[26]Group PC. Randomised trial of a perindopril-based blood-pressurelowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack[J]. Lancet,2001,358:1033-1041.
[27]Ng VG,Baumbach A,Grinfeld L,et al. Impact of bleeding and bivalirudin therapy on mortality risk in women undergoing percutaneous coronary intervention(from the REPLACE-2,ACUITY,and HORIZONS-AMI Trials)[J]. Am J Cardiol,2016,117(2):186-191.
[2]Abbate R,Cioni G,Ricci I,et al. Thrombosis and acute coronary syndrome[J]. Thromb Res,2012,129(3):235-240.
[3]Eisen A,Giugliano RP,Braunwald E. Updates on acute coronary syndrome:a review[J]. JAMA Cardiol,2016,1(6):718-730.
[4]王小东,刘学波.经皮冠状动脉介入治疗围术期抗凝药物应用研究进展[J].中国介入心脏病学杂志,2014,22(11):729-731.
[5]Manoukian SV,Feit F,Mehran R,et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes:an analysis from the ACUITY trial[J]. J Am Coll Cardiol,2007,49(12):1362-1368.
[6]Stone GW,Witzenbichler B,Guagliumi G,et al. Heparin plus a glycoproteinⅡb/Ⅲa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction(HORIZONS-AMI):final 3-year results from a multicentre, randomised controlled trial[J]. Lancet, 2011,377(9784):2193-2204.
[7]Steg PG,van't Hof A,Hamm CW,et al. Bivalirudin started during emergency transport for primary PCI[J]. N Engl J Med,2013,369(23):2207-2217.
[8]Han Y,Guo J,Zheng Y,et al. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction:the BRIGHT randomized clinical trial[J]. Jama,2015,313(13):1336.
[9]Valgimigli M,Frigoli E,Leonardi S,et al. Bivalirudin or unfractionated heparin in acute coronary syndromes[J]. N Engl J Med,2015,373(11):997-1009.
[10]韩雅玲,陈韵岱,姜铁民,等.经皮冠状动脉介入治疗围术期应用比伐芦定多中心、大样本回顾性研究[J].中华心血管病杂志,2016,44(2):121-127.
[11]Mehran R,Rao SV,Bhatt DL,et al. Standardized bleeding definitions for cardiovascular clinical trials[J]. Circulation,2011,123(23):2736-2747.
[12]Sinnaeve PR,Simes J,Yusuf S,et al. Direct thrombin inhibitors in acute coronary syndromes:effect in patients undergoing early percutaneous coronary intervention[J]. Eur Heart J,2005,26(22):2396.
[13]Pham PA,Pham PT,Pham PC,et al. Implications of bleeding in acute coronary syndrome and percutaneous coronary intervention.[J]. Vasc Health Risk Manag,2011,7:551-567.
[14]徐腊生,韩红彦,任勇,等.比较老年冠心病患者行择期PCI与急诊PCI的有效性及安全性[J].中国循证心血管医学杂志,2017,9(3):365-367.
[15]王贺阳,韩雅玲,李毅,等.冠脉介入治疗围手术期应用比伐芦定的中国急性心肌梗死患者临床显著出血事件独立预测因素分析[J].中华医学杂志,2017,97(5):365-369.
[16]抗血小板药物消化道损伤的预防和治疗中国专家共识组.抗血小板药物消化道损伤的预防和治疗中国专家共识(2012更新版)[J].中华内科杂志,2013,52(3):264-270.
[17]海峡两岸医药卫生交流协会老年医学专业委员会. 75岁以上老年抗栓治疗专家共识[J].中国循环杂志,2017,32(6):531-538.
[18] Moscucci M,Fox KA,Cannon CP,et al. Predictors of major bleeding in acute coronary syndromes:the Global Registry of Acute Coronary Events(GRACE)[J]. Eur Heart J,2003,24(20):1815-1823.
[19] Nikolsky E,Aymong ED,Halkin A,et al. Impact of anemia in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention:analysis from the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications(CADILLAC)Trial[J]. J Am Coll Cardiol,2004,44(3):547-553.
[20]Voeltz MD,Patel AD,Feit F,et al. Effect of anemia on hemorrhagic complications and mortality following percutaneous coronary intervention[J]. Am J Cardiol,2007,99(11):1513-1517.
[21]Wang XY,Qiu MH,Qi J,et al. Impact of anemia on long-term ischemic events and bleeding events in patients undergoing percutaneous coronary intervention:a system review and meta-analysis[J]. J Thorac Dis,2015,7(11):2041-2052.
[22]Dündar C,Oduncu V,Erkol A,et al. In-hospital prognostic value of hemoglobin levels on admission in patients with acute ST segment elevation myocardial infarction undergoing primary angioplasty[J]. Clin Res Cardiol,2012,101(1):37-44.
[23] Karrowni W,Vora AN,Dai D,et al. Blood transfusion and the risk of acute kidney injury among patients with acute coronary syndrome undergoing percutaneous coronary intervention[J]. Circ Cardiovasc Interv,2016,9(9):e003279.
[24]Mamas MA,Anderson SG,Ratib K,et al. Arterial access site utilization in cardiogenic shock in the United Kingdom:is radial access feasible[J]. Am Heart J,2014,167(6):900-908. e1.
[25]Neumann FJ,Sousa-Uva M,Ahlsson A,et al. 2018 ESC/EACTS guidelines on myocardial revascularization[J]. Eur Heart J,2019,40(2):87-165.
[26]Group PC. Randomised trial of a perindopril-based blood-pressurelowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack[J]. Lancet,2001,358:1033-1041.
[27]Ng VG,Baumbach A,Grinfeld L,et al. Impact of bleeding and bivalirudin therapy on mortality risk in women undergoing percutaneous coronary intervention(from the REPLACE-2,ACUITY,and HORIZONS-AMI Trials)[J]. Am J Cardiol,2016,117(2):186-191.