常规急诊及尿激酶溶栓失败后补救性冠脉介入治疗急性心肌梗死的疗效

目的:评价急性ST段抬高型心肌梗死(STEMI)常规急诊及尿激酶溶栓失败后行补救性经皮冠状动脉介入治疗(PCI)的近期疗效及安全性。方法:回顾分析2006年6月～2009年12月在我院因急性STEMI而行急诊PCI术的134例患者的基本资料(包括溶栓失败行急诊补救性PCI患者),及其术后30d内的主要终点事件(包括全因死亡、再梗死)以及严重出血性并发症的发生情况。结果:急诊PCI术患者共计134例,其中17例(12.68%)因外院尿激酶溶栓失败转入我院行补救性PCI。134例中30d内共7例(5.22%)发生主要终点事件,死亡6例(4.48%)。多因素Logistic分析显示冠状动脉TIMI血流≤1级和主要终点事件明显相关(OR=60.98,P<0.05)。3例(2.24%)发生严重出血性并发症。单因素Logistic分析显示补救性PCI术与严重出血并发病无显著相关(P>0.05)。结论:急性ST段抬高型心肌梗死尿激酶溶栓失败后行补救性经皮冠状动脉介入治疗安全、有效。     

STEMI患者急诊PCI术中在ACT监测下应用比伐芦定或肝素的安全性及其影响因素分析

目的探讨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)中在全血活化凝血时间(ACT)监测下应用比伐芦定或肝素的安全性及其影响因素。方法选择2019年9月至2020年2月就诊于安徽医科大学阜阳临床学院的160例急性STEMI患者,采用随机数字表法将其分为观察组(监测ACT组)和对照组(不监测ACT组),每组随机分为比伐芦定亚组和肝素亚组。比较观察组和对照组术后30 d内发生出血和支架内血栓事件的差异有无统计学意义。将单因素分析中差异有统计学意义的因素进行多因素Logistic回归分析,分析STEMI患者急诊PCI术后30 d内发生出血事件的独立影响因素。结果观察组术后30 d内发生出血事件少于对照组(P=0.005)。多因素Logistic回归分析表明,肌酐清除率降低(OR=11.090,95%CI:3.160～38.923)、女性(OR=3.355,95%CI:1.045～10.778)和2型糖尿病(OR=3.373,95%CI:1.068～10.652)是STEMI患者急诊PCI术后30 d内发生出血事件的独立影响因素。结论 STEMI患者急诊PCI术中在ACT监测下应用比伐芦定或肝素术后30 d内发生出血事件的风险降低。肌酐清除率降低、女性和2型糖尿病是接受急诊PCI的STEMI患者发生出血事件的独立影响因素。     

急性冠状动脉综合征PCI围术期应用比伐芦定后30天内出血事件独立预测因素分析

目的:分析经皮冠状动脉介入(PCI)围术期应用比伐芦定的急性冠状动脉综合征患者30 d内出血事件发生情况及其独立预测因素。方法:连续入选天津市胸科医院2016-05-2017-10期间PCI术中应用比伐芦定的冠心病患者706例,应用普通肝素患者710例。随访30 d,统计出血事件。根据出血与否将比伐芦定组患者分为出血组与无出血组,比较两组患者临床资料。应用Logistic回归方程分析30 d内出血事件的独立预测因素。结果:30 d内出血事件发生率比伐芦定组与普通肝素组相似(2.3%∶3.4%,P0.05),但比伐芦定组患者CRUSADE评分,合并糖尿病、高血压、贫血、中重度肾功能不全、心肌梗死病史、PCI病史、消化道出血病史比例明显高于普通肝素组(P0.05)。Logistic回归分析显示,女性(OR:8.954,95%CI:1.885～42.528,P=0.006)、贫血(OR:4.746,95%CI:1.407～16.000,P=0.012)是比伐芦定组患者30 d内出血事件的独立危险因素。结论:PCI围术期应用比伐芦定抗凝治疗30 d内出血事件发生率较低,特别是在具有较高出血风险患者中。女性、贫血是PCI围术期应用比伐芦定患者30 d内出血事件的独立危险因素。     

比伐芦定在急性ST段抬高型心肌梗死患者急诊经皮冠状动脉介入治疗术中应用的疗效观察

目的:观察比伐芦定在急性ST段抬高型心肌梗死(STEMI)患者急诊经皮冠状动脉(冠脉)介入治疗(PCI)术中应用的有效性及安全性。方法:选择2011-09至2014-01期间因急性STEMI就诊于我院并行急诊PCI术的患者159例,根据术中是否使用比伐芦定随机分为两组:比伐芦定组及肝素组。术中血小板糖蛋白Ⅱb/Ⅲa受体拮抗剂(GPI)即替罗非班的应用由术者评估患者病情特点决定是否合并应用。分析两组一般情况、冠脉影像特点等一系列基线资料,并对两组围手术期及术后30 d内的出血及主要心血管不良事件(MACE)的发生情况进行随访统计,分析比较其中差异。结果:在最终完成研究的153例样本中,比伐芦定组(n=72)与肝素组(n=81)比较,围手术期出血事件发生率6.5%比11.0%、支架内血栓事件发生率0%比1.2%以及术后30 d内的出血事件发生率9.7%比13.5%、MACE发生率1.4%比7.4%均有所下降,但两组差异均无统计学意义(P均0.05)。结论:比伐芦定应用于急性STEMI患者急诊PCI术中是安全有效的,且其具有降低出血及MACE发生率的趋势。     

比伐芦定在急性冠脉综合征患者PCI围术期的有效性及安全性

目的 探索比伐芦定在急性冠脉综合征（ACS）患者接受经皮冠状动脉介入（PCI）治疗围术期应用的有效性及安全性。 方法 收集2018年1月～2020年6月收治的接受PCI治疗且术前应用阿司匹林与替格瑞洛作为双联抗血小板治疗的ACS患者309例,根据围术期应用的抗凝方案分为比伐芦定组和肝素联用血小板糖蛋白Ⅱb/Ⅲa受体抑制剂（GPI）组（肝素GPI组）,分别收集到58例和251例。进行1:1比例的倾向性评分匹配（两组均n=50）,通过门诊及电话随访统计终点事件发生情况。主要终点为术后30 d净不良临床事件（NACE）发生率,定义为包括符合美国出血学术研究联合会出血标准（BARC）的全部出血和主要不良心脑血管事件（MACCE）,即包括各种原因引起死亡、紧急的靶罪犯血管需行再次血运重建（uTVR）、心肌梗死、卒中的复合终点。次要终点为术后30 d和6月内的MACCE事件及全部出血,以及术后6月内的NACE。 结果 两组术后30 d的NACE事件、MACCE事件、全部出血事件以及术后6月发生的NACE事件、MACCE事件及全部出血的发生率差异均无统计学意义。两组术后30 d发生符合BARC（3~5）型出血事件的发生率差异无统计学意义。其中在CRUSADE评分>30分的中-高危出血风险的人群中应用比伐芦定可以降低PCI术后30 d的NACE事件发生率（P<0.05）（比伐芦定组与肝素GPI组的NACE事件发生率分别为 0 %与 6.0%）。 结论 ①比伐芦定在给予替格瑞洛的ACS患者PCI围术期时应用具有有效的抗栓作用且不增加临床大出血风险;②应用比伐芦定可以降低CRUSADE评分>30分的中-高危出血风险患者术后30 d发生NACE事件的风险。     

比伐芦定对行经皮冠状动脉介入治疗急性冠状动脉综合征患者冠状动脉微循环的影响及短期预后评价

目的 比较经皮冠状动脉介入治疗（PCI）中应用比伐芦定与普通肝素对急性冠状动脉综合征（ACS）患者冠状动脉微循环的影响及预后。方法 回顾性分析2020年1月至2023年3月在新疆医科大学附属中医医院急诊或住院接受PCI的312例ACS患者,分析一般临床资料,根据患者围术期的不同抗凝方案,分为比伐芦定组153例,普通肝素组159例,观察比较两组术后心肌梗死溶栓治疗试验（TIMI）血流分级、TIMI心肌灌注分级（TMPG）、心电图ST段回落率（STR）、心绞痛发作次数、术后7d内不良事件发生率、术后3个月内主要不良心血管事件（MACE）发生率和出血事件发生率。结果 两组患者的一般临床资料及介入术中情况比较,差异均无统计学意义（均P>0.05）。两组患者PCI术后TIMI血流分级差异无统计学意义（P=0.959）,但PCI术后TMPG、心绞痛发作次数、心电图STR比较,差异均有统计学意义（均P<0.05）。两组患者PCI术后7 d内不良事件发生率、PCI术后3个月内MACE的总发生率、PCI术后3个月内出血事件发生率比较,差异均无统计学意义（均P>0.05）。结论 比伐芦定...     

提前应用比伐芦定在直接经皮冠状动脉介入治疗中的疗效与安全性研究

目的:探究急诊介入术前提前应用比伐芦定与常规用药相比在直接经皮冠状动脉介入(PCI)治疗中的疗效及安全性。方法:回顾性分析103例接受直接PCI的急性ST段抬高型心肌梗死(STEMI)患者,分为提前比伐芦定组(治疗组,49例)和常规比伐芦定组(对照组,54例)。所有患者在发病12 h内行急诊PCI术。治疗组在患者及家属同意行急诊PCI时即给予比伐芦定治疗,首先静脉给予比伐芦定负荷量(0.75 mg/kg),然后以1.75 mg·kg~(-1)·h~(-1)持续静脉泵入至术后4 h。对照组在急诊PCI进入导管室穿刺时给予比伐芦定,给药方案同治疗组。观察2组患者造影时罪犯血管血流TIMI分级,校正的TIMI血流帧数计数,出血发生率,术后及随访6个月时死亡、非致死性心肌梗死、靶血管再次血运重建、支架血栓、心功能分级、左室射血分数、出血事件发生率。结果:治疗组冠状动脉(冠脉)造影所见罪犯血管TIMI血流分级优于对照组,0级血流比例低于对照组(44.9%∶74.1%,P0.05),术后血流帧数优于对照组[(31.4±8.9)帧∶(43.6±9.2)帧,P0.05]。2组出血事件发生率与随访6个月时死亡、非致死性心肌梗死、靶血管再次血运重建、心功能分级及左室射血分数均差异无统计学意义。结论:术前及早应用比伐芦定可改善未能尽早行PCI的急性STEMI患者的冠脉血流与心肌灌注,从而部分抵消因PCI延迟导致的心功能、左室射血分数下降及其他不良事件的发生,且不增加出血事件发生率。     

比伐芦定在高出血风险患者介入治疗中抗凝疗效和安全性评价

目的：评价比伐芦定在高出血风险急性冠脉综合征（ACS）患者介入治疗中抗凝疗效和安全性。 方法：随机将入选的ACS患者分为比伐芦定组（104例）和肝素组（102例）,PCI术中分别采用比伐芦定和普通肝素进行抗凝治疗,并根据术中冠脉病变情况决定是否联用血小板糖蛋白IIb/IIIa拮抗剂(glycoprotein IIb/IIIa inhibitor, GPI)。比较两组间一般情况及PCI相关资料,并对两组30天内的出血、支架血栓事件及主要不良心血管事件（MACE）进行统计分析。 结果：两组间支架血栓事件及MACE发生率无显著性差异（P>0,05）, 比伐芦定组出血发生率显著降低（P<0.05）,其中以轻度出血发生率减少更为显著,严重出血方面两组间无统计学性差异（1.9% vs2.9%,P>0.05）,但比伐芦定组有较低的严重出血风险趋势。 结论：比伐芦定在高出血风险的ACS患者的PCI治疗中抗凝治疗是安全有效的,并降低出血风险。     

比伐芦定联合替格瑞洛对老年STEMI患者PCI治疗的疗效及安全性分析

目的:观察比伐芦定联合替格瑞洛对老年ST段抬高型心肌梗死(STEMI)患者行经皮冠脉介入治疗(PCI)的疗效及安全性。方法:2017年1月至2018年11月在我院急诊行PCI治疗的STEMI患者134例被随机均分为对照组(接受普通肝素和替罗非班)和观察组(接受替格瑞洛和比伐芦定),两组均在造影前口服阿司匹林的基础上接受相应药物治疗。观察比较两组术后TIMI血流分级、术后72h内出血情况和术后30d内主要不良心血管事件(MACE)发生情况。结果:与对照组比较,观察组PCI术后梗死相关动脉TIMI血流3级比例(65.7%比82.1%)显著升高,术后72h内出血发生率(22.4%比9.0%)和术后30d内MACE发生率(23.9%比10.5%)显著降低,P均0.05。结论:比伐芦定联合替格瑞洛可以显著改善老年STEMI患者PCI术后冠脉血流,且出血事件和主要不良心血管发生率低,值得推广。     

比伐卢定在高龄急性ST段抬高型心肌梗死患者经皮冠状动脉介入治疗中的疗效观察

目的:观察在年龄70岁的急性ST段抬高型心肌梗死(STEMI)患者经皮冠状动脉介入治疗(PCI)术中应用比伐卢定抗凝的安全性及疗效。方法:采用回顾性病例对照研究,收集2016-01-2017-01因急性STEMI就诊于我院并行急诊PCI术且年龄70岁的患者共136例,根据术中基础抗凝药物的应用分为两组:比伐卢定组66例及普通肝素组70例。主要观察住院期间及术后30d内的出血及主要心血管不良事件(MACE)。结果:两组患者在年龄、性别、高血压、糖尿病、术中联合使用血小板糖蛋白Ⅱb/Ⅲa受体拮抗剂(GPI)等方面无统计学差异。普通肝素组患者术后依诺肝素和磺达肝癸钠使用概率明显大于比伐卢定组(P0.05)。与普通肝素组比较,比伐卢定组术后30d内总体出血事件发生率(5.7%︰3.0%)、支架内血栓事件发生率(1.4%︰0)及MACE发生率(8.6%︰3.0%)均有降低,但两组差异无统计学意义。结论:高龄急性STEMI患者急诊PCI术中抗凝治疗应用比伐卢定与普通肝素相比,出血及MACE事件发生率无明显差异,比伐卢定抗凝治疗安全有效。     

比伐芦定在冠状动脉慢性完全闭塞病变经皮冠状动脉介入治疗围术期应用中的有效性和安全性临床观察

目的评估冠状动脉慢性完全闭塞(CTO)病变患者经皮冠状动脉介入治疗(PCI)围术期应用比伐芦定的有效性和安全性。方法选取2018年5月24日至2019年3月12日在北京阜外医院住院并行CTO-PCI患者78例。根据术中使用抗凝药物情况将患者分为比伐芦定组(39例)和普通肝素组(39例)。观察比较两组术后主要不良心血管事件(MACE)和总出血及并发症事件的发生情况。结果比伐芦定组与普通肝素组围术期心肌损伤发生率(2.6%比5.1%,P=0.556)、围术期心肌梗死发生率(15.4%比10.3%,P=0.498)比较,差异均无统计学意义。两组患者在全因死亡、心脏死亡、计划外的血运重建、缺血事件上均未见不良事件,差异均无统计学意义(均P>0.05)。比伐芦定组与普通肝素组出血学术研究联合会分型(BARC)1型出血事件发生率(12.8%比10.3%,P=0.723)、BARC 2型出血事件发生率(2.6%比0,P>0.999)比较,差异均无统计学意义。两组患者均未发生BARC 3~5型严重出血事件。两组患者冠状动脉穿孔发生率(0比2.6%,P>0.999)比较,差异无统计学意义。结论与常规应用肝素抗凝治疗比较,比伐芦定在CTO-PCI中的应用是安全和有效的,在出血高风险患者中应用能否获益仍需较大样本的研究进一步证实。     

国产比伐卢定在老年急性冠脉综合征患者介入术中治疗效果

目的 研究老年（年龄>65岁）急性冠脉综合征（ACS）患者在经皮冠脉介入（PCI）治疗术中使用国产比伐卢定的安全和有效性。方法 本研究通过回顾性分析我院35例PCI术中应用比伐卢定的老年ACS患者的临床资料,按1∶1匹配选取同期35例PCI治疗过程中常规应用普通肝素的老年ACS患者作为对照组,分析术后30 d内的主要不良心脑血管事件(major adverse cardiac and cerebrovascular events,MACCE)及出血并发症的发生情况。结果 两组临床资料对比,差异无统计学意义。术后30 d内MACCE发生率分别为4例（11%）和5例（14%）,差异无统计学意义;出血并发症发生率分别为1例（3%）和6例（17%）,比伐卢定组优于普通肝素组（P<0.05）。结论 老年ACS患者PCI术中使用比伐卢定与普通肝素相比,可减少术后30d内的出血事件发生率,且不增加MACCE的风险。     

Novel Approaches for Preventing or Limiting Events (Naples) III Trial: Randomized Comparison of Bivalirudin Versus Unfractionated Heparin in Patients at Increased Risk of Bleeding Undergoing Transfemoral Elective Coronary Stenting

ObjectivesThis study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI).BackgroundBivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI.MethodsThis is a single-center, investigator-initiated, randomized, double-blind, controlled trial. Consecutive biomarker-negative patients at increased bleeding risk undergoing PCI through the femoral approach were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n = 418). The primary endpoint was the rate of in-hospital major bleeding.ResultsThe primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and non–access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in the bivalirudin group (p = 0.10).ConclusionsThe results of this randomized study, carried out at a single institution, suggest that there is no difference in major bleeding rate between bivalirudin and UFH in increased-risk patients undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503)     

国产比伐卢定在急诊介入治疗中对血小板功能的影响

目的：探讨国产比伐卢定在急诊经皮冠状动脉介入治疗（PCI）中对血小板功能的影响。方法：100例急性ST段抬高性心肌梗死接受急诊PCI的患者随机分为肝素组（53例）和比伐卢定组（47例）。检测两组 PCI术前后二磷酸腺苷（ADP）诱导的血小板聚集率,并进行统计学比较。结果：急诊PCI术前,两组 ADP诱导的血小板凝聚率差异无统计学意义（ P＝0.99）。急诊 PCI术后,比伐卢定组 ADP 诱导的血小板凝聚率显著低于肝素组[（16.46±10.23）％比（25.21±15.91）％, P＜0.01]。结论：PCI术中,与常规肝素抗凝相比,作为抗凝剂的比伐卢定可以更明显抑制血小板凝聚,具有抗血小板的功能。     

Bleeding risk and outcomes of Bivalirudin versus Glycoprotein IIb/IIIa inhibitors with targeted low-dose unfractionated Heparin in patients having percutaneous coronary intervention for either stable or unstable angina pectoris

For patients undergoing elective percutaneous coronary intervention (PCI), procedural anticoagulation with bivalirudin was previously shown to significantly reduce bleeding complications at the cost of a modest increase in ischemic events compared with unfractionated heparin (UFH) and glycoprotein IIb/IIIa inhibitors (GPIs). However, the excess bleeding in patients treated with UFH and GPIs may have been caused by excessively high UFH doses and increased activated clotting times. This study sought to determine the bleeding risk of targeted low-dose UFH with GPIs compared with bivalirudin in patients undergoing elective PCI. Of 1,205 patients undergoing elective PCI, 602 underwent PCI with adjunctive UFH and GPIs with the UFH dose targeted to an activated clotting time of approximately 250 seconds, and 603 patients matched for baseline characteristics underwent PCI with bivalirudin. Outcomes were analyzed for major bleeding (hematocrit decrease >15%, gastrointestinal bleed, or major hematoma) and 6-month major adverse cardiac events (death, myocardial infarction, and target-lesion revascularization). The maximum activated clotting time achieved was 261.7 +/- 61.6 seconds in the UFH/GPI group and 355.4 +/- 66.6 in the bivalirudin group (p <0.001). In-hospital major bleeding rates were similar between groups (1.8% UFH/GPI vs 1.7% bivalirudin; p = 0.83), as were transfusion requirements (1.2% UFH/GPI vs 0.5% bivalirudin; p = 0.61). The 6-month major adverse cardiac event rate was also similar between groups (9.5% UFH/GPI vs 9.0% bivalirudin; p = 0.81). In conclusion, there were no significant differences in major bleeding and 6-month major adverse cardiac events for patients undergoing elective PCI treated with targeted low-dose UFH and GPIs compared with those treated with bivalirudin.     

Bivalirudin versus unfractionated heparin in patients undergoing percutaneous coronary intervention after acute myocardial infarction.

BACKGROUND: Bivalirudin is replacing heparin as the anticoagulant agent of choice for elective percutaneous coronary intervention (PCI). This study aimed to assess the safety and clinical outcomes of bivalirudin versus unfractionated heparin (UFH) in patients undergoing PCI for acute myocardial infarction (AMI). METHODS: A cohort of 672 consecutive patients presenting with AMI without prior thrombolytic therapy were treated with either bivalirudin (216 patients) or UFH (456 patients). Platelet glycoprotein IIb/IIIa inhibitors were administered at the operator's discretion. The in-hospital, 30-day, and 6-month outcomes of the two groups were compared. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. In-hospital complications were similar, although there was a trend of a less major hematocrit drop in the bivalirudin group (0.9% vs. 3.1%, P=.09). All clinical outcomes were similar between the groups at 30-day and 6-month follow-ups. There was no statistical significance for acute thrombosis and subacute thrombosis between the groups, and there was no late thrombosis from either group. The event-free survival rate was similar between the groups (P=.41). CONCLUSION: The use of bivalirudin in patients undergoing PCI after AMI is safe and feasible. Bivalirudin should be considered as an alternative anticoagulant agent during PCI to treat patients presenting with AMI.     

Bivalirudin in PCI: an overview of the REPLACE-2 trial

The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial is one of the largest acute randomized controlled trials evaluating the efficacy of two anticoagulant strategies during contemporary urgent or elective percutaneous coronary intervention (PCI). The direct thrombin inhibitor, bivalirudin, with provisional use of glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitor was compared to low-dose unfractionated heparin (UFH) plus planned GP IIb/IIIa inhibitor. At 30-day follow-up, the primary quadruple composite endpoint (death, myocardial infarction (MI), urgent repeat revascularization, or in-hospital major bleeding) occurred in 9.2% of patients in the bivalirudin group versus 10.0% of patients in the UFH plus GP IIb/IIIa inhibitor group. The secondary triple composite endpoint (death, MI, urgent repeat revascularization) occurred in 7.6% of patients in the bivalirudin group compared with 7.1% of patients in the UFH plus GP IIb/IIIa inhibitor group. Both endpoints met formal statistical criteria for noninferiority to UFH plus GP IIb/IIIa inhibitor. By imputed comparison from historic GP IIb/IIIa trials between bivalirudin versus UFH alone, REPLACE-2 demonstrated that bivalirudin was superior to UFH alone with respect to the quadruple and triple composite endpoints. Furthermore, bivalirudin plus provisional GP IIb/IIIa blockade was associated with a significant reduction in in-hospital bleeding (2.4% vs. 4.1%; p < 0.001). At 6 months' follow-up, there was no significant difference in rates of death, MI, or revascularization between the two groups. Furthermore, there was no evidence that the early, nonsignificant 0.5% excess non-Q-wave MI in the bivalirudin group translated into later mortality. There was a trend toward decreased mortality at 6 months in the bivalirudin arm (0.95% vs. 1.35%; p = 0.148). The relative efficacy of bivalirudin versus UFH plus GP IIb/IIIa inhibitor was similar in several high-risk subgroups, including patients with diabetes mellitus or prior MI, women, the elderly (age > 65 years), and patients undergoing PCI of bypass grafts. Bivalirudin represents an exciting alternative to UFH plus GP IIb/IIIa inhibitor in patients undergoing urgent and elective PCI with similar suppression of ischemic events, fewer bleeding complications, and the potential for greater cost savings and ease of administration.     

Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in high-risk patients undergoing percutaneous coronary intervention (from the Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin study)

Bivalirudin, a direct thrombin inhibitor, is as effective as unfractionated heparin (UFH), with decreased bleeding in patients with acute coronary syndromes who undergo percutaneous coronary intervention (PCI). The aim of this study was to evaluate the effectiveness of bivalirudin versus UFH in selected PCI patients at high bleeding risk. Four hundred one consecutive patients who underwent PCI fulfilling ≥ 1 enrollment criterion (age >75 years, chronic renal failure, and diabetes mellitus) were randomized to bivalirudin (bolus 0.75 mg/kg followed by infusion during the procedure; n = 198) or UFH (75 IU/kg; n = 203). In the overall population, 39% were aged >75 years, 22% had renal failure, 63% had diabetes, and 29% had acute coronary syndromes. The primary efficacy end point was the 30-day incidence of major adverse cardiac events (cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization). The primary safety end point was the occurrence of any bleeding or entry-site complications after PCI. All patients were preloaded with clopidogrel 600 mg. Glycoprotein IIb/IIIa inhibitors were used at the operators' discretion. Thirty-day major adverse cardiac event rates were 11.1% in the bivalirudin group and 8.9% in the UFH group (p = 0.56); the primary efficacy end point was reached mainly because of periprocedural myocardial infarction; 1 patient in the bivalirudin group had stent thrombosis. Occurrence of the primary safety end point was 1.5% in the bivalirudin group and 9.9% in the UFH group (p = 0.0001); this benefit was essentially driven by the prevention of entry-site hematomas >10 cm (0.5% vs 6.9%, p = 0.002). In conclusion, Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin (ARMYDA-7 BIVALVE) indicates that bivalirudin, compared with UFH, causes significantly lower bleeding and has a similar incidence of major adverse cardiac events in patients with older age, diabetes mellitus, or chronic renal failure who undergo PCI.     

The impact of unfractionated heparin or bivalirudin on patients with stable coronary artery disease undergoing percutaneous coronary intervention

Objectives

To compare bleeding and clinical events of patients with stable angina or silent ischemia undergoing percutaneous coronary intervention (PCI) treated with unfractionated heparin (UFH) or bivalirudin.

Background

Few direct comparisons between UFH monotherapy versus bivalirudin exist for patients with stable ischemic heart disease undergoing PCI.

Methods

A prospective, investigator‐initiated, single‐center, single‐blinded, randomized trial of UFH versus bivalirudin was conducted. The primary endpoint was all bleeding (major and minor) from index‐hospitalization to 30 days post discharge. Secondary endpoints included major adverse cerebral and cardiovascular events (MACCE) and net adverse clinical events (NACE).

Results

Two‐hundred‐sixty patients were randomized for treatment with either UFH (n = 123) (47%) or bivalirudin (n = 137) (53%) There were no significant differences in baseline clinical and angiographic characteristics between the two groups. Primary endpoint was similar in both groups (10.9% with bivalirudin vs 7.3% with UFH [P = 0.31]). Major bleeding rates were 5.8% and 2.4%, respectively (P = 0.17). There was a higher MACCE (3.5% vs 0%, P = 0.03) and NACE (8.8% vs 2.4%, P = 0.03) rate with bivalirudin compared to UFH, respectively. Bivalirudin had increased odds of NACE (OR = 3.65, 95% CI: 1.00‐13.3.6). Death and stent thrombosis rates were low and similar in both groups. Radial access was associated with fewer bleeding events compared to femoral access but not statistically significant (P = 0.29).

Conclusions

Among patients with stable angina or silent ischemia, there was no difference between UFH and bivalirudin in bleeding rates up to 30‐days post‐PCI. MACCE and NACE were higher among the bivalirudin group. Radial access was associated with a numerically lower rate of bleeding compared with femoral access.