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【ACC热点】比伐卢定vs低分子肝素：没有更多获益但可减少出血
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ISAR-REACT 3: No clinical benefit but reduction in bleeding with bivalirudin versus UFH on optimal antiplatelet backdrop30 March 2008MedWire News: Anticoagulation treatment with the direct thrombin inhibitor (DTI) bivalirudin reduces bleeding rates but does not improve clinical outcomes in comparison with unfractionated heparin (UFH) in low-to-intermediate risk patients undergoing percutaneous coronary intervention (PCI) with optimal clopidogrel pretreatment, results of the ISAR-REACT-3 trial indicate. Previous studies have shown that bivalirudin treatment during angioplasty and coronary stenting is associated with better outcomes compared with UFH and adjunctive glycoprotein (GP) IIb/IIIa inhibitors, but these were not done on a backdrop of optimal antiplatelet therapy. To investigate further, Adnan Kastrati (Deutsches Herzzentrum and Technical University, Munich, Germany) and colleagues conducted the double-blind, controlled ISAR-REACT-3 trial, in which they randomly assigned 4570 coronary artery disease patients without troponin T elevation undergoing PCI to receive bivalirudin (n=1189) or unfractionated heparin (n=2281). All patients received 600 mg clopidogrel and =325 mg aspirin at least 2 hours before the procedure. Bivalirudin was given as an intravenous (iv) bolus at 0.75 mg/kg prior to PCI, followed by continuous iv infusion during the procedure at 1.75 mg/kg/hour. Patients in the UFH arm received UFH as an iv bolus of 0.75 units/kg followed by a continuous infusion of placebo for the duration of the procedure. The results were presented by Kastrati at the American College of Cardiology Scientific Sessions, being held in Chicago, Illinois. The primary composite endpoint comprising death, myocardial infarction (MI), urgent target vessel revascularization (UTVR), or in-hospital major bleeding at 30 days was similar between treatment groups, at 8.3% in the bivalirudin arm compared with 8.7% in the UFH arm, giving a relative risk of 0.94. Rates of the primary endpoint components death, MI, and UTVR were 0.1 and 0.2%, 5.6 and 4.8%, and 0.8 and 0.7% among patients who received bivalirudin versus those given UFH, respectively. The secondary composite endpoint of death, MI, and UTVR at 30 days was also similar between groups, at 5.9 and 5.0% among bivalirudin- versus UFH-treated patients, giving a relative risk of 1.16. In contrast, rates of major and minor bleeding at 30 days were significantly lower among patients who received bivalirudin than among those given UFH, at 3.1 versus 4.6% (p=0.008) and 6.8 versus 9.9% (p=0.0001), respectively, for the prespecified trial definition of bleeding used in the earlier REPLACE trial. The difference in major bleeding translated into a 33% lower relative risk with bivalirudin. The reduction in both major and minor bleeding with bivalirudin held true when the results were analyzed according to Thombolysis in MI (TIMI) bleeding definitions. Thrombocytopenia rates were similar between groups. Kastrati cautioned that the dose of UFH used is higher than has been used in recent US PCI trials. He said: “Whether and to what degree this affected outcome cannot be determined.” Commentator on the trial Harvey White (Green Lane Hospital, Auckland, New Zealand) emphasized that the reduction in bleeding with bivalirudin is clinically relevant. He noted: “Interestingly and strikingly, in my view, TIMI major bleeding was reduced by 50%, with a marginal p value of 0.04.” White noted that the bleeding rate with UFH was low in the trial, despite the relatively high dose. He compared it with the higher rate of major bleeding of 8.5% seen in STEEPLE, in which elective patients received the current US-recommended 70 units/kg UFH dose, guided by activated clotting time. White said: “I think the real question in a low-risk ischemic group is: Does bivalirudin reduce bleeding? And I think this should have been the primary endpoint.” He concluded that the composite results were numerically in favor of bivalirudin, with no increase in ischemic events but a marked reduction in major bleeding. “Importantly there was no signal of stent thrombosis,” he added.American College of Cardiology Annual Scientific S Chicago, Illinois: 29 March – 1 April 2008
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bivalirudin versus UFH
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ISAR-REACT 3: No clinical benefit but reduction in bleeding with bivalirudin versus UFH on optimal antiplatelet backdropISAR-REACT 3：在优化抗血小板治疗基础上加用比伐卢定与加用普通肝素相比：没有临床获益，但减少出血的发生30 March 2008日MedWire News: Anticoagulation treatment with the direct thrombin inhibitor (DTI) bivalirudin reduces bleeding rates but does not improve clinical outcomes in comparison with unfractionated heparin (UFH) in low-to-intermediate risk patients undergoing percutaneous coronary intervention (PCI) with optimal clopidogrel pretreatment, results of the ISAR-REACT-3 trial indicate. MedWire新闻：ISAR-REACT-3试验结果提示，在经优化氯吡格雷预处理后行PCI术的中-低危险度的病人中使用直接凝血酶抑制剂（DTI）比伐卢定进行抗凝治疗，与普通肝素（UFH）相比，能降低出血发生率但不改善临床结果。Previous studies have shown that bivalirudin treatment during angioplasty and coronary stenting is associated with better outcomes compared with UFH and adjunctive glycoprotein (GP) IIb/IIIa inhibitors, but these were not done on a backdrop of optimal antiplatelet therapy. 以往研究已表明，行血管成形术和冠脉支架术时用比伐卢定比用普通肝素和GPIIb/IIIa抑制剂的结果更好；不过这是在没有用优化抗血小板治疗的基础上完成的。To investigate further, Adnan Kastrati (Deutsches Herzzentrum and Technical University, Munich, Germany) and colleagues conducted the double-blind, controlled ISAR-REACT-3 trial, in which they randomly assigned 4570 coronary artery disease patients without troponin T elevation undergoing PCI to receive bivalirudin (n=1189) or unfractionated heparin (n=2281). 为了深入研究，Adnan Kastrati（德国慕尼黑Deutsches Herzzentrum技术大学）和同事们进行了一项双盲对照的ISAR-REACT-3试验；他们把4570位不伴肌钙蛋白T升高的行PCI术的冠心病病人随机分配为接受比伐卢定治疗（n=1189）或普通肝素治疗（n=2281）。All patients received 600 mg clopidogrel and =325 mg aspirin at least 2 hours before the procedure. Bivalirudin was given as an intravenous (iv) bolus at 0.75 mg/kg prior to PCI, followed by continuous iv infusion during the procedure at 1.75 mg/kg/hour. Patients in the UFH arm received UFH as an iv bolus of 0.75 units/kg followed by a continuous infusion of placebo for the duration of the procedure. 所有病人在手术开始至少2小时以前，接受600mg氯吡格雷和325mg阿司匹林治疗。比伐卢定PCI术前按0.75mg/kg静脉推注，术中按1.75mg/kg/小时连续静脉滴注。UFH治疗组病人术前接受UFH0.75单位/kg的静脉推注，术中用安慰剂连续静脉滴注。The results were presented by Kastrati at the American College of Cardiology Scientific Sessions, being held in Chicago, Illinois. The primary composite endpoint comprising death, myocardial infarction (MI), urgent target vessel revascularization (UTVR), or in-hospital major bleeding at 30 days was similar between treatment groups, at 8.3% in the bivalirudin arm compared with 8.7% in the UFH arm, giving a relative risk of 0.94. 在Illinois的芝加哥举行的ACC科学会议上，Kastrati公布了试验结果。治疗组间30天时由死亡、心肌梗死（MI）、紧急血管重建（UTVR）或院内严重出血等组成的一级复合终点结果相似，比伐卢定治疗组为8.3%，UFH治疗组为8.7%，相对危险度为0.94。Rates of the primary endpoint components death, MI, and UTVR were 0.1 and 0.2%, 5.6 and 4.8%, and 0.8 and 0.7% among patients who received bivalirudin versus those given UFH, respectively. 比伐卢定治疗组与UFH治疗组一级终点各成分的发生率分别为：死亡0.1%和0.2%，MI 5.6%和4.8%，UTVR 0.8%和0.7%。The secondary composite endpoint of death, MI, and UTVR at 30 days was also similar between groups, at 5.9 and 5.0% among bivalirudin- versus UFH-treated patients, giving a relative risk of 1.16. 比伐卢定治疗组与UFH治疗组间由死亡、MI和UTVR等组成的二级复合终点结果同样相似，分别为5.9%和5.0%，相对危险度为1.16.In contrast, rates of major and minor bleeding at 30 days were significantly lower among patients who received bivalirudin than among those given UFH, at 3.1 versus 4.6% (p=0.008) and 6.8 versus 9.9% (p=0.0001), respectively, for the prespecified trial definition of bleeding used in the earlier REPLACE trial. The difference in major bleeding translated into a 33% lower relative risk with bivalirudin. The reduction in both major and minor bleeding with bivalirudin held true when the results were analyzed according to Thombolysis in MI (TIMI) bleeding definitions. 相反，根据较早前用于REPLACE试验的事先确定的出血定义，比伐卢定治疗组三十天时严重及轻度出血的发生率显著低于UFH治疗组，分别为3.1%比4.6%（p=0.008）和6.8%比9.9%（p=0.0001）。用比伐卢定引起严重出血的差异使相对危险度降低33%。试验结果用心肌梗死溶栓（TIMI）分析时，比伐卢定引起的严重和轻微出血发生率仍然较低。Thrombocytopenia rates were similar between groups. 各组间的血小板减少的发生率相似。Kastrati cautioned that the dose of UFH used is higher than has been used in recent US PCI trials. He said: “Whether and to what degree this affected outcome cannot be determined.” Kastrati提醒说，UFH的剂量比最近美国一些PCI试验的要高。他说：“还不能确定这是否以及在何种程度上影响试验的结果。”Commentator on the trial Harvey White (Green Lane Hospital, Auckland, New Zealand) emphasized that the reduction in bleeding with bivalirudin is clinically relevant. 该试验的评论家Harvey White（新西兰奥克兰Green Lane医院）强调，比伐卢定引起出血的发生率较低是有临床意义的。He noted: “Interestingly and strikingly, in my view, TIMI major bleeding was reduced by 50%, with a marginal p value of 0.04.” 他说：“在我看来，有趣而明显的是，TIMI严重出血减少了50%，p值为0.04的边缘值。”White noted that the bleeding rate with UFH was low in the trial, despite the relatively high dose. He compared it with the higher rate of major bleeding of 8.5% seen in STEEPLE, in which elective patients received the current US-recommended 70 units/kg UFH dose, guided by activated clotting time. White注意到，尽管UFH剂量相对较高，该试验中的出血发生率较低。他将它与STEEPLE试验中观察到的8.5%较高的出血发生率作了比较，后一试验中入选病人接受的UFH剂量为当前美国推荐的70单位/kg，根据凝血活化时间调节。White said: “I think the real question in a low-risk ischemic group is: Does bivalirudin reduce bleeding? And I think this should have been the primary endpoint.” White说：“我认为低位缺血组的真正问题是：比伐卢定是否降低出血？而且我认为这原本应该是一级终点。”He concluded that the composite results were numerically in favor of bivalirudin, with no increase in ischemic events but a marked reduction in major bleeding. “Importantly there was no signal of stent thrombosis,” he added.他总结道，复合结果在数字上是支持比伐卢定，因为（它）不增加缺血事件却降低严重出血的发生。“重要的是，没有支架血栓形成的信号，”他补充说道。American College of Cardiology Annual Scientific S Chicago, Illinois: 29 March – 1 April 2008伊利诺州芝加哥ACC科学年会：日-4月1日。ISAR-REACT 3：在优化抗血小板治疗基础上加用比伐卢定与加用普通肝素相比：没有临床获益，但减少出血的发生日MedWire新闻：ISAR-REACT-3试验结果提示，在经优化氯吡格雷预处理后行PCI术的中-低危险度的病人中使用直接凝血酶抑制剂（DTI）比伐卢定进行抗凝治疗，与普通肝素（UFH）相比，能降低出血发生率但不改善临床结果。以往研究已表明，行血管成形术和冠脉支架术时用比伐卢定比用普通肝素和GPIIb/IIIa抑制剂的结果更好；不过这是在没有用优化抗血小板治疗的基础上完成的。为了深入研究，Adnan Kastrati（德国慕尼黑Deutsches Herzzentrum技术大学）和同事们进行了一项双盲对照的ISAR-REACT-3试验；他们把4570位不伴肌钙蛋白T升高的行PCI术的冠心病病人随机分配为接受比伐卢定治疗（n=1189）或普通肝素治疗（n=2281）。所有病人在手术开始至少2小时以前，接受600mg氯吡格雷和325mg阿司匹林治疗。比伐卢定PCI术前按0.75mg/kg静脉推注，术中按1.75mg/kg/小时连续静脉滴注。UFH治疗组病人术前接受UFH0.75单位/kg的静脉推注，术中用安慰剂连续静脉滴注。在Illinois的芝加哥举行的ACC科学会议上，Kastrati公布了试验结果。治疗组间30天时由死亡、心肌梗死（MI）、紧急血管重建（UTVR）或院内严重出血等组成的一级复合终点结果相似，比伐卢定治疗组为8.3%，UFH治疗组为8.7%，相对危险度为0.94。比伐卢定治疗组与UFH治疗组一级终点各成分的发生率分别为：死亡0.1%和0.2%，MI 5.6%和4.8%，UTVR 0.8%和0.7%。比伐卢定治疗组与UFH治疗组间由死亡、MI和UTVR等组成的二级复合终点结果同样相似，分别为5.9%和5.0%，相对危险度为1.16.相反，根据较早前用于REPLACE试验的事先确定的出血定义，比伐卢定治疗组三十天时严重及轻度出血的发生率显著低于UFH治疗组，分别为3.1%比4.6%（p=0.008）和6.8%比9.9%（p=0.0001）。用比伐卢定引起严重出血的差异使相对危险度降低33%。试验结果用心肌梗死溶栓（TIMI）分析时，比伐卢定引起的严重和轻微出血发生率仍然较低。各组间的血小板减少的发生率相似。Kastrati提醒说，UFH的剂量比最近美国一些PCI试验的要高。他说：“还不能确定这是否以及在何种程度上影响试验的结果。”该试验的评论家Harvey White（新西兰奥克兰Green Lane医院）强调，比伐卢定引起出血的发生率较低是有临床意义的。他说：“在我看来，有趣而明显的是，TIMI严重出血减少了50%，p值为0.04的边缘值。”White注意到，尽管UFH剂量相对较高，该试验中的出血发生率较低。他将它与STEEPLE试验中观察到的8.5%较高的出血发生率作了比较，后一试验中入选病人接受的UFH剂量为当前美国推荐的70单位/kg，根据凝血活化时间调节。White说：“我认为低位缺血组的真正问题是：比伐卢定是否降低出血？而且我认为这原本应该是一级终点。”他总结道，复合结果在数字上是支持比伐卢定，因为（它）不增加缺血事件却降低严重出血的发生。“重要的是，没有支架血栓形成的信号，”他补充说道。伊利诺州芝加哥ACC科学年会：日-4月1日。
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关于丁香园PCI术后用药：比伐卢定优于肝素
作者：Tylen Chen
急性心肌梗死（AMI）患者行 PCI 后可使用比伐卢定（bivalirudin）、单独使用肝素或肝素 + 替罗非班，但三者的安全性和有效性尚未明确。为此，我国的韩雅玲院士所带领的研究团队展开了多中心的开放标志性试验，旨在明确PCI术后使用比伐卢定的预后是否优于肝素和肝素+替罗非班。文章于2015年4月发表在JAMA杂志。该研究纳入了2012年8月至2013年6月期间，在我国82个研究中心的2194例行PCI治疗的AMI患者。患者被随机分配到比伐卢定组、仅使用肝素组和肝素+替罗非班组，在术后给予药物输液治疗。其中，比伐卢定组的给药剂量和速度为1.75mg/Kg/h，中位给药时间为180min。主要终点为30天的净不良临床事件，包括主要不良心脑血管事件（全因死亡、再梗死、缺血后靶血管血运重建或卒中）或者出血。其他预指定的安全终点包括30天获得性血小板减少症的发病率以及30天和1年的支架内栓塞形成的发病率。结果显示：净不良临床事件的发生分别为：比伐卢定组为 8.8% ，肝素组为 13.3% ，肝素+替罗非班组为 17%
。30 天出血率分别为：4.1% ，7.5% ，12.3% （P＜0.001）。30天内比伐卢定组、肝素组和肝素+替罗非班组，组间30天不良心脑血管事件、支架内血栓形成、获得性血小板减少症和急性支架内血栓形成的发病率皆无统计学差异。经过1年的随访，统计结果无明显差异。综上所述，相比较单独使用肝素或者肝素+替罗非班，AMI患者术后在中位3h内输入额定剂量的比伐卢定可有效降低不良临床事件。这种获益或许主要归功于比伐卢定可降低出血事件，且在主要不良心脑血管事件和支架内血栓形成方面无统计学差异。
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