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首页> 外文期刊>The American Journal of Cardiology >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)
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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)

机译：比伐卢定与普通肝素在经皮冠状动脉介入治疗的高危患者中的安全性和有效性比较（来自在血管成形术中减少心肌损害的抗血栓策略-比伐卢定与肝素研究）

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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.
机译：比伐卢定是一种直接的凝血酶抑制剂，与普通肝素（UFH）一样有效，并且在接受经皮冠状动脉介入治疗（PCI）的急性冠脉综合征患者中出血减少。这项研究的目的是评估比伐卢定与UFH在选定的高出血风险PCI患者中的有效性。连续接受PCI且符合<1入组标准（年龄> 75岁，慢性肾功能衰竭和糖尿病）的411位患者随机分为比伐卢定（推注0.75 mg / kg，然后在过程中输注; n = 198）或UFH （75 IU / kg; n = 203）。在总人口中，年龄在75岁以上的人群占39％，肾衰竭的人群占22％，糖尿病的患病比例为63％，急性冠脉综合征的患病比例为29％。主要疗效终点是主要不良心脏事件（心脏死亡，心肌梗塞，支架血栓形成或靶血管血运重建）的30天发生率。主要安全终点是PCI后发生任何出血或进入部位并发症。所有患者均预先加载了氯吡格雷600 mg。糖蛋白IIb / IIIa抑制剂是由操作人员自行决定使用的。比伐卢定组30天主要不良心脏事件发生率为11.1％，UFH组为8.9％（p = 0.56）;达到主要疗效终点的主要原因是围手术期心肌梗塞。比伐卢定组中有1例患者发生了支架血栓。比伐卢定组的主要安全终点发生率为1.5％，UFH组的发生率为9.9％（p = 0.0001）。这种益处主要是由预防> 10 cm的进入部位血肿（0.5％对6.9％，p = 0.002）驱动的。总之，减少血栓形成期间抗心肌梗死的抗血栓形成策略-比伐卢定vs肝素（ARMYDA-7 BIVALVE）表明，比伐卢定，比伐卢定与UFH相比，可显着降低出血，并且在老年患者中主要不良心脏事件的发生率相似接受PCI的年龄，糖尿病或慢性肾功能衰竭。

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