fondaparinux对死亡率的影响和reinfarction急性st段抬高心肌梗死患者:OASIS-6随机试验。
文章的细节
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引用
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优素福,梅塔SR Chrolavicius年代,阿夫扎尔R, Pogue J,格兰杰CB, Budaj,彼得斯RJ, Bassand JP, Wallentin L, Joyner C,狐狸KA
fondaparinux对死亡率的影响和reinfarction急性st段抬高心肌梗死患者:OASIS-6随机试验。
《美国医学协会杂志》上。2006年4月5日,295 (13):1519 - 30。Epub 2006年3月14日。
- PubMed ID
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16537725 (在PubMed]
- 文摘
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背景:尽管许多治疗的进步,死亡率在急性st段抬高心肌梗死患者肝素)仍然很高。额外的抗血栓形成的药物的作用尚不清楚,特别是在患者没有接受再灌注治疗。目的:探讨fondaparinux的影响,一个因素Xa抑制剂,早些时候发起并给予长达8天与常规治疗(安慰剂的人依诺肝素[能]不表示(1层)或依诺肝素48小时后跟安慰剂长达8天(2层))在STEMI患者。设计、设置和参与者:随机双盲比较fondaparinux 2.5毫克,每日一次或控制长达8天12092年STEMI患者从447年的41个国家医院(2003年9月- 2006年1月)。从每天3到9,所有患者接受fondaparinux或安慰剂治疗根据原始随机分配。主要结果测量:复合在30天内死亡或reinfarction(初级)与二级评估9天,在最后的随访(3或6个月)。结果:在30天内死亡或reinfarction显著降低从677年的6056名患者(11.2%),对照组585例(9.7%)的6036名患者fondaparinux集团(危险比[HR], 0.86;95%可信区间(CI), 0.77 - -0.96;P = .008);绝对风险降低1.5%; 95% CI, 0.4%-2.6%). These benefits were observed at 9 days (537 [8.9%] placebo vs 444 [7.4%] fondaparinux; HR, 0.83; 95% CI, 0.73-0.94; P = .003, and at study end (857 [14.8%] placebo vs 756 [13.4%] fondaparinux; HR, 0.88; 95% CI, 0.79-0.97; P = .008). Mortality was significantly reduced throughout the study. There was no heterogeneity of the effects of fondaparinux in the 2 strata by planned heparin use. However, there was no benefit in those undergoing primary percutaneous coronary intervention. In other patients in stratum 2, fondaparinux was superior to unfractionated heparin in preventing death or reinfarction at 30 days (HR, 0.82; 95% CI, 0.66-1.02; P = .08) and at study end (HR, 0.77; 95% CI, 0.64-0.93; P = .008). Significant benefits were observed in those receiving thrombolytic therapy (HR, 0.79; P = .003) and those not receiving any reperfusion therapy (HR, 0.80; P = .03). There was a tendency to fewer severe bleeds (79 for placebo vs 61 for fondaparinux; P = .13), with significantly fewer cardiac tamponade (48 vs 28; P = .02) with fondaparinux at 9 days. CONCLUSION: In patients with STEMI, particularly those not undergoing primary percutaneous coronary intervention, fondaparinux significantly reduces mortality and reinfarction without increasing bleeding and strokes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00064428.
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