主要与tenecteplase-facilitated患者经皮冠状动脉介入的st段抬高急性心肌梗死(ASSENT-4 PCI):随机试验。

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主要与tenecteplase-facilitated患者经皮冠状动脉介入的st段抬高急性心肌梗死(ASSENT-4 PCI):随机试验。

柳叶刀》。2006年2月18日,367 (9510):569 - 78。

PubMed ID

16488800 (在PubMed

]

文摘

背景:主要经皮冠状动脉介入治疗(PCI)比纤溶治疗更有效的st段抬高急性心肌梗死肝素),但是时间可以相当大的干预。我们的目的是调查是否足量管理tenecteplase延迟PCI之前可以减轻这种延迟的负面影响。方法:我们做了一个随机调查我们分配STEMI患者少于6小时的时间(计划接受PCI术后的拖期1 - 3 h)标准的PCI (n = 838)或PCI之前管理的最大剂量tenecteplase (n = 829)。所有患者接受阿司匹林和丸,没有输液,依诺肝素。我们的主要终点是死亡或充血性心力衰竭或冲击90天内。由意图治疗分析。本研究是注册,NCT00168792数量。发现:我们计划招收4000名患者,但早期停止招生数据和安全监测委员会推荐的,因为在促进住院死亡率高于标准的PCI组(6% vs 3%[664] 43[22 656年],p = 0.0105)。就读,六人失访了PCI组和另一组7。中位数时间从随机在两组第一个气球通货膨胀是相似的。 The median time from bolus tenecteplase to first balloon inflation was 104 min. We noted the primary endpoint in 19% (151 of 810) of patients assigned facilitated PCI versus 13% (110 of 819) of those randomised to primary PCI (relative risk 1.39, 95% CI 1.11-1.74; p=0.0045). During hospital stay, significantly more strokes (1.8% [15 of 829] vs 0, p<0.0001), but not major non-cerebral bleeding complications (6% [46 of 829] vs 4% [37 of 838], p=0.3118), were reported in patients assigned facilitated rather than standard PCI. We also noted more ischaemic cardiac complications, such as reinfarction (6% [49 of 805] vs 4% [30 of 820], p=0.0279) or repeat target vessel revascularisation (7% [53 of 805] vs 3% [28 of 818], p=0.0041) within 90 days in this study group. INTERPRETATION: A strategy of full-dose tenecteplase with antithrombotic co-therapy, as used in this study and preceding PCI by 1-3 h, was associated with more major adverse events than PCI alone in STEMI and cannot be recommended.

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Tenecteplase