Wall T C, Califf R M, Ellis S G, Sigmon K, Kereiakes D, George B S, Samaha J, Sane D, Stump D C, Stack R S
Department of Medicine, Duke University Medical Center, Durham, North Carolina.
J Am Coll Cardiol. 1993 Mar 1;21(3):597-603. doi: 10.1016/0735-1097(93)90090-n.
The aim of this study was to assess the hemorrhagic risk associated with fibrin-specific thrombolytic therapy and invasive procedures with acute myocardial infarction.
Successful coronary artery reperfusion has important prognostic implications. Because immediate coronary angiography is the only method proved to differentiate early fibrinolytic success from failure, its use may be important for selected patients.
Five hundred seventy-five patients were evaluated with six combined thrombolytic and catheterization strategies. Patients were randomized to intravenous urokinase alone, recombinant tissue-type plasminogen activator (rt-PA) alone, or both; simultaneously they were randomized to an immediate versus a deferred catheterization strategy. Hemorrhagic events were assessed. The correlation of hemorrhage with clinical and hemostatic variables was evaluated. Prespecified transfusion criteria were employed.
No difference in baseline characteristics or in hemorrhagic complications was noted among the three thrombolytic regimens. Although mild (< 250 ml) bleeding was more common in the group with immediate catheterization, no clinically significant difference among catheterization groups was seen in moderate to life-threatening hemorrhagic events. Most bleeding occurred at vascular access sites, yet severe and life-threatening hemorrhage occurred in < 1% of patients. Baseline and nadir fibrinogen levels, change in baseline fibrinogen levels and peak fibrin and fibrinogen degradation products did not correlate with bleeding risk. A clinical predisposition for bleeding was observed in women as well as older (> or = 65 years) and lighter (< or = 70 kg) patients. With prespecified transfusion criteria, only a minimal increase in blood product usage was noted with immediate catheterization.
Immediate cardiac catheterization can be accomplished without a clinically significant difference in bleeding risk. Fibrin specificity offers no clear advantage in reducing hemorrhagic risk. Bleeding risk correlates best with baseline patient characteristics. Finally, the amount of blood transfused can be reduced with lower transfusion criteria.
本研究旨在评估纤维蛋白特异性溶栓治疗及急性心肌梗死侵入性操作相关的出血风险。
成功的冠状动脉再灌注具有重要的预后意义。由于即时冠状动脉造影是唯一被证明能区分早期溶栓成功与失败的方法，其应用对特定患者可能很重要。
采用六种联合溶栓及导管插入术策略对575例患者进行评估。患者被随机分为单独静脉注射尿激酶组、单独重组组织型纤溶酶原激活剂（rt-PA）组或两者联合组；同时，他们被随机分为即时与延迟导管插入术策略组。评估出血事件。评估出血与临床及止血变量的相关性。采用预先设定的输血标准。
三种溶栓方案在基线特征或出血并发症方面无差异。尽管即时导管插入术组轻度（<250 ml）出血更常见，但在中度至危及生命的出血事件中，各导管插入术组之间未观察到临床显著差异。大多数出血发生在血管穿刺部位，但<1%的患者发生了严重和危及生命的出血。基线和最低纤维蛋白原水平、基线纤维蛋白原水平变化以及纤维蛋白和纤维蛋白原降解产物峰值与出血风险无关。在女性以及年龄较大（≥65岁）和体重较轻（≤70 kg）的患者中观察到出血的临床易感性。根据预先设定的输血标准，即时导管插入术仅使血液制品使用量略有增加。
即时心脏导管插入术可在不增加临床显著出血风险的情况下完成。纤维蛋白特异性在降低出血风险方面无明显优势。出血风险与患者基线特征最相关。最后，采用较低的输血标准可减少输血量。
