Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non-Q-wave myocardial infarction. Results of the TIMI IIIB Trial. Thrombolysis in Myocardial Ischemia.
Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non-Q-wave myocardial infarction. Results of the TIMI IIIB Trial. Thrombolysis in Myocardial Ischemia.
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组织纤溶酶原激活剂对不稳定心绞痛和非 Q 波心肌梗死的影响以及早期侵入性和保守性策略的比较。
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< jats: sec>< jats: title>背景< jats: p>虽然冠状动脉血栓形成在不稳定型心绞痛和非Q波心肌梗死（NQMI）的发病机制中起着关键作用，但溶栓治疗在这些疾病中的作用尚不清楚。此外，常规早期冠状动脉造影术后再行血运重建的作用尚未确定。< jats: sec>< jats: title>方法和随访患者（n= 1473）在休息时24小时内出现缺血性胸部不适，被认为是不稳定型心绞痛或NQMI< jats: p>，采用2 × 2析因设计，随机比较（1）TPA与安慰剂作为初始治疗和（2）早期侵入性策略（早期冠状动脉造影，然后在解剖结构合适时进行血运重建）与早期保守策略（如果初始药物治疗失败，则进行冠状动脉造影，然后进行血运重建）。所有患者均接受卧床休息、抗缺血药物、阿司匹林和肝素治疗。TPA-安慰剂比较的主要终点（6周时死亡、心肌梗死或初始治疗失败）发生在54.2%的TPA治疗患者和55.5%的安慰剂治疗患者中（P= NS）。随机分组后，TPA治疗组患者（7.4%）的致死性和非致死性心肌梗死（NQMI患者的再梗死）发生率高于安慰剂治疗组（4.9%，P= 0.001）。Kaplan-Meier估计）。TPA治疗组发生4例颅内出血，而安慰剂治疗组未发生（P=. 06）。两种策略比较的终点（死亡、心肌梗死或6周时运动负荷试验不满意）发生在18.1%的早期保守策略患者和16.2%的早期侵入性策略患者中（P= NS）。在后者中，初次住院的平均时间、6周内再住院的发生率和再住院天数均显著较低。< jats: sec>< jats: title>结论：< jats: p>在整个试验中，不稳定型心绞痛和NQMI患者在6周访视时的死亡率（2.4%）和心肌梗死或再梗死率（6.3%）较低。这些结果可以使用早期保守或早期侵入性策略来实现，后者导致住院天数和再住院天数以及抗心绞痛药物的使用减少。加入血栓溶解剂是没有好处的，可能是有害的。
< jats: sec>< jats: title> BACKGROUND< jats: p> Although coronary thrombosis plays a critical role in the pathogenesis of unstable angina and non-Q-wave myocardial infarction (NQMI), the effects of thrombolytic therapy in these disorders is not clear. Also, the role of routine early coronary arteriography followed by revascularization has not been established.< jats: sec>< jats: title> METHODS AND RESULTS< jats: p> Patients (n= 1473) seen within 24 hours of ischemic chest discomfort at rest, considered to represent unstable angina or NQMI, were randomized using a 2 x 2 factorial design to compare (1) TPA versus placebo as initial therapy and (2) an early invasive strategy (early coronary arteriography followed by revascularization when the anatomy was suitable) versus an early conservative strategy (coronary arteriography followed by revascularization if initial medical therapy failed). All patients were treated with bed rest, anti-ischemic medications, aspirin, and heparin. The primary end point for the TPA-placebo comparison (death, myocardial infarction, or failure of initial therapy at 6 weeks) occurred in 54.2% of the TPA-treated patients and 55.5% of the placebo-treated patients (P= NS). Fatal and nonfatal myocardial infarction after randomization (reinfarction in NQMI patients) occurred more frequently in TPA-treated patients (7.4%) than in placebo-treated patients (4.9%, P=. 04, Kaplan-Meier estimate). Four intracranial hemorrhages occurred in the TPA-treated group versus none in the placebo-treated group (P=. 06). The end point for the comparison of the two strategies (death, myocardial infarction, or an unsatisfactory symptom-limited exercise stress test at 6 weeks) occurred in 18.1% of patients assigned to the early conservative strategy and 16.2% of patients assigned to the early invasive strategy (P= NS). In the latter, the average length of initial hospitalization, incidence of rehospitalization within 6 weeks, and days of rehospitalization all were significantly lower.< jats: sec>< jats: title> CONCLUSIONS< jats: p> In the overall trial, patients with unstable angina and NQMI were managed with low rates of mortality (2.4%) and myocardial infarction or reinfarction (6.3%) at the time of the 6-week visit. These results can be achieved using either an early conservative or early invasive strategy, the latter resulting in a reduced incidence of days of hospitalization and of rehospitalization and in the use of antianginal drugs. The addition of a thrombolytic agent is not beneficial and may be harmful.