Hamm C W, Heeschen C, Goldmann B, Vahanian A, Adgey J, Miguel C M, Rutsch W, Berger J, Kootstra J, Simoons M L
Department of Cardiology, University Hospital Eppendorf, Hamburg, Germany.
N Engl J Med. 1999 May 27;340(21):1623-9. doi: 10.1056/NEJM199905273402103.
In patients with refractory unstable angina, the platelet glycoprotein IIb/IIIa-receptor antibody abciximab reduces the incidence of cardiac events before and during coronary angioplasty. We investigated whether serum troponin T levels identify patients most likely to benefit from therapy with this drug.
Among 1265 patients with unstable angina who were enrolled in the c7E3 Fab Antiplatelet Therapy in Unstable Refractory Angina (CAPTURE) trial, serum samples drawn at the time of randomization to abciximab or placebo were available from 890 patients; we used these samples for the determination of troponin T and creatine kinase MB levels. Patients with postinfarction angina were not included.
Serum troponin T levels at the time of study entry were elevated (above 0.1 ng per milliliter) in 275 patients (30.9 percent). Among patients receiving placebo, the risk of death or nonfatal myocardial infarction was related to troponin T levels. The six-month cumulative event rate was 23.9 percent among patients with elevated troponin T levels, as compared with 7.5 percent among patients without elevated troponin T levels (P<0.001). Among patients treated with abciximab, the respective six-month event rates were 9.5 percent for patients with elevated troponin T levels and 9.4 percent for those without elevated levels. As compared with placebo, the relative risk of death or nonfatal myocardial infarction associated with treatment with abciximab in patients with elevated troponin T levels was 0.32 (95 percent confidence interval, 0.14 to 0.62; P=0.002). The lower event rates in patients receiving abciximab were attributable to a reduction in the rate of myocardial infarction (odds ratio, 0.23; 95 percent confidence interval, 0.12 to 0.49; P<0.001). In patients without elevated troponin T levels, there was no benefit of treatment with respect to the relative risk of death or myocardial infarction at six months (odds ratio, 1.26; 95 percent confidence interval, 0.74 to 2.31; P=0.47).
The serum troponin T level, which is considered to be a surrogate marker for thrombus formation, identifies a high-risk subgroup of patients with refractory unstable angina suitable for coronary angioplasty who will particularly benefit from antiplatelet treatment with abciximab.
在难治性不稳定型心绞痛患者中,血小板糖蛋白IIb/IIIa受体抗体阿昔单抗可降低冠状动脉血管成形术之前及术中心脏事件的发生率。我们研究了血清肌钙蛋白T水平是否能识别出最有可能从该药治疗中获益的患者。
在参与难治性不稳定型心绞痛的c7E3 Fab抗血小板治疗(CAPTURE)试验的1265例不稳定型心绞痛患者中,有890例患者在随机分组接受阿昔单抗或安慰剂治疗时采集了血清样本;我们用这些样本测定肌钙蛋白T和肌酸激酶MB水平。不包括心肌梗死后心绞痛患者。
研究入组时,275例患者(30.9%)的血清肌钙蛋白T水平升高(高于0.1 ng/ml)。在接受安慰剂治疗的患者中,死亡或非致死性心肌梗死的风险与肌钙蛋白T水平有关。肌钙蛋白T水平升高的患者6个月累积事件发生率为23.9%,而肌钙蛋白T水平未升高的患者为7.5%(P<0.001)。在接受阿昔单抗治疗的患者中,肌钙蛋白T水平升高的患者6个月事件发生率分别为9.5%,未升高的患者为9.4%。与安慰剂相比,肌钙蛋白T水平升高的患者接受阿昔单抗治疗相关的死亡或非致死性心肌梗死的相对风险为0.32(95%置信区间为0.14至0.62;P=0.002)。接受阿昔单抗治疗的患者事件发生率较低归因于心肌梗死发生率的降低(比值比为0.23;95%置信区间为0.12至0.49;P<0.001)。在肌钙蛋白T水平未升高的患者中,6个月时死亡或心肌梗死的相对风险方面,治疗无益处(比值比为1.26;95%置信区间为0.74至2.31;P=0.47)。
血清肌钙蛋白T水平被认为是血栓形成的替代标志物,可识别出适合冠状动脉血管成形术的难治性不稳定型心绞痛高危亚组患者;这些患者将特别从阿昔单抗抗血小板治疗中获益。