Berger P B, Bell M R, Rihal C S, Ting H, Barsness G, Garratt K, Bellot V, Mathew V, Melby S, Hammes L, Grill D, Holmes D R
Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota 55905, USA.
J Am Coll Cardiol. 1999 Dec;34(7):1891-4. doi: 10.1016/s0735-1097(99)00442-8.
The study compared the safety and efficacy of ticlopidine with clopidogrel in patients receiving coronary stents.
Stent thrombosis is reduced when ticlopidine is administered with aspirin. Clopidogrel is similar to ticlopidine in chemical structure and function but has fewer side effects; few data are available about its use in stent patients.
We compared 30-day event rates in 500 consecutive coronary stent patients treated with aspirin and clopidogrel (300 mg loading dose immediately prior to stent placement, and 75 mg/day for 14 days) to 827 consecutive stent patients treated with aspirin and ticlopidine (500 mg loading dose and 250 mg twice daily for 14 days).
Patients treated with clopidogrel had more adverse clinical characteristics including older age, more severe angina, and more frequent infarction within the prior 24 h. Nonetheless, mortality was 0.4% in clopidogrel patients versus 1.1% in ticlopidine patients; nonfatal myocardial infarction occurred in 0% versus 0.5%, stent thrombosis in 0.2% versus 0.7%, bypass surgery or repeat angioplasty in 0.4% versus 0.5%, and any event occurred in 0.8% versus 1.6% of patients, respectively (p = NS). Based on the observed 30-day event rate of 1.6% with ticlopidine, the statistical power of the study was 43% to detect an even rate of 0.5% with clopidogrel, and 75% to detect an event rate with of 4% with clopidogrel, with a p value of 0.05.
These data indicate that clopidogrel can be safely substituted for ticlopidine in patients receiving coronary stents.
本研究比较了噻氯匹定与氯吡格雷在接受冠状动脉支架置入术患者中的安全性和有效性。
噻氯匹定与阿司匹林联用时可降低支架血栓形成的发生率。氯吡格雷在化学结构和功能上与噻氯匹定相似，但副作用较少；关于其在支架置入患者中的应用数据较少。
我们比较了500例连续接受阿司匹林和氯吡格雷治疗的冠状动脉支架置入患者（在支架置入前立即给予300mg负荷剂量，随后14天每天给予75mg）与827例连续接受阿司匹林和噻氯匹定治疗的支架置入患者（500mg负荷剂量，每天两次，每次250mg，共14天）的30天事件发生率。
接受氯吡格雷治疗的患者具有更多不良临床特征，包括年龄较大、心绞痛更严重以及在之前24小时内梗死更频繁。尽管如此，氯吡格雷组患者的死亡率为0.4%，而噻氯匹定组为1.1%；非致命性心肌梗死发生率分别为0%和0.5%，支架血栓形成发生率分别为0.2%和0.7%，搭桥手术或再次血管成形术发生率分别为0.4%和0.5%，任何事件发生率分别为0.8%和1.6%（p = 无显著性差异）。基于观察到的噻氯匹定30天事件发生率为1.6%，该研究检测氯吡格雷事件发生率为0.5%的统计效能为43%，检测氯吡格雷事件发生率为4%的统计效能为75%，p值为0.05。
这些数据表明，在接受冠状动脉支架置入术的患者中，氯吡格雷可安全替代噻氯匹定。
