Cardiovascular Institute and Fuwai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100037, China.
Chin Med J (Engl). 2011 Mar;124(6):879-86.
American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC) guidelines gave fondaparinux a class I recommendation for use in patients with non-ST elevation acute coronary syndromes (NSTE-ACS) undergoing invasive or conservative strategy. Nadroparin is one of the common anticoagulants used in NSTE-ACS in China. Accordingly, this study compared the safety and efficacy between fondaparinux and nadroparin in patients with NSTE-ACS.
In this prospective, randomized, open-label, and single center study, a total of 300 patients with NSTE-ACS were randomized to receive either fondaparinux (group F, n = 150, 2.5 mg/d) or nadroparin (group N, n = 150, 0.1 ml/10 kg q12 h) for a mean of 4 days. The primary safety endpoint was the incidence of major or minor bleeding at 9 days that was not related to coronary artery bypass grafting (CABG). The primary efficacy endpoints included death, myocardial infarction, or recurrent ischemia at 9 days. All patients underwent a 180-day follow-up.
Baseline characteristics were well matched between the two groups. There was a non-significant 28% relative risk reduction in the primary safety endpoint in group F compared with group N (4.7% vs. 6.7%, HR 0.72, 95%CI 0.42-1.65, P = 0.38). The primary efficacy endpoint was 8.0% in group F and 10.0% in group N (HR, 0.82, 95%CI 0.54-1.71, P = 0.49). The composite of the safety and efficacy endpoints at 9 days (10.0% vs. 16.0%, HR 0.61, 95%CI 0.31-1.10, P = 0.10), 30 days (14.0% vs. 17.9%, HR 0.72, 95%CI 0.47-1.16, P = 0.21), or 180 days (18.7% vs. 27.3%, HR 0.65, 95%CI 0.38-1.11, P = 0.11) showed a non-significant trend toward a lower value in group F.
Fondaparinux resulted in a nonsignificant risk reduction in patients with NSTE-ACS in both bleeding and ischaemic events during short- and long-term follow-up compared with nadroparin.
美国心脏病学会/美国心脏协会/欧洲心脏病学会（ACC/AHA/ESC）指南将磺达肝素钠列为 I 类推荐，用于接受侵入性或保守策略的非 ST 段抬高型急性冠状动脉综合征（NSTE-ACS）患者。那屈肝素钙是中国 NSTE-ACS 中常用的抗凝剂之一。因此，本研究比较了磺达肝素钠和那屈肝素钙在 NSTE-ACS 患者中的安全性和疗效。
这是一项前瞻性、随机、开放标签、单中心研究，共纳入 300 例 NSTE-ACS 患者，随机分为磺达肝素钠组（F 组，n = 150，2.5mg/d）或那屈肝素钙组（N 组，n = 150，0.1ml/10kg，q12h），平均治疗 4 天。主要安全性终点为 9 天内与冠状动脉旁路移植术（CABG）无关的大出血或小出血发生率。主要疗效终点包括 9 天内死亡、心肌梗死或再发缺血。所有患者均接受 180 天随访。
两组患者的基线特征匹配良好。与 N 组相比，F 组主要安全性终点的相对风险降低了 28%（4.7% vs. 6.7%，HR 0.72，95%CI 0.42-1.65，P = 0.38）。F 组主要疗效终点为 8.0%，N 组为 10.0%（HR 0.82，95%CI 0.54-1.71，P = 0.49）。9 天（10.0% vs. 16.0%，HR 0.61，95%CI 0.31-1.10，P = 0.10）、30 天（14.0% vs. 17.9%，HR 0.72，95%CI 0.47-1.16，P = 0.21）和 180 天（18.7% vs. 27.3%，HR 0.65，95%CI 0.38-1.11，P = 0.11）时，9 天、30 天和 180 天安全性和疗效复合终点的发生率也呈非显著性下降趋势。
与那屈肝素钙相比，磺达肝素钠可降低 NSTE-ACS 患者短期和长期随访期间出血和缺血事件的风险，但无统计学意义。
