The Lancet：新药有效降低支架术后凝血风险
美国研究人员新公布的临床试验结果显示，一种新药能大幅降低心血管疾病患者植入支架后发生凝血的风险，其效果要优于目前通常采用的药物。
据华盛顿媒体3月30日报道，美国哈佛大学医学院的斯蒂芬·威维奥特博士等人在美国心脏病学院年会上介绍说，他们对约1.3万名患者进行了研究。这些患者体内分别植入了药物涂层支架和其他多种类型的心脏支架。
在研究中，有一半患者接受名为Prasugrel的新药结合阿司匹林治疗，这种新药由美国礼来公司等开发。另外一半患者接受氯吡格雷结合阿司匹林治疗，这是目前预防支架手术后发生凝血的通行治疗方法。研究结果发现，与后一组患者相比，前一组患者支架周围血小板形成的风险平均要低58%左右。
威维奥特等人的研究结果已在《柳叶刀》（The Lancet）杂志网络版上发表。据悉，Prasugrel目前正在接受美国食品和药物管理局的审批。（来源：新华网）
生物谷推荐原始出处：
The Lancet Early Online Publication, 31 March 2008
The Lancet DOI:10.1016/S0140-6736(08)60422-5
Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial
a 
, a, a, b, c, d, e, f, a, a and a, for the TRITON–TIMI 38 Investigators
Summary
Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON–TIMI 38 trial has shown that prasugrel—a novel, potent thienopyridine—can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON–TIMI 38 study.
Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591.
12 844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9·7 vs 11·9%, HR 0·81, p=0·0001) in the stented cohort, in patients with only drug-eluting stents (9·0 vs 11·1%, HR 0·82, p=0·019), and in patients with only bare-metal stents (10·0 vs 12·2%, HR 0·80, p=0·003). Stent thrombosis was associated with death or myocardial infarction in 89% (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1·13 vs 2·35%, HR 0·48, p<0·0001), in patients with drug-eluting stents only (0·84 vs 2·31%, HR 0·36, p<0·0001), and in those with bare-metal stents only (1·27 vs 2·41%, HR 0·52, p=0·0009).
Intensive antiplatelet therapy with prasugrel resulted in fewer ischaemic outcomes including stent thrombosis than with standard clopidogrel. These findings were statistically robust irrespective of stent type, and the data affirm the importance of intensive platelet inhibition in patients with intracoronary stents.
TRITON–TIMI 38 was supported by research grants from Daiichi Sankyo and Eli Lilly.
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