2012国际卒中大会：脑卒中二级预防，双抗不优于单用阿司匹林
2012-02-06
来源：医学论坛网
2012年国际卒中大会上，来自加拿大的皮质下卒中二级预防（SPS3）试验中期结果表明，不支持阿司匹林联合氯吡格雷治疗对皮质下小卒中二级预防的益处，联合抗血小板治疗被提前终止。但血压干预仍在继续，试验预计将在2012年5月完成。
皮质下小卒中（S3）是超过25％脑梗死的致病原因，也是导致血管性痴呆的最常见原因。尽管其发作频繁且重要，但没有临床试验聚焦这一卒中亚型。SPS3试验（NCT00059306）是在8个国家进行的一项随机多中心临床试验，旨在为减少卒中复发、认知能力的下降和严重血管事件制定策略。
研究采用磁共振成像（MRI）确诊症状性S3，受试者在180天内无颈动脉狭窄或心脏来源的严重栓塞。采用析因设计，将受试者分为2个干预措施组：即阿司匹林325 mg/d与阿司匹林325 mg/d +氯吡格雷mg/d（双盲）。两项收缩压靶目标为“常规”（130-149 mmHg）与“强化”（<130 mmHg，标签开放的盲法事件评估）。
结果表明，至2011年4月共完成3020例受试者的招募。2011年6月，在安全监测委员会提出的建议基础上，抗血小板干预被过早终止，原因为联合治疗组（阿司匹林+氯吡格雷）受试者的出血和死亡危险增加，无价值分析显示，鉴于目前的监测数据显示，如果该试验继续按计划进行至结束，那么联合治疗获益超过阿司匹林单药治疗的可能性微乎其微。
相关链接：
International Stroke Conference
Late-BreakingScience Oral Abstracts：LB9
Publishing Title: The Secondary Prevention of Small Subcortical Strokes (SPS3) Trial: Results of the Antiplatelet Intervention
Abstract:
Background: Small subcortical strokes (S3) account for more than 25% of brain infarcts and are the most common cause of vascular dementia. Despite their frequency and importance, no clinical trial has focused on this stroke subtype. The SPS3 trial (NCT00059306) is a randomized multicenter clinical trial conducted in 8 countries, aimed to define strategies for reducing stroke recurrence, cognitive decline, and major vascular events.
Methods: Patients with symptomatic S3 verified by MRI, within 180 days and without carotid stenosis or major cardiac sources of embolism were assigned in a factorial design to 2 interventions: A) Aspirin 325 mg/d vs. Aspirin 325 mg/d + Clopidogrel 75 mg/d. (double-blinded). B) Two targets of systolic blood pressure, “usual” (130-149 mmHg) vs.“intensive” (<130 mmHg, open-label with blinded event assessment).
Results: Recruitment was completed with 3020 participants in April 2011. On June 2011, the antiplatelet intervention was prematurely stopped based on the recommendation made by the DSMB, due to: 1) A suggested increased risk of bleeding and death among subjects assigned to combination therapy (aspirin + clopidogrel); (Table), and 2) A futility analysis showing that, given the current observed data, there was a small probability of showing a benefit in favor of combination therapy over aspirin alone if this part of the trial continued to the planned end. Efficacy and the final safety data will be presented.
Conclusions: These interim results do not support the use of combination clopidogrel plus aspirin for secondary stroke prevention in patients with small subcortical strokes. The blood pressure intervention continues and is anticipated to be completed in May 2012.
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