日前，美国国立神经病和中风研究所宣布停止一项旨在比较“血管形成术＋血管内支架术＋药物强化”治疗（简称“三重疗法”）与仅用药物强化治疗对一过性脑缺血或非致残性中风的临床疗效之研究的被试者之招募工作，其原因是三重疗法治疗组于实验后的前30天内患者之再发中风率和死亡率显著高于仅用药物治疗组（14％对5.8％）。

　　（彭博评述：这一结果充分说明，凡事都有一个度，一味追求高科技而不掌握指征有时往往是效果不佳。事实上，关于血管成形和/或血管内支架术治疗冠心病亦可类似的报道，即与仅用药物治疗相比，这些高科技的手段并未显示出明显的优势。遗憾的是有些医生为了追逐经济效益和/或科研指标往往放宽上述方法治疗的指征，其结果不仅增加了患者的经济负担，更可能伤害患者的生活质量、甚至是危及患者的生命。难道这些不值得人们反思？）

　　更多资讯，请参阅原文：

　　Clinical Alert: Angioplasty Combined with Stenting Plus Aggressive Medical Therapy vs. Aggressive Medical Therapy Alone for Intracranial Arterial Stenosis: NINDS Stops Trial Enrollment Due to a Higher Risk of Stroke and Death in the Stented Group

　　The National Institute of Neurological Disorders and Stroke (NINDS) has stopped enrollment in a clinical trial that is evaluating whether intracranial angioplasty combined with stenting adds benefit to aggressive medical therapy alone for preventing stroke in patients with symptomatic intracranial arterial stenosis. The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) study is the first prospective randomized multicenter trial to compare aggressive medical management alone versus aggressive medical management plus angioplasty combined with stenting in patients with symptomatic highgrade (70-99%) stenosis of a major intracranial artery (intracranial carotid, middle cerebral artery, intracranial vertebral artery, and basilar artery). All patients were enrolled within 30 days after a TIA or non-disabling stroke that was attributed to the intracranial arterial stenosis. Aggressive medical management in both arms consists of aspirin 325 mg / day for the entire follow-up, clopidogrel 75mg / day for 90 days after enrollment, intensive management of vascular risk factors (primarily targeting systolic blood pressure < 140 mm Hg (< 130 mm Hg if diabetic) and LDL < 70mg / dl), and provision of a lifestyle modification program to all study patients. Recruitment began in November of 2008 and was halted on April 5, 2011 after 451 (59%) of the planned 764 patients had been enrolled at 50 participating sites in the US. The angioplasty and stenting system used in the trial is the Gateway-Wingspan system.

　　The NINDS acted on the recommendation of the study’s Data Safety Monitoring Board (DSMB). At the time of the most recent DSMB review, 14% of patients treated with angioplasty combined with stenting experienced a stroke or died within the first 30 days after enrollment compared with 5.8% of patients treated with medical therapy alone, a highly significant difference. The 30-day rate of stroke or death in the intensive medical treatment arm is substantially lower than the estimated rate of 10.7% based on historical controls, most of whom received standard medical care. In addition the 30-day rate in the stented patients is substantially higher than the estimated rate of 5.2% – 9.6% based on registry data. There were 5 stroke-related deaths within 30 days after enrollment, all in the stenting arm. There was one non stroke-related death in the medical arm within 30 days after enrollment. Beyond 30 days, the rates of stroke in the territory of the stenotic artery are similar in the two groups, but fewer than half the patients have been followed for one year. As such, follow-up of currently enrolled patients and comprehensive analysis of the total trial data set will be important in the final interpretation of this study.

　　The SAMMPRIS Executive Committee ¹ is in agreement with NINDS and the DSMB that enrollment in the study should be stopped and that the trial data currently available indicate that aggressive medical management alone is superior to angioplasty combined with stenting in patients with recent symptoms and high grade intracranial arterial stenosis. All are indebted to the patients who contributed to this important study.

　　Further information about this trial (NCT00576693) can be found at www.clinicaltrials.gov.

¹SAMMPRIS Executive Committee: Marc Chimowitz MBChB (Neurology PI), Colin Derdeyn MD (Interventional Co-PI), David Fiorella MD (Interventional Co-PI), Michael Lynn M.S. (Statistical PI), Tanya Turan MD (Director Risk Factor Management), Bethany Lane RN (Project Manager), Janice Malloy MBA (Study Administrator), Scott Janis PhD (NINDS Representative) 

　　The trial is sponsored by NINDS, the Clinical Coordinating Center is based at the Medical University of South Carolina, the Statistical Coordinating Center is based at Emory University, and the Imaging Coordinating Center is based at Washington University.

NINDS (www.ninds.nih.gov) is the nation’s leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world.

　　The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.