Department of Neurosurgery, State University of New York, Health Sciences Center, T-12 080, Stony Brook, NY 11794-8122, USA.
Stroke. 2012 Oct;43(10):2682-8. doi: 10.1161/STROKEAHA.112.661173. Epub 2012 Sep 13.
Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial.
Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm.
Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P ≤ 0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P ≤ 0.05) with ischemic events.
Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice. Clinical Trial Registration Information- URL: http://clinicaltrials.gov. Unique Identifier: NCT00576693.
由于经皮腔内血管成形术和支架置入组与药物组相比，在入组后 30 天内发生中风或死亡的风险较高，因此对颅内狭窄的支架置入和积极药物治疗预防再发中风（SAMMPRIS）试验进行了入组。本分析重点关注可能与试验中经皮腔内血管成形术和支架置入术相关的围手术期脑血管事件相关的患者和手术因素。
进行了双变量和多变量分析，以评估患者和手术变量是否与经皮腔内血管成形术和支架置入组入组后 30 天内（称为围手术期）发生的脑缺血或出血事件相关。
224 例随机分配至经皮腔内血管成形术和支架置入组的患者中，213 例接受单纯血管成形术（n=5）或支架置入术（n=208）。其中，13 例发生出血性中风（7 例实质内，6 例蛛网膜下腔），19 例发生缺血性中风，2 例发生围手术期短暂性脑梗死伴局部体征。缺血性事件分为穿支闭塞（13 例）、栓塞（4 例）、穿支和栓塞混合（2 例）和支架延迟闭塞（2 例）。多变量分析显示，较高的狭窄百分比、较低的改良 Rankin 评分以及与高于目标范围的激活凝血时间相关的氯吡格雷负荷与出血性中风相关（P≤0.05）。不吸烟、基底动脉狭窄、糖尿病和年龄较大与缺血性事件相关（P≤0.05）。
SAMMPRIS 中的围手术期中风有多种原因，最常见的是穿支闭塞。虽然可以确定围手术期中风的危险因素，但将这些特征的患者排除在经皮腔内血管成形术和支架置入术之外以降低手术风险，将使经皮腔内血管成形术和支架置入术仅限于一小部分患者。此外，鉴于事件数量较少，本数据应用于产生假设，而不是指导临床实践中的患者选择。临床试验注册信息- URL：http://clinicaltrials.gov。独特标识符：NCT00576693。
