重与中度颅内动脉狭窄择期支架成形术的比较研究

Comparison of Elective Stenting between Severe and Moderate Intracranial Atherosclerotic Stenoses

目的症状性重度颅内动脉粥样硬化性狭窄患者在择期支架成形术治疗后,卒中复发风险可能仍较中度狭窄者为高。本研究旨在检验这个假设,并探索卒中复发的关联因素。方法2001年9月-2005年6月,213例患者因220处症状性颅内动脉粥样硬化性狭窄在北京天坛医院接受了择期支架成形术治疗。121例患者的126处病变为重度狭窄（狭窄率〉70%）;92例患者的94处病变为中度狭窄（狭窄率50%-69%）。研究的主要终点事件是靶病变关联性缺血性卒中、症状性脑实质出血和蛛网膜下腔出血。结果重度狭窄组有10个主要终点事件,6个发生在术后30 d内,4个发生在30 d后平均随访26.0个月期间;中度狭窄组有7个主要终点事件,4个发生在术后30 d内,3个发生在30 d后平均随访27.6个月期间。重度狭窄组的主要终点事件累积概率第1年为7.2%,第2年为8.2%;中度狭窄组的主要终点事件累积概率第1年为5.3%,第2年为8.3%;2组间差异无统计学意义。在中度狭窄组未能发现主要终点事件关联因素;在重度狭窄组,多因素分析显示支架术失败是发生主要终点事件的独立预测因素（HR为5.31,C I为1.35-20.91）。结论症状性重度颅内动脉粥样硬化性狭窄患者,在择期支架成形术治疗后并未呈现较中度狭窄者为高的卒中复发风险。重度动脉粥样硬化性狭窄患者能够从成功的支架成形术中获益。

Objective To investigate whether symptomatic severe intracranial atherosclerotic stenosis was associated with a higher subsequent stroke risk than moderate stenosis after elective angioplasty with balloon-expandable stent and to explore which factors were associated with the subsequent stroke.Methods During September 2001 till June 2005,there were 220 symptomatic intracranial atherosclerotic stenoses in 213 patients undergoing elective stenting at our institute.Of these stenoses,126 in 121 patients had ≥70% severe stenoses,and 94 in 92 patients had 50%~69% moderate stenoses.Primary endpoints included lesion-related ischemic stroke,and symptomatic brain or subarachnoid hemorrhages.Results Ten primary endpoint events occurred in the severe stenosis group（six within 30 days and four in mean follow-up of 26.0 months after 30 days）,and seven occurred in the moderate stenosis group（four within 30 days and 3 in mean follow-up of 27.6 months after 30 days）.There was no significant difference in cumulative probability of primary endpoints between the severe（7.2% at 1 year and 8.2% at 2 years） and moderate（5.3% at 1 year and 8.3% at 2 years） stenoses groups.No single factor was found to be associated with primary endpoints in the moderate stenosis group.Multivariable analysis revealed that stent failure was the only predictor of primary endpoints in the severe stenosis group（hazard 5.31,95% CI 1.35 to 20.91）.Conclusion Symptomatic severe intracranial atherosclerotic stenosis did not present a higher subsequent stroke risk than moderate stenosis after elective angioplasty with balloon-expandable stent.Patients with severe stenosis may benefit from successful stent placement,and randomized trials are necessary to demonstrate this possible benefit.