Josephson S Andrew, Saver Jeffrey L, Smith Wade S
Department of Neurology, University of California, San Francisco, CA, 94143-0114, USA.
Neurocrit Care. 2009;10(1):43-9. doi: 10.1007/s12028-008-9167-7. Epub 2008 Nov 22.
Intraarterial thrombolysis and mechanical embolectomy have been studied for endovascular treatment of stroke. The MERCI and Multi MERCI trials of mechanical embolectomy with or without adjuvant intraarterial thrombolysis demonstrated effective recanalization, but with a higher mortality compared with control patients in the PROACT II trial of intraarterial thrombolysis. Differences in trial design may account for this mortality difference.
We identified patients in the MERCI and Multi MERCI trials who would have been eligible for PROACT II. Rates of good outcome (mRS < or =2) and mortality at 90 days were compared, adjusting for differences in baseline NIHSS score and age.
Sixty-eight patients enrolled in MERCI and 81 enrolled in Multi MERCI were eligible for PROACT II. In both unadjusted and adjusted analyses, PROACT II-eligible embolectomy patients showed a trend toward better clinical outcomes compared to the PROACT II control arm (adjusted, MERCI 35.4% [p = ns], Multi MERCI 42.8% [p = 0.048], PROACT II control, 25.4%). In both unadjusted and adjusted analyses, mortality rates did not significantly differ between embolectomy patients and PROACT II control patients (adjusted analysis, MERCI 29.1%, Multi MERCI 18.0%, PROACT II control, 27.1%). Compared with the PROACT II treatment group, embolectomy groups showed similar rates of good outcome and mortality.
Differences in mortality and proportion of good outcome between the MERCI/Multi MERCI trials and the PROACT II trial are explained by differences in study design and baseline characteristics of patients. Mechanical embolectomy and IA thrombolysis may each be reasonable strategies for acute stroke; a randomized trial is necessary to confirm these results.
动脉内溶栓和机械取栓已被用于研究中风的血管内治疗。MERCI和Multi MERCI试验对机械取栓联合或不联合辅助动脉内溶栓进行了研究,结果显示血管再通有效,但与动脉内溶栓的PROACT II试验中的对照患者相比,死亡率更高。试验设计的差异可能是导致这种死亡率差异的原因。
我们在MERCI和Multi MERCI试验中确定了符合PROACT II标准的患者。比较了90天时的良好预后(改良Rankin量表评分≤2)率和死亡率,并对基线美国国立卫生研究院卒中量表(NIHSS)评分和年龄的差异进行了校正。
MERCI试验中68例患者和Multi MERCI试验中81例患者符合PROACT II标准。在未校正和校正分析中,符合PROACT II标准的取栓患者与PROACT II对照组相比,均显示出临床预后更好的趋势(校正后,MERCI试验为35.4%[p=无统计学意义],Multi MERCI试验为42.8%[p=0.048],PROACT II对照组为25.4%)。在未校正和校正分析中,取栓患者与PROACT II对照患者的死亡率均无显著差异(校正分析,MERCI试验为29.1%,Multi MERCI试验为18.0%,PROACT II对照组为27.1%)。与PROACT II治疗组相比,取栓组的良好预后率和死亡率相似。
MERCI/Multi MERCI试验与PROACT II试验在死亡率和良好预后比例上的差异可通过研究设计和患者基线特征的差异来解释。机械取栓和动脉内溶栓可能都是急性中风的合理治疗策略;需要进行随机试验来证实这些结果。