Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain.
Cerebrovasc Dis. 2014;38(5):328-36. doi: 10.1159/000368433. Epub 2014 Nov 21.
Among the acute ischemic stroke patients with large vessel occlusions and contraindications for the use of IV thrombolysis, mainly on oral anticoagulation or presenting too late, primary endovascular therapy is often performed as an alternative to the standard therapy even though evidence supporting the use of endovascular reperfusion therapies is not yet established. Using different statistical approaches, we compared the functional independence rates at 3 months among patients undergoing primary endovascular therapy and patients treated only with IV thrombolysis.
We used data from a prospective, government-mandated and externally audited registry of reperfusion therapies for ischemic stroke (January 2011 to November 2012). Patients were selected if treated with either IV thrombolysis alone (n = 1,582) or primary endovascular thrombectomy (n = 250). A series of exclusions were made to homogenize the clinical characteristics among the two groups. We then carried out multivariate logistic regression and propensity score matching analyses on the final study sample (n = 1,179) to compare functional independence at 3 months, as measured by the modified Rankin scale scores 0-2, between the two groups.
The unadjusted likelihood of good outcome was poorer among the endovascular group (OR: 0.69; 95% CI: 0.47-1.0). After adjustment, no differences by treatment modality were seen (OR: 1.51; 95% CI: 0.93-2.43 for primary endovascular therapy). Patients undergoing endovascular thrombectomy within 180-270 min (OR: 2.89; 95% CI: 1.17-7.15) and patients with severe strokes (OR: 1.84; 95% CI: 1.02-3.35) did better than their intravenous thrombolysis counterparts. The propensity score-matched analyses with and without adjustment by additional covariates showed that endovascular thrombectomy was as effective as intravenous thrombolysis alone in achieving functional independence (OR for unadjusted propensity score matched: 1.35; 95% CI: 0.9-2.02, OR for adjusted propensity score matched: 1.45; 95% CI: 0.91-2.32).
This comparative effectiveness study shows that in ischemic stroke patients with contraindications for IV thrombolysis, primary endovascular treatment might be an alternative therapy at least as effective as IV thrombolysis alone. Randomized controlled trials are urgently needed.
对于有大血管闭塞且不适合静脉溶栓治疗的急性缺血性脑卒中患者，主要是因为正在服用口服抗凝药物或就诊时间太晚，常采用血管内治疗作为标准治疗的替代方法，尽管支持血管内再灌注治疗的证据尚未确立。本研究采用不同的统计方法，比较了单纯接受静脉溶栓治疗的患者与单纯接受血管内治疗的患者在 3 个月时的功能独立性率。
我们使用了一项前瞻性、政府强制要求和外部审核的缺血性脑卒中再灌注治疗登记研究的数据（2011 年 1 月至 2012 年 11 月）。入选标准为患者接受了单纯静脉溶栓治疗（n=1582）或单纯血管内血栓切除术治疗（n=250）。通过一系列排除标准，使两组的临床特征具有同质性。然后，我们对最终的研究样本（n=1179）进行了多变量逻辑回归和倾向评分匹配分析，以比较两组患者在 3 个月时的功能独立性，通过改良 Rankin 量表评分 0-2 进行评估。
血管内治疗组的预后不良的可能性更大（OR：0.69；95%CI：0.47-1.0）。在调整后，治疗方式之间没有差异（OR：1.51；95%CI：0.93-2.43）。180-270min 内行血管内血栓切除术（OR：2.89；95%CI：1.17-7.15）和病情严重的患者（OR：1.84；95%CI：1.02-3.35）比接受静脉溶栓治疗的患者预后更好。有和没有调整其他协变量的倾向评分匹配分析均表明，血管内血栓切除术与单纯静脉溶栓治疗同样有效，能够实现功能独立性（未调整的倾向评分匹配 OR：1.35；95%CI：0.9-2.02，调整的倾向评分匹配 OR：1.45；95%CI：0.91-2.32）。
这项比较有效性研究表明，对于不适合静脉溶栓治疗的缺血性脑卒中患者，血管内治疗可能是一种有效的替代治疗方法，至少与单纯静脉溶栓治疗效果相当。目前急需开展随机对照试验。
