BACKGROUND:Outcome in stroke trials is often based on a 3-month modified Rankin scale (mRS). How 3-month mRS relates to longer-term outcomes will depend on late recovery, delayed stroke-related deaths, recurrent strokes, and nonstroke deaths. We evaluated 3-month mRS and death/disability at 1 and 5 years in a population-based cohort study. METHODS AND RESULTS:In 3-month survivors of ischemic stroke (Oxford Vascular Study; 2002-2014), we related 3-month mRS to disability (defined as mRS >2) at 1 and 5 years and/or death rates (age/sex adjusted). Accrual of disability and index-stroke-related and nonstroke deaths in each poststroke year was categorized according to 3-month mRS. Among 1606 patients with acute ischemic stroke, 181 died within 3 months, but 126 index-stroke-related deaths and 320 other deaths occurred during the subsequent 4866 patient-years of follow-up up to 5 years. Although 69/126 (54.8%) post-3-month index-stroke-related deaths occurred after 1 year, mRS>2 at 1 year strongly predicted these deaths (adjusted hazard ratio=21.94, 95%CI 7.88-61.09, P<0.0001). Consequently, a 3-month mRS >2 was a strong independent predictor of death at both 1 year (adjusted hazard ratio=6.67, 95%CI 4.16-10.69, P<0.0001) and 5 years (adjusted hazard ratio=2.93, 95%CI 2.38-3.60, P<0.0001). Although mRS improved by ≥1 point from 3 months to 1 year in 317/1266 (25.0%) patients with 3-month mRS ≥1, improvement in mRS after 1 year was limited (improvement by ≥1 point: 91/858 [10.6%]; improvement to mRS ≤2: 13/353 [3.7%]). CONCLUSIONS:Our results reaffirm use of the 3-month mRS outcome in stroke trials. Although later recovery does occur, extending follow-up to 1 year would capture most long-term stroke-related disability. However, administrative mortality follow-up beyond 1 year has the potential to demonstrate translation of early disability gains into additional reductions in long-term mortality without much erosion by non-stroke-related deaths.

译文

背景:中风试验的结果通常基于3个月的改良兰金量表(mRS)。 3个月的mRS与长期结果的关系将取决于晚期康复,中风相关的延迟死亡,中风复发和非中风死亡。在一项基于人群的队列研究中,我们评估了3个月的mRS和1年和5年时的死亡/残疾。
方法和结果:在3个月的缺血性卒中幸存者中(牛津血管研究; 2002-2014年),我们将3个月的mRS与1岁和5岁时的残疾(定义为mRS> 2)和/或死亡率(年龄/性别调整)。根据每个月的3个月mRS对残疾的累积以及与卒中相关的卒中和非卒中死亡进行分类。在1606例急性缺血性中风患者中,有3个月内有181例死亡,但在随后的4866个患者年的随访中(长达5年)发生了126例与中风相关的死亡,还有320例其他死亡。尽管1年后发生69/126(54.8%)的3个月后与指数卒中相关的死亡,但1年时的mRS> 2强烈预测了这些死亡(调整后的危险比= 21.94,95%CI 7.88-61.09,P < 0.0001)。因此,在1年(调整后的危险比= 6.67,95%CI 4.16-10.69,P <0.0001)和5年(调整后的危险比= 2.93,95%)下,三个月的mRS> 2是死亡的强有力的独立预测因子。 CI 2.38-3.60,P <0.0001)。尽管317/1266(35.0%)3个月mRS≥1的患者在3个月至1年间mRS改善了≥1点,但1年后mRS的改善是有限的(≥1点的改善:91/858 [10.6 %]; mRS≤2的改善:13/353 [3.7%])。
结论:我们的研究结果重申了在卒中试验中使用3个月的mRS结果。尽管确实会出现稍后的康复,但将随访延长至1年将捕获大多数与中风相关的长期残疾。但是,对1年以上的行政死亡率进行随访,有可能证明将早期残疾的增加转化为长期死亡率的进一步降低,而不会因非中风相关的死亡而受到很大的侵蚀。

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