Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).
Berlin Institute of Health, Germany (M.A., J.E.W.).
Stroke. 2022 Sep;53(9):2730-2738. doi: 10.1161/STROKEAHA.120.037503. Epub 2022 Jun 15.
The INSPiRE-TMS trial (Intensified Secondary Prevention Intending a Reduction of Recurrent Events in Transient Ischemic Attack and Minor Stroke Patients) investigated effects of a multicomponent support program in patients with nondisabling stroke or transient ischemic attack. Although secondary prevention targets were achieved more frequently in the intensified care group, no significant differences were seen in rates of recurrent major vascular events. Here, we present the effects on prespecified patient-centered outcomes.
In a multicenter trial, we randomized patients with modifiable risk factors either to the intensified or conventional care alone program. Intensified care was provided by stroke specialists and used feedback and motivational interviewing strategies (≥8 outpatient visits over 2 years) aiming to improve adherence to secondary prevention targets. We measured physical fitness, disability, cognitive function and health-related quality of life by stair-climbing test, modified Rankin Scale, Montreal Cognitive Assessment, and European Quality of Life 5 Dimension 3 Level during the first 3 years of follow-up.
Of 2072 patients (mean age: 67.4years, 34% female) assessed for the primary outcome, patient-centered outcomes were collected in 1,771 patients (877 intensified versus 894 conventional care group). Physical fitness improved more in the intensified care group (mean between-group difference in power (Watt): 24.5 after 1 year (95% CI, 5.5-43.5); 36.1 after 2 years (95% CI, 13.1-59.7) and 29.6 (95% CI, 2.0-57.3 after 3 years). At 1 year, there was a significant shift in ordinal regression analysis of modified Rankin Scale in favor of the intensified care group (common odds ratio, 1.23 [95% CI, 1.03-1.47]) but not after 2 (odds ratio, 1.17 [95% CI, 0.96-1.41]) or 3 years (odds ratio, 1.16 [95% CI, 0.95-1.43]) of follow-up. However, Montreal Cognitive Assessment and European Quality of Life 5 Dimension scores showed no improvement in the intensified intervention arm after 1, 2, or 3 years of follow-up.
Patients of the intensified care program group had slightly better results for physical fitness and modified Rankin Scale after 1 year, but none of the other patient-centered outcomes was significantly improved.
URL: https://www.
gov; Unique identifier: NCT01586702.
INSPiRE-TMS 试验（旨在减少短暂性脑缺血发作和小卒中患者复发事件的强化二级预防）研究了多组分支持计划对非致残性卒中和短暂性脑缺血发作患者的影响。尽管强化护理组更频繁地达到了二级预防目标，但在复发性主要血管事件的发生率方面没有显著差异。在这里，我们介绍了对预先指定的以患者为中心的结果的影响。
在一项多中心试验中，我们将有可改变风险因素的患者随机分配到强化护理或常规护理组。强化护理由卒中专家提供，并使用反馈和动机访谈策略（2 年内至少 8 次门诊就诊），旨在提高对二级预防目标的依从性。我们在最初的 3 年随访期间通过爬楼梯测试、改良 Rankin 量表、蒙特利尔认知评估和欧洲生活质量 5 维 3 级量表来测量身体适应性、残疾、认知功能和健康相关生活质量。
在评估主要结局的 2072 名患者中，有 1771 名患者（强化护理组 877 名，常规护理组 894 名）收集了以患者为中心的结局。强化护理组的身体适应性改善更为明显（1 年后的组间差异均值（瓦特）：24.5（95%CI，5.5-43.5）；2 年后为 36.1（95%CI，13.1-59.7）；3 年后为 29.6（95%CI，2.0-57.3））。在 1 年时，改良 Rankin 量表的有序回归分析倾向于强化护理组（常见优势比，1.23[95%CI，1.03-1.47]），但在 2 年（优势比，1.17[95%CI，0.96-1.41]）或 3 年（优势比，1.16[95%CI，0.95-1.43]）时则没有。然而，蒙特利尔认知评估和欧洲生活质量 5 维 3 级评分在 1、2 或 3 年的随访中均未显示强化干预组有改善。
强化护理组的患者在 1 年后的身体适应性和改良 Rankin 量表方面有略好的结果，但其他以患者为中心的结果均无显著改善。
NCT01586702。
