Home Time Is Extended in Patients With Ischemic Stroke Who Receive Thrombolytic Therapy

Abstract

Background and Purpose-"Home time" (HT) refers to the number of days over the first 90 after stroke onset that a patient spends residing in their own home or a relative's home versus any institutional care. It is an accessible and objective parameter, free from subjective bias, with potential as an outcome measure in acute stroke trials. We sought to validate HT and assess treatment responsiveness using independent data. Methods-We estimated HT in the Stroke Acute Ischemic NXY Treatment (SAINT) I neuroprotection trial. We compared outcomes between thrombolyzed (T) and nonthrombolyzed comparators (C) using HT and the modified Rankin Scale.For our primary analysis, we adjusted for baseline covariates that significantly influence HT and in sensitivity analyses considered all variables that differed between groups at baseline. We report ordinal logistic regression and analysis of covariance with 95% CIs. We describe the relationship of HT with baseline National Institutes of Health Stroke Scale and its components and with Day 90 modified Rankin Scale and Barthel Index. Results-SAINT I included 1699 patients from 23 countries, of whom 28.7% received alteplase. HT correlated with age, baseline severity, alteplase use, side of ischemic lesion, presence of diabetes, and country of patient enrolment (each PϽ0.05). We found an association between use of alteplase with better adjusted outcomes by either measure (OR for extended HT, 1.36; 95% CI, 1.08 to 1.72; Pϭ0.009; analysis of covariance Pϭ0.007 with a 5.5-day advantage; OR for more favorable modified Rankin Scale, 1.6; 95% CI, 1.28 to 2.00; PϽ0.0001; Cochran-Mantel-Haenszel Pϭ0.046). HT was significantly associated with baseline National Institutes of Health Stroke Scale and each component of the National Institutes of Health Stroke Scale except level of consciousness, dysarthria, and ataxia. HT was significantly associated with Day 90 modified Rankin Scale and Barthel Index. Conclusions-HT is a responsive measure for use in multinational acute stroke trials. Its inclusion as a complementary outcome is reasonable. We propose treatment effects are adjusted for age, baseline National Institutes of Health Stroke Scale, side of stroke lesion, country of enrollment, and the presence of diabetes.

Assessment of Home-Time After Acute Ischemic Stroke in Medicare Beneficiaries

“…In an analysis of the Stroke Acute Ischemic NXY Treatment (SAINT) I trial, tissue-type plasmiogen activator treatment was associated with a 5.5-day gain in home-time, and home-time was correlated with mRS (R 2 =57.5%; P<0.0001). 6 Stroke severity by NIHSS was also inversely associated with home-time. 6 The findings of the present study extend these findings to a cohort of Medicare Beneficiaries encountered in clinical practice and measuring home-time with administrative data.…”

“…6 Stroke severity by NIHSS was also inversely associated with home-time. 6 The findings of the present study extend these findings to a cohort of Medicare Beneficiaries encountered in clinical practice and measuring home-time with administrative data. Home-time was closely correlated with mRS. Clinical variables, including stroke severity by NIHSS, associated with worse functional outcomes in previous studies, Odds ratio indicates the ratio of odds that the patient is home on any given day between presence vs absence of the factor.…”

“…5,6 Even with the use of standardized instruments and formal training, mRS can be limited by interobserver variability. 1,4 Home-time, can be easily, objectively, and reproducibly measured from clinical or claims data and is not dependent on the level of training and interpretation of those performing the assessment.…”

“…In addition, as a continuous measure with an expanded range, home-time as an outcome measure may lend itself to statistical analyses with greater discrimination than potentially more limited categorical or ordinal outcome measures. 6 An additional strength of home-time is that it may be more easily understood by patient and family members than other functional scales and potentially more useful in engaging patients and family members in shared decision making. 5,8,9 Home-time may also be an important measure from the perspective of health system administrators and insurers as increased time in the hospital, inpatient rehabilitation, and skilled nursing care facilities entails substantial additional expenditures.…”

“…5 This has been proposed as a graded and objective functional outcome measure for international acute ischemic stroke trials and has been shown to correlate with mRS in clinical trial populations and demonstrate gains in response to effective stroke therapies, such as intravenous tissue-type plasmiogen activator and mechanical thrombectomy treatment. [5][6][7] More recently, stroke survivors have identified home-time as a meaningful and highly prioritized outcome. [8][9][10] Home-time may thus represent an outcome measure that is more easily understood by patients with stroke, their families, and clinicians.…”