Dataset Information

Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.

ABSTRACT: Background and Purpose- While combination aspirin and clopidogrel reduces recurrent stroke compared with aspirin alone in patients with transient ischemic attack (TIA) or minor stroke, the effect on disability is uncertain. Methods- The POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) randomized patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ?3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, myocardial infarction, or vascular death. We performed a post hoc exploratory analysis to examine the effect of treatment on overall disability (defined as modified Rankin Scale score >1) at 90 days, as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results- At 90 days, 188 of 1964 (9.6%) of patients enrolled with TIA and 471 of 2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% versus 14.3%; odds ratio, 0.97 [95% CI, 0.82-1.14]; P=0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% versus 4.0%; odds ratio, 0.73 [95% CI, 0.53-1.01]; P=0.06) and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% versus 7.4%; odds ratio, 0.78 [95% CI, 0.62-0.99]; P=0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% versus 6.0%; odds ratio, 0.74 [95% CI, 0.57-0.96]; P=0.02). In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability. Conclusions- In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, DAPT might reduce stroke-related disability. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00991029.

SUBMITTER: Cucchiara B

PROVIDER: S-EPMC7313376 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.

Cucchiara Brett B Elm Jordan J Easton J Donald JD Coutts Shelagh B SB Willey Joshua Z JZ Biros Michelle H MH Ross Michael A MA Johnston S Claiborne SC

Stroke 20200212 3

Background and Purpose- While combination aspirin and clopidogrel reduces recurrent stroke compared with aspirin alone in patients with transient ischemic attack (TIA) or minor stroke, the effect on disability is uncertain. Methods- The POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) randomized patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopi ...[more]

PMID: 32078486

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Project description:ImportanceStroke incidence is higher among black than white individuals in the United States. It is unclear whether black individuals have a higher risk of stroke recurrence after a minor ischemic stroke or transient ischemic attack (TIA), a high-risk setting in which focused preventive efforts can be effective.ObjectiveTo examine the association between black race and early ischemic stroke recurrence.Design, setting, and participantsThis cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017. The trial enrolled 4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4). For this analysis, we excluded 598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data.Main outcomes and measuresThe primary outcome for this analysis was ischemic stroke within 90 days after randomization. Covariates included age, sex, Hispanic ethnicity, study assignment to take clopidogrel vs placebo, index stroke vs TIA, vascular risk factors, statin use, study drug adherence, and index event etiological subtype.ResultsAmong 4044 patients included in the analysis, 918 (22.7%) were black. In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3). Findings were similar in subgroup analyses and in analyses limited to sites that enrolled black patients.Conclusions and relevanceAmong US participants in the POINT trial, black individuals faced a higher risk of early stroke recurrence after a minor ischemic stroke or TIA. Our findings support research into black-white racial differences in the underlying mechanisms of recurrent stroke. In the meantime, extra effort should be made to ensure that black patients have access to proven secondary prevention measures.Trial registrationclinicaltrials.gov Identifier: NCT00991029.

Project description:Background and purposePremature death after transient ischemic attack or stroke is more often because of heart disease or cancer than stroke. Previous studies found blood biomarkers not usefully predictive of nonfatal stroke but possibly of all-cause death. This association might be explained by potentially treatable occult cardiac disease or cancer. We therefore aimed to validate the association of a panel of biomarkers with all-cause death, particularly cardiac death and cancer death, despite the absence of associations with risk of nonfatal vascular events.MethodsFifteen biomarkers were measured in 929 consecutive patients in a population-based study (Oxford Vascular Study), recruited from 2002 and followed up to 2013. Associations were determined by Cox regression. Model discrimination was assessed by c-statistic and the integrated discrimination improvement.ResultsDuring 5560 patient-years of follow-up, none of the biomarkers predicted risk of nonfatal vascular events. However, soluble tumor necrosis factor α receptor-1, von Willebrand factor, heart-type fatty-acid-binding protein, and N-terminal pro-B-type natriuretic peptide were independently predictive of all-cause death (n=361; adjusted hazard ratio per SD, 95% confidence interval: heart-type fatty-acid-binding protein: 1.31, 1.12-1.56, P=0.002; N-terminal pro-B-type natriuretic peptide: 1.34, 1.11-1.62, P=0.002; soluble tumor necrosis factor α receptor-1: 1.45, 1.26-1.66, P=0.02; von Willebrand factor: 1.19, 1.04-1.36, P=0.01). The independent contribution of the four biomarkers taken together added prognostic information and improved model discrimination (integrated discrimination improvement=0.028, P=0.0001). N-terminal pro-B-type natriuretic peptide was most predictive of vascular death (adjusted hazard ratio=1.80, 95% confidence interval, 1.34-2.41, P<0.0001), whereas heart-type fatty-acid-binding protein predicted cancer deaths (1.64, 1.26-2.12, P=0.0002). Associations were strongest in patients without known prior cardiac disease or cancer.ConclusionsSeveral biomarkers predicted death of any cause after transient ischemic attack and minor stroke. N-terminal pro-B-type natriuretic peptide and heart-type fatty-acid-binding protein might improve patient selection for additional screening for occult cardiac disease or cancer, respectively. However, our results require validation in future studies.

Project description:Importance:The timely delivery of guideline-concordant care may reduce the risk of recurrent vascular events for patients with transient ischemic attack (TIA) and minor stroke. Although many health care organizations measure stroke care quality, few evaluate performance for patients with TIA or minor stroke, and most include only a limited subset of guideline-recommended processes. Objective:To assess the quality of guideline-recommended TIA and minor stroke care across the Veterans Health Administration (VHA) system nationwide. Design, Setting, and Participants:This cohort study included 8201 patients with TIA or minor stroke cared for in any VHA emergency department (ED) or inpatient setting during federal fiscal year 2014 (October 1, 2013, through September 31, 2014). Patients with length of stay longer than 6 days, ventilator use, feeding tube use, coma, intensive care unit stay, inpatient rehabilitation stay before discharge, or receipt of thrombolysis were excluded. Outlier facilities for each process of care were identified by constructing 95% CIs around the facility pass rate and national pass rate sites when the 95% CIs did not overlap. Data analysis occurred from January 16, 2016, through June 30, 2017. Main Outcomes and Measures:Ten elements of care were assessed using validated electronic quality measures. Results:In the 8201 patients included in the study (mean [SD] age, 68.8 [11.4] years; 7877 [96.0%] male; 4856 [59.2%] white), performance varied across elements of care: brain imaging by day 2 (6720/7563 [88.9%]; 95% CI, 88.2%-89.6%), antithrombotic use by day 2 (6265/7477 [83.8%]; 95% CI, 83.0%-84.6%), hemoglobin A1c measurement by discharge or within the preceding 120 days (2859/3464 [82.5%]; 95% CI, 81.2%-83.8%), anticoagulation for atrial fibrillation by day 7 after discharge (1003/1222 [82.1%]; 95% CI, 80.0%-84.2%), deep vein thrombosis prophylaxis by day 2 (3253/4346 [74.9%]; 95% CI, 73.6%-76.2%), hypertension control by day 90 after discharge (4292/5979 [71.8%]; 95% CI, 70.7%-72.9%), neurology consultation by day 1 (5521/7823 [70.6%]; 95% CI, 69.6%-71.6%), electrocardiography by day 2 or within 1 day prior (5073/7570 [67.0%]; 95% CI, 65.9%-68.1%), carotid artery imaging by day 2 or within 6 months prior (4923/7685 [64.1%]; 95% CI, 63.0%-65.2%), and moderate- to high-potency statin prescription by day 7 after discharge (3329/7054 [47.2%]; 95% CI, 46.0%-48.4%). Performance varied substantially across facilities (eg, neurology consultation had a facility outlier rate of 53.0%). Performance was higher for admitted patients than for patients cared for only in EDs with the greatest disparity for carotid artery imaging (4478/5927 [75.6%] vs 445/1758 [25.3%]; P < .001). Conclusions and Relevance:This national study of VHA system quality of care for patients with TIA or minor stroke identified opportunities to improve care quality, particularly for patients who were discharged from the ED. Health care systems should engage in ongoing TIA care performance assessment to complement existing stroke performance measurement.

Dataset Information

Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.

Publications

Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.

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