Trial reportNeurology2022
Stroke Symptoms as a Surrogate in Stroke Primary Prevention Trials: The CREST Experience.
Trial report in Neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
BACKGROUND AND
objectivesThe use of surrogate end points can decrease sample size while maintaining statistical power. This report considers incident stroke symptoms as a surrogate end point in a post hoc analysis of asymptomatic patients from the multicenter, randomized Carotid Revascularization Endarterectomy vs Stenting Trial (CREST).
methodsCREST assessed stroke symptoms using the Questionnaire for Verifying Stroke-free Status (QVSS) at baseline and follow-up. While the primary analysis of CREST defined "asymptomatic" as having been free of stroke/transient ischemic attack for 180 days, herein the population was further restricted by requiring no stroke symptoms at baseline. Incident adjudicated stroke was defined the same as for the primary analysis; incident stroke symptoms was defined as developing ≥1 stroke symptom in follow-up. Treatment differences between stenting (CAS) and endarterectomy (CEA) were assessed for 3 end points: adjudicated stroke, stroke symptoms, and adjudicated stroke or stroke symptoms.
resultsThe cohort included 826 of the 1,181 asymptomatic patients in CREST. Adjudicated stroke events occurred in 44 patients, and incident stroke symptoms occurred in 183. Analysis of adjudicated stroke end points demonstrated a nonsignificant hazard ratio (HR) for CAS compared with CEA of 1.02 (95% CI 0.57-1.85). The corresponding HR for the incident stroke symptoms outcome was 1.54 (95% CI 1.15-2.08), and the HR for the composite outcome of adjudicated stroke or incident symptoms was 1.38 (95% CI 1.04-1.83), both significant. DISCUSSION: The low stroke event rates in asymptomatic patients challenges the assessment of CAS-versus-CEA treatment differences. Incorporating incident stroke symptoms as a surrogate outcome increased the number of events by over 4-fold. The analysis demonstrated a previously unreported significant difference in cerebrovascular risk with CAS compared with CEA. We propose that broadening the end points of primary stroke prevention trials to include surrogate events such as incident stroke symptoms could make trials more feasible.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.