Importance:Transcatheter closure of patent foramen ovale (PFO) is a definitive therapy to prevent recurrent ischemic events in patients with PFO-associated embolism. However, very long-term outcome data remain scarce; these data are essential to fully understand the enduring safety and efficacy of this therapy. Objective:To assess the 20-year clinical outcomes following PFO closure in patients with PFO-associated embolism. Design, Setting, and Participants:This single-center cohort study with prospective procedure, early follow-up data collection, and retrospective long-term follow-up took place at a tertiary university hospital. The study included 130 consecutive patients who had PFO closure for cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolism between 2001 and 2006. These data were analyzed from February 2025 to June 2025. Exposure:All PFO closure procedures were technically successful and echocardiographic follow-up was performed within 1 to 6 months. Main Outcomes and Measures:Long-term clinical outcomes were assessed via medical record review and telephone interviews. Results:Mean (SD) age of the study population was 46 (14) years, with 67 women (51.5%) and 63 men (48.5%). Follow-up was complete for all but 5 patients (3.8%). At 20-year follow-up, a total of 20 patients (15.3%) had died (noncardiovascular causes in 12.2%) and recurrent ischemic events were infrequent (1 stroke [0.04 per 100 patients, per year] and 6 TIAs [0.25 per 100 patients, per year]). There was a higher prevalence of thrombophilia among patients who had recurrent ischemic events (33% vs 4.8%; P = .04). Up to 20.5% of patients discontinued antithrombotic treatment and none of them had any ischemic event at follow-up. Bleeding events occurred in 17 patients (13%) with 9 cases (6.9%) classified as major. These events were more frequent in women (19.4% vs 6.3%; P = .03) and occurred exclusively in patients receiving long-term antithrombotic therapy (17% vs 0% in patients who discontinued antithrombotic treatment; P = .04). Conclusions and Relevance:The results of this cohort study with 20-year follow-up showed the sustained very long-term safety and efficacy of transcatheter PFO closure, with less than 1% rate of recurrent stroke events. However, bleeding events occurred in about 1 in 10 patients and were more frequent in women and in patients under long-term antithrombotic therapy. These findings underscore the need for tailored long-term antithrombotic strategies after PFO closure. Further studies are warranted.

BACKGROUND:Improvements in medical therapy, carotid-artery stenting, and carotid endarterectomy call into question the preferred management of asymptomatic carotid stenosis. Whether adding revascularization to intensive medical management would provide greater benefit than intensive medical management alone is unclear. METHODS:We conducted two parallel, observer-blinded clinical trials that enrolled patients with high-grade (≥70%) asymptomatic carotid stenosis across 155 centers in five countries. The stenting trial compared intensive medical management alone (medical-therapy group) with carotid-artery stenting plus intensive medical management (stenting group); the endarterectomy trial compared intensive medical management alone (medical-therapy group) with carotid endarterectomy plus intensive medical management (endarterectomy group). The primary outcome was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke, assessed during the remaining follow-up period up to 4 years. RESULTS:A total of 1245 patients underwent randomization in the stenting trial and 1240 in the endarterectomy trial. In the stenting trial, the 4-year incidence of primary-outcome events was 6.0% (95% confidence interval [CI], 3.8 to 8.3) in the medical-therapy group and 2.8% (95% CI, 1.5 to 4.3) in the stenting group (P = 0.02 for the absolute difference). In the endarterectomy trial, the 4-year incidence of primary-outcome events was 5.3% (95% CI, 3.3 to 7.4) in the medical-therapy group and 3.7% (95% CI, 2.1 to 5.5) in the endarterectomy group (P = 0.24 for the absolute difference). From day 0 to 44, in the stenting trial, no strokes or deaths occurred in the medical-therapy group and seven strokes and one death occurred in the stenting group; in the endarterectomy trial, three strokes occurred in the medical-therapy group and nine strokes occurred in the endarterectomy group. CONCLUSIONS:Among patients with high-grade stenosis without recent symptoms, the addition of stenting led to a lower risk of a composite of perioperative stroke or death or ipsilateral stroke within 4 years than intensive medical management alone. Carotid endarterectomy did not lead to a significant benefit. (Funded by the National Institute of Neurological Disorders and Stroke and others; CREST-2 ClinicalTrials.gov number, NCT02089217.).

Diffusion weighted magnetic resonance imaging’s (MRI) role in predicting subsequent strokes beyond the validated Canadian TIA Score in in transient ischemic attack (TIA)/minor stroke patients with normal CT scans is unknown. In this study, we assessed the incidence of acute cerebral infarction on MRI in these patients, overall and stratified by the Canadian TIA Score levels and then we assessed subsequent stroke rates at 7, 30 and 90 days based on the presence of acute infarct on MRI. This pre-planned substudy of the Canadian TIA risk score cohort was conducted across 13 Canadian emergency departments over an 11-year period. Eligible patients included adult TIA/minor stroke patients with negative CT scans who underwent MRI within 7 days. Among 11,507 patients, 1048 with negative CT scans had early MRI, which revealed infarction in 330 (31.5

Background: We aimed to derive a clinical decision rule to identify patients with transient ischemic attack (TIA) or minor stroke most likely to benefit from echocardiography. Methods: This multicentre prospective cohort study enrolled adults diagnosed with TIA/minor stroke in the emergency department who underwent echocardiograms within 90 days, from 13 Canadian academic emergency departments from October 2006 to May 2017. Our outcome was clinically significant echocardiogram findings. Results: In 7149 eligible patients, a clinically significant fi nding was found in 556 (7.8%). There were a further 2421 (33.9%) with potentially significant findings. History of heart failure (adjusted odds ratio [OR], 3.9) or coronary artery disease (OR, 2.7) were the factors most strongly associated with clinically significant echocardiogram findings, whereas young age, male sex, valvular heart disease, and infarct (any age) on neuroimaging were modestly associated (OR, 1.3-1.9). The model combining these predictors into a score (range: 0-15), had a Cstatistic of 0.67 (95% confidence interval [CI], 0.65-0.70). A cut point of 6 points or more classified 6.6% of cases as high likelihood, defined as > 15% for clinically significant echocardiogram findings. Conclusions: Echocardiography is a very useful test in the investigations of patients with TIA/minor stroke. We identified high-risk clinical features- combined to create a clinical decision rule- to identify which patients with TIA/minor stroke are likely to have clinically significant echocardiogram findings requiring an immediate change in management. These patients should have echocardiography prioritized, whereas others may continue to have echocardiography conducted in a less urgent fashion.

Emergent vascular imaging identifies a subset of patients requiring immediate specialized care (i.e. carotid stenosis > 50

Introduction: Patients with a diagnosis of transient ischemic attack (TIA) or minor stroke with an acute infarction on brain imaging are at higher risk of subsequent stroke. Our goal was to establish if the Canadian TIA Score (CTS) could predict infarction on magnetic resonance imaging (MRI) when a computed tomography (CT) scan was negative for stroke and aimed to identify clinical factors predictive of a positive MRI. Methods: Patients were selected from the prospective cohort used for the validation of the CTS in 13 centers. Patients with negative CT scans who underwent MRI within 7 days were analyzed. The main outcome was cerebral infarction defined as MRI diffusion-weighted imaging (DWI) positivity. Associations between confirmed stroke and demographic characteristics, clinical features, laboratory findings, and medications were determined using a multivariate logistic regression model. Subsequent stroke rate at 7, 30, and 90 days was analyzed. Results: From 11,507 patients, 1,048 met inclusion criteria. MRI positivity was 15.4%, 30.4%, and 50.0% for the low, medium, and high-risk CTS groups, respectively. Subsequent stroke/TIA rates were higher with confirmed ischemic lesions on MRI at 90 days: twice (10.0%) in the low-risk group, 51 (22.3%) in the medium-risk group, and 20 (24.7%) in high-risk patients. 1.7% of DWI negative patients had a subsequent stroke. Predictive factors in multivariable models for DWI positivity in the medium-risk group were male (OR=1.53; 95% CI 1.11-2.12), hypertension (OR=1.63; 95% CI 1.17-2.27), clinical history of unilateral weakness (OR=2.09; 95% CI 1.50-2.91), language disturbance (OR=1.43; 95% CI 1.03-1.97), and the presence of pronator drift on examination (OR=2.18; 95% CI 1.37-3.47). Conclusion: The CTS helps predict MRI findings and confirmed ischemic lesion is a predictor of the recurrence risk of stroke. The low-risk group showed few positive MRIs and had a lower recurrence rate justifying less urgent MRI. In the medium-risk group, we highlighted findings that should raise the suspicion of an ischemic lesion and these patients should be prioritize for rapid investigation of stroke etiology. In the high-risk group, patients are at risk for stroke despite negative imaging and MRI should not delay management.

Background For patients with atrial fibrillation seen in the emergency department (ED) following a transient ischemic attack (TIA) or minor stroke, the impact of initiating oral anticoagulation immediately rather than deferring the decision to outpatient follow‐up is unknown. Methods and Results We conducted a planned secondary data analysis of a prospective cohort of 11 507 adults in 13 Canadian EDs between 2006 and 2018. Patients were eligible if they were aged 18 years or older, with a final diagnosis of TIA or minor stroke with previously documented or newly diagnosed atrial fibrillation. The primary outcome was subsequent stroke, recurrent TIA, or all‐cause mortality within 90 days of the index TIA diagnosis. Secondary outcomes included stroke, recurrent TIA, or death and rates of major bleeding. Of 11 507 subjects with TIA/minor stroke, atrial fibrillation was identified in 11.2% (1286, mean age, 77.3 [SD 11.1] years, 52.4% male). Over half (699; 54.4%) were already taking anticoagulation, 89 (6.9%) were newly prescribed anticoagulation in the ED. By 90 days, 4.0% of the atrial fibrillation cohort had experienced a subsequent stroke, 6.5% subsequent TIA, and 2.6% died. Results of a multivariable logistic regression indicate no association between prescribed anticoagulation in the ED and these 90‐day outcomes (composite odds ratio, 1.37 [95% CI, 0.74–2.52]). Major bleeding was found in 5 patients, none of whom were in the ED‐initiated anticoagulation group. Conclusions Initiating oral anticoagulation in the ED following new TIA was not associated with lower recurrence rates of neurovascular events or all‐cause mortality in patients with atrial fibrillation.

Stroke presenting as dizziness is a diagnostic challenge in frontline settings, given the multitude of benign conditions that present similarly. The risk of stroke after episodic dizziness is unknown, leading to divergent guidance on optimal workup and management. Prior TIA risk scores have shown a history of dizziness is a negative predictor of subsequent stroke. Our objective was to assess the subsequent stroke risk within 90 days following emergency department assessment (ED) for isolated dizziness diagnosed as TIA during the index visit. We conducted prospective, multicenter cohort studies at 13 Canadian EDs over 11 years. We enrolled patients diagnosed with TIA and compared patients with isolated dizziness to those with other neurological deficits. Our primary outcome was subsequent stroke within 90 days. Secondary outcomes were subsequent stroke within 2, 7, and 30 days, respectively, as well as subsequent TIA within 90 days. Only 4/483 (0.8

OBJECTIVE:To validate the previously derived Canadian TIA Score to stratify subsequent stroke risk in a new cohort of emergency department patients with transient ischaemic attack. DESIGN:Prospective cohort study. SETTING:13 Canadian emergency departments over five years. PARTICIPANTS:7607 consecutively enrolled adult patients attending the emergency department with transient ischaemic attack or minor stroke. MAIN OUTCOME MEASURES:The primary outcome was subsequent stroke or carotid endarterectomy/carotid artery stenting within seven days. The secondary outcome was subsequent stroke within seven days (with or without carotid endarterectomy/carotid artery stenting). Telephone follow-up used the validated Questionnaire for Verifying Stroke Free Status at seven and 90 days. All outcomes were adjudicated by panels of three stroke experts, blinded to the index emergency department visit. RESULTS:Of the 7607 patients, 108 (1.4%) had a subsequent stroke within seven days, 83 (1.1%) had carotid endarterectomy/carotid artery stenting within seven days, and nine had both. The Canadian TIA Score stratified the risk of stroke, carotid endarterectomy/carotid artery stenting, or both within seven days as low (risk ≤0.5%; interval likelihood ratio 0.20, 95% confidence interval 0.09 to 0.44), medium (risk 2.3%; interval likelihood ratio 0.94, 0.85 to 1.04), and high (risk 5.9% interval likelihood ratio 2.56, 2.02 to 3.25) more accurately (area under the curve 0.70, 95% confidence interval 0.66 to 0.73) than did the ABCD2 (0.60, 0.55 to 0.64) or ABCD2i (0.64, 0.59 to 0.68). Results were similar for subsequent stroke regardless of carotid endarterectomy/carotid artery stenting within seven days. CONCLUSION:The Canadian TIA Score stratifies patients' seven day risk for stroke, with or without carotid endarterectomy/carotid artery stenting, and is now ready for clinical use. Incorporating this validated risk estimate into management plans should improve early decision making at the index emergency visit regarding benefits of hospital admission, timing of investigations, and prioritisation of specialist referral.

OBJECTIVE:To measure the global impact of COVID-19 pandemic on volumes of IV thrombolysis (IVT), IVT transfers, and stroke hospitalizations over 4 months at the height of the pandemic (March 1 to June 30, 2020) compared with 2 control 4-month periods.METHODS:We conducted a cross-sectional, observational, retrospective study across 6 continents, 70 countries, and 457 stroke centers. Diagnoses were identified by their ICD-10 codes or classifications in stroke databases.RESULTS:There were 91,373 stroke admissions in the 4 months immediately before compared to 80,894 admissions during the pandemic months, representing an 11.5% (95% confidence interval [CI] -11.7 to -11.3, p < 0.0001) decline. There were 13,334 IVT therapies in the 4 months preceding compared to 11,570 procedures during the pandemic, representing a 13.2% (95% CI -13.8 to -12.7, p < 0.0001) drop. Interfacility IVT transfers decreased from 1,337 to 1,178, or an 11.9% decrease (95% CI -13.7 to -10.3, p = 0.001). Recovery of stroke hospitalization volume (9.5%, 95% CI 9.2-9.8, p < 0.0001) was noted over the 2 later (May, June) vs the 2 earlier (March, April) pandemic months. There was a 1.48% stroke rate across 119,967 COVID-19 hospitalizations. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was noted in 3.3% (1,722/52,026) of all stroke admissions.CONCLUSIONS:The COVID-19 pandemic was associated with a global decline in the volume of stroke hospitalizations, IVT, and interfacility IVT transfers. Primary stroke centers and centers with higher COVID-19 inpatient volumes experienced steeper declines. Recovery of stroke hospitalization was noted in the later pandemic months.

The objectives of this study were to measure the global impact of the pandemic on the volumes for intravenous thrombolysis (IVT), IVT transfers, and stroke hospitalizations over 4 months at the height of the pandemic (March 1 to June 30, 2020) compared with two control 4-month periods.

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Introduction: Occurrence of stroke and myocardial infarction (MI) after carotid endarterectomy or stenting have each been associated with increased later mortality. Methods: In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) 69 strokes, 37 protocol MIs, and 19 biomarker + only events occurred within 30 days among 2272 patients followed up to 10 years. Mortality was determined and compared for patients with stroke, MI, or biomarker + only to those without. Cox proportional hazard models adjusting for age, sex, symptomatic status and treatment were calculated to assess the relationship between mortality and stroke and mortality and MI status. Kaplan-Meier survival curves were plotted. Results: Patients with peri-procedural stroke had a 67% greater likelihood of long-term mortality compared to those without stroke (HR=1.67, 95% CI 1.15,2.43; p<0.007)(Figure A). Patients with a protocol MI had a 249% greater likelihood of mortality, and biomarker+ only patients had a 104% greater likelihood of mortality, compared to those without MI (HR=3.49; 95%CI 2.20,5.53, p<0.0001; and HR=2.04; 95% CI 1.09,3.83, p=0.03)(Figure B). Discussion: Stroke, MI, and biomarker + only events following CEA or CAS are associated with increased long-term mortality. The higher risk for MI may be a marker for patients with serious underlying heart disease, rather than causal, providing an opportunity to decrease long-term mortality through aggressive diagnostic evaluation and preventive treatment.

BACKGROUND:In the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years.METHODS:Among patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period.RESULTS:Among 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately.CONCLUSIONS:Over 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.).

OBJECTIVE:Cranial nerve injury (CNI) is the most common neurologic complication of carotid endarterectomy (CEA) and can cause significant chronic disability. Data from prior randomized trials are limited and provide no health-related quality of life (HRQOL) outcomes specific to CNI. Incidence of CNIs and their outcomes for patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) were examined to identify factors predictive of CNI and their impact on HRQOL. METHODS:Incidence of CNIs, baseline and procedural characteristics, outcomes, and HRQOL scores were evaluated in the 1151 patients randomized to CEA and undergoing surgery ≤30 days. Patients with CNI were identified and classified using case report forms, adverse event data, and clinical notes. Baseline and procedural characteristics were compared using descriptive statistics. Clinical outcomes at 1 and 12 months were analyzed. All data were adjudicated by two neurologists and a vascular surgeon. HRQOL was evaluated using the Medical Outcomes Short-Form 36 (SF-36) Health Survey to assess general health and Likert scales for disease-specific outcomes at 2 weeks, 4 weeks, and 12 months after CEA. The effect of CNI on SF-36 subscales was evaluated using random effects growth curve models, and Likert scale data were compared by ordinal logistic regression. RESULTS:CNI was identified in 53 patients (4.6%). Cranial nerves injured were VII (30.2%), XII (24.5%), and IX/X (41.5%), and 3.8% had Horner syndrome. CNI occurred in 52 of 1040 patients (5.0%) receiving general anesthesia and in one of 111 patients (0.9%) operated on under local anesthesia (P = .05). No other predictive baseline or procedural factors were identified. Deficits resolved in 18 patients (34%) at 1 month and in 42 of 52 patients (80.8%) by 1 year. One patient died before the 1-year follow-up visit. The HRQOL evaluation showed no statistical difference between groups with and without CNI at any interval. By Likert scale analysis, the group with CNI showed a significant difference in the difficulty eating/swallowing parameter at 2 and 4 weeks (P < .001) but not at 1 year. CONCLUSIONS:In CREST, CNI occurred in 4.6% of patients undergoing CEA, with 34% resolution at 30 days and 80.8% at 1 year. The incidence of CNI was significantly higher in patients undergoing general anesthesia. CNI had a small and transient effect on HRQOL, negatively affecting only difficulty eating/swallowing at 2 and 4 weeks but not at 1 year. On the basis of these findings, we conclude that CNI is not a trivial consequence of CEA but rarely results in significant long-term disability.

Background:Computed tomography (CT) findings of acute and chronic ischemia are associated with subsequent stroke risk in patients with transient ischemic attack. We sought to validate these associations in a large prospective cohort of patients with transient ischemic attack or minor stroke. Methods:This prospective cohort study enrolled emergency department patients from 13 hospitals with transient ischemic attack who had CT imaging. Primary outcome was stroke within 90 days. Secondary outcomes were stroke within 2 or 7 days. CT findings were abstracted from radiology reports and classified for the presence of acute ischemia, chronic ischemia, or microangiopathy. Multivariable logistic regression was used to test associations with primary and secondary end points. Results:From 8670 prospectively enrolled patients between May 2010 and May 2017, 8382 had a CT within 24 hours. From this total population, 4547 (54%) patients had evidence of acute ischemia, chronic ischemia, or microangiopathy on CT, of whom 175 had a subsequent stroke within 90 days (3.8% subsequent stroke rate; adjusted odds ratio [aOR], 2.33 [95% CI, 1.62-3.36]). This was in comparison to those with CT imaging without ischemia. Findings associated with an increased risk of stroke at 90 days were isolated acute ischemia (6.0%; aOR, 2.42 [95% CI, 1.03-5.66]), acute ischemia with microangiopathy (10.7%; aOR, 3.34 [95% CI, 1.57-7.14]), chronic ischemia with microangiopathy (5.2%; aOR, 1.83 [95% CI, 1.34-2.50]), and acute ischemia with chronic ischemia and microangiopathy (10.9%; aOR, 3.49 [95% CI, 1.54-7.91]). Acute ischemia with chronic ischemia and microangiopathy were most strongly associated with subsequent stroke within 2 days (aOR, 4.36 [95% CI, 1.31-14.54]) and 7 days (aOR, 4.50 [95% CI, 1.73-11.69]). Conclusions:In patients with transient ischemic attack or minor stroke, CT evidence of acute ischemia with chronic ischemia or microangiopathy significantly increases the risk of subsequent stroke within 90 days of index visit. The combination of all 3 findings results in the greatest early risk.

Background: With patients living a decade or longer post-procedure, long-term data are needed to assess the durability of carotid artery stenting versus carotid endarterectomy. Identifying characteristics of those consenting or declining to continue in long-term follow-up may suggest strategies to improve retention in clinical trials. Purpose: This report describes differences between patients choosing or declining to continue follow-up for up to 10 years in the Carotid Revascularization Endarterectomy versus Stenting Trial. Methods: Following completion of the primary outcome, patients who were in active Carotid Revascularization Endarterectomy versus Stenting Trial follow-up were asked to continue beyond their original 4-year commitment for a maximum of 10 years. The characteristics of those who consented were compared with those who declined. Univariate and multivariable logistic regression were used for analysis, and backwards stepwise logistic regression (the most parsimonious model) was used to determine the factors associated with continuation. Results: Of the 1921 active Carotid Revascularization Endarterectomy versus Stenting Trial participants for whom consent to extend follow-up was requested, 1695 (88%; mean age: 68.4) consented; 226 (12%; mean age: 69.6) declined. Of those who did not consent versus those who consented, 66% versus 48% were symptomatic at baseline (p < 0.0001), at follow-up 28% versus 20% were smokers (p = 0.009), 85% versus 90% were hypertensive (p = 0.01), and 84% versus 94% were dyslipidemic (p < 0.0001). Additional factors that differed between those who did not consent and those who consented included the mean number of years in the study at time of consent (4.8 years vs 3.7 years (p = <0.0001)) and patients from sites that enrolled <30 patients compared to sites randomizing 30 or more (70% vs 52% (p < 0.0001)). Multivariable logistic regression indicated that those with lesser odds of consenting to the extended follow-up were older (odds ratio: 0.80; 95% confidence interval: 0.67, 0.96), more likely to be symptomatic (odds ratio: 0.58; 95% confidence interval: 0.42, 0.80), smokers (odds ratio: 0.48; 95% confidence interval: 0.34, 0.70), were in the study 5+ years versus <3 (odds ratio: 0.21; 95% confidence interval: 0.13, 0.34), and at a site that randomized <30 patients (odds ratio: 0.46; 95% confidence interval: 0.33, 0.63), while patients with dyslipidemia at follow-up had increased odds of consenting (odds ratio: 2.28 (1.47, 3.54)). Conclusion: Symptomatic status, increasing age, randomized at lower volume centers, and longer time in follow-up were associated with reduced odds of consenting to long-term follow-up. Identifying factors associated with reduced willingness to extend participation long-term can suggest targeted strategies to improve retention in future clinical trials.

OBJECTIVE: To describe differences between patients choosing or declining extended CREST follow-up (≤10 years). BACKGROUND: Long-term data are needed to assess the durability of CEA versus CAS. Identifying characteristics of those asked to extend participation may suggest mechanisms to improve long-term retention. DESIGN/METHODS: Following completion of the primary outcome, active CREST participants were asked to extend their original four-year commitment up to ten years. Characteristics of those who consented were compared with those who declined. Univariate and multivariable logistic regression were used for analysis; backwards stepwise logistic regression was used to determine the factors associated with continuation. RESULTS: Of 1921 active participants for whom extended follow-up consent was requested, 1695 (89[percnt]; mean age 68.4) consented; 226 (12[percnt]; mean age 69.6) declined. Of those who consented versus those who declined, 48[percnt] vs. 65[percnt] were symptomatic at baseline (p<0.0001), 24[percnt] vs. 35[percnt] were smokers (p=0.001), 87[percnt] vs. 81[percnt] were dyslipidemic (p=0.01) and 29[percnt] vs. 36[percnt] were diabetic (p=0.5). Additional differences between those who consented versus declined included mean years followed at time of consent (3.7 years vs. 4.8 years (p=30 patients versus sites randomizing <30 (48[percnt] vs. 30[percnt] (p<0.0001)). Multivariable logistic regression indicated that those with lower odds of consenting were older (OR 0.75; 95[percnt] CI 0.63, 0.91), more likely symptomatic (OR 0.56; 95[percnt] CI 0.41, 0.78), smokers (OR 0.45; 95[percnt] CI 0.32, 0.63), diabetic (OR 0.70; 95[percnt] CI 0.51, 0.95), followed 5+ years vs. <3 (OR 0.21;95[percnt] CI 0.13, 0.73) and randomized at sites with <30 patients (OR 0.48;95[percnt]CI 0.35, 0.66). CONCLUSIONS: Symptomatic status, increasing age, higher levels of atherosclerotic risk factors, randomized at lower volume centers, and longer time in follow-up, were associated with declining long-term participation. Identifying factors associated with reduced willingness to extend participation can suggest targeted mechanisms to improve long-term retention. Funding: NINDS (US) [R01 NS038384] Disclosure: Dr. Sheffet has nothing to disclose. Dr. Mackey has nothing to disclose. Dr. Brooks has nothing to disclose. Dr. Clark has nothing to disclose. Dr. Hill has received personal compensation for activities with Boehringer Ingelheim and Pfizer, Inc. as advisory board member. Dr. Voeks has nothing to disclose. Dr. Hughes has nothing to disclose. Dr. Tom has nothing to disclose. Dr. Longbottom has nothing to disclose. Dr. Howard has nothing to disclose. Dr. Brott has received personal compensation for activities with 3D Communications and Edwards Lifesciences as a consultant.