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This randomized clinical trial investigates the effectiveness of integrative cognitive behavioral therapy vs present-centered therapy in patients with prolonged grief disorder.
This randomized clinical noninferiority trial investigates whether a brief online self-guided cognitive behavioral therapy intervention is noninferior to a comprehensive online clinician-guided cognitive behavioral therapy treatment.
To the Editor The Original Investigation by Rodriguez et al compared the effectiveness of semaglutide and tirzepatide, each labeled for type 2 diabetes (T2D), in promoting weight loss among adults with overweight or obesity. Tirzepatide was associated with greater weight loss than semaglutide. However, the study did not account for differences in dosages, despite the known dose-response relationship with weight loss for both medications. Accounting for dosage is especially important given that only formulations labeled for T2D were assessed. Consequently, it is likely that semaglutide users receiving the 2.4-mg dosage regimen—the higher dosing recommended only for weight loss—were excluded.
In Reply We appreciate the commentary by Levy et al related to our comparative effectiveness study of semaglutide and tirzepatide, with the suggestion that a direct comparison be made between the 2 drugs by dosage regimen. Although we agree that dosages plays a critical role in weight change outcomes, dose comparisons were intentionally omitted from our study because of the potential for bias. Dose-response relationships have been assessed in randomized clinical trials in which doses are assigned at baseline. However, in real-world settings, where doses are escalated over time based on tolerability and response, dose comparisons may threaten internal and external validity.
Stroke, Volume 56, Issue Suppl_1, Page ATMP35-ATMP35, February 1, 2025. Introduction:Studies have suggested efficacy of glycoprotein IIb/IIIa antagonists such as tirofiban for patients with acute ischemic stroke (AIS). However, neurological deterioration is still common in many of the recommended antiplatelet regimens. We aimed to evaluate the efficacy and safety of tirofiban versus dual antiplatelet therapy (DAPT) or aspirin in patients with AIS.Methods:Following PRISMA guidelines, we searched Pubmed, Embase, Scopus and Cochrane databases for studies comparing effects of tirofiban versus DAPT or aspirin alone in patients with AIS. Main outcomes were increase in NIHSS score, Modified Rankin Scale (mRS) scores at 90 days (0 to 2), intracranial hemorrhage (ICH) and mortality. Statistics analysis was performed using Review Manager 5.4.1 software. Heterogeneity was assessed with I2statistics.Results:We included 5 RCT and 5 non-RCT studies covering 1,857 patients, of whom 926 were treated with Tirofiban. Neurological deterioration, assessed by changes in NIHSS scores from baseline across four studies, was less pronounced in the Tirofiban group (MD -0.32; 9% CI -0.83-0.19; p
Stroke, Volume 56, Issue Suppl_1, Page ATMP26-ATMP26, February 1, 2025. Introduction:Telestroke has the potential to revolutionize acute stroke treatment by improving access to optimal stroke care, including time-sensitive care such as thrombolysis. Yet few studies have compared acute stroke treatment metrics and outcomes in patients treated using telestroke versus standard in-person stroke evaluation.Methods:This was a retrospective cohort study of acute ischemic stroke patients age ≥18 presenting to 53 Paul Coverdell Michigan hospitals between 2022 and 2023 who were potentially eligible for thrombolysis (i.e., presented ≤ 4 hours of last known well, no contraindications to thrombolysis). The primary exposure was telestroke (vs non-telestroke), and primary outcomes were receipt of thrombolysis and door-to-needle (DTN) time. Secondary outcomes included discharge ambulatory status and door-in-door-out (DIDO) time in transferred patients. Multivariable hierarchical models evaluated associations between the telestroke (vs. non-telestroke) activation and outcomes, sequentially adjusted for demographics, medical history, presenting/arrival, and hospital characteristics.Results:Among the 4974 stroke patients potentially eligible for thrombolysis (mean age 69.2 [SD: 14.6], 48.3% female), 1078 (21.7%) were evaluated using telestroke and 3896 (78.3%) without telestroke. Telestroke patients were more commonly at primary stroke centers (71.1% vs 39.0%) and less at comprehensive stroke centers (13.3% vs 53.9%; P
Stroke, Volume 56, Issue Suppl_1, Page ATP115-ATP115, February 1, 2025. Background:Mechanical thrombectomy (MT) as treatment for acute ischemic stroke (AIS) has demonstrated superior functional outcomes compared to intravenous thrombolysis (IVT). Yet AIS survivors often experience a range of unstudied post-stroke complications which negatively affect patient reported outcomes. To inform clinical practice, we assessed 90-day differences in the medical management of common stroke post-complications among patients treated with MT vs. IVT.Methods:A retrospective cohort of hospitalized AIS patients treated with IVT or MT were identified from Electronic Medical Records of 92 large healthcare organizations (01/2015-09/2024). Matched propensity scores were used to adjust for baseline differences across 36 factors. Outcomes included the use of medication(s) for the management of fatigue, spasticity, mood, sleep, seizure, neurogenic bowel&neurogenic bladder. Pre-specified subgroup analyses included differences in post-stroke sequelae management stratified by NIHSS scores of ≤9 (mild AIS) or >9 (moderate/severe AIS)&differences in post-stroke sequelae between AIS patients treated with MT vs MT + IVT.Results:The final cohort consisted of n=87,819 AIS patients treated with either IVT (n=82,534) or MT (n=5,285). PS matching resulted in 5,285 matched pairs with good balance across all baseline covariates. At 90-days, AIS patients treated with MT were more likely to receive medications for spasticity (RR: 1.15, 95%CI: 1.01, 1.31), mood (RR: 1.06, 95%CI: 1.01, 1.13)&neurogenic bowel (RR: 1.11, 95%CI: 1.09, 1.14) (Table 1). Approximately 7% (n=6,344) of AIS patients had NIHSS scores – PS matching resulted in 877 matched pairs with NIHSS ≤9&848 matched pairs with NIHSS >9. Following stratification, AIS patients treated with MT were significantly more likely to receive treatment of neurogenic bowel&bladder (Table 2). For the MT vs MT + IVT comparison, patients treated with MT were 5% less likely to receive treatment for neurogenic bowel RR: 0.95 (95%CI: 0.92, 0.99) among 1,900 matched pairs (Table 3).Discussion:Using real world data, AIS patients treated with MT (vs IVT) were more likely to receive treatment for spasticity, mood&neurogenic bowel. Among patients with documented NIHSS scores, differences remained significant for treatment of neurogenic bowel and bladder after stratifying by stroke severity. Healthcare providers should screen for these post-stroke sequelae, which substantially affect quality of life for AIS survivors.
Stroke, Volume 56, Issue Suppl_1, Page ATMP83-ATMP83, February 1, 2025. Introduction:Despite the proven effectiveness of endovascular therapy (EVT) in acute ischemic strokes (AIS) involving anterior circulation large vessel occlusions, isolated posterior cerebral artery (PCA) occlusions (iPCAo) remain underexplored in clinical trials. This study investigates the comparative effectiveness and safety of EVT against medical management (MM) in patients with iPCAo.Methods:This multinational, multicenter propensity score-weighted study analyzed data from the Multicenter Analysis of primary Distal medium vessel occlusions: effect of Mechanical Thrombectomy (MAD-MT) registry, involving 37 centers across North America, Asia, and Europe. We included iPCAo patients treated with either EVT or MM. The primary outcome was the modified Rankin Scale (mRS) at 90 days, with secondary outcomes including functional independence, mortality, and safety profiles such as hemorrhagic complications.Results:A total of 177 patients were analyzed (88 MM and 89 EVT). Baseline characteristics were balanced using Inverse Probability of Treatment Weighting (IPTW). EVT showed a statistically significant improvement in 90-day mRS scores (OR=0.55, 95% CI=0.30 to 1.00, P=0.048), functional independence (OR=2.52, 95% CI=1.02 to 6.20, P=0.045), and a reduction in 90-day mortality (OR=0.12, 95% CI=0.03 to 0.54, P=0.006) compared to MM. Hemorrhagic complications were not significantly different between the groups.Conclusion:EVT for iPCAo is associated with better neurological outcomes and lower mortality compared to MM, without an increased risk of hemorrhagic complications. These findings emphasize on the potential benefits of EVT in this understudied patient group, highlighting the need for randomized controlled trials to further validate these results.
Stroke, Volume 56, Issue Suppl_1, Page ATMP65-ATMP65, February 1, 2025. Background:We aimed to evaluate whether the implementation of regional prehospital transport to comprehensive stroke center (CSC) protocol has any impact on inter-hospital transfer rate and neurologic outcomes of intracranial hemorrhage (ICH) patients.Methods:We performed a retrospective multicenter study comparing outcomes in patients with ICH arriving at 15 Primary Stroke Centers (PSC) and 8 CSC in Chicago, Illinois via emergency medical services transport from January 1 2017 and December 31 2023 – before and after implementation of a prehospital transport protocol in September 2018 which uses a 3-item stroke scale to identify patients with more severe stroke types and
Stroke, Volume 56, Issue Suppl_1, Page AWMP3-AWMP3, February 1, 2025. Introduction:There is no established acute intervention for central retinal artery occlusion (CRAO) which often results in poor visual outcomes. Intravenous Alteplase (tPA) has emerged as a promising acute treatment for CRAO. Intravenous Tenecteplase (TNK) is non-inferior to tPA in the acute treatment of ischemic stroke. However, there is limited data on its use for CRAO.Methods:Retrospective data of patients from January 2016 to February 2024 with CRAO who received TNK or tPA and a medical management (MM) matched cohort were collected, including demographics, suspected etiology of CRAO, presenting and final central visual acuity, symptomatic intracranial hemorrhage (sICH), vitreous hemorrhage, and neovascularization. In cases where the presenting central visual acuity was not quantified, it was assigned a value by the investigator based on qualitative descriptions. Visual acuity was converted to LogMAR units to enable quantitative comparison, where the ability to count fingers was assigned a value of 1.85, hand motions 2.28, light perception 2.70, and no light perception 3.00. Functional visual recovery was defined as a final visual acuity of 20/100 or better. Patients without a documented final central visual acuity were excluded from the analysis. T-test, chi-square, and ANOVA were used for statistical analysis.Results:A total of 15 TNK, 19 tPA, and 31 MM patients were included. MM patients were older than the thrombolytic patients (74.5±8.8 vs. 68.2±14.4 yrs) p=0.04. More patients had diabetes in tPA (52.6%) vs TNK (13.3%) vs MM (29.0%) p=0.04. There was no difference in suspected etiologies of CRAO. Functional visual recovery trended toward improvement in TNK (33.3%) vs. tPA (5.3%) vs. MM (16.1%) p=0.09. Quantitative assessment of final visual acuity by LogMAR trended toward improvement in TNK (1.45±1.03) vs. tPA (1.97±0.55) vs. MM (2.04±0.86) p=0.07. Fewer patients were legally blind in TNK (60.0%) vs. tPA (94.7%) vs. MM (83.9%) p=0.03. There was no difference in sICH, vitreous hemorrhage, or neovascularization.Conclusions:This is the first case series comparing CRAO treated with TNK, tPA, and MM. There were fewer patients who were legally blind and there was a trend toward improved final visual acuity in the TNK group. There was no difference in sICH, vitreous hemorrhage, or neovascularization. This study adds to the growing body of evidence that TNK can be an effective and safe treatment for CRAO.
Stroke, Volume 56, Issue Suppl_1, Page ATMP105-ATMP105, February 1, 2025. Background:Paradoxical embolism through a PFO is a common etiologic mechanism in the 18-60 yo patients with otherwise cryptogenic stroke (CS). However, its importance as a cause of stroke in the elderly is less clear. Older individuals have more competing causes of stroke, potentially reducing the relevance of PFO-associated stroke; but they have more venous thromboembolism and greater right-to-left shunting, potentially enhancing PFO-associated stroke frequency. Clinical management would be aided by estimates of how often a PFO in an older patient with CS is causal vs. incidental.Methods:Through systematic search, we identified all case–control studies of the comparative frequency of PFO in patients with CS vs known stroke cause (KS). We performed a random-effects meta-analysis across these studies to determine the best estimate of the differential frequency of PFO in CS and KS among three age cohorts: 1) age 60 and older 2) age 50/55 and older; and age 70/75 and older. We then applied Bayes’ theorem to determine the probability that detected PFO is causal or incidental in these groups.Results:The systematic search identified: for age 60+, 1 study enrolling 397 patients (190 CS, 207 KS); for age 50/55+, 5 studies enrolling 1203 patients (534 CS, 669 KS); and for age 70/75+, 3 studies enrolling 431 patients (171 CS, 260 KS). Methods of PFO detection were TCD in 47% of patients, TTE in 5%, and TEE in 48%. Crude cumulative rates of PFO detection were: age 60+, CS 68/190 (35.8%) vs. KS 44/207 (21.3%); age 50/55+, CS 198/554 (35.7%) vs. KS 81/669 (12.1%); and age 70/75+, CS 58/171 (33.9%) vs. KS 43/260 (16.5%). In the formal meta-analyses, summary odds ratios for PFO in CS vs. KS patients were: age 60+, 2.06 (95% CI, 1.32-3.23), p = 0.001; age 50/55+, 4.23 (95% CI, 2.44-7.32), p = 0.00001;.and age 70/75+ 3.77 (95% CI, 1.27-11.24), p = 0.02. With the application of Bayes’ theorem, the corresponding probabilities indicated that, when present, PFO in patients with CS is causal in: age 60+, 51.5% (95% CI, 24.2-69.0%); age 50/55, 78.2% (95% CI, 60.4-83.9%); and age 70/75+,61.5% (95%CI, 21.0-91.1%).Conclusion:Although confidence intervals are wide reflecting moderate study sizes, current evidence indicates that in older patients with cryptogenic stroke and PFO, the PFO is causal in at least one half of patients. These findings support the performance of randomized trials of PFO closure in older patients with otherwise cryptogenic stroke.
Stroke, Volume 56, Issue Suppl_1, Page AWP42-AWP42, February 1, 2025. Background and Objectives:Moyamoya disease (MMD) is characterized by progressive steno-occlusion of the internal carotid arteries, leading to compensatory collateral vessel formation. The optimal surgical approach for MMD remains debated, with bilateral revascularization potentially offering more comprehensive protection but involving more extensive surgery compared to unilateral revascularization. This study aims to compare bilateral revascularization and unilateral revascularization short-term safety profile in the treatment of MMD.Methods:This multicenter retrospective study included patients with MMD who underwent surgical revascularization at 13 academic institutions. Patients were categorized into unilateral and bilateral revascularization groups. Data collected included demographics, clinical characteristics, and outcomes. Propensity score matching (PSM) was used to balance baseline characteristics. Statistical analyses were conducted using Stata (V.17.0; StataCorp).Results:A total of 497 patients were included, including 90 that had bilateral revascularization and 407 that had unilateral revascularization. Bilateral revascularization was associated with more perioperative asymptomatic strokes (10% vs. 2.4%; OR 4.41, 95% CI 1.73 to 11.19, p = 0.002) and higher rates of excellent functional outcomes (mRS 0-1) at discharge (92.2% vs. 79.1%; OR 3.12, 95% CI 1.39 to 7, p = 0.006). After PSM, 57 matched pairs were analyzed. There was a higher rate, though not statistically significant difference, of perioperative stroke in the bilateral revascularization group (15.7% vs. 8.7%; OR 1.95, 95% CI 0.61 to 6.22, p = 0.26). No significant differences were noted in mRS 0-1 and 0-2 scores at discharge, NIHSS at discharge, intraoperative complications, or length of hospital stay. The follow-up stroke rates were also not significantly different (OR 0.40, 95% CI 0.11 to 1.39, p = 0.15).Conclusion:This study found no significant differences between bilateral and unilateral revascularization in MMD. Patients who had bilateral revascularization had higher tendency of perioperative stroke, though not statistically significant. Further prospective studies are needed to validate these results.
Stroke, Volume 56, Issue Suppl_1, Page AWP110-AWP110, February 1, 2025. Introduction:Delaware (DE) is comprised of 3 counties, with 7 hospitals within the stroke system. The state’s only CSC located in the northernmost county receives transfers from 1 PSC midway in the state and 3 PSCs in the southernmost county (figure 1). Historically PSC door time to CSC skin puncture time by interfacility transport can range from 3.5 to >5 hours from the furthest DE PSC. Utilizing ground EMS and Delaware State Police (DSP) helicopter EMS (HEMS) transport, DE developed a process to identify potential acute LVO patients and transport directly to the CSC to reduce time to mechanical thrombectomy (MT).Methods:In November 2022, DE EMS Standing Orders changed the pre-hospital stroke evaluation tool from RACE to the Visual, Aphasia, Neglect (VAN) assessment. DE EMS identified patients who were VAN+ and utilized HEMS for direct transport to the CSC statewide.If EMS identified a VAN+ patient in Kent or Sussex counties, the local PSC medical control approved for direct CSC transport while considering thrombolytic timing.DSP met the ground EMS crews at a pre-designated landing zone to receive the patient.Ground EMS notified the CSC to prepare for the standard stroke alert evaluation.Results:From January 2023 to June 2024, 183 patients were flown by DSP HEMS directly to the CSC bypassing a PSC.Of those, 59% had a final diagnosis of stroke (AIS and nontraumatic ICH/SAH)Of those with AIS, 60% were positive for an LVOOf those patients with LVO, MT was completed on 71%, compared to rate of 52% in prior yearsKent County: EMS arrival to skin puncture median time was 2.00 hours compared to 3.75 hours for interfacility transfer from the PSC.Sussex County: EMS arrival to skin puncture median time was 2.5 hours compared to 4.00 hours for interfacility transfer time from the 2 Sussex PSCs combined (figure 2).Statewide the median time for EMS arrival to skin puncture for patients who were MT candidates was 2.25 hours vs 3.88 hours, 1.6 hours faster than PSC to CSC transferred patients.CSC time includes obtaining imaging which may already have been completed at the PSC for interfacility transfers.Conclusion:Early LVO patient identification and pre-hospital helicopter EMS transport directly to the CSC reduced the time from EMS arrival to skin puncture for MT patients in Delaware by 1.6 hours. This was 41% faster compared to those arriving at the CSC via interfacility transfer from PSC, and increased the rate of thrombectomy on eligible patients by 19%.
Stroke, Volume 56, Issue Suppl_1, Page AWMP85-AWMP85, February 1, 2025. Introduction:Eligibility for clinical trial enrollment is often determined by site investigators with subsequent re-adjudication by an imaging core lab. We sought to assess the differences between site-investigator reported CT ASPECTS with core lab adjudication, and how these differences affected trial eligibility and endovascular thrombectomy (EVT) treatment effect.Methods:Absolute and relative differences between site and core-lab reported CT ASPECTS were recorded in the SELECT2 randomized trial. The agreement between measures was illustrated using Bland-Altman plots. Cases with extreme discordance were further examined for differences in baseline characteristics, as well as whether trial eligibility and EVT treatment effect were impacted.Results:Of 352 enrolled, 346 patients had both site and core-lab ASPECTS available for evaluation. Median (IQR) values for site ASPECTS, core lab ASPECTS and the difference between site and core-lab ASPECTS were 4 (3, 5), 4 (3, 5) and 0 (-1, 1). Mean (95% CI) difference between site and core-lab ASPECTS was -0.03 (-0.19, 0.13), with higher limit of agreement at 2.83 and lower limit of agreement at -2.9 – Fig 1. Significant disagreement of ≥3-point difference between site ASPECTS and core-lab ASPECTS was observed in 25 (7%) patients, with 14 having site ASPECTS ≥ 3 points higher and 11 having core-lab ASPECTS ≥ 3 points higher.EVT treatment effect was maintained based on site ASPECTS reads of 3-5 (aGenOR: 1.48, 95% CI: 1.16 to 1.89, p-value: 0.001) without significant heterogeneity as compared to other ASPECTS strata (p-interaction: 0.69) (Figure 2). In a sensitivity analysis excluding potential ineligible patients based on core lab reads [a) with core lab CT ASPECTS 0-2 and b) with core lab CT ASPECTS 6-10 and ischemic core estimates of
Stroke, Volume 56, Issue Suppl_1, Page A9-A9, February 1, 2025. Introduction:For patients transferred for EVT considerations, direct-to-angio approach is shown to reduce time to procedure and improve clinical outcomes. We aimed to assess if IV thrombolytics status prior to transfer modifies the association between direct-to-angio approach and improved clinical outcomes in transferred patients who received EVT.Methods:In a secondary analysis of a retrospective cohort of transferred EVT patients from 6 centers across US and Europe, patients were stratified based on IV thrombolytic status. Association of direct-to-angio approach vs repeated imaging approach with functional outcomes was assessed among patients with and without IV thrombolytics using appropriate regression models adjusted for age, stroke severity, time to procedure, occlusion location, serum glucose and successful reperfusion status. Heterogeneity of association was evaluated using multiplicative interaction.Results:Of 1135 patients with documented IV thrombolysis status, 612 (54%) received IVT – with younger age (IVT – 68 (57-78)y, no IVT – 70 (60-79)y, p=0.032) and higher CT ASPECTS (IVT: 8 (7-10) vs no IVT: 8 (7-9), p=0.038), but similar NIHSS (IVT: 17 (13-21) vs no IVT: 17 (12-21), p=0.91). Estimates of association favored direct-to-angio approach among both no IVT (acOR: 2.06, 95% CI: 1.38 to 3.08, p-value
Stroke, Volume 56, Issue Suppl_1, Page AWMP95-AWMP95, February 1, 2025. Introduction:Isolated anterior cerebral artery occlusions (iACAo) in acute ischemic stroke (AIS) patients present significant challenges due to their rarity and complex symptomatology. The efficacy of endovascular therapy (EVT) versus best medical management (BMM) for iACAo remains unclear. In light of context we aim in this investigation to assess the outcomes of these treatments.Methods:This multinational, multicenter study analyzed data from the Multicenter Analysis of Distal Medium Vessel Occlusions: Effect of Mechanical Thrombectomy (MAD-MT) registry. We included 108 patients with iACAo, who underwent either EVT or BMM. Data were collected retrospectively from 37 sites across North America, Asia, and Europe. Inverse Probability of Treatment Weighting (IPTW) was applied to balance confounding variables between treatment groups. The primary outcome was functional independence at 90 days. Secondary outcomes included excellent outcomes (mRS 0-1), mortality, and NIHSS score on day one post-EVT. Safety outcomes assessed hemorrhagic complications.Results:Of the 108 patients, 36 received BMM and 72 underwent EVT. The median age was 75 years (IQR 67-87), with 60 (56%) male patients overall. The primary outcome of 90-day mRS 0-2 was achieved in 40% of the cohort, with no significant difference between the EVT and BMM groups (38% vs. 45%, p=0.46). Procedural success (TICI 2b-3) was high in EVT patients at 91%, with a low sICH rate of 2.9%. The IPTW-adjusted analysis showed no significant association between EVT and improved functional outcomes (OR 1.17, 95% CI 0.23-6.02, p=0.85) or reduced mortality (23% overall; 25% EVT vs. 21% BMM, p=0.71). However, EVT was associated with higher NIHSS scores on day one post-stroke in crude analyses (OR 4.8, 95% CI 1.2-8.5, p=0.012), though this was not significant in the IPTW model (OR 2.2, 95% CI -0.51 to 4.8, p=0.11).Conclusions:In this propensity score-weighted analysis, EVT did not demonstrate superior functional outcomes compared to BMM in patients with iACAo. Nonetheless, EVT achieved high procedural success and low rates of symptomatic hemorrhage, indicating its safety. These findings highlight the need for randomized controlled trials to further explore EVT’s potential role as a first-line or rescue therapy in iACAo patients, especially given the low recanalization rates with IV thrombolysis alone.
