Immediate Statin After Acute Stroke Reduces Disability

MUNICH — Giving intensive statin therapy to patients with acute mild ischemic stroke or with high-risk for transient ischemic attack (TIA) immediately after onset significantly reduces the risk for a poor functional outcome compared with delaying treatment, without compromising safety, results of the INSPIRES trial show.

The research, presented at the 9th European Stroke Organisation Conference (ESOC) on May 26, also showed that intensive antiplatelet therapy reduced the risk for recurrent stroke albeit at an increased in bleeding risk vs standard treatment.

The study involved more than 6000 patients with acute mild ischemic stroke or TIA and intracranial or extracranial atherosclerosis (ICAS/ECAS), who were randomly assigned in a 2 x 2 factorial design to compare intensive vs standard antiplatelet therapy and intensive statin therapy within 24 hours vs waiting up to 72 hours after onset.

Intensive antiplatelet therapy with clopidogrel plus aspirin reduced the risk for recurrent stroke within 90 days by 21% vs standard single-agent therapy, although it also doubled the risk for moderate to severe bleeding.

Starting intensive statin therapy with atorvastatin within 24 hours of onset had no impact on recurrent stroke risk but did reduce the risk for a poor functional outcome vs waiting up to 72 hours by 16%.

Moreover, it was “safe, with no increased risk of bleeding, hepatotoxicity, or muscle toxicity,” said study presenter Yilong Wang, MD, Department of Neurology, Beijing Tiantan Hospital, National Clinical Research Center, Beijing, China.

There was, however, a suggestion of an interaction between intensive antiplatelet therapy and immediate intensive statin therapy, he noted, with a trend toward increased bleeding vs delaying the start of statin therapy.

Approached for comment, session co-chair Carlos Molina, MD, director of the Stroke Unit and Brain Hemodynamics in Hospital Universitari Vall d’Hebron, Barcelona. Spain, said that the study is “important because when we look at studies of minor stroke and TIA, they are just focused on long-term outcomes in terms of recurrent stroke.”

He told Medscape Medical News that “putting statins in the equation and looking at their impact on long-term outcomes, the study demonstrates that statins are associated…in particular with reductions in disabling stoke, and that’s good.”

Recurrence and Progression

Wang began by highlighting that acute mild stroke and high-risk TIA are common and underestimated, with a relatively high risk for recurrence and progression, often due to ICAS/ECAS.

Numerous guidelines recommend intensive antiplatelet therapy in the first 24 hours after the event, but Wang pointed out that there is little evidence to support this, and a meta-analysis suggested the window for effective treatment may be up to 72 hours.

In addition, intense statin therapy appears to be beneficial for the secondary prevention of atherosclerotic stroke in the nonacute phase, although there is no evidence for any neuroprotective effects in the acute phase nor for the optimal timing of starting the drugs.

Wang also noted that there is the potential for an interaction between intensive antiplatelet and statin therapy that could increase the risk for bleeding.

To investigate further, the researchers conducted a multicenter study involving patients aged 35-80 years with acute ischemic stroke or TIA.

The former was defined as an acute single infarction with 50% or greater stenosis of a major intracranial or extracranial artery that “probably account for the infarction and symptoms,” or multiple infarctions of large artery origin, including non-stenotic vulnerable plaques.

Patients were required to have a National Institutes of Health Stroke Scale score of 4-5 24 hours or less from acute stoke onset or 0-5 between 24 and 72 hours of onset.

TIA was defined as 50% or more stenosis of major intracranial or extracranial arteries that probably account for the symptoms, and an ABCD² score for stroke risk of 4 or more within 24-72 hours of onset.

Patients were excluded if they had received dual antiplatelet therapy with aspirin and clopidogrel or high-intensity statin therapy within 14 days of random assignment or had intravenous thrombolysis or endovascular therapy after acute stroke or TIA onset.

Those included in the trial were randomly assigned in a 2 x 2 factorial design to receive:

• Intensive or dual antiplatelet therapy with clopidogrel and aspirin plus immediate high-intensity statin therapy with atorvastatin
• Intensive antiplatelet therapy plus delayed high-intensity statin therapy
• Standard antiplatelet therapy with aspirin alone plus immediate high-intensity statin therapy
• Standard antiplatelet therapy plus delayed high-intensity statin therapy

In all, 6100 patients were enrolled from 222 hospitals in 99 cities across 25 provinces in China. The mean age was 65 years, and 34.6%-37.0% were women. TIA was recorded in 12.2%-14.1% of patients; 19.5%-19.7% had a single acute infarction, and 66.4%-68.1% had acute multiple infarctions.

The time to randomization was 24 hours or less after event onset in 12.5%-13.2% of cases vs 24-48 hours in 41.2%-42.5% and 48 hours or more in 44.9%-45.7% of patients.

The primary efficacy outcome, defined as stroke at 90 days, was significantly less common with intensive vs standard antiplatelet therapy, at a cumulative probability of 9.2% vs 7.3%, or a hazard ratio of 0.79 (95% CI, 0.66-0.94; P = .007).

Clopidogrel plus aspirin was also associated with a significant reduction in a composite vascular event of stroke, myocardial infarction, or vascular death vs aspirin alone, at 7.5% vs 9.3%, or a hazard ratio of 0.80 (95% CI, 0.67-0.95, P = .01), as well as a reduction in rates of ischemic stroke (P = .002), and TIA (P = .02).

The primary safety outcome, defined as moderate to severe bleeding on the GUSTO criteria, was increased with intensive antiplatelet therapy, at 0.9% vs 0.4% for aspirin alone, with a hazard ratio of 2.08 (95% CI, 1.07-4.03; P = .02).

Turning to statin use, Wang showed that there was no significant difference in rates of stroke at 90 days between delayed and immediate intensive therapy, at a cumulative probability of 8.4% vs 8.1%, or a hazard ratio of 0.95 (P = .58).

There was also no difference in rates of moderate to severe bleeding, at 0.8% with immediate vs 0.6% for delayed intensive statin therapy, or a hazard ratio of 1.36 (95% CI, 0.73-2.54; P = .34).

Wang reported that there were no significant differences in key secondary efficacy and safety outcomes.

Analysis of the distribution of modified Rankin Scale scores at 90 days, however, indicated that there was a significant reduction in the risk for poor functional outcome, defined as a score of 2-6, with immediate vs delayed statin therapy, at an odds ratio of 0.84 (95% CI, 0.72-0.99; P = .04).

Finally, it was found that combining dual antiplatelet therapy with immediate intensive statin therapy was associated with an increase in moderate to severe bleeding vs delayed statin therapy, affecting 1.1% vs 0.7% of patients. The association nonetheless did not reach statistical significance, at a hazard ratio of 1.70 (95% CI, 0.78-3.71; P = .18).

The study was funded by the National Natural Science Foundation of China, the National Key R&D Program of China, the Beijing Outstanding Young Scientist Program, the Beijing Youth Scholar Program, and the Beijing Talent Project. The drug was provided by Sanofi and Jialin Pharmaceutical. No relevant financial relationships declared.

9th European Stroke Organisation Conference (ESOC) 2023. Presented May 26, 2023. Abstract 3116

Ticagrelor May Reduce Brain Lesions After Carotid Stenting

MUNICH — Patients undergoing carotid artery stenting (CAS) may have fewer ischemic lesions and a lower lesion burden if they are given the reversible P2Y12 receptor antagonist ticagrelor rather than clopidogrel, another P2Y12 inhibitor, prior to the procedure, secondary endpoint results of the PRECISE-MRI trial suggest.

More than 200 patients with carotid artery stenosis underwent magnetic resonance imaging (MRI) and were randomized to ticagrelor or clopidogrel before undergoing CAS. They then had two follow-up MRIs to assess the presence of emergent ischemic lesions.

Although the trial, which was stopped early, failed to show a difference between the two treatments in the primary endpoint — occurrence of at least one ischemic lesion — it did show that ticagrelor was associated with significant reductions in secondary endpoints including the total number and total volume of new lesions.

There were also significantly fewer cases of a composite of adverse clinical events with ticagrelor versus clopidogrel, but no difference in rates of hemorrhagic bleeds.

The research was presented at the 9th European Stroke Organisation Conference (ESOC) 2023 on May 25.

Highlighting the failure of the trial to meet its primary endpoint, study presenter Leo Bonati, MD, head of the Stroke Center, Rena Rheinfelden, University Hospital Basel, Switzerland, pointed out that the proportion of patients with one or more ischemic brain lesions was “much higher than expected.”

Based on the secondary outcomes, the study nevertheless indicates that, “compared with clopidogrel, ticagrelor reduces the total burden of ischemic brain lesions occurring during CAS,” he said.

Ticagrelor is therefore a “safe alternative to clopidogrel as an add-on to aspirin to cover carotid artery stent procedures.”

Bonati cautioned, however, that the findings are preliminary.

“Promising” Results

Session cochair Else Charlotte Sandset, MD, PhD, a consultant neurologist in the Stroke Unit, Department of Neurology, Oslo University Hospital, Norway, called the results “interesting” and “promising.”

She told Medscape Medical News that they “also provide us with an additional option” in the management of patients undergoing CAS.

Sandset suggested that “it may have been a little bit hard to prove the primary endpoint” chosen for the trial, but believes that the secondary endpoint results “are very interesting.”

“Of course, we would need more data and further trials to provide some reassurance that we can use ticagrelor in this fashion,” she said.

Major Complication

Bonati began by noting that the major procedural complication of CAS is embolic stroke, but this may be prevented with optimized antiplatelet therapy.

Previous studies have shown that ticagrelor is superior to clopidogrel as an add-on to aspirin in reducing rates of major adverse cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention.

Adding the drug to aspirin is also superior to aspirin alone in preventing recurrent stroke in patients with minor stroke or transient ischemic attack, Bonati said.

To examine whether ticagrelor is superior to clopidogrel as an add-on to aspirin in preventing ischemic brain lesions during CAS, the team conducted a randomized, open, active-controlled trial.

They recruited patients with ≥ 50% symptomatic or asymptomatic carotid stenosis undergoing CAS in line with local guidelines and performed a baseline MRI scan and clinical examination.

The patients were then randomized to ticagrelor or clopidogrel plus aspirin 1 to 3 days before undergoing CAS. A second MRI and clinical examination, as well as an ultrasound scan, was performed at 1 to 3 days post-CAS, with a third set of examinations performed at 28 to 32 days after the procedure.

The study included 14 sites in Belgium, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. Enrollment was stopped after 209 of the originally planned 370 patients, “due to slow recruitment and a lack of further funding,” Bonati said.

Of those, 207 patients were included in the intention-to-treat safety analysis, and 172 in the per-protocol efficacy analysis.

The mean age of the patients was 69.0 – 69.5 years in the two treatment groups, and 67% – 71% were male. Bonati noted that 52% – 55% of the patients had symptomatic stenosis, and that in 83% – 88% the stenosis was severe.

The majority (79% – 82%) of patients had hypertension, alongside hypercholesterolemia, at 76% in both treatment groups.

Bonati showed that there was no significant difference in the primary efficacy outcome of the presence of ≥ 1 new ischemic brain lesion on the second or third MRI, at 74.7% for patients given ticagrelor versus 79.8% with clopidogrel, or a relative risk of 0.94 (95% confidence interval [CI], 0.79 – 1.10; P = .43).

However, there was a significant reduction in the number of new ischemic lesions, at a median of 2 (interquartile range [IQR] 0.5 – 5.5) with ticagrelor versus 3 with clopidogrel (IQR 1 – 8), or an exponential beta value of 0.63 (95% CI, 0.42 – 0.95; P = .027).

Ticagrelor was also associated with a significant reduction in the total volume of lesions, at a median of 66 µl (IQR 2.5 – 2.19) versus 91 µl (IQR 25 – 394) for clopidogrel, or an exponential beta value of 0.30 (95% CI, 0.10 – 0.92; P = .030).

Patients assigned to ticagrelor also had a significantly lower rate of the primary clinical safety outcome, a composite of stroke, myocardial infarction, major bleeding, or cardiovascular death, at 2.9% versus 7.8%, or a relative risk of 0.36 (95% CI, 0.08 – 1.20). This was driven by a reduction in rates of post-CAS stroke.

Bonati noted that there was no significant difference in the presence of ≥ 1 hemorrhagic lesion after CAS, at 42.7% with ticagrelor and 47.6% in the clopidogrel group, or a relative risk of 0.90 (95% CI, 0.63 – 1.26).

There was also a similar rate of microbleeds between the two treatment groups, at 36.6% in patients given ticagrelor and 47.6% in those assigned to clopidogrel.

European Stroke Organisation Conference (ESOC) 2023: Abstract 658. Presented May 25.

The study was investigator-initiated and funded by an unrestricted research grant from AstraZeneca. No relevant financial relationships declared.

Cardiopathy No Basis for Choosing Anticoagulation in ESUS

MUNICH — Anticoagulation using apixaban (Eliquis) offers no benefit over aspirin in patients with embolic stroke of undetermined source (ESUS) who have atrial cardiopathy but no overt atrial fibrillation, suggest findings from the ARCADIA trial.

The trial, which was halted early, randomized more than 1000 ESUS patients with atrial cardiomyopathy to apixaban or placebo. Results showed that apixaban did not improve rates of recurrent stroke of any kind nor safety outcomes such as major hemorrhage and all-cause mortality.

The results were presented May 24 at the 9th European Stroke Organisation Conference (ESOC).

“We found no benefit of apixaban over aspirin in patients with ESUS who had evidence of atrial cardiopathy, at least based on the criteria in our trial,” said study presenter Hooman Kamel, MD, MS, vice chair for research and chief of neurocritical care in the Department of Neurology, Weill Cornell Medicine, New York City.

“It could be that this concept of thrombogenic atrial cardiopathy really isn’t present unless there is also atrial fibrillation,” he continued, suggesting alternatively that results may be due to the “incorrect choice of atrial cardiopathy biomarkers or thresholds.”

“We chose these because they were clinically scalable and usable in a multicenter design,” Kamel explained, adding that there are a number of different proposed biomarkers that could be used in a future study.

The team will now perform secondary analyses over the coming months to “try to help sort out some of these potential explanations.”

Kamel concluded, however, that, “as of now, no strategy of anticoagulation has been found to be better than antiplatelet therapy for secondary stroke prevention after ESUS.”

Similar Results

Approached for comment, session co-chair Robin Lemmens, MD, PhD, a neurologist in the Department of Neurosciences, UZ Leuven, Leuven, Belgium, noted that this is the third ESUS trial, after the NAVIGATE and RE-SPECT trials, and they have all showed “similar results.”

He told Medscape Medical News, however, that there “could be various reasons for that, and it’s good that they mentioned looking into the subgroups,” as has been done for those other studies.

“Most of these trials were initiated under the concept that most of these patients would have had underlying atrial fibrillation, and then of course there would have been a benefit for anticoagulation.”

“It turns out that that’s not the case,” Lemmens said, “probably because there’s a lot of heterogeneity in these patients,” with different reasons for developing stroke, “not just only potentially underlying atrial fibrillation.”

Session co-chair Arthur Liesz, MD, PhD, Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany, added that it is important to consider the definition of atrial cardiopathy in this context.

If this was limited only to structural cardiopathy, then this “was a rather small subpopulation in this study,” he told Medscape Medical News.

Liesz said that it could instead have been conducted with “more stringent cutoffs,” and could have considered blood biomarkers, “which then would have delivered more overlap with structural cardiopathy,” and allowed those patients to be analyzed separately.

Heterogeneous Etiologies?

Kamel began by noting that the failure of NAVIGATE and RESPECT to show a benefit from anticoagulation in the prevention of recurrent stroke in patients with ESUS led to the hypothesis that this is “perhaps due to heterogeneous underlying etiologies.”

Moreover, these etiologies “may require different types of antithrombotic therapy to best prevent recurrence, and one such underlying etiology may be atrial cardiopathy.”

He explained that several observational studies have found, in the absence of atrial fibrillation, associations between stroke and different markers of atrial cardiopathy and, “given the proven benefit of anticoagulation in preventing strokes in patients with atrial fibrillation, it seems plausible” that they may also benefit.

To investigate further, the team conducted ARCADIA, an investigator-initiated, multicenter, randomized trial involving patients aged 45 years and older from 185 sites in the US and Canada with a clinical diagnosis of stroke that met the consensus criteria for ESUS.

They also were required to have undergone brain imaging to rule out hemorrhagic stroke, and to have a modified Rankin Scale score ≤4, indicating up to a moderately severe degree of disability.

They also had atrial cardiopathy, as determined by P-wave terminal force in V1 >5000µV*ms on electrocardiography, serum N-terminal prohormone of brain natriuretic peptide levels >250 pg/mL, or a left atrium diameter ≥3 cm/m².

The patients were randomly assigned to apixaban 5 mg or 2.5 mg twice daily plus aspirin placebo, or apixaban placebo plus aspirin 81 mg daily. Those diagnosed with atrial fibrillation after randomization crossed over to open-label anticoagulant therapy at physician discretion.

Kamel reported that in 2022, after enrollment of 1015 patients with a mean follow-up of 1.8 years, the trial was halted at the planned interim efficacy/futility analysis, adding that there were “no safety concerns.”

The apixaban and aspirin groups were well balanced in terms of their baseline characteristics. The mean age was 68 years, and 54% were female. Three quarters of the participants were White, 21.1% Black.

Prior stroke was reported in 19% of patients. Hypertension was common, in about 77%, and type 2 diabetes was seen in 31%. There were relatively few cases of ischemic heart disease, heart failure, and peripheral arterial disease.

The primary efficacy outcome of recurrent stroke of any type occurred in 4.4% of both patients treated with apixaban and those given aspirin, at a hazard ratio (HR) of 1.00 (95% CI, 0.64 – 1.55). Similar findings were seen when looking individually at ischemic and hemorrhagic stroke, and stroke of undetermined type.

There was also no significant difference in the secondary outcomes of recurrent ischemic stroke or systemic embolism, at 4.1% vs 4.4% (HR, 0.92; 95% CI, 0.59 – 1.44), and recurrent stroke of any type or death from any cause, at 7.3% v 6.8% (HR, 1.08; 95% CI, 0.76 – 1.52).

In terms of safety, rates of major hemorrhage were low and almost identical between the groups, at 0.7% with apixaban and 0.8% for aspirin (HR, 1.02; 95% CI, 0.29 – 3.51), and were similar for all-cause mortality, at 1.8% vs 1.2% (HR, 1.53; 95% CI, 0.63 – 3.74).

Proportionately more patients treated with aspirin experienced symptomatic intracranial hemorrhage, at 1.1% vs 0%.

The trial results generated a flurry of interest on Twitter.

Thomas Ford, MD, a vascular neurology fellow from Boston Medical Center, described the results as “disappointing,” although he was “curious to see if there was any signal of benefit in subgroup analyses.”

Shadi Yaghi, co-director of the Comprehensive Stroke Center at Brown University, Providence, Rhode Island, added that the trial “begs the question [as to] whether all device-detected atrial fibrillation warrants anticoagulation.”

Replying, Mitchell Elkind, MD, MD, MPhil, professor of neurology and epidemiology at Columbia University Irving Medical Center, New York City, said that he agrees with this interpretation.

“Maybe the issue is not with the concept of atrial cardiopathy but with the need to [anticoagulate] all patients with low AF burden or incidental AF after stroke.”

The study was funded by the National Institutes of Health and the National Institute of Neurological Disorders and Stroke. The study drug was provided in kind by BMS-Pfizer, and ancillary funding for the NT.proBNP assays was provided by Roche. No relevant financial relationships were reported.

9th European Stroke Organisation Conference (ESOC) 2023: Abstract 2709. Presented May 24, 2023.

Post-Stroke Care Need to Improve Clinical Endpoints?

MUNICH — A multidisciplinary post-stroke care program failed to show a reduction in hard clinical endpoints over standard care after 1 year of follow-up, a new study shows, although it did achieve improvements in cardiovascular risk-related measures.

Experts argued that the trial, presented at the European Stroke Organisation Conference (ESOC) 2023 on May 24, would always have struggled to show a benefit when the background standard of care was so high and the study period was so short.

The program, dubbed structured ambulatory post-stroke care program (SANO), was a complex intervention that brought together a host of healthcare professionals and facilities to cooperate with patients to achieve a whole series of cardiovascular risk factor targets.

They randomly assigned 30 clusters or regions in southwestern Germany, each representing one stroke unit, to the intervention or standard care. A total of almost 2800 patients participated. The primary endpoint was a reduction in the rate of a composite of major cardiovascular adverse events at 1-year follow-up.

This was not met, but patients in the intervention arm were significantly more likely than those receiving standard care to achieve their low-density lipoprotein (LDL) cholesterol target, to be receiving statin therapy, and to have quit smoking.

The program “has shown positive effects in optimizing control of some cardiovascular risk factors in stroke patients,” said Christopher J. Schwarzbach, MD, Neurology Department, Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen am Rhein, Germany.

However, “These effects did not translate into a reduction of the rate of major cardiovascular events at 12 months after ischemic stroke,” he said, potentially because the “follow-up period might be too short to demonstrate a positive effect.”

Schwarzbach suggested that the long-term effects of the intervention may need to be considered, along with other potentially favorable effects of the structured intervention of stroke-related sequelae and quality of life.

Evidence-Based Guidelines

Schwarzbach said that the aim was to improve post-stroke care for patients after their first ischemic stroke by “focusing on the management of cardiovascular risk factors, based on evidence-based clinical guidelines.”

To do this, they developed a “complex, inter-sectoral, and patient-centered intervention” that combined behavioral and organizational elements to reduce the risk of recurrent vascular events and deaths and to improve cardiovascular risk factors at 12 months.

The intervention incorporated a range of targets, including blood pressure <140/90 mm Hg, A1c ≤7%, LDL cholesterol <100 mg/dL, appropriate prescription of antithrombotic therapy, consumption of ≥5 portions of fruit and vegetables per day, and ≥120 minutes of moderate exercise per week, among others.

These were to be achieved through a multidisciplinary network that linked together a range of healthcare professionals and facilities, including cardiologists, diabetologists, psychotherapists, physiotherapists, smoking cessation programs, sports groups, social workers, support groups, and dieticians, as well as the patient’s general practitioner.

Patients were educated on cardiovascular risk and lifestyle factors. They were given specialist nutritional advice, and targets were defined with the patient. Motivational interviewing was used to support decision-making, and patients were followed up on a regular basis.

To examine its effectiveness, the researchers conducted a prospective, open-label trial in which regions in southwest Germany that had a stroke unit that provided acute stroke care, labeled “clusters,” were randomly assigned either to standard care or to the novel complex intervention.

Patients were included if they were aged ≥18 years, had no severe disability on the Modified Rankin Scale prior to their index stroke, and had at least one modifiable cardiovascular risk factor. They were also required to be enrolled within 14 days of symptom onset.

Thirty clusters took part in the trial; 15 were assigned to the complex intervention, and 15 were assigned to standard care. A total of 2791 patients were enrolled between January 1, 2019, and January 17, 2022; 1396 were assigned to the intervention, and 1395 were assigned to the control group.

The mean age of the patients was 67 years, and 38.1% were women. The median National Institute of Health Stroke Scale score at baseline was 1 (interquartile range, 0–3).

Schwarzbach said that there were no major clinically relevant differences between the groups at baseline and that prevalence of cardiovascular risk factors was comparable, albeit there was a slightly higher percentage of hyperlipidemia among the intervention group.

Turning to the results, he showed that the trial did not meet its combined primary endpoint of a composite of first recurrent stroke, myocardial infarction, or death from any cause within the first 12 months after the index stroke.

In the intervention group, 5.3% of patients experienced the composite endpoint, vs 6.2% in the control arm, at an odds ratio adjusted for predefined unmodified confounders of 0.95 (95% CI, 0.54 – 1.67).

Similar findings were seen with respect to the rate of individual components of the endpoint, including recurrent stroke, myocardial infarction, all-cause death, and transient ischemic attack.

Exploratory analyses also failed to identify any significant increases in the proportion of patients who achieved their blood pressure or A1c targets or in those adherent to antithrombotic therapy with the intervention vs standard care, despite numerical differences.

However, the intervention was associated with a significant increase in the proportion of patients who achieved their LDL cholesterol target, at 67.3% vs 60.9% in the control group (adjusted odds ratio, 1.65; 95% CI, 1.22 – 2.22).

Significantly more intervention patients were also receiving statin therapy at final assessment, at 92.5% vs 86.4% with standard care (odds ratio, 1.83; 95% CI, 1.32 – 2.56).

The smoking cessation rate was also markedly higher in the intervention group, at 49.5% of patients vs 25.8% among control persons (odds ratio, 2.82; 95% CI, 1.58 – 5.04).

Despite a numerical increase in the proportion of patients who performed ≥120 minutes of at least moderate physical activity per week with the intervention vs standard care, at 79.1% vs 72.1%, this did not reach statistical significance.

The study was funded by the Innovation Fund of the Federal Joint Committee (G-BA). Schwarzbach reports relationships with b4c Solutions, Elsevier, Boehringer-Ingelheim. Other authors declare numerous financial relationships.

European Stroke Organisation Conference (ESOC) 2023: Abstract 2021. Presented May 24, 2023.