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.
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.