While patients treated via a structured ambulatory post-stroke care programme (SANO) in a recent cluster-randomised study experienced better control of their cardiovascular risk factors compared to a control group, this did not translate into any significant reduction in recurrent stroke, myocardial infarction (MI) or death at one year.
On the opening day of the European Stroke Organisation Conference (ESOC; 24–26 May, Munich, Germany), results from the SANO trial were delivered for the first time by Christopher Schwarzbach (Klinikum Ludwigshafen, Ludwigshafen am Rhein, Germany).
“The SANO programme has shown positive effects in optimising control of cardiovascular risk factors in stroke patients,” he stated. “Unfortunately, this did not translate into a reduction of the rate of major cardiovascular events one year after ischaemic stroke. However, all-cause mortality within one year after the index stroke was lower in the intervention-group in the crude analysis—an effect already observed in the STROKE-CARD trial.”
SANO—a cluster-randomised, parallel-arm interventional trial—set out to assess whether a comprehensive programme could enhance outpatient aftercare for stroke patients in Germany by improving risk factor control and, thus, reducing future risks of cardiovascular events.
According to an ESO press release, advances in acute stroke care have made a “tremendous impact” on reducing stroke-related death and disability, but risks of subsequent vascular events after the acute phase remain significant, with some studies suggesting a one-year recurrent stroke risk as high as 10%. As such, efforts to improve post-acute phase care are “urgently needed”.
The trial presented at ESOC 2023 sought to evaluate SANO’s ability to reduce the frequencies of recurrent stroke, myocardial infarction and death—as well as optimising control of cardiovascular risk factors like hypertension, diabetes, smoking, hypercholesterolaemia and physical activity—after a first ever ischaemic stroke.
Thirty participating clusters in Germany were randomised to either the intervention group, receiving a one-year behavioural, organisational and patient-centred intervention within a cross-sectoral multidisciplinary network, or the control group, receiving routine care.
The multidisciplinary network deployed in the intervention group involved general practitioners, specialists and therapists as well as social workers, sports groups, support groups and providers of smoking-cessation programmes. Schwarzbach also detailed several patient-centred elements in SANO, including education on the management of cardiovascular risk factors, target setting, motivational interviewing, dietary counselling, and regular hospital follow-up visits.
A total of 2,791 patients were enrolled in the SANO trial between January 2019 and December 2020; 1,396 in the intervention group and 1,395 in the control group.
Delivering results from the present study, Schwarzbach reported that patients in the intervention group had better control of their cardiovascular risk factors versus the control group after 12 months, but that this did not translate into a significant reduction in one-year recurrent stroke, MI or death, as per the trial’s primary endpoint (5.3% in the intervention arm vs 6.2% in the control group; adjusted odds ratio [OR] 0.95, 95% confidence interval [CI] 0.54–1.67).
“As a one-year follow-up period might be too short to demonstrate a positive effect on recurrent cardiovascular events, longer-term effects still need to be considered,” Schwarzbach stated. “Furthermore, other potentially favourable effects of the structured intervention on stroke-related sequelae and quality of life require further evaluation.”