This year marked the tenth edition of the European Stroke Organization. Since the first conference, it has provided a platform for the presentation of studies that have changed clinical practice. In addition, the ESOC has created an atmosphere of personal exchange and discussion between researchers from different disciplines, which has led to many years of collaboration.
The PROMOTE trial was conducted to prove the World Stroke Organization ‘s concept of a comprehensive intervention approach in primary prevention to cut stroke in half, developed by former World Stroke Organization President Michael Brainin from Austria and Professor Valery Feigin from New Zealand [1]. The intervention is based on a lifestyle change using the Stroke Riskometer and a polypill containing antihypertensives and statins for patients at low to moderate risk of stroke – a population for whom there is currently no recommendation to take medication. The main study will evaluate the effectiveness of the intervention in reducing the incidence of stroke and cognitive impairment in this population. The Polypill regimen includes valsartan 80 mg, amlodipine 5 mg and rosuvastatin 10 mg.
PROMOTE is a randomized, double-blind, placebo-controlled Phase III clinical trial recruiting participants aged 50-75 years with no history of hypertension, diabetes, stroke or cardiovascular disease, but with a systolic blood pressure (SBP) of 120-139 mmHg and at least one lifestyle risk factor (including unhealthy diet, physical inactivity, obesity or smoking). The aim of this pilot study was to assess the feasibility of the strategy, the tolerability of the new polypill and the potential impact of the integrated intervention. The primary outcome was a 2.5 mmHg reduction in SBP and a 0.4 point improvement in Life’s Simple 7 score over a 9-month period. Participants underwent a 28-day induction period to assess adherence and tolerability of the polypill. Primary healthcare facilities in southern Brazil were randomized into groups to implement a Stroke Riskometer-guided lifestyle change or standard care, while individual participants were assigned to the polypill or placebo.
The pilot study involved 371 patients with an average age of 59 years, 64% were women and 87% were white. The estimated 10-year risk of cardiovascular disease was 4-5% on average. The Polypill regimen was very well tolerated, with only 4% of participants being excluded after the introductory phase due to mild side effects. Serious adverse events occurred in only 1.4% of patients and were not related to the Polypill.
In the participants who received the Polypill, blood pressure fell significantly by 13 mmHg over the entire duration of the study compared to 4 mmHg in the placebo group. In particular, the participants in the Polypill+Riskometer group showed the most significant reduction in blood pressure. The participants taking the Polypill also showed a reduction in LDL cholesterol of 38 mg/dl, while no difference was observed in the placebo group. The riskometer did not provide any additional benefit in lowering cholesterol levels, but encouragingly, 71% of participants who used the stroke riskometer reported that it made it easier for them to change their lifestyle. The pilot study has shown that the new polypill can already be used in hypertensive patients and that it is effective and well tolerated in patients with lower blood pressure but still at increased risk of stroke. The Riskometer is a free, easy-to-use app that can help with lifestyle changes.
The earlier, the better
The fact that early blood pressure reduction also has a positive effect on hematoma growth in acute intracerebral hemorrhage is confirmed by the results of four randomized, controlled INTERACT trials [2]. Data from 2921 patients with intracerebral hemorrhage (ICH) were analyzed, in which the reduction of blood pressure to a systolic blood pressure of less than 180 or less than 140 mmHg was compared. Standardized blood pressure treatment protocols with intravenous agents and standardized imaging assessment and evaluation protocols were used. The aim of the study was to determine whether the timing of the onset of blood pressure lowering influences hematoma growth. The results showed that the likelihood of hematoma growth was lower when antihypertensive treatment was started early. The earlier treatment could be started, the more the growth was reduced – up to a threshold of 3 hours.
Ischemic remote conditioning
A group of researchers from Spain investigated the potential benefits of remote ischemic perconditioning (RIPerC) during transport by ambulance to the hospital for the treatment of acute ischemic stroke [3]. Their results show that this intervention can improve outcome and functional status after stroke in certain patient subgroups, supporting further research into this technique. As part of the REMOTE-CAT project, a multicenter, double-blind trial was conducted to investigate the effects of RIPerC on patients with acute ischemic stroke. The primary outcome focused on the proportion of patients who achieved a modified Rankin Score (mRS) of 2 or less at 90 days post-stroke, while the secondary outcomes examined the reduction in infarct volume. The results revealed a potential association between RIPerC and improved functional outcomes, particularly in patients with lower NIHSS and in patients without large vessel occlusion.
Income lowers mortality risk
New research shows that people with a high income have a 32% lower risk of dying after a stroke. In addition, people with higher education have a 26% lower risk of dying after a stroke. This illustrates the striking differences in survival rates after a stroke, which depend on important social health factors. In the register-based study, data from 6901 stroke patients in Gothenburg, Sweden, between November 2014 and December 2019 were analyzed to investigate the influence of SDoH factors on the risk of mortality after stroke [4]. The study focused on four SDoH factors: Area of residence, country of birth, education and income. In addition to finding a significant association between income, education level and post-stroke mortality risk, the study uncovered a worrying trend regarding the cumulative impact of SDoH factors. Patients with an unfavorable SDoH factor had an 18% higher risk of death than patients without unfavorable SDoH factors. For patients with two to four SDoH factors, this risk increased to 24%.
The study also found an association between an increased risk of death and additional risk factors such as physical inactivity, diabetes, alcohol abuse and atrial fibrillation. When examining patient characteristics within the study cohort, the main findings were gender differences and the potential impact of risk factors. The proportion of female patients increased with the number of unfavorable SDoH factors; 41% of the group with no unfavorable SDoH factors were female, while 59% of the group with two to four unfavorable SDoH factors were female. In addition, smoking, whether current or within the past year, was more prevalent in the group with two to four unfavorable SDoH factors than in the group without SDoH factors (19% vs. 12%).
Congress: European Stroke Organization Conference (ESOC)
Literature:
- Polypill and risikometer to prevent stroke and cognitive impairment in primary health care – final results of the promote pilot study. Presented at the European Stroke Organisation Conference; 15 May 2024; Basel, Switzerland.
- Timing of BP lowering to mitigate hematoma expansion in intracerebral hemorrhage: IPD pooled analysis of 4 interact trials. Presented at the European Stroke Organisation Conference; 16 May 2024; Basel, Switzerland.
- Remote ischemic perconditioning among acute ischemic stroke patients in Catalonia: remote-cat project. Presented at the European Stroke Organisation Conference; 17 May 2024; Basel, Switzerland.
- A register-based study on associations between stroke mortality and risk factors including social determinants of health. Presented at the European Stroke Organization Conference; 15 May 2024; Basel, Switzerland.
InFo NEUROLOGIE PSYCHIATRIE 2024; 22(4): 18–19 (publicado el 26.8.24, antes de impresión)
