Long-term outcome of a pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack: study protocol.

BACKGROUND: Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of incident cardiovascular events and recurrent stroke. Despite compelling evidence about the efficacy of secondary prevention, a substantial gap exists between risk factor management in real life and that recommended by international guidelines. We conducted the STROKE-CARD trial (NCT02156778), a multifaceted pragmatic disease management program between 2014 and 2018 with follow-up until 2019. This program successfully reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA within 12 months after the index event. To investigate potential long-term effects of STROKE-CARD care compared to standard care, an extension of follow-up is warranted. METHODS: We aim to include all patients from the STROKE-CARD trial (n = 2149) for long-term follow-up between 2019 and 2021 with the study visit scheduled 3-6 years after the stroke/TIA event. The co-primary endpoint is the composite of major recurrent cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) from hospital discharge until the long-term follow-up visit and health-related quality of life measured with the European Quality of Life-5 Dimensions (EQ-5D-3L) at the final visit. Secondary endpoints include overall mortality, long-term functional outcome, and target-level achievement in risk factor management. DISCUSSION: This long-term follow-up will provide evidence on whether the pragmatic post-stroke/TIA intervention program STROKE-CARD is capable of preventing recurrent cardiovascular events and improving quality-of-life in the long run. Trial registration clinicaltrials.gov: NCT04205006 on 19 December 2019.

Sex-differences in psychosocial sequelae after spontaneous cervical artery dissection.

Short- to mid-term functional outcome in spontaneous cervical artery dissection is favorable, but the concomitant psychosocial impact is underreported. We aimed to determine these possible sequelae, with a special focus on sex differences, in our cohort of spontaneous cervical artery dissection subjects. During a standardized prospective in-house follow-up visit we, among other values, evaluated functional outcome (modified Rankin Scale [mRS]), psychosocial measures (return to work-, divorce rate) and health-related quality of life (WHO-QoL-BREF and SF-36-questionnaires). 145 patients participated in the long-term prospective follow-up. Median follow-up time was 6.5 years and excellent functional outcome (mRS ≤ 1) was achieved in 89.0% subjects. 87.6% returned to work and 17.6% married patients had a divorce during follow-up. Even though relevant baseline-/discharge characteristics and functional outcome did not differ between the sexes, women were less likely to return to work compared to men (79.7% vs. 93.8%; P = 0.010) and divorce rate was considerably higher in women (30.2% vs. 9.2%; P = 0.022). Health related quality of life did not differ significantly between the sexes, but women consistently reported lower values. Even though functional outcome is beneficial in most patients, measures to prevent poor psychosocial outcome should be considered in the long-term care of patients with spontaneous cervical artery dissection, especially women.

The dimension of preventable stroke in a large representative patient cohort.

OBJECTIVE: To analyze the frequency of inadequately treated risk factors in a large representative cohort of patients with acute ischemic stroke or TIA and to estimate the proportion of events potentially avertable by guideline-compliant preventive therapy compared to the status quo. METHODS: A total of 1,730 patients from the Poststroke Disease Management STROKE-CARD trial (NCT02156778) were recruited between 2014 and 2017. We focused on 8 risk conditions amenable to drug therapy and 3 lifestyle risk behaviors and assessed pre-event risk factor control in retrospect. RESULTS: The proportion of patients with at least 1 inadequately treated risk condition was 79.5% (95% confidence interval [CI] 77.6%-81.4%) and increased to 95.1% (95% CI 94.1%-96.1%) upon consideration of the lifestyle risk behaviors. Risk factor control was worse in patients with recurrent vs first-ever events (p < 0.001), men vs women (p = 0.003), and patients ≤75 vs >75 years of age (p < 0.001). The estimated degree of stroke preventability ranged from 0.4% (95% CI 0.2%-0.6%) to 13.7% (95% CI 12.2%-15.2%) for the individual risk factors. Adequate control of the 5 most relevant risk factors combined (hypertension, hypercholesterolemia, atrial fibrillation, smoking, and overweight) would have averted ≈1 of 2 events or 1 in 4 with a highly conservative computation approach. CONCLUSIONS: Our study confirms the existence of a considerable gap between risk factor control recommended by guidelines and real-world stroke prevention. Our study intends to increase awareness among physicians about stroke preventability and provides a quantitative basis for the emerging discussion on how to best tackle this challenge.