Stroke and high-risk TIA outcomes with reduction of treatment duration when treatment initiated in emergency rooms (SHORTER-study).

BACKGROUND: Following transient ischemic attack (TIA) and minor stroke, the risk of recurrent stroke can be significantly reduced with short-duration dual antiplatelet therapy (DAPT). We wish to investigate whether 10 days of DAPT is as effective as 21 days' treatment. STUDY DESIGN: This is an open-label, randomized, parallel-group study comparing whether 10 days of DAPT treatment (ASA + clopidogrel) is non-inferior to 21 days of DAPT in patients with acute ischemic stroke (AIS) or high-risk TIA. In both groups, DAPT is started within 24 hours of symptom onset. This study is being conducted in approximately 15 study sites in the Kingdom of Saudi Arabia. The planned sample size is 1932. OUTCOMES: Non-inferiority of 10 days compared to 21 days of DAPT in the prevention of the composite endpoint of stroke and death at 90 days in AIS/TIA patients. The primary safety outcome is major intra-cranial and systemic hemorrhage. STUDY PERIOD: Enrolment started in the second quarter of 2023, and the completion of the study is expected in the fourth quarter of 2025. DISCUSSION: The trial is expected to show that 10 days of DAPT is non-inferior for the prevention of early recurrence of vascular events in patients with high-risk TIAs and minor strokes.

Reference values for the incremental shuttle walk test in patients with cardiovascular disease entering exercise-based cardiac rehabilitation.

The incremental shuttle walk test (ISWT) is used to assess functional capacity of patients entering cardiac rehabilitation. Factors such as age and sex account for a proportion of the variance in test performance in healthy individuals but there are no reference values for patients with cardiovascular disease. The aim of this study was to produce reference values for the ISWT. Participants were n = 548 patients referred to outpatient cardiac rehabilitation who underwent a clinical examination and performed the ISWT. We used regression to identify predictors of performance and produced centile values using the generalised additive model for location, scale and shape model. Men walked significantly further than women (395 ± 165 vs. 269 ± 118 m; t = 9.5, P < 0.001) so data were analysed separately by sex. Age (years) was the strongest predictor of performance in men (ß = -5.9; 95% CI: -7.1 to -4.6 m) and women (ß = -4.8; 95% CI: -6.3 to 3.3). Centile curves demonstrated a broadly linear decrease in expected ISWT values in males (25-85 years) and a more curvilinear trend in females. Patients entering cardiac rehabilitation present with highly heterogeneous ISWT values. Much of the variance in performance can be explained by patients' age and sex. Comparing absolute values with age-and sex-specific reference values may aid interpretation of ISWT performance during initial patient assessment at entry to cardiac rehabilitation.

Effects of exercise-based cardiac rehabilitation on cardiorespiratory fitness: A meta-analysis of UK studies.

BACKGROUND: Exercise-based cardiac rehabilitation can promote meaningful improvements in cardiorespiratory fitness (fitness) but the magnitude of such improvements varies according to local characteristics of exercise programmes. We aimed to determine if cardiac rehabilitation (CR), as practised in the United Kingdom (UK), could promote meaningful changes in fitness and to identify programme characteristics which may moderate these changes. METHODS: Electronic and manual searches to identify UK CR studies reporting fitness at baseline and follow up. Change in fitness (Δfitness) was expressed as mean difference (95% CI) and effect size (ES). A random effects model was used to calculate the mean estimate for change in Δfitness. Between-group heterogeneity was quantified (Q) and investigated using planned sub-group analyses. RESULTS: We identified n=11 studies containing 16 patient groups (n=1 578) which used the incremental shuttle walking test (ISWT) (distance walked) to assess fitness. The overall mean estimate for Δfitness showed a significant increase in distance walked (ES=0.48, P<0.001), but this estimate was highly heterogeneous (Q=77.1, P<0.001, I(2)=81%). Sub-group analyses showed significantly greater ES (Q=3.94, P=0.046) for Δfitness in patients prescribed n>12 exercise sessions compared with those receiving n≤12 sessions. CONCLUSION: We found significant increases in fitness (based on ISWT) in patients attending exercise-based CR in the UK. However, UK studies provide approximately one-third of the exercise "dose", and produce gains in fitness less than half the magnitude reported in international studies.

Cardiorespiratory fitness changes in patients receiving comprehensive outpatient cardiac rehabilitation in the UK: a multicentre study.

BACKGROUND: Exercise training is a key component of cardiac rehabilitation but there is a discrepancy between the high volume of exercise prescribed in trials comprising the evidence base and the lower volume prescribed to UK patients. OBJECTIVE: To quantify prescribed exercise volume and changes in cardiorespiratory fitness in UK cardiac rehabilitation patients. METHODS: We accessed n=950 patients who completed cardiac rehabilitation at four UK centres and extracted clinical data and details of cardiorespiratory fitness testing pre- and post-rehabilitation. We calculated mean and effect size (d) for change in fitness at each centre and converted values to metabolic equivalent (METs). We calculated a fixed-effects estimate of change in fitness expressed as METs and d. RESULTS: Patients completed 6 to 16 (median 8) supervised exercise sessions. Effect sizes for changes in fitness were d=0.34-0.99 in test-specific raw units and d=0.34-0.96 expressed as METs. The pooled fixed effect estimate for change in fitness was 0.52 METs (95% CI 0.51 to 0.53); or an effect size of d=0.59 (95% CI 0.58 to 0.60). CONCLUSION: Gains in fitness varied by centre and fitness assessment protocol but the overall increase in fitness (0.52 METs) was only a third the mean estimate reported in a recent systematic review (1.55 METs). The starkest difference in clinical practice in the UK centres we sampled and the trials which comprise the evidence-base for cardiac rehabilitation was the small volume of exercise completed by UK patients. The exercise training volume prescribed was also only a third that reported in most international studies. If representative of UK services, these low training volumes and small increases in cardiorespiratory fitness may partially explain the reported inefficacy of UK cardiac rehabilitation to reduce patient mortality and morbidity.