# APBA Kısa Özet
The PACESETTER trial evaluated a digital intervention for blood pressure control after stroke but was stopped early due to low recruitment and funding constraints. At 12 months, there was no significant difference in systolic BP <130 mmHg between the intervention and usual care groups (50% vs 47.2%, P=0.82).
# Çalışma neyi araştırdı?
The PACESETTER (Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor) trial investigated whether a digital intervention could improve blood pressure (BP) control after stroke. Despite strong evidence that BP reduction improves stroke outcomes, fewer than one third of stroke survivors achieve BP control within one year of the index event. The study aimed to address this gap using a technology-driven approach.
# Yöntem
This was a randomized controlled trial conducted across three safety-net health care systems in South Carolina. Patients with stroke and uncontrolled BP were enrolled and randomized 1:1 to the PACESETTER intervention or usual care. The intervention group received a Bluetooth-enabled electronic pill tray, a BP monitor, and a smartphone application for automated data transmission of medication adherence and BP data to a central server. The primary outcome was systolic BP <130 mmHg at 12 months, analyzed according to the intention-to-treat principle. The trial was stopped early due to low recruitment during the COVID-19 pandemic and funding constraints. A total of 120 participants were randomized between September 2019 and February 2023.
# Temel bulgular
At 12 months, the primary outcome of systolic BP <130 mmHg was achieved in 50% of the PACESETTER intervention group and 47.2% of the usual care group (P = 0.82). This indicates no statistically significant difference in BP control between the two groups. The effect of the intervention on 12-month BP control after stroke remains uncertain due to the premature termination of the trial. While the intervention successfully collected medication adherence and BP data via digital means, it did not translate into improved BP outcomes compared to standard care.
# Bulgular ne anlama geliyor?
The findings suggest that the specific digital intervention tested—Pill tray, BP monitor, and app combination—did not achieve a statistically significant improvement in systolic BP control at 12 months post-stroke. The lack of significant difference, combined with the trial's early termination, means the true effect of the intervention remains unknown. The study highlights the challenges of implementing digital health interventions in real-world, safety-net settings and the difficulty of achieving BP targets in the critical year following a stroke.
# Klinik önem
These results indicate that this particular digital tracking system did not provide a significant additional benefit over usual care for blood pressure management after stroke. Clinicians should not rely on this specific technology bundle to achieve BP targets in the post-stroke period. However, the broader challenge of achieving BP control after stroke remains; fewer than one third of survivors achieve control within one year. Future research should explore different digital strategies, implementation approaches, or patient populations to address this persistent gap in secondary stroke prevention.
# Sınırlılıklar
The PACESETTER trial has several important limitations. The trial was stopped early due to low recruitment during the COVID-19 pandemic and funding constraints, which limited statistical power and the ability to detect significant differences. The trial population was limited to patients from safety-net health care systems in South Carolina, potentially limiting generalizability to other settings or populations. No blinding was implemented, which may introduce performance and detection bias. The study was underpowered to evaluate key short-term endpoints as intended. Additionally, the premature termination means the effect of the intervention on 12-month BP control after stroke remains uncertain.