ArticleDigital health
Potential legacy effect of digital therapeutics on mortality in CHD patients treated with PCI: 8-Year result of BAMA trial.
Article in Digital health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
13 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: The original BAMA randomized trial showed that a mobile app-based self-management digital therapeutics (DTx) intervention improved medication adherence and cardiovascular risk-factor control at 12 months in patients with coronary heart disease (CHD). Whether these early benefits are associated with favorable long-term outcomes-a potential legacy effect-remains uncertain. Methods: The BAMA pilot trial was a parallel-group, open-label, single-center randomized controlled trial in which 300 patients with CHD were assigned 1:1 to regular follow-up with or without DTx. The present study was a 12-month landmark post-trial analysis with follow-up through June 2025, corresponding to up to 8 years after randomization. Participants in the landmark cohort were analyzed according to original randomized assignment. Cox models evaluated all-cause and cardiovascular mortality, with Firth penalized Cox regression as a sparse-event sensitivity analysis. Longitudinal lipid trajectories were assessed using linear mixed-effects models based on actual measurement timing. Results: Among 290 participants who completed the 12-month visit, 289 had ascertainable post-landmark follow-up. During a median post-trial follow-up of 7.1 years, 22 participants died, including 13 from cardiovascular causes. After adjustment for baseline age and sex, original DTx assignment was associated with lower all-cause mortality (hazard ratio [HR], 0.38; 95% CI, 0.15-0.98; P=.045) and cardiovascular mortality (HR, 0.19; 95% CI, 0.04-0.87; P=.032). Firth penalized analyses yielded directionally consistent results. No significant group-by-time interactions were observed for total cholesterol, triglycerides, high-density lipoprotein cholesterol, or low-density lipoprotein cholesterol. Conclusions: Original DTx assignment was associated with lower post-landmark all-cause and cardiovascular mortality despite broadly comparable longitudinal lipid trajectories. These findings may be consistent with a potential legacy effect and warrant confirmation in larger prospective studies.
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