Digital therapeutics in peripheral artery disease: a step forward, not yet across the finish line

Graphical Abstract

Graphical Abstract.

This editorial refers to ‘A digital health program enhances walking capacity and health status in symptomatic peripheral artery disease’, by V. Amlani et al. https://doi.org/10.1093/ehjdh/ztag072.

Introduction

Peripheral artery disease (PAD) affects an estimated 200 million people worldwide with a rising prevalence and remains a major contributor to global cardiovascular morbidity and mortality.^1,2 Intermittent claudication (IC) represents its most common and functionally limiting manifestation. Despite clear guideline recommendations supporting supervised exercise therapy (SET) as first-line treatment for claudication, real-world implementation remains strikingly poor.^3,4 Structural barriers, such as limited programme availability, reimbursement constraints, and challenges in patient adherence, have resulted in a substantial gap between evidence and clinical practice. Against this backdrop, digital health interventions have emerged as a promising and scalable approach to improve walking performance and clinical outcome in patients with PAD.^5,6 The IPAD trial provides important evidence supporting the role of a novel, multimodal, smartphone-based digital health programme in improving walking capacity in patients with IC. In this multicentre randomized controlled study, the addition of a 12-week digital intervention to standard care led to a statistically significant and clinically meaningful improvement in maximum walking distance (MWD) during the 6-min walk test (6MWT), exceeding the predefined minimal clinically important difference (MCID) compared with standard care alone. Improvements in pain-free walking distance and health-related quality of life (HRQoL) further reinforce the potential of this approach to address both functional limitations and patient-reported health status.⁷

Discussion

Several aspects of the intervention merit attention. The programme integrates behavioural change techniques, physical activity guidance, and gamification, elements increasingly recognized as central to sustaining patient engagement in digital interventions.⁸ This reflects a broader paradigm shift in chronic disease management from episodic, clinic-based care towards continuous, patient-centred, digitally supported self-management. Importantly, the intervention does not simply digitize existing care pathways but reconfigures them by incorporating real-time feedback and motivational strategies to promote adherence. Adherence remains the key challenge in PAD management, affecting not only exercise therapy but also medication use and the implementation of guideline-recommended treatments.^9,10

However, while the results are encouraging, they should be interpreted with appropriate caution. The improvement in MWD, although exceeding MCID thresholds at the group level, translated less consistently into clinically meaningful gains at the individual level when applying the prespecified 12-m threshold. Only in exploratory analyses using a higher MCID did a significant between-group difference emerge. This highlights a broader challenge in PAD research, namely the heterogeneity of response to exercise-based interventions.

Moreover, the comparator standard care likely reflects routine practice in many healthcare systems, where structured exercise support is limited or absent. The observed benefit may therefore partly reflect the contrast between an active, engaging intervention and a relatively passive control condition. Whether digital programmes can match or even surpass the efficacy of supervised exercise therapy remains an open and clinically important question. In this context, home-based exercise programmes have emerged as a viable alternative to supervised exercise therapy, demonstrating meaningful improvements in walking capacity under real-world conditions. Building on this concept, digital interventions may further enhance the effectiveness of home-based approaches by providing structured guidance, real-time feedback, and behavioural support. As such, digitally supported home-based exercise may represent a particularly promising and scalable strategy to bridge existing gaps in PAD care.¹¹

Adherence and engagement, which are key determinants of success in digital interventions, also warrant closer attention. While the study demonstrates efficacy under trial conditions, real-world implementation may encounter challenges related to digital literacy, patient motivation, and long-term sustainability. The relatively high mean age of participants (∼72 years) underscores the importance of designing patient-tailored, user-friendly interfaces, but also raises questions about generalizability to broader and more diverse PAD populations. This is particularly relevant given the heterogeneity in digital health literacy and attitudes towards eHealth technologies observed among patients with cardiovascular disease.¹²

From a clinical perspective, the findings support the integration of digital therapeutics into the PAD treatment pathway, particularly in settings where supervised exercise therapy is not readily available. Such programmes may serve as a pragmatic bridge, expanding access to structured lifestyle interventions while healthcare systems work to address existing gaps in care delivery. Importantly, digital health should be considered a complement rather than a replacement for established therapies within a multimodal treatment strategy.

Looking ahead, several priorities emerge. Comparative effectiveness studies against supervised exercise therapy are needed to define the relative and additive benefits of digital interventions. Longer follow-up will be essential to assess the durability of effects and their impact on clinical outcomes, including cardiovascular events and limb-related endpoints. In addition, integration with comprehensive cardiovascular risk management, including pharmacotherapy, smoking cessation, and metabolic control, will be critical to realizing the full potential of digital health in PAD.

In conclusion, the IPAD trial represents an important step towards addressing the unmet needs of patients with IC. By demonstrating that a scalable digital intervention can achieve clinically meaningful improvements in walking capacity, it highlights new opportunities to expand access to effective, non-invasive therapies. The remaining challenge lies in translating these findings into routine clinical practice and ensuring that innovation leads to measurable improvements in patient outcomes.

Author contributions

Christos Rammos (Writing—review & editing [lead]) and Julia Lortz (Writing—review & editing [supporting])

Funding

None.