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July 21, 2026Frontiers in Digital HealthOpen Access

Use of a digital health solution after percutaneous coronary intervention: a randomised controlled trial

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Key result

The SK-121 digital health intervention did not significantly reduce the SMART2 risk score at 6 months compared to standard of care alone in patients following percutaneous coronary intervention.

Why the study?

To evaluate a multimodal digital health intervention (SK-121) as an adjunct to standard of care to reduce the risk of recurrent cardiovascular events in patients following PCI.

Does a multimodal digital health intervention added to standard of care reduce the SMART2 risk score in patients following percutaneous coronary intervention?

Population

200 patients who underwent PCI

Comparison

SoC plus a 48-week gamified digital program vs SoC alone

Design

Single-centre randomised controlled trial

Follow-up

6 months for primary endpoint, up to 12 months

Authors

EGElías F. GuðmundssonBDBartosz DobiesBLBrynja Laxdal

Discussion

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Overview

Does not support routine SK-121 use to lower recurrent risk post-PCI; leaves open potential benefit in overweight patients.

Study Design

Type

RCT (n=200)

Blinding

Open-label

Randomization

1:1

Multicenter

No

Structured PICO

Does a multimodal digital health intervention added to standard of care reduce the SMART2 risk score in patients following percutaneous coronary intervention?

P
Population
200 adults with coronary artery disease who underwent percutaneous coronary intervention within the prior 7 to 30 days, followed for up to 12 months.
I
Intervention
48-week gamified digital health program (SK-121) focusing on lifestyle modification and remote patient monitoring (RPM), added to standard of care.
C
Comparator
Standard of care alone.
O
Outcome
Baseline-adjusted between-group difference in the Second Manifestations of ARTerial disease, version 2 (SMART2) risk score at 6 months.surrogate

Main Result

Mean Difference: -0.3 (95% CI -2.4–1.9)

Absolute Event Rate: 23.9% vs 24.2%

p-value: p=0.821

A 48-week digital health intervention after PCI did not significantly reduce the SMART2 risk score at 6 months compared to standard of care, though it improved disease knowledge and short-term medication adherence.

Limitations

  • Single-centre study design
  • Blinding of patients, nurses, and physicians was not feasible
  • Relatively short follow-up period of 12 months
  • Small sample size for detecting differences in hard clinical events
  • Single-centre design
  • Short follow-up period (1 year) which may be insufficient to detect benefits on top of optimized therapy

Cite This Study

Guðmundsson et al. (2026) conducted an RCT in Coronary artery disease following percutaneous coronary intervention (n=200). SK-121 digital health program vs. Standard of care alone was evaluated on Baseline-adjusted between-group difference in the SMART2 risk score at 6 months (adjusted mean difference -0.3%, 95% CI -2.4 to 1.9, p=0.821). The SK-121 digital health intervention did not significantly reduce the SMART2 risk score at 6 months compared to standard of care alone in patients following percutaneous coronary intervention.

synapsesocial.com/papers/6a759728f1e99ff85ab1fc3dhttps://doi.org/10.3389/fdgth.2026.1851777
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