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

Evaluation of a Digital Health Intervention Following Percutaneous Coronary Intervention: Results from a Randomized Controlled Study

  • By

  • Elias Freyr Gudmundsson

  • Bartosz Dobies

  • Brynja Laxdal

  • Inga Valborg Olafsdottir

  • Ingibjörg Davidsdottir

  • Heida Birna Bragadottir

  • Svala Sigurdardottir

  • Ari Pall Isberg

  • Andrew Grannell

  • Berglind Libungan

  • Brynjolfur A. Mogensen

  • Hulda Halldorsdottir

  • Maria V. Gudmundsdottir

  • Bylgja Kaernested

  • Tryggvi Thorgeirsson

  • Saemundur Jon Oddsson

  • David O. Arnar

  • July 21, 2026

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Clinical Report: Evaluation of a Digital Health Intervention Following PCI

Overview

This study evaluated the effectiveness of a multimodal digital health intervention (SK-121) in reducing recurrent cardiovascular events post-percutaneous coronary intervention (PCI). The intervention did not significantly lower the SMART2 risk score overall. However, it improved disease knowledge, medication adherence, and diastolic blood pressure in participants.

Background

Coronary artery disease (CAD) is a leading cause of mortality globally, with many risk factors being modifiable. There is a notable gap between clinical guidelines for CAD management and real-world implementation. Digital health technologies may offer solutions to enhance adherence to lifestyle changes for patients following PCI.

Data Highlights

MeasureIntervention GroupControl GroupP-value
SMART2 Risk Score Change at 6 Months-0.3%-0.821
Disease Knowledge ImprovementSignificant-P < 0.001
Medication Adherence at 6 MonthsSignificant-P = 0.030
Diastolic Blood Pressure Change at 12 Months-3.7 mmHg-P = 0.003
SMART2 Score Change in Overweight Participants at 12 Months-3.7%-P = 0.033

Key Findings

  • The digital health intervention did not significantly reduce the SMART2 risk score in the overall population.
  • Participants in the intervention group showed significant improvements in disease knowledge at both 6 and 12 months (P < 0.001).
  • Medication adherence was significantly higher in the intervention group at 6 months (P = 0.030).
  • Diastolic blood pressure was significantly lower in the intervention group at 12 months (−3.7 mmHg; P = 0.003).
  • In overweight participants, the intervention significantly reduced SMART2 scores at 12 months (−3.7%; P = 0.033).

Clinical Implications

The findings indicate that while the digital health intervention did not reduce cardiovascular risk scores broadly, it improved disease knowledge and medication adherence.

Conclusion

The multimodal digital health intervention demonstrated positive effects on knowledge and adherence but did not achieve the primary endpoint of reducing cardiovascular risk scores in the overall cohort.

Related Resources & Content

  1. Journal of Medical Internet Research (JMIR), 2026 -- Correction: Effects of an eHealth Cardiac Exercise Rehabilitation Platform for Patients After Percutaneous Coronary Intervention Based on the Persuasive Systems Design Model: Randomized Controlled Trial
  2. Clinical Research in Cardiology, 2020 -- Impact of Remote Monitoring on Anxiety, Depression, Quality of Life, and Device Acceptance in Patients with Implantable Cardioverter-Defibrillators: A Prospective, Randomized, Controlled Single-Center Study
  3. Clinical Research in Cardiology, 2024 -- Factors Influencing Symptom Relief in Chronic Coronary Syndrome Patients Following Percutaneous Coronary Intervention
  4. European Journal of Preventive Cardiology -- Digital health interventions for cardiac rehabilitation in stable coronary artery disease
  5. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes - Professional Heart Daily | American Heart Association
  6. Comparative efficacy and adherence of telehealth cardiac rehabilitation interventions for patients with cardiovascular disease: A systematic review and network meta-analysis - PubMed
  7. JMIR mHealth and uHealth - Wearable Devices in Remote Cardiac Rehabilitation With and Without Weekly Online Coaching for Patients With Coronary Artery Disease: Randomized Controlled Trial
  8. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes - Professional Heart Daily | American Heart Association
  9. Comparative efficacy and adherence of telehealth cardiac rehabilitation interventions for patients with cardiovascular disease: A systematic review and network meta-analysis - PubMed
  10. JMIR mHealth and uHealth - Wearable Devices in Remote Cardiac Rehabilitation With and Without Weekly Online Coaching for Patients With Coronary Artery Disease: Randomized Controlled Trial

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