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

AIMS: To evaluate a multimodal digital health intervention (SK-121) as an adjunct to standard of care (SoC) to reduce the risk of recurrent cardiovascular events in patients following percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this single-centre, randomised controlled trial of 200 patients (mean age 64.4 years; 79.5% male) who underwent PCI, patients were randomised 1:1 to receive SoC alone or SoC plus a 48-week gamified digital program focusing on lifestyle modification and remote patient monitoring (RPM). User retention and engagement were high with 84% remaining active at 24 weeks and weekly RPM completion averaging 94%. The primary endpoint was the baseline-adjusted between-group difference in the Second Manifestations of ARTerial disease, version 2 (SMART2) risk score at 6 months. These SMART2 scores did not differ between the intervention and control groups (adjusted mean difference -0.3%; 95% confidence interval -2.4% to 1.9%; P = 0.821). However, the intervention group significantly improved in disease knowledge at 6 and 12 months (P < 0.001) and medication adherence 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 a post hoc exploratory hypothesis-generating subgroup analysis of overweight participants, the intervention significantly reduced SMART2 scores at 12 months compared to controls (-3.7%; P = 0.033). CONCLUSION: While the intervention did not reduce the SMART2 risk score in the overall population, it significantly improved disease knowledge, short-term medication adherence, and diastolic blood pressure. The program was well-accepted and may offer prognostic benefits for overweight patients. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05713565, NCT05713565.