A real-world evidence study to evaluate the efficacy of software-driven digital therapeutics on major adverse cardiovascular events, vitals, adherence to medication and lifestyle changes among patients with coronary artery disease or post-coronary interventions

Abhijeet Palshikar; Chetan H. Gharat; Kamlesh Patel

doi:10.18203/2320-6012.ijrms20231037

Authors

Abhijeet Palshikar Department of Cardiology, Cardiomet Clinic, Pune, Maharashtra, India
Chetan H. Gharat Lupin Digital Health Limited, Santacruz (East), Mumbai, Maharashtra, India
Kamlesh Patel Lupin Digital Health Limited, Santacruz (East), Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2320-6012.ijrms20231037

Keywords:

ACS, CAD, PCI, DTx, Medication adherence, Blood pressure changes

Abstract

Background: Coronary artery disease (CAD), a leading cause of cardiovascular disease (CVD) mortality worldwide, is a major health concern in India due to the high rates of the disease. Acute coronary syndrome (ACS) is a prevalent form of CAD that requires prompt treatment. Digital therapeutics (DTx) is an emerging field that employs remote monitoring and behavioural changes to manage diseases, with promising outcomes in ACS and post-percutaneous coronary intervention (PCI) patients. This study evaluates the efficacy of a software-driven DTx intervention in enhancing outcomes for CAD patients.

Methods: This pilot, single-centred, prospective and real-world evidence cohort study aims to evaluate the effectiveness of a software-driven therapeutic intervention (LYFE) in patients with ACS and/or post-PCI. The study enrolled 30 patients over a 3-month follow-up period from October to November 2022. The main outcomes measured were changes in blood pressure, heart rate, medication adherence, the incidence of major adverse cardiovascular events (MACE), all-cause readmission, and lifestyle adherence at 1 and 3 months.

Results: The mean age of the patients was 53.2±12.1 years; 27 (93%) males and 2 (7%) were females. Mean BMI of the patients was 26.3±5.0. The mean difference for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was 7.8±10.9 (p=0.001*), 3.7±5.7 (p=0.002*) respectively with statistically significant reduction, at 3 months. The 25 (83.3%) patients had controlled blood pressure at 3 months. 27 (90%) patients were adherent to the medication and physically active, while 3 (10%) inactive throughout the study period. No CVD death/major bleeding event was reported.

Conclusions: DTx improved medication adherence and blood pressure control in CAD, ACS with post-PCI patients during the study period.

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References

WHO. Cardiovascular diseases. Available at: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds). Accessed on 14 February, 2023.

Naghavi M, Wang H, Lozano R, Davis A, Liang X, Zhou M, et al. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385(9963):117-71.

Sreeniwas Kumar A, Sinha N. Cardiovascular disease in India: A 360 degree overview. Med J Armed Forces India. 2020;76(1):1-3.

Choxi R, Kapoor K, Mackman N, Jovin IS. Direct Oral Anticoagulants and Coronary Artery Disease. Arteriosclerosis, Thrombosis, and Vascular Biology. 2022;42(5):553-64.

Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2021;42(14):1289-367.

World Health Organization. Adherence to long-term therapies : evidence for action. World Health Organization. Available at: https://apps.who.int/iris/ handle/10665/42682. Accessed on 20 February 2023.

Chinwong S, Doungsong K, Channaina P, Phrommintikul A, Chinwong D. Association between medication adherence and cardiovascular outcomes among acute coronary syndrome patients. Res Social Adm Pharm. 2021;17(9):1631-5.

Desai NR, Choudhry NK. Impediments to Adherence to Post Myocardial Infarction Medications. Curr Cardiol Rep. 2012;15(1):322.

Zhang J, Gong Y, Zhao Y, Jiang N, Wang J, Yin X, et al. Post-stroke medication adherence and persistence rates: a meta-analysis of observational studies. J Neurol. 2021;268(6):2090-8.

Murad H, Basheikh M, Zayed M, Albeladi R, Alsayed Y. The Association Between Medication Non-Adherence and Early and Late Readmission Rates for Patients with Acute Coronary Syndrome. IJGM. 2022;15:6791-9.

Rahhal A, Mahfouz A, Khir F, Okleh N, Aljundi AH, Al Khalaila O. Medications adherence post-primary percutaneous coronary intervention in acute myocardial infarction: A population-based cohort study. J Clin Pharm Ther. 2021;46(3):772-9.

Sverdlov O, Van Dam J, Hannesdottir K, Thornton-Wells T. Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development. Clin Pharmacol Ther. 2018;104(1):72-80.

Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, et al. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016;2(4):237-44.

Quilici J, Fugon L, Beguin S, Morange PE, Bonnet JL, Alessi MC, et al. Effect of motivational mobile phone short message service on aspirin adherence after coronary stenting for acute coronary syndrome. Int J Cardiol. 2013;168(1):568-9.

Park LG, Howie-Esquivel J, Chung ML, Dracup K. A text messaging intervention to promote medication adherence for patients with coronary heart disease: a randomized controlled trial. Patient Educ Couns. 2014;94(2):261-8.

Khonsari S, Subramanian P, Chinna K, Latif LA, Ling LW, Gholami O, et al. Effect of a reminder system using an automated short message service on medication adherence following acute coronary syndrome. Eur J Cardiovasc Nurs. 2015;14(2):170-9.

Cheng K, Ingram N, Keenan J, Choudhury RP. Evidence of poor adherence to secondary prevention after acute coronary syndromes: possible remedies through the application of new technologies. Open Heart. 2015;2(1):e000166.

Kassab Y, Hassan Y, Abd Aziz N, Ismail O, AbdulRazzaq H. Patients’ adherence to secondary prevention pharmacotherapy after acute coronary syndromes. Int J Clin Pharm. 2013;35(2):275-80.

Rivers JT, Smith C, Smith I, Cameron J. The Impact of a Mobile App on Participation in Cardiac Rehabilitation and Understanding Barriers to Success: Comparative Cohort Study. JMIR Cardio. 2022;6(1):e24174.

Paruchuri K, Finneran P, Marston NA, Healy EW, Andreo J, Lynch R, et al. Outcomes of a smartphone-based application with live health-coaching post-percutaneous coronary intervention. eBio Med. 2021;72:103593.

Indraratna P, Biswas U, McVeigh J, Mamo A, Magdy J, Vickers D, et al. A Smartphone-Based Model of Care to Support Patients with Cardiac Disease Transitioning From Hospital to the Community (TeleClinical Care): Pilot Randomized Controlled Trial. JMIR MhealthUhealth. 2022;10(2):e32554.

Krackhardt F, Jörnten-Karlsson M, Waliszewski M, Knutsson M, Niklasson A, Appel KF, et al. Results from the “Me & My Heart” (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome. Cardiovasc Drugs Ther. 2022;10.

Santo K, Singleton A, Rogers K, Thiagalingam A, Chalmers J, Chow CK, et al. Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial. Heart. 2019;105(4):323-9.

Senoo K, Miki T, Ohkura T, Iwakoshi H, Nishimura T, Shiraishi H, et al. A Smartphone App to Improve Oral Anticoagulation Adherence in Patients With Atrial Fibrillation: Prospective Observational Study. JMIR MhealthUhealth. 2022;10(1):e30807.

Marvel FA, Spaulding EM, Lee MA, Yang WE, Demo R, Ding J, et al. Digital Health Intervention in Acute Myocardial Infarction. Circulation: Cardiovascular Quality and Outcomes. 2021;14(7):e007741.

Widmer RJ, Allison TG, Lerman LO, Lerman A, et al. Digital health intervention as an adjunct to cardiac rehabilitation reduces cardiovascular risk factors and rehospitalizations. J Cardiovascular Translational Res. 2015;8(5):283.

Wita K, Kułach A, Wita M, Wybraniec MT, Wilkosz K, Polak M, et al. Managed Care after Acute Myocardial Infarction (KOS-zawał) reduces major adverse cardiovascular events by 45% in 3-month follow-up-single-center results of Poland’s National Health Fund program of comprehensive post-myocardial infarction care. Arch Med Sci. 2020;16(3):551-8.

Wita K, Kułach A, Sikora J, Fluder J, Nowalany-Kozielska E, Milewski K, et al. Managed Care after Acute Myocardial Infarction (MC-AMI) Reduces Total Mortality in 12-Month Follow-Up-Results from a Poland’s National Health Fund Program of Comprehensive Post-MI Care-A Population-Wide Analysis. J Clin Med. 2020;9(10):3178.

Jorstad HT, Birgelen C Von, Alings AMW, Liem A, Dantzig JM Van, Jaarsma W, et al. Effect of a nurse-coordinated prevention programme on cardiovascular risk after an acute coronary syndrome: main results of the RESPONSE randomised trial. Heart. 2013;99(19):1421-30.

Lunde P, Bye A, Bergland A, Grimsmo J, Jarstad E, Nilsson BB, et al. Long-term follow-up with a smartphone application improves exercise capacity post cardiac rehabilitation: A randomized controlled trial. Eur J Prev Cardiol. 2020;27(16):1782-92.

Yudi MB, Clark DJ, Tsang D, Jelinek M, Kalten K, Joshi SB, et al. SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes: a randomized controlled trial. Coron Artery Dis. 2021;32(5):432-40.