Key result
Cardiac stents were associated with 2,075 reported adverse events in an Indian national database, of which 93% were serious and 5% resulted in death.
Why the study?
Cardiac stents treat coronary artery disease, but the frequency and nature of adverse events associated with cardiac stents in the Indian population required investigation.
What are the frequency and nature of reported adverse events associated with cardiac stents in the Indian population?
Observational (n=2,075)
What are the frequency and nature of reported adverse events associated with cardiac stents in the Indian population?
A retrospective analysis of an Indian materiovigilance database reveals a high proportion of serious adverse events among reported cardiac stent complications, emphasizing the need for continued post-market safety monitoring.
May support enhanced materiovigilance for cardiac stents in India; leaves open comparative AE risks versus global data.
BACKGROUND: Cardiac stents are utilized to treat coronary artery diseases, a leading cause of death worldwide including in India. We investigated frequency and nature of adverse events (AEs) associated with cardiac stents in the Indian population. METHODS: The source data was systematically collected by National Coordination Centre-Materiovigilance programme of India (NCC-MvPI), anonymized from 2020 to 2022. The database contained 10,542 reports of medical devices adverse events, with cardiac stents accounting for 2,075 of these events. These reports were meticulously collected, cleaned, segregated, and analyzed. RESULTS: We observed that 93% AEs associated with cardiac stents were serious, with the most common being dissection followed by chest pain, thrombosis, and breathing difficulties. However, only 5% of reports resulted in death. Additionally, male patients experienced more AEs than female and elderly patients had a higher incidence of AEs after stent placement. CONCLUSION: The study highlights the need for continued research in this area to identify the root cause of AEs associated with cardiac stents and develop effective measures to reduce these incidences. Future studies can also focus on evaluating the long-term outcomes of patients with cardiac stents to gauge safety and effectiveness of different stent types.
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Mewada et al. (2025) conducted an observational in Coronary artery diseases (n=2,075). Cardiac stents was evaluated on Serious adverse events. Cardiac stents were associated with 2,075 reported adverse events in an Indian national database, of which 93% were serious and 5% resulted in death.
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