A PROSPECTIVE AND RETROSPECTIVE STUDY ON SAFETY AND CLINICAL OUTCOMES OF NOVEL ORAL ANTICOAGULANT (NOAC) DRUGS IN A TERTIARY CARE HOSPITAL

Ashtami B. S., Shirin Jaffar, Adil, Saritha M.*, Kiron S. S., Annmaria Tom

Introduction: Anticoagulants are highly effective in preventing thromboembolic events but are often used cautiously in clinical practice, sometimes leading to undertreatment despite a lower burden of certain risk factors. In this context, assessing the safety and clinical outcomes of NOAC therapy using real-world data, alongside clinical trials is essential to support informed clinical decision-making. Materials and Methods: This is a prospective and Retrospective (Ambispective) observational cohort study conducted over a period of six months in a tertiary care hospital setting. Data collection was performed using the electronic medical record system. All the data collected were analyzed based on the standard protocol. Results: The safety and clinical outcome parameters include mortality rate, which was found to be 1.7%, liver dysfunction which was seen 28.3% of patients and renal dysfunction which was seen in 24.16% all points toward a favorable safety profile of NOACs. HAS BLED Score, which assesses the risk for major bleeding was found to have been 0-1 in 18.3% patients 2 in 18.3% patients and 3or >3 in 63.3% patients. Conclusion: This study found that, in a real-world population of patients requiring NOAC therapy, treatment was associated with a favorable safety profile and excellent clinical outcomes. Conducted as both a prospective and retrospective observational study in a tertiary care hospital in Kannur, Kerala, it highlights the long-term performance of these medications in real-life clinical settings.