Abstract

EVALUATION ON THE SAFETY OF TICAGRELOR AMONG INDIAN ACUTE CORONARY SYNDROME (ACS) PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION

Author(s): G. H. Nabi Maknoo1, Mayank Jain2, Himanshu Dabral3, Rajneesh Kapoor4

BACKGROUND Ticagrelor is the novel class of anti-platelet drugs, has a simpler and faster metabolism (rapid onset of action), high potency and most importantly reversibility. The latter makes this drug safer in patients with bleeding complications. With this background, we studied the safety and tolerability of ticagrelor in Indian patients with acute coronary syndrome undergoing PCI. Primary Objective was to find out the assessment of bleeding events (major, minor or minimal) in acute coronary syndrome patients on Ticagrelor undergoing PCI. Secondary objective was to assess the incidence of dyspnea and other adverse events during 6-months follow up. MATERIALS AND METHODS This was single center, prospective, observational study involving 200 patients hospitalized in Medanta, The Medicity, Hospital, Gurgaon because of ACS undergoing PCI and were treated with Ticagrelor (180mg loading dose and 90mg thereafter) between December 2015 to May 2016. Study Design: Prospective Observational Study. RESULTS Total bleeding was observed in 29 (14.5%) patients, in which major bleeding was seen in 08 (4%) patients, minor bleeding was seen in 07 (3.5%) patients, minimal bleeding was observed in 13 (6.5%) patients, and fatal bleeding was seen in 01 (0.5%) patient Upper Gastro-Intestinal Bleeding (UGIB) was most commonly seen, followed by ecchymosis, lower gastrointestinal bleeding, haematuria, nasal bleeding, haemoptysis and intracranial haemorrhage. Dyspnea was observed in 39 (19.5%) patients among whom only 02 (1%) required discontinuation of study drug. CONCLUSION Study showed that Ticagrelor is a safe newer antiplatelet drug. Since chance of bleeding was significantly higher in females and diabetics, care should be taken in these patients with high risk for bleeding. Also, incidence of major bleeding and myocardial infarction was seen significantly less in our patients as compared to western counter parts. As our study was small observational study, these conclusions need to be confirmed with larger randomized trials in Indian patients.