Key result
In a real-world Indian cohort of 2,997 ACS patients, ticagrelor was predominantly used following PCI (92.4%), with a low overall incidence of clinical events (4.5%) over 12 months.
Why the study?
The study was designed to understand real-life ticagrelor usage patterns and associated clinical events among ACS patients undergoing PCI, CABG, or medical management.
Observational (n=2,997)
Yes
In a real-world Indian cohort of acute coronary syndrome patients, ticagrelor was widely used with high adherence and demonstrated a low incidence of major bleeding and cardiovascular events.
Adds real-world Indian ACS data on ticagrelor; extends limited evidence but remains hypothesis-generating pending RCTs.
OBJECTIVE: This observational study was designed to understand the usage pattern of ticagrelor in real-life clinical practice among a large number of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or medical management (MM). The study also recorded clinical events, i.e., bleeding, dyspnea, and cardiovascular (CV) events, reported by the investigator during the follow-up period. METHODS: The ACS patients aged ≥18 years hospitalized for ACS and were prescribed ticagrelor upon discharge or ≤1 month and patients who underwent PCI, CABG, or MM for ACS were enrolled. The subjects were followed up for a period of up to 12 months. The data were collected on a case report form. RESULT: The study recruited 2997 subjects from 49 sites in India. Approximately half of the ACS subjects had ST segment elevation myocardial infarction (48.9%), and PCI was used as management in 92.4% subjects. The mean (±SD) duration of use of ticagrelor was 314 (±110.2) days over a period of 12 months. Of 136 subjects (4.5%) who experienced any clinical events, CV deaths were reported in 20 (0.7%), myocardial infraction in 19 (0.6) subjects and ischemic stroke in 23 (0.8%) subjects, and severe dyspnea was reported in 68 (2.2%) subjects. Out of 33 bleeding cases, 25 (0.8%) subjects had thrombolysis in myocardial infarction (TIMI) minimal, seven (0.2%) had TIMI minor, and one TIMI major. Platelet inhibition and patient outcomes (PLATO) major was reported in two subjects and CABG bleed in one subject. The incidence of PLATO defined major and minimal bleeding were lower in subjects undergoing fibrinolysis than overall population. CONCLUSION: Ticagrelor has been used across ACS types and in different management strategies in real world settings in India. The incidence of clinical events was lower as compared with data in literature. ClinicalTrials.gov Identifier: NCT02408224.
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Sawhney et al. (2019) conducted an observational in Acute coronary syndrome (ACS) (n=2,997). Ticagrelor was evaluated on Incidence of any clinical event (CV death, MI, ischemic stroke, bleeding, or dyspnea). In a real-world Indian cohort of 2,997 ACS patients, ticagrelor was predominantly used following PCI (92.4%), with a low overall incidence of clinical events (4.5%) over 12 months.
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