PMID- 32425434 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220414 IS - 1011-6842 (Print) IS - 1011-6842 (Linking) VI - 36 IP - 3 DP - 2020 May TI - Safety and Cumulative Incidence of Major Cardiovascular Events with Ticagrelor in Taiwanese Patients with Non-ST-Segment Elevation Myocardial Infarction: A 12-Month, Prospective, Phase IV, Multicenter, Single-Arm Study. PG - 195-206 LID - 10.6515/ACS.202005_36(3).20191007B [doi] AB - BACKGROUND: Ticagrelor, an oral, direct-acting, and reversible P2Y(12) receptor antagonist, inhibits platelet activation and aggregation. This phase IV, single-arm study analyzed the safety and tolerability of ticagrelor in Taiwanese patients with non-ST-segment elevation myocardial infarction (NSTEMI) during 1 year of follow-up. METHODS: Patients aged >/= 20 years with an index event of NSTEMI received ticagrelor (180 mg loading and 90 mg doses twice daily thereafter) plus low-dose aspirin (100 mg/day) for up to 1 year. Safety was evaluated according to adverse events (AEs), serious AEs (SAEs), and PLATO-defined bleeding events. The cumulative incidence of major cardiovascular (CV) events including CV death, myocardial infarction, and stroke was also evaluated. RESULTS: The safety population included 108 patients across 13 centers in Taiwan. During treatment, 32 (29.6%) patients had >/= one PLATO-defined bleeding event. Major bleeding events occurred in seven (6.5%) patients with a Kaplan-Meier (KM) estimated event risk [95% confidence interval (CI)] of 7.1% (3.4%-14.4%), including life-threatening bleeding [four (3.7%) patients] and other major bleeding [three (2.8%) patients]. No PLATO-defined fatal bleeding was observed. SAEs were reported in 23 (21.3%) patients. Six (5.6%) patients experienced major CV events during the 1-year follow-up period, with a KM-estimated event risk (95% CI) of 5.6% (2.6%-12.0%). CONCLUSIONS: Ticagrelor for up to 1 year was associated with a low rate of major bleeding events and a low incidence of major CV events in Taiwanese patients with NSTEMI. The overall safety of ticagrelor was in accordance with the known safety profile of ticagrelor. FAU - Mar, Guang-Yuan AU - Mar GY AD - Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan. AD - College of Health and Nursing, Meiho University, Pingtung, Taiwan. FAU - Ridderstrale, Wilhelm AU - Ridderstrale W AD - AstraZeneca Gothenburg, Molndal, Sweden. FAU - Wei, Jianxin AU - Wei J AD - AstraZeneca Gothenburg, Molndal, Sweden. FAU - Liu, Chun-Peng AU - Liu CP AD - Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan. AD - College of Health and Nursing, Meiho University, Pingtung, Taiwan. LA - eng PT - Journal Article PL - China (Republic : 1949- ) TA - Acta Cardiol Sin JT - Acta Cardiologica Sinica JID - 101687085 PMC - PMC7220962 OTO - NOTNLM OT - Cardiovascular events OT - Non-ST-segment elevation myocardial infarction OT - P2Y12 inhibition OT - Safety OT - Taiwan OT - Ticagrelor EDAT- 2020/05/20 06:00 MHDA- 2020/05/20 06:01 PMCR- 2020/05/01 CRDT- 2020/05/20 06:00 PHST- 2020/05/20 06:00 [entrez] PHST- 2020/05/20 06:00 [pubmed] PHST- 2020/05/20 06:01 [medline] PHST- 2020/05/01 00:00 [pmc-release] AID - 10.6515/ACS.202005_36(3).20191007B [doi] PST - ppublish SO - Acta Cardiol Sin. 2020 May;36(3):195-206. doi: 10.6515/ACS.202005_36(3).20191007B.