Abstract
BackgroundThe PEGASUS-TIMI 54 trial inclusion criteria effectively identified high-risk patients with recent myocardial infarction (MI) who would benefit from continuing dual antiplatelet therapy (DAPT) with ticagrelor for more than 12 months. It is unknown how many real-world patients meet these criteria during the acute phase of ST-elevation MI (STEMI), or the extent to which these criteria predict a patient's risk and prognosis. Study objectives were: (1) determine the proportion of PEGASUS-TIMI 54-like patients (PG-l) in a real-world cohort of patients hospitalized with STEMI and to assess their ischemic and hemorrhagic risk; (2) examine their ischemic and hemorrhagic in-hospital events (major adverse cardiovascular and cerebrovascular events [MACCE] and clinically relevant bleeding); (3) evaluate their long-term outcomes and the impact on the long-term prognosis of the type of DAPT prescribed at discharge.MethodsThis observational study was conducted in 1086 patients admitted to hospital with a diagnosis of STEMI between February 2011 and March 2018 and enrolled in the CARDIO-STEMI Sanremo registry. Patients’ demographic and clinical characteristics, procedural variables, and individual ischemic and hemorrhagic risk scores were assessed in-hospital. Four-year survival was also analyzed.ResultsThe proportion of PG-I patients was 69.2%. Compared with non-PG-l patients, PG-l patients were older, had more multivessel disease and comorbidities, and experienced more frequent MACCE (8.3% vs. 3.6%, p = 0.005) and clinically significant bleeding events (6.7% vs. 2.7%, p = 0.008), a higher rate of in-hospital death (6.5% vs. 1.5%, p < 0.001), and higher follow-up mortality rate (14.8% vs. 7.7%; p = 0.002). Four-year survival was significantly lower in the PG-l group (83.9% vs. 91.8%; Log-rank = 0.001) and was related to the cumulative number of concurrent risk factors. In the unadjusted analysis, survival was greater in patients discharged on ticagrelor than on another P2Y12 inhibitor (90.2% vs. 76.7%, Log-rank = 0.001), and the difference was particularly evident in PG-l patients.ConclusionsThe risk of MACCE for PG-l patients increased with the number of concurrent PEGASUS-TIMI 54 risk features. Treatment with ticagrelor on discharge was associated with improved survival rates during 4 years of follow-up.
Highlights
The PEGASUS-Thrombolysis in Myocardial Infarction (TIMI) 54 trial inclusion criteria effectively identified high-risk patients with recent myocardial infarction (MI) who would benefit from continuing dual antiplatelet therapy (DAPT) with ticagrelor for more than 12 months
The aim of the study was (1) to evaluate the proportion of ST-elevation MI (STEMI) patients enrolled in the Italian CARDIOSTEMI Sanremo registry who met the PEGASUS-TIMI 54 trial inclusion criteria (PG-l patients) during hospitalization; (2) to evaluate the ischemic risk and the hemorrhagic risk of these patients and the incidence of hospital events (death, major adverse CV or cerebrovascular event [MACCE], any clinically significant bleeding based on Bleeding Academic Research Consortium (BARC) type ≥ 2); and (3) to evaluate the overall long-term survival in PG-l and non-PG-l patients and the impact of the type of DAPT on the long-term prognosis in these groups
All the consenting patients admitted to the hospital with a diagnosis of STEMI between February 2011 and March 2018 were enrolled; for every patient, demographic and clinical characteristics were recorded and individual ischemic risk factors and hemorrhagic risk scores were assessed during hospitalization; TIMI flow grade, the rate of in-hospital MACCE, ST segment resolution, bleeding, and survival were collected
Summary
The PEGASUS-TIMI 54 trial inclusion criteria effectively identified high-risk patients with recent myocardial infarction (MI) who would benefit from continuing dual antiplatelet therapy (DAPT) with ticagrelor for more than 12 months. It is unknown how many real-world patients meet these criteria during the acute phase of ST-elevation MI (STEMI), or the extent to which these criteria predict a patient’s risk and prognosis. While it has been proposed that this risk could be mitigated in patients with high bleeding risk by a shorter DAPT duration of at least 6 months [3, 20,21,22], evidence from the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin) trial suggested a benefit with prolonged DAPT in patients with high ischemic risk and prior MI [7]
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