title: Characteristics and outcomes of patients with ST-segment elevation myocardial infarction excluded from the harmonizing outcomes with revascularization and stents in acute myocardial infarction (HORIZONS-AMI) trial.
abstract: Randomized controlled trials assessing new drugs and devices tend to exclude subjects who are at greatest risk. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial incorporated broader inclusion criteria in an attempt to include a more representative spectrum of patients presenting with ST-segment elevation myocardial infarction (STEMI). To identify the differences between this modern trial and the real world, we analyzed the characteristics and outcomes of patients with STEMI who were screened but not enrolled at a high-volume recruiting center. Of 318 consecutive patients with STEMI who were screened, 200 (62.9%) were randomized, and 118 (37.1%) were excluded. The baseline characteristics and 30-day and 1-year clinical outcomes were compared in the 2 groups. The excluded patients had numerous high-risk features compared to those randomized, including being older (67.0 ± 12.8 vs 63.0 ± 11.4 years, p = 0.004), more often had had a previous MI (34.7% vs 8.0%, p <0.001), Killip class III-IV (27.4% vs 4.0%, p <0.001), and lower hemoglobin (13.4 ± 2.3 vs 14.8 ± 1.5 g/dl, p <0.001). The excluded patients had markedly greater 30-day and 1-year rates of all-cause mortality (17.4% vs 2.0%, p <0.001, and 27.6% vs 2.5%, p <0.001, respectively), major adverse cardiovascular events (death, MI, ischemia-driven target vessel revascularization, and stroke), major bleeding, and net adverse clinical events (major adverse cardiovascular events or major bleeding). On multivariate analysis, Killip class III-IV at presentation, age, left ventricular ejection fraction, and final Thrombolysis In Myocardial Infarction flow grade 3 were independent predictors of outcome. In conclusion, despite the broadened entry criteria of the HORIZONS-AMI trial, 37.1% of all patients presenting with STEMI at a center with a high rate of enrollment were judged to be ineligible and were excluded. The excluded patients had a significantly greater risk profile and markedly increased mortality and adverse events compared to the trial-eligible group.
authors.affiliation: Cardiovascular Department, Ospedali Riuniti di Bergamo, Bergamo, Italy. luigifiocca@gmail.com
authors.forename: Luigi
authors.initials: L
authors.lastname: Fiocca
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Roberta
authors.initials: R
authors.lastname: Rossini
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Musumeci
authors.forename: Vasile
authors.initials: V
authors.lastname: Sirbu
authors.forename: Nikoloz
authors.initials: N
authors.lastname: Lortkipanidze
authors.forename: Jennifer
authors.initials: J
authors.lastname: Yu
authors.forename: Laurian
authors.initials: L
authors.lastname: Mihalcsik
authors.forename: Angelina
authors.initials: A
authors.lastname: Vassileva
authors.forename: Orazio
authors.initials: O
authors.lastname: Valsecchi
authors.forename: Antonello
authors.initials: A
authors.lastname: Gavazzi
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D015607:Stents; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors