title: Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial.
abstract: BACKGROUND
  A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non-ST-segment elevation myocardial infarction.
  
  
  OBJECTIVE
  The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization.
  
  
  METHODS
  In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year.
  
  
  RESULTS
  The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups.
  
  
  CONCLUSIONS
  In multivessel non-ST-segment elevation myocardial infarction patients, complete 1-stage coronary revascularization is superior to multistage PCI in terms of major adverse cardiovascular and cerebrovascular events. (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction [NSTEMI]
  
  
  METHODS
  One Stage Versus Multistaged Percutaneous Coronary Intervention [PCI] [SMILE]: NCT01478984).
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy. Electronic address: rino.sardella@uniroma1.it.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Lucisano
authors.affiliation: Interventional Cardiology, San Giovanni Bosco Hospital, Turin, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Garbo
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Pennacchi
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Erika
authors.initials: E
authors.lastname: Cavallo
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Rocco Edoardo
authors.initials: RE
authors.lastname: Stio
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Calcagno
authors.affiliation: Interventional Cardiology, San Giovanni Bosco Hospital, Turin, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ugo
authors.affiliation: Interventional Cardiology, San Giovanni Bosco Hospital, Turin, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Boccuzzi
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Fedele
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Mancone
mesh_terms: D003331:Coronary Vessels; D006801:Humans; D009203:Myocardial Infarction; D062645:Percutaneous Coronary Intervention / Q000379:methods*
keywords: acute coronary syndrome; coronary artery disease; intention-to-treat analysis; myocardial infarction; myocardial ischemia; troponin