title: Early invasive versus early conservative strategy in non-ST-elevation acute coronary syndrome: An outcome research study.
abstract: BACKGROUND
  An early invasive strategy (EIS) has been shown to yield a better clinical outcome than an early conservative strategy (ECS) in patients with non-ST-elevation acute coronary syndromes (NSTEACSs), particularly in those at higher risk according to the GRACE risk score. However, findings of the clinical trials have not been confirmed in registries.
  
  
  OBJECTIVE
  To investigate the outcome of patients with NSTEACS treated according to an EIS or a ECS in a real-world all-comers outcome research study.
  
  
  METHODS
  The primary hypothesis of the study was the non-inferiority of an ECS in comparison with an EIS as to a combined primary end-point of death, non-fatal myocardial infarction and hospital readmission for acute coronary syndromes at one year. Participating centres were divided into two groups: those with a pre-specified routine EIS and those with a pre-specified routine ECS. Two statistical analyses were performed: a) an 'intention to treat' analysis: all patients were considered to be treated according to the pre-specified routine strategy of that centre; b) a 'per protocol' analysis: patients were analysed according to the actual treatment applied. Cox model including propensity score correction was applied for all analyses.
  
  
  RESULTS
  The intention to treat analysis showed an equivalence between EIS and ECS (11.4% vs. 11.1%) with regard to the primary end-point incidence at one year. In the three subgroups of patients according to the GRACE risk score (⩽ 108, 109-140, > 140), EIS and ECS confirmed their equivalence (5.3% vs. 3.9%, 8.4% vs. 7.6%, and 20.3% vs. 20.9%, respectively). When the per protocol analysis was applied, a reduction of the primary end-point at one year with EIS vs. ECS was demonstrated (6.2% vs. 15.3%, p=0.021); analysis of the subgroups according to the GRACE risk score numerically confirmed these data (3.1% vs. 6.5%, 5.1% vs. 10.0%, and 10.8% vs. 24.5%, respectively).
  
  
  CONCLUSIONS
  In a real-life registry of all-comers NSTEACS patients, ECS was non-inferior to EIS; however, when EIS was applied according to clinical judgement, a reduction of clinical events at one year was demonstrated.
authors.affiliation: 1 San Filippo Neri Hospital, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Tubaro
authors.affiliation: 2 Sandro Pertini Hospital, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sciahbasi
authors.affiliation: 3 Santo Spirito Hospital, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ricci
authors.affiliation: 4 San Sebastiano Hospital, Frascati, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Ciavolella
authors.affiliation: 5 Santo Spirito Hospital, Pescara, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Di Clemente
authors.affiliation: 6 CTO, Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Bisconti
authors.affiliation: 2 Sandro Pertini Hospital, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ferraiuolo
authors.affiliation: 7 S Maria della Misericordia Hospital, Perugia, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Del Pinto
authors.affiliation: 8 Parodi Delfino Hospital, Colleferro, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Mennuni
authors.affiliation: 9 S Giuseppe Hospital, Albano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Monti
authors.affiliation: 10 Umberto I Hospital, Siracusa, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Vinci
authors.affiliation: 11 MG Vannini Hospital, Rome, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Semeraro
authors.affiliation: 12 S Giovanni Hospital, Rome, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Greco
authors.affiliation: 13 G Pasquinucci Hospital, Massa, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Berti
authors.affiliation: 14 Umberto I Hospital, Nocera Inferiore, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Romano
authors.affiliation: 1 San Filippo Neri Hospital, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Aiello
authors.affiliation: 2 Sandro Pertini Hospital, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Lo Bianco
authors.affiliation: 15 Belcolle Hospital, Viterbo, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Pellecchia
authors.affiliation: 16 FBF Isola Tiberina, Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Azzolini
authors.affiliation: 17 SS Trinità Hospital, Sora, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Ciuffetta
authors.affiliation: 18 S Scolastica Hospital, Cassino, Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Zappulo
authors.affiliation: 19 Ruggi D'Aragona Hospital, Salerno, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Gigantino
authors.affiliation: 20 I University of Rome Sapienza, Rome, Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Arima
authors.affiliation: 1 San Filippo Neri Hospital, Rome, Italy.
authors.forename: Furio
authors.initials: F
authors.lastname: Colivicchi
authors.affiliation: 1 San Filippo Neri Hospital, Rome, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Santini
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D000368:Aged; D000072700:Conservative Treatment / Q000592:standards*; D004562:Electrocardiography; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis / Q000379:methods*; D008297:Male; D009204:Myocardial Revascularization / Q000592:standards*; D017410:Practice Guidelines as Topic; D061665:Time-to-Treatment
keywords: Acute coronary syndrome; NSTEACS; invasive strategy; outcome research