title: Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial.
abstract: BACKGROUND
  In patients with ST-segment elevated myocardial infarction (STEMI), early post-thrombolysis routine angioplasty has been discouraged because of its association with high incidence of events. The GRACIA-1 trial was designed to reassess the benefits of an early post-thrombolysis interventional approach in the era of stents and new antiplatelet agents.
  
  
  METHODS
  500 patients with thrombolysed STEMI (with recombinant tissue plasminogen activator) were randomly assigned to angiography and intervention if indicated within 24 h of thrombolysis, or to an ischaemia-guided conservative approach. The primary endpoint was the combined rate of death, reinfarction, or revascularisation at 12 months. Analysis was by intention to treat.
  
  
  RESULTS
  Invasive treatment included stenting of the culprit artery in 80% (199 of 248) patients, bypass surgery in six (2%), non-culprit artery stenting in three, and no intervention in 40 (16%). Predischarge revascularisation was needed in 51 of 252 patients in the conservative group. By comparison with patients receiving conservative treatment, by 1 year, patients in the invasive group had lower frequency of primary endpoint (23 [9%] vs 51 [21%], risk ratio 0.44 [95% CI 0.28-0.70], p=0.0008), and they tended to have reduced rate of death or reinfarction (7% vs 12%, 0.59 [0.33-1.05], p=0.07). Index time in hospital was shorter in the invasive group, with no differences in major bleeding or vascular complications. At 30 days both groups had a similar incidence of cardiac events. In-hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative group than in those in the invasive group.
  
  
  CONCLUSIONS
  In patients with STEMI, early post-thrombolysis catheterisation and appropriate intervention is safe and might be preferable to a conservative strategy since it reduces the need for unplanned in-hospital revascularisation, and improves 1-year clinical outcome.
authors.affiliation: Instituto de Ciencias del Corazón, Hospital Universitario, Valladolid, Spain. faviles@secardiologia.es
authors.forename: Francisco
authors.initials: F
authors.lastname: Fernandez-Avilés
authors.forename: Joaquín J
authors.initials: JJ
authors.lastname: Alonso
authors.forename: Alfonso
authors.initials: A
authors.lastname: Castro-Beiras
authors.forename: Nicolás
authors.initials: N
authors.lastname: Vázquez
authors.forename: Jesús
authors.initials: J
authors.lastname: Blanco
authors.forename: Juan
authors.initials: J
authors.lastname: Alonso-Briales
authors.forename: Juan
authors.initials: J
authors.lastname: López-Mesa
authors.forename: Felipe
authors.initials: F
authors.lastname: Fernández-Vazquez
authors.forename: Isabel
authors.initials: I
authors.lastname: Calvo
authors.forename: Luis
authors.initials: L
authors.lastname: Martínez-Elbal
authors.forename: José A
authors.initials: JA
authors.lastname: San Román
authors.forename: Benigo
authors.initials: B
authors.lastname: Ramos
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003326:Coronary Circulation; D023903:Coronary Restenosis; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D015607:Stents; D013318:Stroke Volume; D015996:Survival Rate; D015912:Thrombolytic Therapy / Q000009:adverse effects