title: Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial.
abstract: OBJECTIVE
  The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction.
  
  
  BACKGROUND
  The routine removal of thrombus before infarct artery stenting is still a matter of debate.
  
  
  METHODS
  This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter ≥2.5 mm. Coprimary end points were early ST-segment resolution and (99m)Tc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months.
  
  
  RESULTS
  From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009).
  
  
  CONCLUSIONS
  Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990).
authors.affiliation: Careggi Hospital, Florence, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Migliorini
authors.forename: Amerigo
authors.initials: A
authors.lastname: Stabile
authors.forename: Alfredo E
authors.initials: AE
authors.lastname: Rodriguez
authors.forename: Caterina
authors.initials: C
authors.lastname: Gandolfo
authors.forename: Alfredo M
authors.initials: AM
authors.lastname: Rodriguez Granillo
authors.forename: Renato
authors.initials: R
authors.lastname: Valenti
authors.forename: Guido
authors.initials: G
authors.lastname: Parodi
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery* / Q000628:therapy*; D015607:Stents; D017131:Thrombectomy; D016896:Treatment Outcome