title: A regional pharmacoinvasive PCI strategy incorporating selected bleeding avoidance strategies.
abstract: BACKGROUND
  Pharmacoinvasive therapy (PIT) is a potential treatment for ST-segment elevation myocardial infarction patients who are not able to achieve primary percutaneous intervention (PCI) within guideline-recommended time limits. The risk for bleeding complications with PIT has not been studied in the setting of routine use of two selected bleeding avoidance strategies (BAS): bivalirudin and vascular closure devices.
  
  
  METHODS
  We analyzed a contemporary multicenter registry (2009-2013) of consecutive patients undergoing PCI as part of a 10-hospital regional algorithm involving one PCI center and nine transfer centers: PIT for hospitals greater than 60 min (N=140), and primary PCI if less than 60-min travel time to the PCI center (N=346). We compared the risk for Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS) major bleeding among patients undergoing PIT versus primary PCI in the setting of routine use of selected BAS and determined the independent predictors of major bleeding in the entire cohort.
  
  
  RESULTS
  The PIT patients had a median travel time of 103±49 min, were more frequently female, had a higher incidence of renal failure, and had a lower frequency of cardiogenic shock compared with the primary PCI group. BAS were routine and similar in both groups. Rates of death, stroke, and ischemic and major bleeding outcomes were similar between the two groups, and the length of stay was shorter in the PIT group. Multivariate logistic models indicated that two independent predictors of major bleeding were cardiac arrest [odds ratio (OR)=3.89, 95% confidence interval (CI): 1.2-12.1, P=0.02] and bailout glycoprotein IIb/IIIa inhibitor utilization (OR=3.29, 95% CI: 1.1-9.6, P=0.03). The PIT strategy in conjunction with selected BAS did not predict major bleeding (OR=2.1, 95% CI: 0.85-5.44, P=0.11).
  
  
  CONCLUSIONS
  Bleeding and ischemia rates were similar between the PIT and primary PCI strategies in the setting of routine use of selected BAS; further study on a broader range of BAS including the radial approach may be warranted. Cardiac arrest and bailout glycoprotein IIb/IIIa inhibitor, but not PIT in conjunction with selected BAS, are independent predictors of bleeding risk in a regional ST-segment elevation myocardial infarction population.
authors.affiliation: Department of Cardiology, College of Medicine, University of Vermont, Vermont, USA.
authors.forename: Sreedivya
authors.initials: S
authors.lastname: Chava
authors.forename: Samreen
authors.initials: S
authors.lastname: Raza
authors.forename: Mohammad A
authors.initials: MA
authors.lastname: El-Haddad
authors.forename: Jeff
authors.initials: J
authors.lastname: Priest
authors.forename: Takamaru
authors.initials: T
authors.lastname: Ashikaga
authors.forename: Harold L
authors.initials: HL
authors.lastname: Dauerman
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D002391:Catchment Area, Health; D004867:Equipment Design; D005260:Female; D006297:Health Services Accessibility; D006301:Health Services Needs and Demand; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016017:Odds Ratio; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D014187:Transportation of Patients; D016896:Treatment Outcome; D014707:Vermont
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; C074619:bivalirudin