title: Effect of Short Procedural Duration With Bivalirudin on Increased Risk of Acute Stent Thrombosis in Patients With STEMI: A Secondary Analysis of the HORIZONS-AMI Randomized Clinical Trial.
abstract: Bivalirudin has been associated with reduced bleeding and mortality during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). However, increased rates of acute stent thrombosis (AST) have been noted when bivalirudin is discontinued at the end of the procedure, which is perhaps related to this medication's short half-life.
  
  
  
  To evaluate the clinical effect of procedure duration on AST when either bivalirudin or heparin plus glycoprotein IIb/IIIa receptor inhibitor (GPI) is used.
  
  
  
  An ad hoc analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) clinical trial was performed between March 1, 2015, and April 30, 2016, on patients who underwent primary percutaneous coronary intervention with stents and were randomized 1:1 to bivalirudin or heparin plus GPI. Defined as the difference between the patient's arrival at the catheterization laboratory and the patient's final angiogram. Participants included 3602 patients with STEMI, aged 18 years or older, who were undergoing primary percutaneous coronary intervention and presenting less than 12 hours from symptom onset.
  
  
  
  Clinical events committee-adjudicated definite AST (occurring ≤24 hours after percutaneous coronary intervention).
  
  
  
  Among patients included in this analysis, procedure time was identified in 1286 receiving bivalirudin and 1412 receiving heparin plus GPI. Shorter procedures were defined as the lowest quartile of duration (<45 minutes). Patients undergoing shorter procedures were younger and less likely to be hypertensive and smokers. Shorter procedures were less complicated with fewer stents implanted, less multivessel stenting, less thrombus, and less no-reflow. An increased risk of definite AST was associated with shorter than with longer procedures with bivalirudin (7 [2.1%] vs 7 [0.7%]; relative risk, 2.87; 95% CI, 1.01-8.17; P = .04) but not with heparin plus GPI (0 vs 3 [0.3%]; P = .30).
  
  
  
  Despite less procedural complexity, shorter primary percutaneous coronary intervention time was associated with an increased risk of AST in patients treated with bivalirudin but not patients treated with heparin plus GPI, possibly because of the rapid offset of bivalirudin's antithrombotic effect during a window of limited oral antiplatelet action.
  
  
  
  clinicaltrials.gov Identifier: NCT00433966.
authors.affiliation: Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Hector
authors.initials: H
authors.lastname: Tamez
authors.affiliation: Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Duane S
authors.initials: DS
authors.lastname: Pinto
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York3Associate Editor, JAMA Cardiology.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Claire
authors.initials: C
authors.lastname: Litherland
authors.affiliation: Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Yeh
authors.affiliation: Mount Sinai Medical Center, New York, New York.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
authors.affiliation: Mount Sinai Medical Center, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Ortiz
authors.affiliation: Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000208:Acute Disease; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010446:Peptide Fragments / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011183:Postoperative Complications / Q000453:epidemiology*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000601:surgery*; D015607:Stents; D013927:Thrombosis / Q000453:epidemiology*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin