title: Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials.
abstract: BACKGROUND
  Early stent thrombosis (ST) within 30 days after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction is a serious event. We sought to determine the predictors of and risk of mortality after early ST according to procedural antithrombotic therapy.
  
  
  RESULTS
  In a patient-level pooled analysis from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) and European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trials, we examined 30-day outcomes in 4935 patients undergoing primary percutaneous coronary intervention with stent implantation at 188 international sites, randomized to either bivalirudin or heparin±a glycoprotein IIb/IIIa inhibitor (GPI). Early ST occurred in 100 patients (2.0%), 20 of whom (20.0%) died. Bivalirudin was associated with higher rates of early ST compared with heparin±GPI (2.5% versus 1.6%, P=0.04), because of more acute (≤24 h) ST (1.5% versus 0.2%, P<0.0001), with the risk limited to the first 4 hours after percutaneous coronary intervention. The rates of subacute (1-30 days) ST were similar with bivalirudin and heparin±GPI (1.0% versus 1.4%, P=0.24). Among patients with early ST, mortality within 30 days occurred in 4 of 60 (6.7%) bivalirudin-treated patients compared with 16 of 40 (40.0%) heparin±GPI-treated patients (adjusted hazard ratio, 0.12; 95% CI, 0.04-0.39; P=0.0004 and adjusted hazard ratio, 0.122; 95% CI, 0.04-0.39; P=0. 0004). Thus, 30-day mortality attributable to early ST occurred in 4 of 2479 (0.2%) bivalirudin-treated patients versus 16 of 2456 (0.7%) heparin±GPI-treated patients (P=0.007).
  
  
  CONCLUSIONS
  In the present large-scale pooled analysis from 2 multicenter randomized trials, early ST was more frequent in patients treated with bivalirudin compared with heparin±GPI because of increased ST within 4 hours after primary percutaneous coronary intervention. However, the mortality attributable to early ST was significantly lower after bivalirudin than after heparin±GPI.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00433966 (HORIZONS-AMI) and NCT01087723 (EUROMAX).
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.). George.Dangas@mountsinai.org.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Mikkel M
authors.initials: MM
authors.lastname: Schoos
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Arnoud
authors.initials: A
authors.lastname: van 't Hof
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Debra
authors.initials: D
authors.lastname: Bernstein
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.).
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D004562:Electrocardiography; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000401:mortality / Q000628:therapy*; D063868:Patient Outcome Assessment; D010446:Peptide Fragments / Q000627:therapeutic use; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011183:Postoperative Complications / Q000401:mortality / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000627:therapeutic use; D015607:Stents / Q000706:statistics & numerical data; D016019:Survival Analysis; D013927:Thrombosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*
chemical_list: D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: mortality; myocardial infarction; pharmacology; stent; thrombosis