Document Detail


Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial.
MedLine Citation:
PMID:  19717185     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In the HORIZONS-AMI trial, patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) who were treated with the thrombin inhibitor bivalirudin had substantially lower 30-day rates of major haemorrhagic complications and net adverse clinical events than did patients assigned to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). Here, we assess whether these initial benefits were maintained at 1 year of follow-up. METHODS: Patients aged 18 years or older were eligible for enrolment in this multicentre, open-label, randomised controlled trial if they had STEMI, presented within 12 h after the onset of symptoms, and were undergoing primary PCI. 3602 eligible patients were randomly assigned by interactive voice response system in a 1:1 ratio to receive bivalirudin (0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; n=1800) or heparin plus a GPI (control; 60 IU/kg intravenous bolus followed by boluses with target activated clotting time 200-250 s; n=1802). The two primary trial endpoints were major bleeding and net adverse clinical events (NACE; consisting of major bleeding or composite major adverse cardiovascular events [MACE; death, reinfarction, target vessel revascularisation for ischaemia, or stroke]). This prespecified analysis reports data for the 1-year follow-up. Analysis was by intention to treat. Patients with missing data were censored at the time of withdrawal from the study or at last follow-up. This trial is registered with ClinicalTrials.gov, number NCT00433966. FINDINGS: 1-year data were available for 1696 patients in the bivalirudin group and 1702 patients in the control group. Reasons for participant dropout were loss to follow-up and withdrawal of consent. The rate of NACE was lower in the bivalirudin group than in the control group (15.6%vs 18.3%, hazard ratio [HR] 0.83, 95% CI 0.71-0.97, p=0.022), as a result of a lower rate of major bleeding in the bivalirudin group (5.8%vs 9.2%, HR 0.61, 0.48-0.78, p<0.0001). The rate of MACE was similar between groups (11.9%vs 11.9%, HR 1.00, 0.82-1.21, p=0.98). The 1-year rates of cardiac mortality (2.1%vs 3.8%, HR 0.57, 0.38-0.84, p=0.005) and all-cause mortality (3.5%vs 4.8%, HR 0.71, 0.51-0.98, p=0.037) were lower in the bivalirudin group than in the control group. INTERPRETATION: In patients with STEMI undergoing primary PCI, anticoagulation with bivalirudin reduced the rates of net adverse clinical events and major bleeding at 1 year compared with treatment with heparin plus a GPI. This finding has important clinical implications for the selection of optimum treatment strategies for patients with STEMI. FUNDING: Cardiovascular Research Foundation, with unrestricted grant support from Boston Scientific Corporation and The Medicines Company.
Authors:
Roxana Mehran; Alexandra J Lansky; Bernhard Witzenbichler; Giulio Guagliumi; Jan Z Peruga; Bruce R Brodie; Dariusz Dudek; Ran Kornowski; Franz Hartmann; Bernard J Gersh; Stuart J Pocock; S Chiu Wong; Eugenia Nikolsky; Louise Gambone; Lynn Vandertie; Helen Parise; George D Dangas; Gregg W Stone;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-08-28
Journal Detail:
Title:  Lancet     Volume:  374     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-10-05     Completed Date:  2009-10-15     Revised Date:  2010-02-04    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1149-59     Citation Subset:  AIM; IM    
Affiliation:
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA. rm2266@columbia.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00433966
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Angioplasty, Transluminal, Percutaneous Coronary* / adverse effects
Anticoagulants / adverse effects,  therapeutic use*
Female
Follow-Up Studies
Hemorrhage / chemically induced,  epidemiology
Heparin / adverse effects,  therapeutic use
Hirudins / adverse effects
Humans
Kaplan-Meiers Estimate
Male
Middle Aged
Myocardial Infarction / drug therapy*,  mortality
Peptide Fragments / adverse effects,  therapeutic use*
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
Proportional Hazards Models
Recombinant Proteins / adverse effects,  therapeutic use
Stents / adverse effects
Survival Rate
Thrombosis / etiology,  prevention & control
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Hirudins; 0/Peptide Fragments; 0/Platelet Aggregation Inhibitors; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 9005-49-6/Heparin
Investigator
Investigator/Affiliation:
G W Stone / ; B R Brodie / ; D A Cox / ; C L Grines / ; B D Rutherford / ; D Bhatt / ; G Dangas / ; F Feit / ; M Ohman / ; A Colombo / ; G Guagliumi / ; E Garcia / ; E Grube / ; A Kastrati / ; H Bonnier / ; P Serruys / ; H Suryapranata / ; J Belardi / ; L Grinfeld / ; K Huber / ; L Rasmussen / ; E Grube / ; A Kastrati / ; Y Almagor / ; A Colombo / ; G Guagliumi / ; H Bonnier / ; H Suryapranata / ; D Nilsen / ; D Dudek / ; E Garcia / ; G Olivecrona / ; A Banning / ; S C Wong / ; M Farkouh / ; M Attubato / ; G Dangas / ; F Feit / ; R Mehran / ; D Target / ; J Tyson / ; D Winsted / ; R Mehran / ; I Bihl / ; H Parise / ; S J Pocock / ; B J Gersh / ; D Faxon / ; S King / ; D O Williams / ; A J Lansky / ; E Cristea / ; J Reiffel / ; G Mintz / ; Oscar A Mendiz / ; Jose Amadeo Alvarez / ; Jose Alvarez / ; Diego David Grinfeld / ; Cosme Argerich / ; Miguel Angel Riccitelli / ; Daniel Berrocal / ; Jorge Belardi / ; Anibal Agustin Damonte / ; Guillermo Cugat / ; A Rodriguez / ; Ernesto M Torresani / ; Hugo F Londero / ; Dietmar Glogar / ; Kurt Huber / ; George Gaul / ; Johann Altenberger / ; Othmar Pachinger / ; Hans-Georg Olbrich / ; Bernhard Witzenbichler / ; Martin Moeckel / ; Wolfgang Rutsch / ; Eberhard Grube / ; Gert Richardt / ; Klaus Pethig / ; Martin Desaga / ; Gerald Werner / ; Johannes Brachmann / ; Helmut Kuecherer / ; Rainer Hoffmann / ; Franz Hartmann / ; Stefan Willems / ; Jochen Wöhrle / ; Adnan Kastrati / ; Ricardo Krakover / ; Uri Rosenschein / ; Basil S Lewis / ; Morris Mosseri / ; Ran Petach-Tikva Kornowski / ; Luis Gruberg / ; Yaron Almagor / ; Victor Guetta / ; Ariel Finkelstein / ; Yoseph Rozenman / ; Giulio Guagliumi / ; Antonio Colombo / ; Hans Bonnier / ; Harry Suryapranata / ; Peter Smits / ; Jan Erik Nordrehaug / ; Dennis Nilsen / ; Adam Witkowski / ; Dariusz Dudek / ; Andrzej Rynkiewicz / ; Jan Z Peruga / ; Andrzej Ochala / ; Krzysztof Zmudka / ; Robert Gil / ; Pascual Bordes / ; Adrian Banning / ; Daniel Blackman / ; Magdi El-Omar / ; Adam De Belder / ; Ever Grech / ; Bernard Prendergast / ; Sarah Johnson / ; Brent McLaurin / ; Tommy Lee / ; Duane S Pinto / ; Joe Choo / ; Ronald Karlsberg / ; Louis A Cannon / ; Trilok Sharma / ; James Ritter / ; Leroy Rabbani / ; Pierre P Leimgruber / ; Ofsman Quintana / ; Joseph McGarvey / ; Oscar Aguilar / ; Henry Liberman / ; Jim Blankenship / ; Ali Razavi / ; Rajesh Dave / ; John Rashid / ; Joseph F Stella / ; Edmund Finkinski / ; Matthew Bach / ; Bruce Brodie / ; Mirle A Kellett / ; Ofsman Quintana / ; Ron Waksman / ; Robert Iwaoka / ; Gregory M Eaton / ; Keith Atassi / ; Michael Attubato / ; Raj Chandwaney / ; Bradley Evans / ; Oscar Aguilar / ; Henry Lui / ; David Rizik / ; John Griffin / ; Jason O Hall / ; Michael C Foster / ; Jorge A Hernandez / ; Noel Camba / ; Thomas LaLonde / ; Mahesh Bikkina / ; Barry Rutherford / ; Vibhuti Singh / ; John McPherson / ; Richard B Zelman / ; James B Hermiller / ; Kenneth S Korr / ; Christopher Metzger / ; Paul Gordon / ; Cary Hirsch / ; Venkatraman Srinivasan / ; Kalim Habet / ; Mark A Turco / ; Douglas Ebersole / ; Cindy L Grines /
Comments/Corrections
Comment In:
Lancet. 2010 Jan 30;375(9712):375   [PMID:  20113821 ]
Lancet. 2009 Oct 3;374(9696):1125-7   [PMID:  19717183 ]

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