ArticlesBivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Introduction
Glycoprotein IIb/IIIa inhibitors (GPIs) are frequently used in the USA and Europe in patients with ST-segment elevation myocardial infarction (STEMI) who are undergoing primary percutaneous coronary intervention (PCI) to reduce ischaemic complications.1, 2, 3 These agents, however, increase the rates of haemorrhagic events and of thrombocytopenia,4, 5, 6, 7 both of which have been strongly associated with early and late mortality.8, 9, 10, 11, 12 The direct thrombin inhibitor bivalirudin, when used instead of heparin plus a GPI during PCI, reduces the rates of major and minor bleeding and thrombocytopenia across a broad range of patients with coronary artery disease.13, 14, 15, 16, 17 In the large-scale prospective HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, patients with high-risk STEMI undergoing primary PCI were randomly assigned to receive bivalirudin alone or heparin plus a GPI. Patients in the bivalirudin group had lower 30-day rates of major bleeding and thrombocytopenia, similar rates of composite ischaemic events, and improved survival compared with those in the heparin plus GPI group.17 Whether the beneficial effects of bivalirudin seen at 30 days are preserved, increased, or diminished at 1 year is not known. We report the prespecified analysis of 1-year outcomes from the HORIZONS-AMI trial.
Section snippets
Participants
The study design of the HORIZONS-AMI trial has been reported elsewhere.17, 18 Briefly, consecutive patients aged 18 years or older were eligible for enrolment if they presented within 12 h after the onset of symptoms with STEMI of 1 mm or more in two or more contiguous leads, new left bundle branch block, or true posterior myocardial infarction. Exclusion criteria included contraindications to any of the study drugs; previous administration of fibrinolytic therapy, bivalirudin, GPI,
Results
Between March 25, 2005, and May 7, 2007, 3602 eligible patients at 123 centres in 11 countries were randomly assigned to receive bivalirudin (n=1800) or control (n=1802). Figure 1 shows the trial profile. Following emergency angiography, the primary management strategy was primary PCI in 92·9% of patients (bivalirudin, n=1679; control, n=1666), deferred PCI in 0·1% (bivalirudin, n=2; control, n=0), CABG in 1·7% (bivalirudin, n=24; control, n=38), and medical management in 5·4% (bivalirudin,
Discussion
In this large-scale, prospective, randomised controlled trial of patients with STEMI undergoing primary PCI, procedural anticoagulation with the direct thrombin inhibitor bivalirudin reduced the rates of net adverse clinical events and major bleeding at 1 year compared with treatment with heparin plus routine use of a GPI. All-cause mortality and cardiac mortality at 1 year were also substantially reduced in patients assigned to bivalirudin compared with those assigned to heparin plus a GPI.
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