Journal Article

Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial

Wong, S Chiu, Parise, Helen, Witzenbichler, Bernhard, Pocock, Stuart J, Fahy, Martin, Stone, Gregg W, Hartmann, Franz, Dudek, Dariusz, Gersh, Bernard J, Peruga, Jan Z, Guagliumi, Giulio, Brodie, Bruce R, Dangas, George, Kornowski, Ran, Mehran, Roxana

2011

Overview

Primary results of the HORIZONS-AMI trial have been previously reported. In this final report, we aimed to assess 3-year outcomes. HORIZONS-AMI was a prospective, open-label, randomised trial undertaken at 123 institutions in 11 countries. Patients aged 18 years or older were eligible for enrolment if they had ST-segment elevation myocardial infarction (STEMI), presented within 12 h after onset of symptoms, and were undergoing primary percutaneous coronary intervention. By use of a computerised interactive voice response system, we randomly allocated patients 1:1 to receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI; pharmacological randomisation; stratified by previous and expected drug use and study site) and, if eligible, randomly allocated 3:1 to receive a paclitaxel-eluting stent or a bare metal stent (stent randomisation; stratified by pharmacological group assignment, diabetes mellitus status, lesion length, and study site). We produced Kaplan-Meier estimates of major adverse cardiovascular events at 3 years by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00433966. Compared with 1802 patients allocated to receive heparin plus a GPI, 1800 patients allocated to bivalirudin monotherapy had lower rates of all-cause mortality (5·9% vs 7·7%, difference −1·9% [−3·5 to −0·2], HR 0·75 [0·58–0·97]; p=0·03), cardiac mortality (2·9% vs 5·1%, −2·2% [−3·5 to −0·9], 0·56 [0·40–0·80]; p=0·001), reinfarction (6·2% vs 8·2%, −1·9% [−3·7 to −0·2], 0·76 [0·59–0·99]; p=0·04), and major bleeding not related to bypass graft surgery (6·9% vs 10·5%, −3·6% [−5·5 to −1·7], 0·64 [0·51–0·80]; p=0·0001) at 3 years, with no significant differences in ischaemia-driven target vessel revascularisation, stent thrombosis, or composite adverse events. Compared with 749 patients who received a bare-metal stent, 2257 patients who received a paclitaxel-eluting stent had lower rates of ischaemia-driven target lesion revascularisation (9·4% vs 15·1%, −5·7% [−8·6 to −2·7], 0·60 [0·48–0·76]; p<0·0001) after 3 years, with no significant differences in the rates of death, reinfarction, stroke or stent thrombosis. Stent thrombosis was high (≥4·5%) in both groups. The effectiveness and safety of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained at 3 years for patients with STEMI undergoing primary percutaneous coronary intervention. Boston Scientific and The Medicines Company.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Angioplasty, Balloon - methods / Angioplasty, Balloon - mortality / Biological and medical sciences / Cardiology / Cardiology. Vascular system / Combined Modality Therapy / Confidence Intervals / Coronary heart disease / death / diabetes mellitus / Dose-Response Relationship, Drug / Drug Administration Schedule / Drug Therapy, Combination / Drug-Eluting Stents / drugs / Electrocardiography / Female / Follow-Up Studies / General aspects / glycoproteins / Heart / Heart attacks / hemorrhage / heparin / Heparin - administration & dosage / Heparin - adverse effects / Hirudins - administration & dosage / Hirudins - adverse effects / Humans / Internal Medicine / Kaplan-Meier Estimate / Lesions / Male / Medical sciences / Mortality / Myocardial infarction / Myocardial Infarction - diagnosis / Myocardial Infarction - mortality / Myocardial Infarction - therapy / Paclitaxel - pharmacology / patients / Peptide Fragments - administration & dosage / Peptide Fragments - adverse effects / Platelet Glycoprotein GPIIb-IIIa Complex - administration & dosage / Platelet Glycoprotein GPIIb-IIIa Complex - antagonists & inhibitors / Prospective Studies / Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) / randomized clinical trials / Recombinant Proteins - administration & dosage / Recombinant Proteins - adverse effects / Stents / stroke / surgery / Survival Analysis / Thromboembolism / thrombosis / Time Factors / Treatment Outcome