The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study
Roxana Mehran1, Bruce Brodie, David A Cox
1Columbia University Medical Center and The Cardiovascular Research Foundation, New York, NY 10032, USA. rmehran@crf.org
Insights
The HORIZONS-AMI trial investigates bivalirudin versus heparin for acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI). It also compares drug-eluting stents to bare-metal stents to reduce bleeding and restenosis.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has advanced, but hemorrhagic complications and restenosis remain significant issues.
- Intense anticoagulation during PCI increases bleeding risk, linked to mortality.
- Bare-metal stents (BMSs) are associated with restenosis, leading to repeat procedures.
Purpose of the Study:
- To evaluate bivalirudin monotherapy versus unfractionated heparin plus glycoprotein (GP) IIb/IIIa inhibitors for reducing bleeding in primary PCI for AMI.
- To determine if paclitaxel-eluting stents reduce ischemic target lesion revascularization compared to BMSs in primary PCI.
Main Methods:
- The HORIZONS-AMI trial randomized 3,602 AMI patients undergoing primary PCI.
- Patients were assigned to either bivalirudin or unfractionated heparin with GP IIb/IIIa inhibitors.
- A second randomization assigned 3,011 patients to paclitaxel-eluting stents or BMSs.
Main Results:
- (Results not yet available in the provided abstract, but the study is designed to assess sequential safety and efficacy endpoints.)
Conclusions:
- The HORIZONS-AMI trial aims to establish if bivalirudin improves event-free survival by reducing bleeding complications.
- The study will determine the safety and efficacy of paclitaxel-eluting stents in reducing revascularization rates compared to BMSs.
Background:
Advances in coronary angioplasty and adjunct pharmacology have improved patient outcomes after primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). However, several areas for improvement remain. Hemorrhagic complications, which are common in patients receiving intense anticoagulant and antiplatelet agents during primary PCI to suppress ischemia, have been strongly associated with early and late mortality. Moreover, restenosis after bare-metal stents (BMSs) frequently results in symptom recurrence and the need for repeat rehospitalization and revascularization procedures. Newer pharmacologic agents and drug-eluting stents may address both of these issues.
Study Design:
In the HORIZONS-AMI trial, 3,602 patients with AMI undergoing primary PCI were prospectively randomized to unfractionated heparin plus routine use of glycoprotein (GP) IIb/IIIa inhibitors versus the direct thrombin inhibitor bivalirudin plus provisional use of GP IIb/IIIa inhibitors reserved for predefined thrombotic complications. In a second randomization, 3,011 eligible patients were randomly assigned to either a polymer-based paclitaxel-eluting stent or to an otherwise identical BMS. The study was powered for the assessment of sequential safety and efficacy end points for each specific randomization, with clinical end points assessed at 30 days, 1 year, and then annually for 5 years.
Summary:
The ongoing HORIZONS-AMI trial will determine whether bivalirudin monotherapy reduces bleeding complications and improves overall event-free survival compared with unfractionated heparin plus the routine use of GP IIb/IIIa inhibitors in patients undergoing primary PCI for AMI. Furthermore, this study will determine whether paclitaxel-eluting stents safely reduce rates of ischemic target lesion revascularization compared with BMSs in the setting of primary PCI.
Related Concept Videos
01:30Acute Coronary Syndrome I: Introduction
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:19Acute Coronary Syndrome II: Pathophysiology and Clinical Manifestations