Impact of diabetes mellitus on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty: Analysis from the HORIZONS-AMI (Harmonizing outcomes with revasculariZatiON and stents in acute myocardial infarction) trial

Bernhard Witzenbichler, Roxana Mehran, Giulio Guagliumi, Dariusz Dudek, Kurt Huber, Ran Kornowski, Thomas D. Stuckey, Martin Fahy, Helen Parise, Gregg W. Stone*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: We sought to evaluate the safety and efficacy of bivalirudin compared with glycoprotein IIb/IIIa inhibitors (GPI) in diabetic patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background: Prior studies have demonstrated that GPI are especially beneficial in patients with diabetes with acute coronary syndromes and/or those undergoing PCI. Methods: In the multicenter, prospective HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 patients with STEMI were randomized to bivalirudin or unfractionated heparin plus a GPI. Clinical outcomes were analyzed at 30 days and 1 year in patients with diabetes. Results: Diabetes mellitus was present in 593 patients (16.5%). The rates of cardiac death were significantly lower in diabetic patients treated with bivalirudin compared with heparin plus GPI (30 days: 2.1% vs. 5.5%, p = 0.04; 1 year: 2.5% vs. 7.1%, p = 0.01), and bivalirudin resulted in lower 30-day rates of stroke (0% vs. 2%, p = 0.02). There were no significant differences among diabetic patients randomized to bivalirudin versus heparin plus GPI in the 1-year rates of major adverse cardiac events (14.2% vs. 16.2%, p = 0.44), major bleeding (8.7% vs. 10.7%, p = 0.42), or stent thrombosis (4.2% vs. 3.8%, p = 0.85). By interaction testing, the relative effects of bivalirudin compared with heparin plus GPI were not significantly different in patients with and without diabetes. Conclusions: In patients with diabetes mellitus presenting with STEMI undergoing primary PCI, anticoagulant therapy with bivalirudin compared with heparin plus GPI is safe and effective and might reduce cardiac mortality at 30 days and 1 year. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966)

Original languageEnglish
Pages (from-to)760-768
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume4
Issue number7
DOIs
StatePublished - Jul 2011
Externally publishedYes

Keywords

  • ST-segment elevation myocardial infarction
  • diabetes mellitus
  • major adverse cardiac event(s)
  • primary percutaneous coronary intervention
  • stent thrombosis

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