TY - JOUR
T1 - Impact of diabetes mellitus on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty
T2 - Analysis from the HORIZONS-AMI (Harmonizing outcomes with revasculariZatiON and stents in acute myocardial infarction) trial
AU - Witzenbichler, Bernhard
AU - Mehran, Roxana
AU - Guagliumi, Giulio
AU - Dudek, Dariusz
AU - Huber, Kurt
AU - Kornowski, Ran
AU - Stuckey, Thomas D.
AU - Fahy, Martin
AU - Parise, Helen
AU - Stone, Gregg W.
N1 - Funding Information:
This work was sponsored by the Cardiovascular Research Foundation (New York, New York) with grant support from Boston Scientific and The Medicines Company . Dr. Witzenbichler has received lecture fees from Boston Scientific, Abbott Vascular, and The Medicines Company. Dr. Mehran serves on advisory boards for/consultant to Abbott Vascular, AstraZeneca, OrthoMcNeil, and Regado Sciences, and has received research support from Bristol-Myers Squibb/sanofi-aventis. Dr. Guagliumi serves as a consultant for Boston Scientific, Volcano, and Cordis, and has received research grant support from Medtronic , Boston Scientific , LightLab Imaging , and Abbott Vascular . Dr. Dudek has received research grants or served as consultant/advisory board member for Abbott , Adamed , Biotronik , Balton , Bayer , BBraun , BioMatrix , Boston Scientific , Boehringer , Ingelheim , Bristol-Myers Squibb , Cordis , Cook , Eli Lilly , EuroCor , GlaxoSmithKline , Invatec , Medtronic , The Medicines Company , Merck Sharp & Dohme , Nycomed , Orbus-Neich , Pfizer , Possis , Promed , Sanofi-Aventis , Siemens , Solvay , Terumo , and Tyco . Dr. Stuckey serves on the Speakers' Bureau and medical advisory board for Boston Scientific. Dr. Stone serves as a consultant to Boston Scientific, Abbott Vascular, The Medicines Company, Merck, Eli Lilly, AstraZeneca, and Bristol-Myers Squibb-Sanofi. All other authors have reported that they have no relationships to disclose.
PY - 2011/7
Y1 - 2011/7
N2 - 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)
AB - 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)
KW - ST-segment elevation myocardial infarction
KW - diabetes mellitus
KW - major adverse cardiac event(s)
KW - primary percutaneous coronary intervention
KW - stent thrombosis
UR - http://www.scopus.com/inward/record.url?scp=79960603166&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2011.04.008
DO - 10.1016/j.jcin.2011.04.008
M3 - Article
C2 - 21777884
AN - SCOPUS:79960603166
SN - 1936-8798
VL - 4
SP - 760
EP - 768
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 7
ER -