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

被引:26
作者
Witzenbichler, Bernhard [2 ]
Mehran, Roxana [1 ]
Guagliumi, Giulio [3 ]
Dudek, Dariusz [4 ]
Huber, Kurt [5 ]
Kornowski, Ran [6 ]
Stuckey, Thomas D. [7 ,8 ]
Fahy, Martin [1 ]
Parise, Helen [1 ]
Stone, Gregg W. [1 ]
机构
[1] Columbia Univ, Med Ctr, Cardiovasc Res Fdn, New York, NY 10022 USA
[2] Charite Campus Benjamin Franklin, Dept Cardiol & Pneumol, Berlin, Germany
[3] Osped Riuniti Bergamo, I-24100 Bergamo, Italy
[4] Jagiellonian Univ, Krakow, Poland
[5] Wilhelminenhosp, Vienna, Austria
[6] Rabin Med Ctr, Petah Tiqwa, Israel
[7] LeBauer Cardiovasc Res Fdn, Greensboro, NC USA
[8] Moses Cone Hosp, Greensboro, NC USA
关键词
diabetes mellitus; major adverse cardiac event(s); primary percutaneous coronary intervention; stent thrombosis; ST-segment elevation myocardial infarction; PERCUTANEOUS CORONARY INTERVENTION; IIB/IIIA RECEPTOR BLOCKADE; IIB-IIIA INHIBITORS; BARE-METAL STENTS; RANDOMIZED-TRIALS; ABCIXIMAB; METAANALYSIS; MANAGEMENT; PLACEMENT; MORTALITY;
D O I
10.1016/j.jcin.2011.04.008
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 (STEM) 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) (J Am Coll Cardiol Intv 2011;4:760-8) (C) 2011 by the American College of Cardiology Foundation
引用
收藏
页码:760 / 768
页数:9
相关论文
共 32 条
[1]   Clinical outcomes in diabetic and non-diabetic patients with drug-eluting stents: results from the first phase of the prospective multicenter German DES.DE registry [J].
Akin, Ibrahim ;
Bufe, Alexander ;
Schneider, Steffen ;
Reinecke, Holger ;
Eckardt, Lars ;
Richardt, Gert ;
Burska, Detlev ;
Senges, Jochen ;
Kuck, Karl-Heinz ;
Nienaber, Christoph A. .
CLINICAL RESEARCH IN CARDIOLOGY, 2010, 99 (06) :393-400
[2]   A randomized trial comparing primary infarct artery stenting with or without abciximab in acute myocardial infarction [J].
Antoniucci, D ;
Rodriguez, A ;
Hempel, A ;
Valenti, R ;
Migliorini, A ;
Vigo, F ;
Parodi, G ;
Fernandez-Pereira, C ;
Moschi, G ;
Bartorelli, A ;
Santoro, GM ;
Bolognese, L ;
Colombo, A .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2003, 42 (11) :1879-1885
[3]   Early Stent Thrombosis in Patients With Acute Coronary Syndromes Treated With Drug-Eluting and Bare Metal Stents The Acute Catheterization and Urgent Intervention Triage Strategy Trial [J].
Aoki, Jiro ;
Lansky, Alexandra J. ;
Mehran, Roxana ;
Moses, Jeffery ;
Bertrand, Michel E. ;
McLaurin, Brent T. ;
Cox, David A. ;
Lincoff, Michael ;
Ohman, E. Magnus ;
White, Harvey D. ;
Parise, Helen ;
Leon, Martin B. ;
Stone, Gregg W. .
CIRCULATION, 2009, 119 (05) :687-698
[4]   Abciximab reduces mortality in diabetics following percutaneous coronary intervention [J].
Bhatt, DL ;
Marso, SP ;
Lincoff, AM ;
Wolski, KE ;
Ellis, SG ;
Topol, EJ .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2000, 35 (04) :922-928
[5]   Clinical end points in coronary stent trials - A case for standardized definitions [J].
Cutlip, Donald E. ;
Windecker, Stephan ;
Mehran, Roxana ;
Boam, Ashley ;
Cohen, David J. ;
van Es, Gerrit-Anne ;
Steg, P. Gabriel ;
Morel, Marie-angele ;
Mauri, Laura ;
Vranckx, Pascal ;
McFadden, Eugene ;
Lansky, Alexandra ;
Hamon, Martial ;
Krucoff, Mitchell W. ;
Serruys, Patrick W. .
CIRCULATION, 2007, 115 (17) :2344-2351
[6]   Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction - A meta-analysis of randomized trials [J].
De Luca, G ;
Suryapranata, H ;
Stone, GW ;
Antoniucci, D ;
Tcheng, JE ;
Neumann, FJ ;
Van de Werf, F ;
Antman, EM ;
Topol, EJ .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2005, 293 (14) :1759-1765
[7]   Diabetes mellitus is associated with distal embolization, impaired myocardial perfusion, and higher mortality in patients with ST-segment elevation myocardial infarction treated with primary angioplasty and glycoprotein IIb-IIIa inhibitors [J].
De Luca, Giuseppe ;
Gibson, C. Michael ;
Bellandi, Francesco ;
Noc, Marko ;
Dudek, Dariusz ;
Zeymer, Uwe ;
Arntz, Hans-Richard ;
Cutlip, Donald ;
Maioli, Mauro ;
Zorman, Simona ;
Gabriel, H. Mesquita ;
Emre, Ayse ;
Rakowski, Tomasz ;
Gyongyosi, Mariann ;
Huber, Kurt ;
van't Hof, Arnoud W. J. .
ATHEROSCLEROSIS, 2009, 207 (01) :181-185
[8]   Risk profile and benefits from Gp IIb-IIIa inhibitors among patients with ST-segment elevation myocardial infarction treated with primary angioplasty: a meta-regression analysis of randomized trials [J].
De Luca, Giuseppe ;
Navarese, Eliano ;
Marino, Paolo .
EUROPEAN HEART JOURNAL, 2009, 30 (22) :2705-2713
[9]   Benefits of pharmacological facilitation with glycoprotein IIb-IIIa inhibitors in diabetic patients undergoing primary angioplasty for STEMI. A subanalysis of the EGYPT cooperation [J].
De Luca, Giuseppe ;
Gibson, C. Michael ;
Bellandi, Francesco ;
Murphy, Sabina ;
Maioli, Mauro ;
Noc, Marko ;
Zeymer, Uwe ;
Dudek, Dariusz ;
Arntz, Hans-Richard ;
Zorman, Simona ;
Gabriel, H. Mesquita ;
Emre, Ayse ;
Cutlip, Donald ;
Rakowski, Tomasz ;
Gyongyosi, Mariann ;
Huber, Kurt ;
van't Hof, Arnoud W. J. .
JOURNAL OF THROMBOSIS AND THROMBOLYSIS, 2009, 28 (03) :288-298
[10]   Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction [J].
Haffner, SM ;
Lehto, S ;
Rönnemaa, T ;
Pyörälä, K ;
Laakso, M .
NEW ENGLAND JOURNAL OF MEDICINE, 1998, 339 (04) :229-234