CLINICAL RESEARCH: CLINICAL TRIAL
A randomized trial comparing primary infarct artery stenting with or without abciximab in acute myocardial infarction
David Antoniucci, MD*,*,
Alfredo Rodriguez, MD ,
Albrecht Hempel, MD ,
Renato Valenti, MD*,
Angela Migliorini, MD*,
Federico Vigo, MD,
Guido Parodi, MD*,
Carlos Fernandez-Pereira, MD,
Guia Moschi, MD*,
Antonio Bartorelli, MD ,
Giovanni Maria Santoro, MD*,
Leonardo Bolognese, MD* and
Antonio Colombo, MD||
* Division of Cardiology, Careggi Hospital, Florence, Italy
Invasive Cardiology Department, Otamendi Hospital, Buenos Aires, Argentina
Bernau Heart Center, Bernau, Germany
Cardiology Department, Monzino Hospital, Milan, Italy
|| Centro Cuore Columbus, Columbus Hospital, Milan, Italy
Manuscript received April 6, 2003;
revised manuscript received July 8, 2003,
accepted July 10, 2003.
* Reprint requests and correspondence: Dr. David Antoniucci, Head, Division of Cardiology, Careggi Hospital, Viale Morgagni, I-50134, Florence, Italy.
carddept{at}tin.it
This study was presented, in part, at the Transcatheter Cardiovascular Therapeutics Session in Washington, DC, September 2002, and at the 50th Annual Session of the American College of Cardiology, Chicago, Illinois, March 2003.
OBJECTIVES: We sought to evaluate the efficacy of abciximab as adjunctive therapy to routine infarct-related artery (IRA) stenting.
BACKGROUND: The impact of abciximab on the efficacy of myocardial reperfusion and the outcome of patients with acute myocardial infarction (AMI) undergoing IRA stenting have not yet been defined.
METHODS: In a randomized trial, we assigned 400 patients with AMI to undergo IRA stenting alone or stenting plus abciximab. The primary end point was a composite of death, reinfarction, target vessel revascularization (TVR), and stroke at one month.
RESULTS: The incidence of the primary end point was lower in the abciximab group than in the stent only group (4.5% and 10.5%, respectively; p = 0.023), and randomization to abciximab was independently related to the risk of the primary end point (odds ratio 0.41, 95% confidence interval 0.17 to 0.97; p = 0.041). Early ST-segment resolution was more frequent in the abciximab group (85% vs. 68%, p < 0.001). Infarct size, as assessed by one-month technetium-99m sestamibi scintigraphy, revealed smaller infarcts in the abciximab group. At six months, the cumulative difference in mortality between the groups increased (4.5% vs. 8%), and the incidence of the composite of six-month death and reinfarction was lower in the abciximab group than in the stent only group (5.5% and 13.5%, respectively; p = 0.006). Six-month repeat TVR and restenosis rates were similar in the two groups.
CONCLUSIONS: Abciximab plus IRA stenting should be considered the routine reperfusion strategy in patients with AMI undergoing primary percutaneous mechanical revascularization, especially in high-risk patients.
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Abbreviations and Acronyms
| | ADMIRAL | = Abciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long-term follow-up trial | | AMI | = acute myocardial infarction | | CADILLAC | = Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications trial | | CK | = creatine kinase | | CS | = cardiogenic shock | | ECG | = electrocardiogram or electrocardiographic | | IRA | = infarct-related artery | | ISAR | = Intracoronary Stenting and Antithrombotic Regimen trial | | 99mTc | = technetium-99m | | TIMI | = Thrombolysis In Myocardial Infarction | | TVR | = target vessel revascularization |
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|
|
|
|
|
|
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|
|
|
|
|
|
|
U. Zeymer, A. Margenet, M. Haude, C. Bode, J.-M. Lablanche, H. Heuer, R. Schroder, S. Kropff, R. Bourkaib, N. Banik, et al.
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J. Am. Coll. Cardiol.,
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56(6):
463 - 469.
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[PDF]
|
|
|
|
|
|
|
J. M. ten Berg, A. W. J. van 't Hof, T. Dill, T. Heestermans, J. W. van Werkum, A. Mosterd, G. van Houwelingen, P. C. Koopmans, P. R. Stella, E. Boersma, et al.
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J. Am. Coll. Cardiol.,
June 1, 2010;
55(22):
2446 - 2455.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. R. Le May, G. A. Wells, C. A. Glover, D. Y. So, M. Froeschl, J.-F. Marquis, E. R. O'Brien, M. Turek, A. Thomas, M. Kass, et al.
Primary Percutaneous Coronary Angioplasty With and Without Eptifibatide in ST-Segment Elevation Myocardial Infarction: A Safety and Efficacy Study of Integrilin-Facilitated Versus Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction (ASSIST)
Circ Cardiovasc Interv,
August 1, 2009;
2(4):
330 - 338.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Witkowski, P. Maciejewski, W. Wasek, L. A. Malek, M. Niewada, B. Kaminski, J. Drzewiecki, M. Kosmider, J. Kubica, W. Ruzyllo, et al.
Influence of different antiplatelet treatment regimens for primary percutaneous coronary intervention on all-cause mortality
Eur. Heart J.,
July 2, 2009;
30(14):
1736 - 1743.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. Ortolani, A. Marzocchi, C. Marrozzini, T. Palmerini, F. Saia, N. Taglieri, F. Baldazzi, G. Dall'Ara, P. Nardini, S. Gianstefani, et al.
Long-term effectiveness of early administration of glycoprotein IIb/IIIa agents to real-world patients undergoing primary percutaneous interventions: results of a registry study in an ST-elevation myocardial infarction network
Eur. Heart J.,
January 1, 2009;
30(1):
33 - 43.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. Antoniucci
The balance between bleeding and ischaemic complications in percutnaeous coronary intervention practice
Eur. Heart J. Suppl.,
December 1, 2008;
10(suppl_J):
J21 - J25.
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. Thiele, K. Schindler, J. Friedenberger, I. Eitel, G. Furnau, E. Grebe, S. Erbs, A. Linke, S. Mobius-Winkler, D. Kivelitz, et al.
Intracoronary Compared With Intravenous Bolus Abciximab Application in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The Randomized Leipzig Immediate Percutaneous Coronary Intervention Abciximab IV Versus IC in ST-Elevation Myocardial Infarction Trial
Circulation,
July 1, 2008;
118(1):
49 - 57.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. S. Patel, H. Rana, and D. A. N. Mascarenhas
Intracoronary Abciximab Use in Patients Undergoing PCI at a Community Hospital: A Single Operator Experience
Journal of Cardiovascular Pharmacology and Therapeutics,
June 1, 2008;
13(2):
89 - 93.
[Abstract]
[PDF]
|
|
|
|
|
|
|
S. G. Goodman, V. Menon, C. P. Cannon, G. Steg, E. M. Ohman, and R. A. Harrington
Acute ST-Segment Elevation Myocardial Infarction: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Chest,
June 1, 2008;
133(6_suppl):
708S - 775S.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Valgimigli, G. Campo, G. Percoco, L. Bolognese, C. Vassanelli, S. Colangelo, N. de Cesare, A. E. Rodriguez, M. Ferrario, R. Moreno, et al.
Comparison of Angioplasty With Infusion of Tirofiban or Abciximab and With Implantation of Sirolimus-Eluting or Uncoated Stents for Acute Myocardial Infarction: The MULTISTRATEGY Randomized Trial
JAMA,
April 16, 2008;
299(15):
1788 - 1799.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. J. Moliterno and K. M. Ziada
The Safety and Efficacy of Glycoprotein IIb/IIIa Inhibitors for Primary Angioplasty: More Options to Choose and More Time to Decide
J. Am. Coll. Cardiol.,
February 5, 2008;
51(5):
536 - 537.
[Full Text]
[PDF]
|
|
|
|
|
|
|
G De Luca, H Suryapranata, J P Ottervanger, J C A Hoorntje, A T M Gosselink, J-H Dambrink, M-J de Boer, and A W J v. Hof
Postprocedural single-lead ST-segment deviation and long-term mortality in patients with ST-segment elevation myocardial infarction treated by primary angioplasty
Heart,
January 1, 2008;
94(1):
44 - 47.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. J. Kiernan, H. H. Ting, and B. J. Gersh
Facilitated percutaneous coronary intervention: current concepts, promises, and pitfalls
Eur. Heart J.,
July 1, 2007;
28(13):
1545 - 1553.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Menichelli, A. Parma, E. Pucci, R. Fiorilli, F. De Felice, M. Nazzaro, A. Giulivi, D. Alborino, A. Azzellino, and R. Violini
Randomized Trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI)
J. Am. Coll. Cardiol.,
May 15, 2007;
49(19):
1924 - 1930.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Maioli, F. Bellandi, M. Leoncini, A. Toso, and R. P. Dabizzi
Randomized Early Versus Late Abciximab in Acute Myocardial Infarction Treated With Primary Coronary Intervention (RELAx-AMI Trial)
J. Am. Coll. Cardiol.,
April 10, 2007;
49(14):
1517 - 1524.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Montalescot, D. Antoniucci, A. Kastrati, F. J. Neumann, M. Borentain, A. Migliorini, C. Boutron, J.-P. Collet, and E. Vicaut
Abciximab in primary coronary stenting of ST-elevation myocardial infarction: a European meta-analysis on individual patients' data with long-term follow-up
Eur. Heart J.,
February 2, 2007;
28(4):
443 - 449.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T Heer, U Zeymer, C Juenger, A K Gitt, H Wienbergen, R Zahn, M Gottwik, J Senges, and for the Acute Coronary Syndromes (ACOS) Registry I
Beneficial effects of abciximab in patients with primary percutaneous intervention for acute ST segment elevation myocardial infarction in clinical practice
Heart,
October 1, 2006;
92(10):
1484 - 1489.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J.-P. Collet and G. Montalescot
The acute reperfusion management of STEMI in patients with impaired glucose tolerance and type 2 diabetes
Diabetes and Vascular Disease Research,
October 1, 2005;
2(3):
136 - 143.
[Abstract]
[PDF]
|
|
|
|
|
|
|
U. Zeymer, R. Zahn, R. Schiele, W. Jansen, E. Girth, A. Gitt, K. Seidl, R. Schroder, S. Schneider, and J. Senges
Early eptifibatide improves TIMI 3 patency before primary percutaneous coronary intervention for acute ST elevation myocardial infarction: results of the randomized integrilin in acute myocardial infarction (INTAMI) pilot trial
Eur. Heart J.,
October 1, 2005;
26(19):
1971 - 1977.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. Huber, R. D. Caterina, S. D. Kristensen, F. W.A. Verheugt, G. Montalescot, L. B. Maestro, F. V. d. Werf, and for the Task Force on Pre-hospital Reperfusion The
Pre-hospital reperfusion therapy: a strategy to improve therapeutic outcome in patients with ST-elevation myocardial infarction
Eur. Heart J.,
October 1, 2005;
26(19):
2063 - 2074.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Ferenc and F.-J. Neumann
Efficacy of primary PCI: the microvessel perspective
Eur. Heart J. Suppl.,
October 1, 2005;
7(suppl_I):
I4 - I9.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Migliorini and D. Antoniucci
Patient selection bias in primary percutaneous coronary intervention trials: a critical issue
Eur. Heart J. Suppl.,
October 1, 2005;
7(suppl_I):
I21 - I26.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. B. Danzi, L. Mauri, and F. Sozzi
Percutaneous coronary intervention and beyond for ST-elevation acute myocardial infarction
Eur. Heart J. Suppl.,
October 1, 2005;
7(suppl_K):
K26 - K30.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Valgimigli, G. Percoco, G. Cicchitelli, G. Campo, E. Gardini, L. Pellegrino, P. Malagutti, C. Giretti, and R. Ferrari
New and old strategies to afford the liberal use of drug-eluting stents in real-life scenarios
Eur. Heart J. Suppl.,
October 1, 2005;
7(suppl_K):
K31 - K35.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Schomig, J. Mehilli, D. Antoniucci, G. Ndrepepa, C. Markwardt, F. Di Pede, S. G. Nekolla, K. Schlotterbeck, H. Schuhlen, J. Pache, et al.
Mechanical Reperfusion in Patients With Acute Myocardial Infarction Presenting More Than 12 Hours From Symptom Onset: A Randomized Controlled Trial
JAMA,
June 15, 2005;
293(23):
2865 - 2872.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Valgimigli, G. Percoco, P. Malagutti, G. Campo, F. Ferrari, D. Barbieri, G. Cicchitelli, E. P. McFadden, F. Merlini, L. Ansani, et al.
Tirofiban and Sirolimus-Eluting Stent vs Abciximab and Bare-Metal Stent for Acute Myocardial Infarction: A Randomized Trial
JAMA,
May 4, 2005;
293(17):
2109 - 2117.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Sciagra, G. Parodi, A. Pupi, A. Migliorini, R. Valenti, G. Moschi, G. M. Santoro, G. Memisha, and D. Antoniucci
Gated SPECT Evaluation of Outcome After Abciximab-Supported Primary Infarct Artery Stenting for Acute Myocardial Infarction: The Scintigraphic Data of the Abciximab and Carbostent Evaluation (ACE) Randomized Trial
J. Nucl. Med.,
May 1, 2005;
46(5):
722 - 727.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. De Luca, H. Suryapranata, G. W. Stone, D. Antoniucci, J. E. Tcheng, F.-J. Neumann, F. Van de Werf, E. M. Antman, and E. J. Topol
Abciximab as Adjunctive Therapy to Reperfusion in Acute ST-Segment Elevation Myocardial Infarction: A Meta-analysis of Randomized Trials
JAMA,
April 13, 2005;
293(14):
1759 - 1765.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. J. Terkelsen, J. F. Lassen, B. L. Norgaard, J. C. Gerdes, S. H. Poulsen, K. Bendix, J. P. Ankersen, L. B.-H. Gotzsche, F. K. Romer, T. T. Nielsen, et al.
Reduction of treatment delay in patients with ST-elevation myocardial infarction: impact of pre-hospital diagnosis and direct referral to primary percutanous coronary intervention
Eur. Heart J.,
April 2, 2005;
26(8):
770 - 777.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al.
Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology
Eur. Heart J.,
April 2, 2005;
26(8):
804 - 847.
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. De Luca, A. W.J. van 't Hof, J. P. Ottervanger, J. C.A. Hoorntje, A.T. M. Gosselink, J.-H. E. Dambrink, M.-J. de Boer, and H. Suryapranata
Ageing, impaired myocardial perfusion, and mortality in patients with ST-segment elevation myocardial infarction treated by primary angioplasty
Eur. Heart J.,
April 1, 2005;
26(7):
662 - 666.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. Villeneuve and R. Sunderji
Glycoprotein IIb/IIIa Inhibitors in Patients with End-Stage Renal Disease
Ann. Pharmacother.,
April 1, 2005;
39(4):
732 - 735.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Gyongyosi, H. Domanovits, W. Benzer, M. Haugk, B. Heinisch, G. Sodeck, R. Hodl, G. Gaul, G. Bonner, J. Wojta, et al.
Use of abciximab prior to primary angioplasty in STEMI results in early recanalization of the infarct-related artery and improved myocardial tissue reperfusion - results of the Austrian multi-centre randomized ReoPro-BRIDGING Study
Eur. Heart J.,
December 1, 2004;
25(23):
2125 - 2133.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Gibbons, U. S. Valeti, P. A. Araoz, and A. S. Jaffe
The quantification of infarct size
J. Am. Coll. Cardiol.,
October 19, 2004;
44(8):
1533 - 1542.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Ndrepepa, A. Kastrati, F.-J. Neumann, C. Schmitt, J. Mehilli, and A. Schomig
Five-year outcome of patients with acute myocardial infarction enrolled in a randomised trial assessing the value of abciximab during coronary artery stenting
Eur. Heart J.,
September 2, 2004;
25(18):
1635 - 1640.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. A. Kloner and S. H. Rezkalla
Cardiac protection during acute myocardial infarction: Where do we stand in 2004?
J. Am. Coll. Cardiol.,
July 21, 2004;
44(2):
276 - 286.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. R. Chaitman and M. J. Lim
No reflow and the quest to achieve optimal perfusion during the acute phase of myocardial infarction
J. Am. Coll. Cardiol.,
July 21, 2004;
44(2):
313 - 315.
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Montalescot, M. Borentain, L. Payot, J. P. Collet, and D. Thomas
Early vs Late Administration of Glycoprotein IIb/IIIa Inhibitors in Primary Percutaneous Coronary Intervention of Acute ST-Segment Elevation Myocardial Infarction: A Meta-analysis
JAMA,
July 21, 2004;
292(3):
362 - 366.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. De Luca, A. W.J van't Hof, M.-J. de Boer, J. P. Ottervanger, J. C.A Hoorntje, A.T.M. Gosselink, J.-H. E Dambrink, F. Zijlstra, and H. Suryapranata
Time-to-treatment significantly affects the extent of ST-segment resolution and myocardial blush in patients with acute myocardial infarction treated by primary angioplasty
Eur. Heart J.,
June 2, 2004;
25(12):
1009 - 1013.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. M. Antman and F. Van de Werf
Pharmacoinvasive Therapy: The Future of Treatment for ST-Elevation Myocardial Infarction
Circulation,
June 1, 2004;
109(21):
2480 - 2486.
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. W. O'Neill and S. R. Dixon
The year in interventional cardiology
J. Am. Coll. Cardiol.,
March 3, 2004;
43(5):
875 - 890.
[Full Text]
[PDF]
|
|
|
|
