A multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): Trial study design and rationale

Journal of Cardiovascular Medicine

Volumn 11, Issue 7, 2010, Pages 529-535

  Sardella, Gennaro ^a   Sangiorgi, Giuseppe M ^b   Mancone, Massimo ^a   Colantonio, Riccardo ^a   Donahue, Michael ^a   Politi, Luigi ^b   Ducci, Chiara B ^c   Carbone, Iacopo ^a   Francone, Marco ^a   Ligabue, Guido ^b   Fiocchi, Federica ^b   Di Roma, Angelo ^a   Benedetti, Giulia ^a   Lucisano, Luigi ^a   Stio, Rocco E ^a   Agati, Luciano ^a   Modena, Maria G ^b   Genuini, Igino ^a   Fedele, Francesco ^a   Gibson, Michael ^d  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

^b UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^c ROYAL BROMPTON HOSPITAL   (United Kingdom)

^d HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Abciximab; Acute myocardial infarction; Infarct size

Indexed keywords

ABCIXIMAB; CLOPIDOGREL; HEPARIN; PENTETIC ACID; ANTITHROMBOCYTIC AGENT; IMMUNOGLOBULIN F(AB) FRAGMENT; MONOCLONAL ANTIBODY;

ACUTE HEART INFARCTION; ADULT; ARTICLE; CLINICAL EVALUATION; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; ELECTROCARDIOGRAM; FEMALE; HEART CATHETER; HEART INFARCTION SIZE; HUMAN; INTRACORONARY INFUSION; LOADING DRUG DOSE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; ST SEGMENT ELEVATION; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; TREATMENT RESPONSE; ANGIOCARDIOGRAPHY; COMPARATIVE STUDY; CORONARY THROMBOSIS; ELECTROCARDIOGRAPHY; HEART CATHETERIZATION; HEART MUSCLE; INTRAVENOUS DRUG ADMINISTRATION; ITALY; METHODOLOGY; MYOCARDIAL INFARCTION; NUCLEAR MAGNETIC RESONANCE IMAGING; PATHOLOGY; RADIOGRAPHY; SAMPLE SIZE; TIME; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

ANGIOPLASTY, BALLOON, CORONARY; ANTIBODIES, MONOCLONAL; CARDIAC CATHETERIZATION; CORONARY ANGIOGRAPHY; CORONARY THROMBOSIS; ELECTROCARDIOGRAPHY; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRAVENOUS; ITALY; MAGNETIC RESONANCE IMAGING; MYOCARDIAL INFARCTION; MYOCARDIUM; PLATELET AGGREGATION INHIBITORS; RESEARCH DESIGN; SAMPLE SIZE; TIME FACTORS; TREATMENT OUTCOME;

EID: 77953281484     PISSN: 15582027     EISSN: None     Source Type: Journal    
DOI: 10.2459/JCM.0b013e3283341c1c     Document Type: Article

References (33)

1. Bolognese L, Falsini G, Liistro F, Angioli P, Ducci K. Epicardial and microvascular reperfusion with primary percutaneous coronary intervention. Ital Heart J 2005; 6:447-452.
2. Michaels AD, Gibson CM, Barron HV. Microvascular dysfunction in acute myocardial infarction: focus on the roles of platelet and inflammatory mediators in the no-reflow phenomenon. Am J Cardiol 2000; 85:50B- 60B.
3. Ambrosio G, Tritto I. Reperfusion injury: experimental evidence and clinical implications. Am Heart J 1999; 138:S69-S75.
4. Gick M, Jander N, Bestehorn HP, Kienzle RP, Ferenc M, Werner K, et al. Randomized evaluation of the effects of filter-based distal protection on myocardial perfusion and infarct size after primary percutaneous catheter intervention in myocardial infarction with and without ST-segment elevation. Circulation 2005; 112:1462-1469.
5. Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, et al. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA 2005; 293:1063-1072.
6. Ishii H, Ichimiya S, Kanashiro M, Amano T, Imai K, Murohara T, Matsubara T. Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment-elevation myocardial infarction. Circulation 2005; 112:1284-1288.
7. Topol EJ, Byzova TV, Plow EF. Platelet GPIIb-IIIa blockers. Lancet 1999; 353:227-231.
8. Topol EJ. Toward a new frontier in myocardial reperfusion therapy: emerging platelet preeminence. Circulation 1998; 97:211-218.
9. The EPISTENT Investigators. Randomised placebo-controlled and balloonangioplasty- controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet 1998; 352:87-92.
10. The RESTORE Investigators. Effects of platelet glycoprotein IIb/IIIa blockade with tirofiban on adverse cardiac events in patients with unstable angina or acute myocardial infarction undergoing coronary angioplasty. Circulation 1997; 96:1445-1453.
11. ESPRIT Investigators. Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial. Lancet 2000; 356:2037-2044.
12. Lansky AJ, Pietras C, Costa RA, Tsuchiya Y, Brodie BR, Cox DA, et al. Gender differences in outcomes after primary angioplasty versus primary stenting with and without abciximab for acute myocardial infarction: results of the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial. Circulation 2005; 111:1611-1618.
13. The ADMIRAL Investigators. Three-year duration of benefit from abciximab in patients receiving stents for acute myocardial infarction in the randomized double-blind ADMIRAL study. Eur Heart J 2005; 26:2520-2523.
14. De Luca G, Suryapranata H, Stone GW, Antoniucci D, Tcheng JE, Neumann FJ, et al. Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. JAMA 2005; 293:1759-1765.
15. Antman EM, Giugliano RP, Gibson CM, McCabe CH, Coussement P, Kleiman NS, et al. Abciximab facilitates the rate and extent of thrombolysis: results of the thrombolysis in myocardial infarction (TIMI) 14 trial. The TIMI Investigators. Circulation 1999; 99:2720-2732.
16. Herrmann HC, Moliterno DJ, Ohman EM, Stebbins AL, Bode C, Betriu A, et al. Facilitation of early percutaneous coronary intervention after reteplase with or without abciximab in acute myocardial infarction: results from the SPEED (GUSTO-4 Pilot) trial. J Am Coll Cardiol 2000; 36:1489-1496.
17. Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials. Lancet 2006; 367:579-588.
18. Neumann FJ, Blasini R, Schmitt C, Alt E, Dirschinger J, Gawaz M, Kastrati A. Effect of glycoprotein IIb/IIIa receptor blockade on recovery of coronary flow and left ventricular function after the placement of coronary-artery stents in acute myocardial infarction. Circulation 1998; 98:2695-2701.
19. Stone GW, Cox D, Garcia E, Brodie BR, Morice MC, Griffin J, et al. Normal flow (TIMI-3) before mechanical reperfusion therapy is an independent determinant of survival in acute myocardial infarction: analysis from the Primary Angioplasty in Myocardial Infarction trials. Circulation 2001; 104:636-641.
20. De Luca G, Ernst N, van 't Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosslink AT. Preprocedural TIMI flow and mortality in patients with acute myocardial infarction treated by primary angioplasty. J Am Coll Cardiol 2004; 43:1363-1367. (Pubitemid 38496339)
21. Gibson CM, de Lemos JA, Murphy SA, Marble SJ, McCabe CH, Cannon CP, et al. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation 2001; 103:2550-2554.
22. Brener SJ, Barr LA, Burchenal JE, Katz S, George BS, Jones AA, et al. Randomized, placebo-controlled trial of platelet glycoprotein IIb/IIIa blockade with primary angioplasty for acute myocardial infarction. ReoPro and Primary PTCA Organization and Randomized Trial (RAPPORT) Investigators. Circulation 1998; 98:734-741.
23. Keularts IM, Bé guin S, de Zwaan C, Hemker HC. Treatment with a GPIIb/ IIIa antagonist inhibits thrombin generation in platelet rich plasma from patients. Thromb Haemost 1998; 80:370-371.
24. Reverter JC, Bé guin S, Kessels H, Kumar R, Hemker HC, Coller BS, et al. Inhibition of platelet-mediated, tissue factor-induced thrombin generation by the mouse/human chimeric 7E3 antibody. Potential implications for the effect of c7E3 Fab treatment on acute thrombosis and 'clinical restenosis'. J Clin Invest 1996; 98:863-874.
25. Wohrle J, Grebe OC, Nusser T, Al-Khayer E, Schaible S, Kochs M, et al. Reduction of major adverse cardiac events with intracoronary compared with intravenous bolus application of abciximab in patients with acute myocardial infarction or unstable angina undergoing coronary angioplasty. Circulation 2003; 107:1840-1843.
26. Thuraisingham S, Tan KH. Dissolution of thrombus formed during direct coronary angioplasty with a single 10mg intracoronary bolus dose of abciximab. Int J Clin Pract 1999; 53:604-607.
27. Bartorelli AL, Trabattoni D, Galli S, Grancini L, Cozzi S, Ravagnani P, et al. Successful dissolution of occlusive coronary thrombus with local administration of abciximab during PTCA. Catheter Cardiovasc Interv 1999; 48:211-213.
28. Ohman EM, Kleiman NS, Gacioch G, Worley SJ, Navetta FI, Talley JD, et al. Combined accelerated tissue-plasminogen activator and platelet glycoprotein IIb/IIIa integrin receptor blockade with integrilin in acute myocardial infarction. Results of a randomized, placebo-controlled, doseranging trial. IMPACT-AMI Investigators. Circulation 1997; 95:846-854.
29. Mehilli J, Kastrati A, Schulz S, Früngel S, Nekolla SG, Moshage W, et al.; BRAVE-3 Study Investigators. Abciximab in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention after clopidogrel loading: a randomized double-blind trial. Circulation 2009; 119:1933-1940.
30. Moser M, Bertram U, Peter K, Bode C, Ruef J. Abciximab, eptifibatide, and tirofiban exhibit dose-dependent potencies to dissolve platelet aggregates. J Cardiovasc Pharmacol 2003; 41:586-592.
31. Gibson CM, Jennings LK, Murphy SA, Lorenz DP, Giugliano RP, Harrington RA, et al. Association between platelet receptor occupancy after eptifibatide (integrilin) therapy and patency, myocardial perfusion, and ST-segment resolution among patients with ST-segment-elevation myocardial infarction: an INTEGRITI (Integrilin and Tenecteplase in Acute Myocardial Infarction) substudy. Circulation 2004; 110:679-684.
32. Muhlestein JB, Karagounis LA, Treehan S, Anderson JL. 'Rescue' utilization of abciximab for the dissolution of coronary thrombus developing as a complication of coronary angioplasty. J Am Coll Cardiol 1997; 30:1729-1734.
33. Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, et al. Intracoronary compared with intravenous bolus abciximab application in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention. Circulation 2008; 118:49-57.