title: Randomized evaluation of intralesion versus intracoronary abciximab and aspiration thrombectomy in patients with ST-elevation myocardial infarction: The COCTAIL II trial.
abstract: BACKGROUND
  Thrombus burden and distal embolization are predictive of no-reflow during primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). We sought to compare the efficacy of pharmacological and catheter-based strategies for thrombus in patients with STEMI and high atherothrombotic burden.
  
  
  METHODS
  Between January 2012 and December 2013, 128 STEMI patients undergoing primary PCI at 5 centers were randomly assigned in a 2 × 2 factorial design to intracoronary (IC) abciximab bolus (via the guide catheter) versus intralesion (IL) abciximab bolus, each with versus without aspiration thrombectomy (AT). Study end points were residual intrastent atherothrombotic burden, defined as the number of cross-sections with residual tissue area >10% as assessed by optical coherence tomography, and indices of angiographic and myocardial reperfusion.
  
  
  RESULTS
  Residual intrastent atherothrombotic burden did not significantly differ with IL versus IC abciximab (median [interquartile range] 6.0 [1-15] vs 6.0 [2-11], P = .806) and with AT versus no aspiration (6.0 [1-13] vs 6.0 [2-12], P = .775). Intralesion abciximab administration was associated with improved angiographic myocardial reperfusion in terms of thrombolysis in myocardial infarction (TIMI) flow (3 [3-3] vs 3 [2-3], P = .040), corrected TIMI frame count (12 ± 5 vs 17 ± 16, P = .021), and myocardial blush grade (3 [2-3] vs 3 [2-3], P = .035). In particular, IL abciximab was associated with higher occurrence of final TIMI 3 flow (90% vs 73.8%, P = .032) and myocardial blush grade 3 (71.6% vs 52.4%, P = .039). Conversely, AT had no significant effect on indices of angiographic or myocardial reperfusion.
  
  
  CONCLUSIONS
  In patients with STEMI and high thrombotic burden, neither IL versus IC abciximab nor AT versus no aspiration reduced postprocedure intrastent atherothrombotic burden in patients with STEMI undergoing primary PCI. However, IL abciximab improved indices of angiographic and myocardial reperfusion compared to IC abciximab, benefits not apparent with AT.
authors.affiliation: San Giovanni Hospital, Rome, Italy; Centro per la Lotta Contro L'Infarto-CLI Foundation, Rome, Italy. Electronic address: fprati@hsangiovanni.roma.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.affiliation: Centro per la Lotta Contro L'Infarto-CLI Foundation, Rome, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Romagnoli
authors.affiliation: Misericordia Hospital, Grosseto, Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: Limbruno
authors.affiliation: Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pawlowski
authors.affiliation: Sandro Pertini Hospital, Rome, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Fedele
authors.affiliation: San Giovanni Hospital, Rome, Italy; Centro per la Lotta Contro L'Infarto-CLI Foundation, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Gatto
authors.affiliation: San Giovanni Hospital, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Di Vito
authors.affiliation: San Giovanni Hospital, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pappalardo
authors.affiliation: San Giovanni Hospital, Rome, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Ramazzotti
authors.affiliation: Misericordia Hospital, Grosseto, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Picchi
authors.affiliation: Ospedale Civile Ferdinando Veneziale, Isernia, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Trivisonno
authors.affiliation: Centro per la Lotta Contro L'Infarto-CLI Foundation, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Materia
authors.affiliation: Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.
authors.forename: Piotre
authors.initials: P
authors.lastname: Pfiatkosky
authors.affiliation: Centro per la Lotta Contro L'Infarto-CLI Foundation, Rome, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Paoletti
authors.affiliation: Centro per la Lotta Contro L'Infarto-CLI Foundation, Rome, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Marco
authors.affiliation: GVM Care and Research, E.S. Health Science Foundation, Cotignola, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
authors.affiliation: Ospedale Civile Ferdinando Veneziale, Isernia, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Versaci
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000175:diagnosis; D015425:Myocardial Reperfusion / Q000379:methods; D054318:No-Reflow Phenomenon / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011183:Postoperative Complications / Q000175:diagnosis / Q000628:therapy; D017131:Thrombectomy / Q000009:adverse effects / Q000379:methods; D013927:Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D041623:Tomography, Optical Coherence / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077284:Abciximab