title: Randomized trial of standard versus ClearWay-infused abciximab and thrombectomy in myocardial infarction: rationale and design of the COCTAIL II study.
abstract: BACKGROUND
  Patients with ST-elevation myocardial infarction (STEMI) are at substantial risk of suboptimal procedural results and late adverse events. Angiography and optical coherence tomography (OCT) studies have identified residual coronary thrombus and microcirculatory injury as potential culprits for these adverse outcomes. We hypothesized that coronary thrombectomy and local infusion of glycoprotein IIb/IIIa inhibitors by means of a dedicated infusion device can synergistically improve results of percutaneous coronary intervention (PCI) for STEMI, as appraised by OCT.
  
  
  METHODS
  A total of 128 patients with STEMI will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intrastent thrombus formations when compared with intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross-sections with thrombus area more than 10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG and clinical endpoints will be collected and adjudicated.
  
  
  CONCLUSIONS
  This trial will provide important mechanistic insights on the most appropriate invasive treatment strategy for patients with STEMI and significant thrombus burden, by exploiting its factorial design and reliance on sensitive OCT endpoints.
authors.affiliation: Department of Interventional Cardiology, San Giovanni-Addolorata Hospital, Rome, Italy. fprati@hsangiovanni.roma.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.forename: Luca
authors.initials: L
authors.lastname: Di Vito
authors.forename: Vito
authors.initials: V
authors.lastname: Ramazzotti
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Imola
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pawlowski
authors.forename: Laura
authors.initials: L
authors.lastname: Materia
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Mario
authors.initials: M
authors.lastname: Albertucci
mesh_terms: D000077284:Abciximab; D061605:Administration, Intravenous; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D062906:Cardiac Catheters; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004562:Electrocardiography; D004867:Equipment Design; D005060:Europe; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007263:Infusions, Parenteral; D008297:Male; D009203:Myocardial Infarction / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D012107:Research Design; D017131:Thrombectomy; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab