title: Design and rationale for the Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX program.
abstract: BACKGROUND
  Transradial intervention (TRI) and bivalirudin infusion compared with transfemoral coronary intervention or unfractionated heparin plus glycoprotein IIb/IIIa inhibitors decrease bleeding complications in patients with acute coronary syndromes (ACS). Although bleeding is thought to be associated with worse outcomes, it remains unclear whether TRI and bivalirudin both independently lower ischemic or combined ischemic and bleeding complications in ACS patients undergoing contemporary invasive management.
  
  
  OBJECTIVE
  The primary objectives of the MATRIX program are to assess whether TRI or bivalirudin as compared, respectively, with transfemoral coronary intervention (MATRIX access site) or unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors, (MATRIX antithrombin) decrease the 30-day incidence of an ischemic (ie, death, myocardial infarction or stroke) or an ischemic and bleeding composite end point across the whole spectrum of ACS patients, including clarifying the optimal duration of bivalirudin infusion after percutaneous coronary intervention (MATRIX treatment duration).
  
  
  METHODS
  The MATRIX (NCT01433627) study, which incorporates 3 randomized comparisons in a nonfactorial manner and primary end points at 30 days and clinical follow-up ≤ 1 year, is a large-scale, multicenter study with blind event adjudication conducted at approximately 100 European sites. With 8,200 patients in the randomized comparison of access sites and 6,800 individuals participating in the randomized comparison of antithrombin regimens, this study will have ≥ 85% power for the primary end points.
  
  
  CONCLUSIONS
  The MATRIX program aims at conclusively ascertaining the role of TRI and bivalirudin infusion in the whole spectrum of ACS patients undergoing contemporary invasive management.
authors.affiliation: Thoraxcenter, Ba 587, Erasmus MC, Rotterdam, The Netherlands. Electronic address: m.valgimigli@erasmusmc.nl.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D000368:Aged; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control; D017534:Radial Artery / Q000601:surgery*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D020521:Stroke / Q000209:etiology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin