Design and rationale for the minimizing adverse haemorrhagic events by transradial access site and systemic implementation of angioX program

Marco Valgimigli, Andrea Gagnor, Paolo Calabrò, Paolo Rubartelli, Stefano Garducci, Giuseppe Andò, Andrea Santarelli, Mario Galli, Roberto Garbo, Ezio Bramucci, Salvatore Ierna, Carlo Briguori, Bernardo Cortese, Ugo Limbruno, Roberto Violini, Patrizia Presbitero, Nicoletta De Cesare, Paolo Sganzerla, Arturo Ausiello, Paolo TosiGennaro Sardella, Manel Sabate’, Salvatore Brugaletta, Giovanni Saccone, Pietro Vandoni, Antonio Zingarelli, Armando Liso, Stefano Rigattieri, Emilio Di Lorenzo, Carlo Vigna, Cataldo Palmieri, Camillo Falcone, Raffaele De Caterina, Marcello Caputo, Giovanni Esposito, Alessandro Lupi, Pietro Mazzarotto, Fernando Varbella, Tiziana Zaro, Marco Nazzaro, Sunil V. Rao, Arnoud W J Van‘T Hof, Elmir Omerovic, Lucia Uguccioni, Corrado Tamburino, Fabio Ferrari, Roberto Ceravolo, Fabio Tarantino, Gavino Casu, Dionigi Fischetti, The MATRIX investigators

Research output: Contribution to journalArticlepeer-review

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. Hypotheses 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). Study design 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. Summary 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.

Original languageEnglish
Pages (from-to)838-845
Number of pages8
JournalAmerican Heart Journal
Volume168
Issue number6
DOIs
Publication statusPublished - Dec 1 2014

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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