title: Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.
abstract: BACKGROUND
  It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management.
  
  
  METHODS
  We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627.
  
  
  RESULTS
  We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045).
  
  
  CONCLUSIONS
  In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality.
  
  
  BACKGROUND
  The Medicines Company and Terumo.
authors: Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands. Electronic address: m.valgimigli@erasmusmc.nl.
authors: Marco
authors: M
authors: Valgimigli
authors: Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy.
authors: Andrea
authors: A
authors: Gagnor
authors: Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
authors: Paolo
authors: P
authors: Calabró
authors: Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy; EUSTRATEGY Association, Forli', Italy.
authors: Enrico
authors: E
authors: Frigoli
authors: UOC Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors: Sergio
authors: S
authors: Leonardi
authors: A.O. Ospedale Civile di Vimercate (MB), Vimercate, Italy.
authors: Tiziana
authors: T
authors: Zaro
authors: Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy.
authors: Paolo
authors: P
authors: Rubartelli
authors: Clinica Mediterranea, Naples, Italy.
authors: Carlo
authors: C
authors: Briguori
authors: Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino", University of Messina, Messina, Italy.
authors: Giuseppe
authors: G
authors: Andò
authors: UOC Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors: Alessandra
authors: A
authors: Repetto
authors: UO Cardiologia, ASL 9 Grosseto, Grosseto, Italy.
authors: Ugo
authors: U
authors: Limbruno
authors: Ospedale Fate bene Fratelli, Milan, Italy.
authors: Bernardo
authors: B
authors: Cortese
authors: AO Ospedale Treviglio-Caravaggio, Treviglio BG, Italy.
authors: Paolo
authors: P
authors: Sganzerla
authors: University Hospital "Maggiore della Carità", Novara, Italy.
authors: Alessandro
authors: A
authors: Lupi
authors: Ospedaliera Sant'Anna, Como, Italy.
authors: Mario
authors: M
authors: Galli
authors: San Giovanni Bosco Hospital, Turin, Italy.
authors: Salvatore
authors: S
authors: Colangelo
authors: Ospedale Sirai-Carbonia, Carbonia, Italy.
authors: Salvatore
authors: S
authors: Ierna
authors: Casa di Cura Villa Verde, Taranto, Italy.
authors: Arturo
authors: A
authors: Ausiello
authors: IRCCS Humanitas, Rozzano, Italy.
authors: Patrizia
authors: P
authors: Presbitero
authors: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
authors: Gennaro
authors: G
authors: Sardella
authors: Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy.
authors: Ferdinando
authors: F
authors: Varbella
authors: Division of Cardiology-Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
authors: Giovanni
authors: G
authors: Esposito
authors: Cardiovascular Department, Infermi Hospital, Rimini, Italy.
authors: Andrea
authors: A
authors: Santarelli
authors: A.O. Ospedale di Desio (MB), Desio, Italy.
authors: Simone
authors: S
authors: Tresoldi
authors: San Camillo-Forlanini, Rome, Italy.
authors: Marco
authors: M
authors: Nazzaro
authors: IRCCS AOU San Martino, Genoa, Italy.
authors: Antonio
authors: A
authors: Zingarelli
authors: Policlinico San Marco, Zingonia, Italy.
authors: Nicoletta
authors: N
authors: de Cesare
authors: Interventional Cardiology Sandro Pertini Hospital, Rome, Italy.
authors: Stefano
authors: S
authors: Rigattieri
authors: Mater Salutis Hospital-Legnago, Verona, Italy.
authors: Paolo
authors: P
authors: Tosi
authors: Ospedale Pasquinucci, Massa, Italy.
authors: Cataldo
authors: C
authors: Palmieri
authors: Hospital Clinic, University of Barcelona, Thorax Institute, Department of Cardiology, Barcelona, Spain.
authors: Salvatore
authors: S
authors: Brugaletta
authors: Duke Clinical Research Institute, Durham, NC, USA.
authors: Sunil V
authors: SV
authors: Rao
authors: Clinical Trials Unit, University of Bern, Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors: Dik
authors: D
authors: Heg
authors: Clinical Trials Unit, University of Bern, Bern, Switzerland.
authors: Martina
authors: M
authors: Rothenbühler
authors: Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.
authors: Pascal
authors: P
authors: Vranckx
authors: Clinical Trials Unit, University of Bern, Bern, Switzerland; Institute of Primary Health Care, University of Bern, Bern, Switzerland.
authors: Peter
authors: P
authors: Jüni
mesh_terms: D054058:Acute Coronary Syndrome / Q000401:mortality / Q000601:surgery*; D000368:Aged; D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods*; D002423:Cause of Death; D017023:Coronary Angiography; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D017534:Radial Artery; D015996:Survival Rate; D016896:Treatment Outcome