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Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention
Authors:Thomas A. Meijers  Adel Aminian  Marleen van Wely  Koen Teeuwen  Thomas Schmitz  Maurits T. Dirksen  Sudhir Rathore  René J. van der Schaaf  Paul Knaapen  Joseph Dens  Juan F. Iglesias  Pierfrancesco Agostoni  Vincent Roolvink  Renicus S. Hermanides  Niels van Royen  Maarten A.H. van Leeuwen
Affiliation:1. Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands;2. Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium;3. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands;4. Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands;5. Department of Cardiology, Elisabeth Krankenhaus, Essen, Germany;6. Department of Cardiology, Northwest Clinics, Alkmaar, the Netherlands;7. Department of Cardiology, Frimley Health NHS Foundation Trust, Surrey, United Kingdom;8. Department of Cardiology, Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands;9. Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands;10. Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium;11. Department of Cardiology, Geneva University Hospital, Geneva, Switzerland;12. Department of Cardiology, ZNA Middelheim, Antwerp, the Netherlands
Abstract:ObjectivesThe aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site–related bleeding or vascular complications.BackgroundThe femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.MethodsAn international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site–related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.ResultsThe primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.ConclusionsIn patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752)
Keywords:complex PCI  CTO  large bore  vascular access  BARC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0035"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Bleeding Academic Research Consortium  CEC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0045"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  clinical events committee  CTO"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0055"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  chronic total occlusion  DES"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0065"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  drug-eluting stents  MACE"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0075"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  major adverse cardiovascular event(s)  MI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0085"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  myocardial infarction  PCI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0095"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  percutaneous coronary intervention  RAO"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0105"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  radial artery occlusion  TF"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0115"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  transfemoral  TFA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0125"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  transfemoral access  TR"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0135"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  transradial  TRA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0145"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  transradial access
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