PMID- 31563471
OWN - NLM
STAT- MEDLINE
DCOM- 20210329
LR  - 20210329
IS  - 1885-5857 (Electronic)
IS  - 1885-5857 (Linking)
VI  - 73
IP  - 7
DP  - 2020 Jul
TI  - Impact of vascular access on outcome after PCI in patients at high bleeding risk: 
      a pre-specified sub-analysis of the LEADERS FREE trial.
PG  - 536-545
LID - S1885-5857(19)30244-0 [pii]
LID - 10.1016/j.rec.2019.07.010 [doi]
AB  - INTRODUCTION AND OBJECTIVES: The prognostic impact of bleeding in high bleeding 
      risk (HBR) patients depending on the location of bleeding and prognosis in 
      nonaccess site bleeding is unknown. We aimed to assess the impact of vascular 
      access site on bleeding complications after percutaneous coronary interventions 
      for HBR patients at 30-day and 2-year follow-up. METHODS: The LEADERS FREE trial 
      included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a 
      bare-metal stent for safety and efficacy. This is a predefined sub-analysis of 
      the LEADERS FREE trial. RESULTS: Transradial access (TRA) was used in 1454 
      patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to 
      operator preference. The safety and benefits of drug-coated stents over 
      bare-metal stents were independent of vascular access. At 30 days and 2 years, 
      major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% 
      of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% 
      and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess 
      site-related. TRA was associated with a significant reduction in adjusted rates 
      of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 
      years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was 
      driven by both access and nonaccess bleeding. CONCLUSIONS: Operators preferred 
      TRA for most HBR patients, which was associated with a significant reduction in 
      major bleeding events. However, most of these events in this population are 
      unrelated to vascular access.
CI  - Copyright (c) 2019 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, 
      S.L.U. All rights reserved.
FAU - Jimenez Diaz, Victor Alfonso
AU  - Jimenez Diaz VA
AD  - Departamento de Cardiologia, Hospital Alvaro Cunqueiro, Hospital Universitario de 
      Vigo, Vigo, Pontevedra, Spain.
FAU - Hovasse, Thomas
AU  - Hovasse T
AD  - Cardiology Department, Hopital Prive Jacques Cartier, Massy, France.
FAU - Iniguez, Andres
AU  - Iniguez A
AD  - Departamento de Cardiologia, Hospital Alvaro Cunqueiro, Hospital Universitario de 
      Vigo, Vigo, Pontevedra, Spain.
FAU - Copt, Samuel
AU  - Copt S
AD  - Biosensors Europe, Morges, Switzerland.
FAU - Byrne, Jonathan
AU  - Byrne J
AD  - Cardiology Department, King's College, London, United Kingdom.
FAU - Brunel, Philippe
AU  - Brunel P
AD  - Cardiology Department, Clinique de Fontaine, Nantes, France.
FAU - Morice, Marie-Claude
AU  - Morice MC
AD  - Cardiology Department, ICPS, Generale de Sante, Massy, France.
FAU - Abizaid, Alex
AU  - Abizaid A
AD  - Cardiology Department, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, 
      Brazil.
FAU - Tespilli, Maurizio
AU  - Tespilli M
AD  - Cardiology Department, Ospedale Bolognini, Seriate-Bergamo, Italy.
FAU - Walters, Darren
AU  - Walters D
AD  - Cardiology Department, Prince Charles Hospital, Queensland, Australia.
FAU - Ortiz Saez, Alberto
AU  - Ortiz Saez A
AD  - Departamento de Cardiologia, Hospital Alvaro Cunqueiro, Hospital Universitario de 
      Vigo, Vigo, Pontevedra, Spain.
FAU - Bastos Fernandez, Guillermo
AU  - Bastos Fernandez G
AD  - Departamento de Cardiologia, Hospital Alvaro Cunqueiro, Hospital Universitario de 
      Vigo, Vigo, Pontevedra, Spain.
FAU - Stoll, Hans-Peter
AU  - Stoll HP
AD  - Biosensors Europe, Morges, Switzerland.
FAU - Urban, Philip
AU  - Urban P
AD  - Cardiology Department, Hopital de la Tour, Geneva, Switzerland. Electronic 
      address: philip.urban@latour.ch.
LA  - eng
LA  - spa
PT  - Journal Article
DEP - 20190926
PL  - Spain
TA  - Rev Esp Cardiol (Engl Ed)
JT  - Revista espanola de cardiologia (English ed.)
JID - 101587954
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiac Surgical Procedures/*methods
MH  - *Catheterization, Peripheral
MH  - Drug-Eluting Stents
MH  - Female
MH  - Femoral Artery/*surgery
MH  - Hemorrhage/etiology/prevention & control
MH  - Humans
MH  - Male
MH  - Percutaneous Coronary Intervention/*adverse effects/*methods
MH  - Radial Artery/*surgery
MH  - Risk Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Acceso radial
OT  - Alto riesgo de sangrado
OT  - Drug-coated stent
OT  - High bleeding risk
OT  - Intervencion coronaria percutanea
OT  - Percutaneous coronary intervention
OT  - Stent farmacoactivo
OT  - Transradial access
EDAT- 2019/09/30 06:00
MHDA- 2021/03/30 06:00
CRDT- 2019/09/30 06:00
PHST- 2019/02/05 00:00 [received]
PHST- 2019/07/22 00:00 [accepted]
PHST- 2019/09/30 06:00 [pubmed]
PHST- 2021/03/30 06:00 [medline]
PHST- 2019/09/30 06:00 [entrez]
AID - S1885-5857(19)30244-0 [pii]
AID - 10.1016/j.rec.2019.07.010 [doi]
PST - ppublish
SO  - Rev Esp Cardiol (Engl Ed). 2020 Jul;73(7):536-545. doi: 
      10.1016/j.rec.2019.07.010. Epub 2019 Sep 26.