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Vol. 73. Issue 7.
Pages 536-545 (July 2020)
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Vol. 73. Issue 7.
Pages 536-545 (July 2020)
Original article
DOI: 10.1016/j.rec.2019.07.010
Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial
Impacto del acceso vascular en el pronóstico tras la angioplastia coronaria en pacientes con alto riesgo hemorrágico: subanálisis predefinido del estudio LEADERS FREE
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Víctor Alfonso Jiménez Díaza, Thomas Hovasseb, Andrés Íñigueza, Samuel Coptc, Jonathan Byrned, Philippe Brunele, Marie-Claude Moricef, Alex Abizaidg, Maurizio Tespillih, Darren Waltersi, Alberto Ortiz Sáeza, Guillermo Bastos Fernándeza, Hans-Peter Stollc, Philip Urbanj,
Corresponding author
philip.urban@latour.ch

Corresponding author: Cardiology Department, Hôpital de la Tour, 1 Ave Maillard, 1217, Geneva, Switzerland.
a Departamento de Cardiología, Hospital Álvaro Cunqueiro, Hospital Universitario de Vigo, Vigo, Pontevedra, Spain
b Cardiology Department, Hôpital Privé Jacques Cartier, Massy, France
c Biosensors Europe, Morges, Switzerland
d Cardiology Department, King's College, London, United Kingdom
e Cardiology Department, Clinique de Fontaine, Nantes, France
f Cardiology Department, ICPS, Générale de Santé, Massy, France
g Cardiology Department, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
h Cardiology Department, Ospedale Bolognini, Seriate-Bergamo, Italy
i Cardiology Department, Prince Charles Hospital, Queensland, Australia
j Cardiology Department, Hôpital de la Tour, Geneva, Switzerland
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Tables (4)
Table 1. Baseline patient characteristics and inclusion criteria
Table 2. Procedure details and medication
Table 3. Incidence of safety and efficacy endpoints at 30 days and 2 years
Table 4. Incidence and location of major bleeding events (BARC 3-5) at 30 days and 2 years
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Additional material (1)
Abstract
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.

Keywords:
Transradial access
High bleeding risk
Drug-coated stent
Percutaneous coronary intervention
Abbreviations:
ACS
BARC
HBR
OAC
TFA
TRA
Resumen
Introduccion y objetivos

El objetivo es evaluar el impacto del acceso vascular en las complicaciones hemorrágicas tras una intervención coronaria percutánea en pacientes con alto riesgo de sangrado (ARS) a los 30 días y a los 2 años.

Métodos

El presente estudio es un subanálisis predefinido del estudio LEADERS FREE, que incluyó a 2.432 pacientes con ARS y en el que el stent farmacoactivo Biolimus A9 resultó superior al stent convencional en seguridad y eficacia.

Resultados

El acceso radial (AR) se utilizó en 1.454 pacientes (59,8%) y el femoral (AF), en 978 (40,2%), ambos a elección del operador. La seguridad y los beneficios del stent farmacoactivo sobre el convencional fueron independientes del acceso vascular. A los 30 días y a los 2 años, habían sufrido un sangrado mayor el 2,4 y el 7,5% de los pacientes con AR y el 4,6 y el 10,9% de los pacientes con AF (p=0,003), la mayoría en ambos grupos (el 2,1 y el 7,0% del de AR; el 3,2 y el 9,4% del de AF) no relacionados con el sitio de acceso vascular. El AR se asoció con una reducción significativa en las tasas ajustadas de sangrado mayor tanto a 30 días (HR=1,98; IC95%, 1,25-3,11; p=0,003) como a 2 años de seguimiento (HR=1,51; IC95%, 1,14-2,01; p=0,003).

Conclusiones

Los operadores prefirieron el AR en la mayoría de los pacientes con ARS, lo cual se asoció con una reducción significativa del sangrado mayor. Asimismo, un número significativo de sangrados en el seguimiento de esta población son no relacionados con el acceso vascular.

Palabras clave:
Acceso radial
Alto riesgo de sangrado
Stent farmacoactivo
Intervención coronaria percutánea

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