Advanced

Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management : A prespecified subgroup analysis from VALIDATE-SWEDEHEART

Völz, Sebastian ; Angerås, Oskar ; Koul, Sasha LU ; Haraldsson, Inger ; Sarno, Giovanna ; Venetsanos, Dimitrios ; Grimfärd, Per ; Ulvenstam, Anders ; Hofmann, Robin and Hamid, Mehmet , et al. (2019) In European heart journal. Acute cardiovascular care 8(6). p.510-519
Abstract

AIMS: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin.

METHODS AND RESULTS: A total of 6006 patients with acute coronary syndrome... (More)

AIMS: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin.

METHODS AND RESULTS: A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43-0.67, p<0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52-0.84, p<0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60, p<0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75, p<0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint (p=0.976) or major bleeding (p=0.801).

CONCLUSIONS: Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
European heart journal. Acute cardiovascular care
volume
8
issue
6
pages
510 - 519
publisher
SAGE Publications
external identifiers
  • pmid:31237158
ISSN
2048-8734
DOI
10.1177/2048872618817217
language
English
LU publication?
yes
id
dc5649c7-7f23-4689-893d-57a26d328923
date added to LUP
2020-06-16 11:58:35
date last changed
2020-09-24 09:08:42
@article{dc5649c7-7f23-4689-893d-57a26d328923,
  abstract     = {<p>AIMS: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin.</p><p>METHODS AND RESULTS: A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43-0.67, p&lt;0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52-0.84, p&lt;0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60, p&lt;0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75, p&lt;0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint (p=0.976) or major bleeding (p=0.801).</p><p>CONCLUSIONS: Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.</p>},
  author       = {Völz, Sebastian and Angerås, Oskar and Koul, Sasha and Haraldsson, Inger and Sarno, Giovanna and Venetsanos, Dimitrios and Grimfärd, Per and Ulvenstam, Anders and Hofmann, Robin and Hamid, Mehmet and Henareh, Loghman and Wagner, Henrik and Jensen, Jens and Danielewicz, Mikael and Östlund, Ollie and Eriksson, Peter and Scherstén, Fredrik and Linder, Rickard and Råmunddal, Truls and Pétursson, Pétur and Fröbert, Ole and James, Stefan and Erlinge, David and Omerovic, Elmir},
  issn         = {2048-8734},
  language     = {eng},
  month        = {09},
  number       = {6},
  pages        = {510--519},
  publisher    = {SAGE Publications},
  series       = {European heart journal. Acute cardiovascular care},
  title        = {Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management : A prespecified subgroup analysis from VALIDATE-SWEDEHEART},
  url          = {http://dx.doi.org/10.1177/2048872618817217},
  doi          = {10.1177/2048872618817217},
  volume       = {8},
  year         = {2019},
}