TY - JOUR
T1 - Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock - Subanalysis from the CULPRIT-SHOCK trial: Arterial access for PCI in cardiogenic shock
AU - CULPRIT-SHOCK Investigators
AU - Guedeney, Paul
AU - Thiele, Holger
AU - Kerneis, Mathieu
AU - Barthélémy, Olivier
AU - Baumann, Stefan
AU - Sandri, Marcus
AU - de Waha-Thiele, Suzanne
AU - Fuernau, Georg
AU - Rouanet, Stéphanie
AU - Piek, Jan J.
AU - Landmesser, Ulf
AU - Hauguel-Moreau, Marie
AU - Zeitouni, Michel
AU - Silvain, Johanne
AU - Lattuca, Benoit
AU - Windecker, Stephan
AU - Collet, Jean Philippe
AU - Desch, Steffen
AU - Zeymer, Uwe
AU - Montalescot, Gilles
AU - Akin, Ibrahim
N1 - Funding Information:
This is a post hoc analysis of the CULPRIT-SHOCK trial, whose design and results have been previously described. 27-29 Briefly, the CULPRIT-SHOCK trial was an investigator-initiated, international, multicenter, open-label study where patients presenting with acute MI and multivessel coronary artery disease complicated by CS were randomized, in a 1:1 ratio, to a strategy of culprit-lesion-only PCI (with optional staged revascularization) or immediate multivessel PCI. In all patients, the culprit lesion was treated first, with the use of standard PCI techniques and with the recommended use of drug-eluting stents. In the culprit-lesion-only group, staged revascularization was performed according to the patient clinical status and the presence of residual ischemia. In the multivessel PCI group, any >70% stenosis of major coronary arteries (ie, ≥2 mm diameter), including chronic total occlusion, were recommended to be treated with immediate PCI following the treatment of the culprit lesion, with a recommended maximum dose of contrast material of 300 mL. The indication for other therapy, including the use of mechanical circulatory support, was left to the discretion of the local physician, in accordance with generally accepted intensive care guidelines. The investigation was approved by the ethics committee or institutional review board of each participating center, and written informed consent was obtained with the use of a prespecified process that varied slightly according to the country. 28 The type of vascular access was left at the discretion of local operators. Patients undergoing brachial arterial access or concomitant TRA and TFA for the PCI procedures were excluded from this study. The CULPRIT-SHOCK trial was supported by a grant agreement ( 602202 ) from the European Union Seventh Framework Program and by the German Heart Research Foundation and the German Cardiac Society . The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the papers, and its final contents.
Funding Information:
The CULPRIT-SHOCK trial was supported by a grant agreement ( 602202 ) from the European Union Seventh Framework Program and by the German Heart Research Foundation and the German Cardiac Society .
Funding Information:
Dr Montalescot reports the following disclosures during the past 2 years: research grants to the institution or consulting/lecture fees from ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie AG, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women’s Hospital, Cardiovascular Research Foundation, Celladon, CME Resources, Daiichi-Sankyo, Eli-Lilly, Europa, Elsevier, Fédération Française de Cardiologie, Fondazione Anna Maria Sechi per il Cuore, Gilead, ICAN, Janssen, Lead-Up, Menarini, Medtronic, MSD, Pfizer, Sanofi-Aventis, The Medicines Company, TIMI Study Group, and WebMD.
Funding Information:
Dr Windecker has received research, educational, and training grants from Amgen, Abbott, Bayer, Bristol-Myers Squibb, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, St. Jude, and Terumo.
Funding Information:
Dr Kerneis has received research grants from Sanofi, Institut Servier, and Fédération Française de Cardiologie and consultant fees from Bayer and AstraZeneca.
Funding Information:
Dr Lattuca has received research grants from Biotronik, Daiichi-Sankyo, and Fédération Française de Cardiologie; consultant fees from Daiichi-Sankyo and Eli Lilly; and lecture fees from AstraZeneca and Novartis.
Funding Information:
Dr Michel Zeitouni has received research grants from Federation Française de Cardiologie and Institut Servier.
Publisher Copyright:
© 2020 Elsevier Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/7
Y1 - 2020/7
N2 - Background: The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear. Methods: This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes. Results: Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively). Conclusions: In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.
AB - Background: The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear. Methods: This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes. Results: Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively). Conclusions: In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.
UR - http://www.scopus.com/inward/record.url?scp=85085656713&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2020.04.014
DO - 10.1016/j.ahj.2020.04.014
M3 - Journal articles
C2 - 32497906
AN - SCOPUS:85085656713
SN - 0002-8703
VL - 225
SP - 60
EP - 68
JO - American Heart Journal
JF - American Heart Journal
ER -