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

CULPRIT-SHOCK Investigators

doi:10.1016/j.ahj.2020.04.014

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

CULPRIT-SHOCK Investigators

Abstract

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.

Originalsprache	Englisch
Zeitschrift	American Heart Journal
Jahrgang	225
Seiten (von - bis)	60-68
Seitenumfang	9
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2020.04.014
Publikationsstatus	Veröffentlicht - 07.2020

Fördermittel

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. 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 . 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. 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. Dr Kerneis has received research grants from Sanofi, Institut Servier, and Fédération Française de Cardiologie and consultant fees from Bayer and AstraZeneca. 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. Dr Michel Zeitouni has received research grants from Federation Française de Cardiologie and Institut Servier.

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10.1016/j.ahj.2020.04.014

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CULPRIT-SHOCK Investigators (2020). 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. American Heart Journal, 225, 60-68. https://doi.org/10.1016/j.ahj.2020.04.014

@article{e95d3187f14d4be08241fc7bf66ee066,

title = "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",

abstract = "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.",

author = "\{CULPRIT-SHOCK Investigators\} and Paul Guedeney and Holger Thiele and Mathieu Kerneis and Olivier Barth{\'e}l{\'e}my and Stefan Baumann and Marcus Sandri and \{de Waha-Thiele\}, Suzanne and Georg Fuernau and St{\'e}phanie Rouanet and Piek, \{Jan J.\} and Ulf Landmesser and Marie Hauguel-Moreau and Michel Zeitouni and Johanne Silvain and Benoit Lattuca and Stephan Windecker and Collet, \{Jean Philippe\} and Steffen Desch and Uwe Zeymer and Gilles Montalescot and Ibrahim Akin",

note = "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{\textquoteright}s Hospital, Cardiovascular Research Foundation, Celladon, CME Resources, Daiichi-Sankyo, Eli-Lilly, Europa, Elsevier, F{\'e}d{\'e}ration Fran{\c c}aise 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 F{\'e}d{\'e}ration Fran{\c c}aise de Cardiologie and consultant fees from Bayer and AstraZeneca. Funding Information: Dr Lattuca has received research grants from Biotronik, Daiichi-Sankyo, and F{\'e}d{\'e}ration Fran{\c c}aise 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 Fran{\c c}aise de Cardiologie and Institut Servier. Publisher Copyright: {\textcopyright} 2020 Elsevier Inc. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",

year = "2020",

month = jul,

doi = "10.1016/j.ahj.2020.04.014",

language = "English",

volume = "225",

pages = "60--68",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Elsevier Inc.",

}

CULPRIT-SHOCK Investigators 2020, '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', American Heart Journal, Jg. 225, S. 60-68. https://doi.org/10.1016/j.ahj.2020.04.014

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. / CULPRIT-SHOCK Investigators.
in: American Heart Journal, Jahrgang 225, 07.2020, S. 60-68.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

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 - https://www.scopus.com/pages/publications/85085656713

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 -

CULPRIT-SHOCK Investigators. 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. American Heart Journal. 2020 Jul;225:60-68. doi: 10.1016/j.ahj.2020.04.014