A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: The SAFE-PCI for women (study of access site for enhancement of PCI for women) trial

Sunil V. Rao, Connie N. Hess, Britt Barham, Laura H. Aberle, Kevin J. Anstrom, Tejan B. Patel, Jesse P. Jorgensen, Ernest L. Mazzaferri, Sanjit S. Jolly, Alice Jacobs, L. Kristin Newby, C. Michael Gibson, David F. Kong, Roxana Mehran, Ron Waksman, Ian Gilchrist, Brian J. McCourt, John C. Messenger, Eric D. Peterson, Robert A. HarringtonMitchell W. Krucoff

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Objectives This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Background Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Methods Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. Results The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. Conclusions In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)

Original languageEnglish (US)
Pages (from-to)857-867
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume7
Issue number8
DOIs
StatePublished - Jan 1 2014

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Percutaneous Coronary Intervention
Thigh
Registries
Blood Vessels
Hemorrhage
Odds Ratio
Confidence Intervals
Cardiac Catheterization
Pragmatic Clinical Trials
Cohort Studies
Databases

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Rao, Sunil V. ; Hess, Connie N. ; Barham, Britt ; Aberle, Laura H. ; Anstrom, Kevin J. ; Patel, Tejan B. ; Jorgensen, Jesse P. ; Mazzaferri, Ernest L. ; Jolly, Sanjit S. ; Jacobs, Alice ; Newby, L. Kristin ; Gibson, C. Michael ; Kong, David F. ; Mehran, Roxana ; Waksman, Ron ; Gilchrist, Ian ; McCourt, Brian J. ; Messenger, John C. ; Peterson, Eric D. ; Harrington, Robert A. ; Krucoff, Mitchell W. / A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention : The SAFE-PCI for women (study of access site for enhancement of PCI for women) trial. In: JACC: Cardiovascular Interventions. 2014 ; Vol. 7, No. 8. pp. 857-867.
@article{1415a8154950456fad6f1c2289e3e715,
title = "A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: The SAFE-PCI for women (study of access site for enhancement of PCI for women) trial",
abstract = "Objectives This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Background Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Methods Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. Results The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2{\%} vs. 2.9{\%} femoral, odds ratio [OR]: 0.39; 95{\%} confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6{\%} vs. 1.7{\%}; OR: 0.32; 95{\%} CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1{\%} vs. 1.7{\%}; OR: 3.65; 95{\%} CI: 1.45 to 9.17); total randomized cohort: (6.7{\%} vs. 1.9{\%}; OR: 3.70; 95{\%} CI: 2.14 to 6.40). More women preferred radial access. Conclusions In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)",
author = "Rao, {Sunil V.} and Hess, {Connie N.} and Britt Barham and Aberle, {Laura H.} and Anstrom, {Kevin J.} and Patel, {Tejan B.} and Jorgensen, {Jesse P.} and Mazzaferri, {Ernest L.} and Jolly, {Sanjit S.} and Alice Jacobs and Newby, {L. Kristin} and Gibson, {C. Michael} and Kong, {David F.} and Roxana Mehran and Ron Waksman and Ian Gilchrist and McCourt, {Brian J.} and Messenger, {John C.} and Peterson, {Eric D.} and Harrington, {Robert A.} and Krucoff, {Mitchell W.}",
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doi = "10.1016/j.jcin.2014.04.007",
language = "English (US)",
volume = "7",
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Rao, SV, Hess, CN, Barham, B, Aberle, LH, Anstrom, KJ, Patel, TB, Jorgensen, JP, Mazzaferri, EL, Jolly, SS, Jacobs, A, Newby, LK, Gibson, CM, Kong, DF, Mehran, R, Waksman, R, Gilchrist, I, McCourt, BJ, Messenger, JC, Peterson, ED, Harrington, RA & Krucoff, MW 2014, 'A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: The SAFE-PCI for women (study of access site for enhancement of PCI for women) trial', JACC: Cardiovascular Interventions, vol. 7, no. 8, pp. 857-867. https://doi.org/10.1016/j.jcin.2014.04.007

A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention : The SAFE-PCI for women (study of access site for enhancement of PCI for women) trial. / Rao, Sunil V.; Hess, Connie N.; Barham, Britt; Aberle, Laura H.; Anstrom, Kevin J.; Patel, Tejan B.; Jorgensen, Jesse P.; Mazzaferri, Ernest L.; Jolly, Sanjit S.; Jacobs, Alice; Newby, L. Kristin; Gibson, C. Michael; Kong, David F.; Mehran, Roxana; Waksman, Ron; Gilchrist, Ian; McCourt, Brian J.; Messenger, John C.; Peterson, Eric D.; Harrington, Robert A.; Krucoff, Mitchell W.

In: JACC: Cardiovascular Interventions, Vol. 7, No. 8, 01.01.2014, p. 857-867.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention

T2 - The SAFE-PCI for women (study of access site for enhancement of PCI for women) trial

AU - Rao, Sunil V.

AU - Hess, Connie N.

AU - Barham, Britt

AU - Aberle, Laura H.

AU - Anstrom, Kevin J.

AU - Patel, Tejan B.

AU - Jorgensen, Jesse P.

AU - Mazzaferri, Ernest L.

AU - Jolly, Sanjit S.

AU - Jacobs, Alice

AU - Newby, L. Kristin

AU - Gibson, C. Michael

AU - Kong, David F.

AU - Mehran, Roxana

AU - Waksman, Ron

AU - Gilchrist, Ian

AU - McCourt, Brian J.

AU - Messenger, John C.

AU - Peterson, Eric D.

AU - Harrington, Robert A.

AU - Krucoff, Mitchell W.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Objectives This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Background Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Methods Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. Results The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. Conclusions In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)

AB - Objectives This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Background Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Methods Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. Results The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. Conclusions In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)

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