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

被引：204

作者：

Rao, Sunil V. ^{[1
]}

Hess, Connie N. ^{[1
]}

Barham, Britt ^{[1
]}

Aberle, Laura H. ^{[1
]}

Anstrom, Kevin J. ^{[1
]}

Patel, Tejan B. ^{[2
]}

Jorgensen, Jesse P. ^{[3
]}

Mazzaferri, Ernest L., Jr. ^{[4
]}

Jolly, Sanjit S. ^{[5
]}

Jacobs, Alice ^{[6
]}

Newby, L. Kristin ^{[1
]}

Gibson, C. Michael ^{[7
]}

Kong, David F. ^{[1
]}

Mehran, Roxana ^{[8
]}

Waksman, Ron ^{[9
]}

Gilchrist, Ian C. ^{[10
]}

McCourt, Brian J. ^{[1
]}

Messenger, John C. ^{[11
]}

Peterson, Eric D. ^{[1
]}

Harrington, Robert A. ^{[12
]}

Krucoff, Mitchell W. ^{[1
]}

机构：

[1] Duke Clin Res Inst, Durham, NC USA

[2] Unity Hlth Syst, Rochester, NY USA

[3] Univ S Carolina, Sch Med Greenville, Greenville, SC USA

[4] Ohio State Univ, Med Ctr, Columbus, OH 43210 USA

[5] McMaster Univ, Hamilton, ON, Canada

[6] Boston Univ, Sch Med, Boston, MA 02118 USA

[7] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[8] Mt Sinai Hosp, New York, NY 10029 USA

[9] Washington Hosp Ctr, Washington, DC 20010 USA

[10] Penn State Hershey Med Ctr, Hershey, PA USA

[11] Amer Coll Cardiol, Washington, DC USA

[12] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2014年 / 7卷 / 08期

关键词：

PCI; radial approach; women and heart disease; TRANSRADIAL CATHETERIZATION; MYOCARDIAL-INFARCTION; CLINICAL-RESEARCH; UNSTABLE ANGINA; THERAPY; IMPACT; RISK; METAANALYSIS; BIVALIRUDIN; ANGIOGRAPHY;

D O I：

10.1016/j.jcin.2014.04.007

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (C) 2014 by the American College of Cardiology Foundation.

引用

页码：857 / 867

页数：11

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