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.

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Citation: Jacc: Cardiovascular Interventions. 7(8):857-67, 2014 Aug.PMID: 25147030Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Pragmatic Clinical Trial | Randomized Controlled Trial | Research Support, Non-U.S. Gov't | Research Support, U.S. Gov't, Non-P.H.S.Subject headings: *Coronary Artery Disease/th [Therapy] | *Femoral Artery | *Percutaneous Coronary Intervention/mt [Methods] | *Radial Artery | Aged | Canada | Coronary Artery Disease/di [Diagnosis] | Early Termination of Clinical Trials | Female | Hemorrhage/et [Etiology] | Hemorrhage/pc [Prevention & Control] | Humans | Linear Models | Middle Aged | Odds Ratio | Patient Preference | Percutaneous Coronary Intervention/ae [Adverse Effects] | Prospective Studies | Registries | Risk Factors | Sex Factors | Time Factors | Treatment Outcome | United StatesYear: 2014Local holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear.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).Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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.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.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.All authors: Aberle LH, Anstrom KJ, Barham B, Gibson CM, Gilchrist IC, Harrington RA, Hess CN, Jacobs A, Jolly SS, Jorgensen JP, Kong DF, Krucoff MW, Mazzaferri EL Jr, McCourt BJ, Mehran R, Messenger JC, Newby LK, Patel TB, Peterson ED, Rao SV, Waksman RFiscal year: FY2015Digital Object Identifier: Date added to catalog: 2016-05-24
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 25147030 Available 25147030

Available online through MWHC library: 2008 - present

BACKGROUND: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear.

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).Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

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.

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.

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