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).
RCT Entities:
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).
Authors: Kevin D Hill; H Scott Baldwin; David P Bichel; Alicia M Ellis; Eric M Graham; Christoph P Hornik; Jeffrey P Jacobs; Robert D B Jaquiss; Marshall L Jacobs; Prince J Kannankeril; Jennifer S Li; Rachel Torok; Joseph W Turek; Sean M O'Brien Journal: Am Heart J Date: 2020-05-20 Impact factor: 4.749
Authors: Robert W Yeh; Matthew J Czarny; Sharon-Lise T Normand; Dean J Kereiakes; David R Holmes; Ralph G Brindis; W Douglas Weaver; John S Rumsfeld; Matthew T Roe; Sunghee Kim; Priscilla Driscoll-Shempp; Laura Mauri Journal: Circ Cardiovasc Qual Outcomes Date: 2014-11-16
Authors: Allison Tong; John Gill; Klemens Budde; Lorna Marson; Peter P Reese; David Rosenbloom; Lionel Rostaing; Germaine Wong; Michelle A Josephson; Timothy L Pruett; Anthony N Warrens; Jonathan C Craig; Benedicte Sautenet; Nicole Evangelidis; Angelique F Ralph; Camilla S Hanson; Jenny I Shen; Kirsten Howard; Klemens Meyer; Ronald D Perrone; Daniel E Weiner; Samuel Fung; Maggie K M Ma; Caren Rose; Jessica Ryan; Ling-Xin Chen; Martin Howell; Nicholas Larkins; Siah Kim; Sobhana Thangaraju; Angela Ju; Jeremy R Chapman Journal: Transplantation Date: 2017-08 Impact factor: 4.939