Study of Access Site for Enhancement of PCI for Women - SAFE-PCI for Women
The goal of the trial was to evaluate radial artery access compared with femoral artery access among women undergoing cardiac catheterization.
Radial artery access will reduce bleeding and vascular complications.
- Women ≥18 years of age undergoing elective or urgent cardiac catheterization
Number of enrollees: 1,787 women
Duration of follow-up: mean 30 days
Mean patient age: 63 years
Percentage female: 100%
- Condition precluding safe arterial access (nonpalpable pulse, bilateral abnormal Barbeau test, hemodialysis AV fistula or graft in arm, or international normalized ratio ≥1.5 if on warfarin)
- Bilateral internal mammary artery grafts
- Planned staged PCI within 30 days of index procedure
- Valvular heart disease requiring surgery
- Planned right heart catheterization
- Primary PCI for STEMI
- Primary efficacy endpoint:
- Bleeding or vascular complication requiring intervention at 72 hours. Bleeding was defined according to BARC criteria (type 2, 3, or 5). Vascular complication was defined as development of AV fistula, pseudoaneurysm, or arterial access site occlusion.
- Primary feasibility endpoint:
- Inability to complete the procedure from the assigned access site
- Procedure duration
- Total radiation dose
- Total contrast volume
- Death, vascular complication, or unplanned revascularization at 30 days
Women undergoing cardiac catheterization were randomized to radial artery access (n = 893) versus femoral artery access (n = 894).
In the radial artery access group, patent hemostasis was recommended. In the femoral artery access group, vascular closure devices were allowed.
Two cohorts were prespecified: 1) Total cohort, includes diagnostic catheterization and percutaneous coronary intervention (PCI) procedures, and 2) PCI cohort only.
The study was terminated early due to a lower than expected event rate. Overall, 1,787 women were randomized. The median age was 63 years, 35% had diabetes, 18% had prior myocardial infarction (MI), median body mass index was 31 kg/m2, and 53% presented as a non-ST-segment elevation MI (NSTEMI).
In the PCI cohort, the use of bivalirudin was 59% in the radial artery group versus 66% in the femoral artery group. In the femoral artery group, the use of a vascular closure device was 66%. The primary efficacy outcome of bleeding or vascular complications occurred in 1.2% of the radial artery group versus 2.9% of the femoral group (p = 0.12). The primary feasibility outcome of access site failure (conversion to alternative site) occurred in 6.1% of the radial artery group versus 1.7% of the femoral group (p = 0.006).
- Procedure duration (minutes): 52 vs. 50 (p = 0.46), respectively, for radial vs. femoral access
- Total radiation dose (mGy): 1,604 vs. 1,472 (p = 0.26)
- Total contrast volume (ml): 153 vs. 166 (p = 0.03)
- Death, vascular complication, or unplanned revascularization at 30 days: 5.2% vs. 3.4% (p = 0.26)
In the total cohort (PCI + diagnostic catheterization), bleeding or vascular complications occurred in 0.6% of the radial artery group versus 1.7% of the placebo group (p = 0.03). Access site failure (conversion to alternative site) occurred in 6.7% of the radial artery group versus 1.9% of the placebo group (p < 0.001).
Among women undergoing elective or urgent cardiac catheterization, radial artery access is feasible. Radial artery access did not reduce bleeding complications among women undergoing PCI; however, radial artery access was associated with reduced bleeding among all randomized patients (PCI + diagnostic catheterization). There was more conversion to an alternative access site in the radial artery group (~6%). Radial artery access is an acceptable alternative to femoral artery access among women undergoing cardiac catheterization.
Rao SV, Hess CN, Barham B, et al. 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 Cardiovasc Interv 2014;7:857-67.
Presented by Dr. Sunil Rao at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 29, 2013.
Keywords: Myocardial Infarction, Body Mass Index, Radial Artery, Cardiac Catheterization, Femoral Artery, Peptide Fragments, Hemostasis, Hirudins, Diabetes Mellitus, Percutaneous Coronary Intervention
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