Abstract 16084: Bleeding and Vascular Complications at the Femoral Access Site Following Percutaneous Coronary Intervention (PCI): An Evaluation of Hemostasis Strategies
Background Previous research found at least one vascular closure device (VCD) to be associated with excess vascular complications, compared to manual compression (MC) controls, following cardiac catheterization. Since that time, several more vascular closure devices have been approved by the Food and Drug Administration (FDA). This research evaluates the safety profiles of current frequently used VCDs and other hemostasis strategies.
Methods The data used in this study were obtained from the NCDR® CathPCI Registry®. It included data from 1,819,611 PCI procedures performed using a femoral access site, from 2005 through the second quarter of 2009, at 1089 sites in the U.S. Assessed outcomes included bleeding, femoral artery occlusion, embolization, artery dissection, pseudoaneurysm, and A-V fistula. Seven types of hemostasis strategies were evaluated for rate of “any bleeding or vascular complication”, compared to MC controls, using multiple hierarchical logistic regression analysis, controlling for demographic factors, type of hemostasis, body mass index, several indices of comorbidity, use of intra-aortic balloon pump, use of anticoagulants during procedure and institutional PCI volume. Also, rates for different types of hemostasis strategies were plotted over time, using linear regression analysis.
Results Four of the VCDs demonstrated significantly lower “bleeding or vascular complication” rates than MC controls: Angio-Seal (OR = 0.68 [0.65-0.70]); Perclose (OR = 0.54 [0.51-0.57]); StarClose (OR = 0.77 [0.72-0.82]); and Boomerang Closure Wire (OR = 0.63 [0.53-0.75]). There were no statistically significant differences in complication rates exhibited between Mynx and MC. Use of patches exhibited a lower complication rate (OR = 0.70 [0.67-0.74]). Only mechanical compression demonstrated a significantly higher rate than MC (OR = 1.15 [1.10-1.20]). All types of hemostasis strategies, including MC, exhibited reduced complication rates over time, with regression coefficients ranging from -0.51 to -0.92. All trends were statistically significant except one.
Conclusions This large, nationally representative observational study demonstrated better safety profiles for most of the frequently used VCDs, compared to MC controls.
- © 2011 by American Heart Association, Inc.