Major Femoral Bleeding Complications After Percutaneous Coronary Intervention. Incidence, Predictors, and Impact on Long-Term Survival Among 17,901 Patients Treated at the Mayo Clinic From 1994 to 2005

Objectives: The purpose of this study was to evaluate secular trends and factors associated with major femoral bleeding after percutaneous coronary intervention (PCI) in routine clinical practice during the past decade and to assess the impact of these complications on outcomes including mortality. Background: Significant changes in patient demographic data, adjunctive pharmacotherapy, and access site management have occurred during the coronary stent era. Trends in major vascular complications after PCI during this time have not been well characterized. Methods: Consecutive patients who underwent transfemoral PCI from 1994 to 2005 at the Mayo Clinic (n = 17,901) were studied. Patients were divided into 3 groups: Group 1 (1994 to 1995, n = 2,441); Group 2 (1996 to 1999, n = 6,207); and Group 3 (2000 to 2005, n = 9,253). Results: The incidence of major femoral bleeding complications decreased (from 8.4% to 5.3% to 3.5%; p < 0.001). Reductions in sheath size, intensity and duration of anticoagulation with heparin, and procedure time were observed (p < 0.001), and multivariate analysis confirmed each as an independent predictor of complications (p < 0.001). Adverse outcomes of major femoral bleeding included prolonged hospital stay (mean 4.5 vs. 2.7 days; p < 0.0001) and increased requirement for blood transfusion (39% vs. 4.7%; p < 0.0001). Major femoral bleeding and blood transfusion were both associated with decreased long-term survival, driven by a significant increase in 30-day mortality (p < 0.001 for both). Conclusions: We noted a marked decline in the incidence of major femoral bleeding after PCI over the past decade. Mortality associated with these bleeding complications and with blood transfusion remains a significant issue.