Transfemoral approach with systematic use of FemoSeal™ closure device compared to transradial approach in primary angioplasty

Catheter Cardiovasc Interv. 2016 Apr;87(5):849-54. doi: 10.1002/ccd.26076. Epub 2015 Jun 23.


Objectives: To compare the incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombolysis in myocardial infarction (TIMI) bleedings in primary percutaneous coronary intervention (pPCI) performed through transradial approach (TRA) or transfemoral approach (TFA) with systematic closure by FemoSeal™.

Background: Although the risk of bleeding can be reduced using vascular closure devices (VCD), there are few data comparing TRA and TFA with VCD, particularly in the setting of pPCI.

Methods: we included in this retrospective registry 777 patients who underwent pPCI at two centers from years 2010 to 2013. Exclusion criteria were implantation of intra-aortic balloon pump and achievement of femoral hemostasis by other means than FemoSeal™. We performed propensity-score matching and multivariate analysis to adjust for clinical and procedural confounders.

Results: We enrolled 511 patients in TRA group and 266 in TFA group. Both in the general population and in the propensity-matched population, the incidence of MACCE was comparable in TRA vs. TFA patients (3.5 vs. 3.4% and 4.4 vs. 2.6%, respectively; P = ns). On the contrary, we observed a higher incidence of TIMI bleedings in TFA vs. TRA patients (5.6 vs. 2.2% in the general population and 6.6 vs. 1.3% in the propensity-matched population; P < 0.05); this difference was mainly driven by TIMI major bleedings. TFA was an independent predictor of bleeding at multivariate analysis.

Conclusions: In pPCI the rate of TIMI major bleedings was higher in TFA with closure by FemoSeal™ as compared to TRA, whereas the rates of minor bleedings and of MACCE were similar.

Keywords: acute myocardial infarction; bleeding; vascular access.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / methods*
  • Cerebrovascular Disorders / etiology
  • Cerebrovascular Disorders / prevention & control
  • Chi-Square Distribution
  • Equipment Design
  • Femoral Artery* / diagnostic imaging
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control*
  • Hemostatic Techniques / adverse effects
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Logistic Models
  • Multivariate Analysis
  • Myocardial Infarction / etiology
  • Myocardial Infarction / prevention & control
  • Odds Ratio
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Propensity Score
  • Punctures
  • Radial Artery* / diagnostic imaging
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Rome
  • Treatment Outcome
  • Vascular Closure Devices*