Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011

Abstract

Background— The impact of vascular closure devices (VCDs) via the femoral arterial access site on short-term mortality in patients undergoing percutaneous coronary intervention is currently unknown. Methods and Results— The association between femoral arterial vascular access site management (manual pressure [including external clamp] versus VCD) and 30-day mortality was examined in a national real-world registry of 271 845 patients undergoing percutaneous coronary intervention for elective, non–ST-segment–elevation myocardial infarction and ST-segment–elevation myocardial infarction indications in the United Kingdom between 2006 and 2011. Crude and propensity score–corrected analyses were performed using Cox regression, with additional analyses undertaken in clinically relevant subgroups; 40.1% (n=109 001) of subjects were treated with manual pressure and 59.9% (n=162 844) with VCD. Subjects treated with VCD had fewer comorbidities and were less likely to present with ST-segment–elevation myocardial infarction and cardiogenic shock ( P <0.001). Crude 30-day mortality was lower in the group treated with VCD compared with manual pressure (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.54–0.61; 1.4% versus 2.4%, log rank P <0.0001), findings that were substantially reduced but persisted after propensity score correction (HR, 0.91; 95% CI, 0.86–0.97; 1.8% versus 2.0% versus P <0.001). A more pronounced association of VCD with a reduction in 30-day mortality was evident in females (HR, 0.85; 95% CI, 0.77–0.94; P interaction =0.037), presentation with acute coronary syndrome (HR, 0.88; 95% CI, 0.83–0.94; P interaction =0.0027), or recent lysis (HR, 0.63; 95% CI, 0.40–1.01; P interaction =0.0001). Conclusions— When compared with manual pressure, VCD was associated with a minor short-term (30-day) prognostic benefit after propensity score correction in the global population and clinically relevant subgroups. The potential for residual confounding factors impacting on short-term mortality cannot be excluded, despite the study having measured and balanced all recorded confounder factors.