British Study Analyzes Benefit of Femoral Vascular Closure Devices in 271,845 PCI Procedures

June 7, 2016—Findings from a propensity score-corrected analysis from the British Cardiovascular Intervention Society (BCIS) that evaluated the relationship between femoral vascular closure devices (VCDs) and short-term mortality were published online ahead of print by Vasim Farooq, MBChB, et al in Circulation: Cardiovascular Interventions. The study was conducted on behalf of the BCIS and the United Kingdom’s National Institute for Cardiovascular Outcomes Research.

The background of the study is that the impact of VCDs via the femoral arterial access site on short-term mortality in patients undergoing percutaneous coronary intervention (PCI) is currently unknown.

The investigators concluded that when compared with manual pressure, the use of VCDs 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 short-term mortality cannot be excluded, despite the study having measured and balanced all recorded confounding factors.

As summarized in Circulation: Cardiovascular Interventions, the investigators examined the association between femoral arterial vascular access site management (manual pressure [including external clamp] vs VCD) and 30-day mortality in a national real-world registry of 271,845 patients undergoing PCI for elective, ST-segment elevation myocardial infarction (STEMI) and non-STEMI 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 patients were treated with manual pressure and 59.9% (n = 162,844) were treated with a VCD. Patients treated with a VCD had fewer comorbidities and were less likely to present with STEMI and cardiogenic shock (P < .001). 

Crude 30-day mortality was lower in the group treated with a VCD compared with manual pressure (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.54–0.61; 1.4% vs 2.4%; log rank P < .0001), findings that were substantially reduced but persisted after propensity score correction (HR, 0.91; 95% CI, 0.86–0.97; 1.8% vs 2%; P < .001). 

A more pronounced association of VCDs with a reduction in 30-day mortality was evident in females (HR, 0.85; 95% CI, 0.77–0.94; P_interaction = .037), presentation with acute coronary syndrome (HR, 0.88; 95% CI, 0.83–0.94; P_interaction = .0027), or recent lysis (HR, 0.63; 95% CI, 0.40–1.01; P_interaction = .0001), reported the investigators in Circulation: Cardiovascular Interventions.