Outcomes of Vascular Closure Device Use After Transfemoral Coronary Intervention: Insights From the EXCEL Trial.

OBJECTIVES

To assess the safety and efficacy of using vascular closure devices (VCDs) in percutaneous coronary intervention (PCI) for left main coronary artery disease (LM-CAD).

BACKGROUND

VCDs provide rapid hemostasis for patients undergoing PCI with transfemoral access (TFA); however, the safety and efficacy of VCDs continues to be debated.

METHODS

We analyzed data from the EXCEL trial in patients with LM-CAD in whom PCI was performed via TFA with vs without VCD. The primary endpoint was a composite of death, myocardial infarction (MI), or stroke. Bleeding Academic Research Consortium (BARC) type 2-5 bleeding at 30 days was also assessed. Propensity-score matching analysis was used.

RESULTS

Among 694 patients with LM-CAD undergoing TFA-PCI, 423 (61.0%) received VCDs (collagen plug, 320 [75.7%]; suture mediated, 55 [13.0%]; others, 48 [11.3%]). Patients with and without VCD use had similar 30-day rates of BARC type 2-5 bleeding (5.0% vs 6.7%, respectively; P=.30) and BARC type 3-5 bleeding (2.1% vs 3.7%, respectively; P=.20). There were no significant differences in the rates of death, MI, or stroke in patients with and without VCD use at 30 days (4.7% vs 4.1%, respectively; P=.74) or at 5 years (20.3% vs 24.2%, respectively; P=.16). These results were similar after adjustment.

CONCLUSION

In the EXCEL trial, LM-CAD PCI via TFA using VCD was associated with similar 30-day rates of bleeding and comparable early and late major adverse cardiovascular events compared with manual compression.