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Outcomes of Vascular Closure Device Use After Transfemoral Coronary Intervention: Insights From the EXCEL Trial
Toshiki Kuno, Bimmer E Claessen, Paul Guedeney
1Mount Sinai Medical Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY 10019 USA. gregg.stone@mountsinai.org.
Insights
Vascular closure devices (VCDs) are safe and effective for percutaneous coronary intervention (PCI) in left main coronary artery disease (LM-CAD). VCDs showed similar bleeding and major adverse cardiovascular events compared to manual compression.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Surgery
Background:
- Vascular closure devices (VCDs) offer rapid hemostasis after percutaneous coronary intervention (PCI) using transfemoral access (TFA).
- The safety and efficacy of VCDs in complex PCI procedures, such as those involving left main coronary artery disease (LM-CAD), remain a subject of ongoing discussion.
Purpose of the Study:
- To evaluate the safety and efficacy of VCDs in patients undergoing PCI for LM-CAD.
- To compare outcomes between patients treated with VCDs versus manual compression for LM-CAD PCI.
Main Methods:
- Analysis of data from the EXCEL trial, focusing on patients with LM-CAD who underwent PCI via TFA.
- Utilized propensity-score matching to compare outcomes between patients who received VCDs and those who did not.
- Primary endpoint: composite of death, myocardial infarction (MI), or stroke. Secondary endpoint: Bleeding Academic Research Consortium (BARC) type 2-5 bleeding at 30 days.
Main Results:
- Among 694 LM-CAD patients undergoing TFA-PCI, 61.0% received VCDs.
- No significant differences in 30-day BARC type 2-5 bleeding rates (5.0% vs 6.7%) or BARC type 3-5 bleeding rates (2.1% vs 3.7%) between VCD and no-VCD groups.
- Comparable rates of death, MI, or stroke at 30 days (4.7% vs 4.1%) and 5 years (20.3% vs 24.2%) between the groups, even after adjustment.
Conclusions:
- VCD use in LM-CAD PCI via TFA is associated with similar 30-day bleeding rates compared to manual compression.
- VCDs demonstrated comparable early and late major adverse cardiovascular events in this patient population.
- The findings support the safety and efficacy of VCDs for LM-CAD PCI with TFA.
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.
