Closure device or manual compression in patients undergoing percutaneous coronary intervention: a randomized...

Area of Science:

• Cardiovascular Interventions
• Interventional Cardiology
• Vascular Access Management

Background:

• Vascular closure devices offer patient comfort but their clinical benefit in high-bleeding-risk patients undergoing PCI remains uncertain.
• Percutaneous coronary intervention (PCI) frequently requires arterial access, necessitating effective hemostasis methods.

Purpose of the Study:

• To compare the efficacy and safety of a vascular closure device versus manual compression in patients at moderate-to-high risk of bleeding undergoing PCI.
• To evaluate the primary endpoint of in-hospital bleeding complications and specific adverse events at the puncture site.

Main Methods:

• A randomized controlled trial involving 627 patients receiving triple antiplatelet therapy during PCI.
• Comparison between a closure device (Angio-Seal) and manual compression for achieving hemostasis.
• Primary endpoint: combined incidence of severe hematoma/groin bleeding or arteriovenous fistula/surgical intervention.

Main Results:

• No significant difference in the primary endpoint between the closure device (2.6%) and manual compression (4.5%) groups (p = 0.195).
• A significant reduction in the primary endpoint was observed in hypertensive patients randomized to the closure device (0.8% vs. 7.2%; p = 0.008).

Conclusions:

• The study did not demonstrate the superiority of closure devices over manual compression in this patient population.
• The observed benefit in hypertensive patients suggests a potential role for closure devices in specific subgroups, meriting further investigation.