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Published on: May 26, 2023
Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices
Jose E Exaire1, Harold L Dauerman, Eric J Topol
1Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Insights
Closure devices (CDs) are safe for arteriotomy hemostasis in percutaneous coronary intervention patients on triple antiplatelet therapy. This study found no significant difference in bleeding events between CDs and manual compression.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Surgery
Background:
- The use of arteriotomy closure devices (CDs) for femoral artery access in percutaneous coronary intervention (PCI) is increasing.
- Limited safety data exists for these devices in patients on triple antiplatelet therapy.
Purpose of the Study:
- To evaluate the safety and efficacy of closure devices compared to manual compression for arteriotomy hemostasis in patients undergoing PCI on triple antiplatelet therapy.
Main Methods:
- A review of prospectively collected data from the TARGET trial.
- Patients received aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors.
- Closure devices or manual compression were used at physician's discretion for femoral artery access.
Main Results:
- Of 4736 patients with femoral access, 985 used a closure device.
- No significant differences were observed in major bleeding (0.4% vs 0.5%), minor bleeding (1.9% vs 3.1%), or transfusion rates (0.8% vs 1.0%) between manual compression and closure device groups.
- Patients receiving closure devices had a lower ischemic event rate.
Conclusions:
- Closure devices can be safely used for arteriotomy hemostasis in contemporary PCI.
- Appropriate patient selection is key for safe closure device utilization.
- Closure devices are safe despite aggressive polypharmacy for procedural anticoagulation.
Background:
The use of arteriotomy closure devices (CDs) to achieve hemostasis after femoral artery access in percutaneous coronary intervention is steadily increasing. However, the safety information with these devices in the era of triple antiplatelet therapy is limited.
Methods:
We reviewed prospectively collected data from the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes Trial (TARGET), where all patients received aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitor therapy. At the treating physician's discretion, manual compression (MC) or a vascular hemostasis device was selected following femoral angiography. Patients receiving MC were to have sheaths removed 2 to 6 hours postprocedure when the activated clotting time was < or = 175 seconds.
Results:
Of 4809 patients, 4736 had femoral access, and 985 of these had a CD (Perclose 47%, Angio-Seal 43%, VasoSeal 5%, and other 5%). The MC and CD groups were similar regarding most demographic characteristics, including age, systolic blood pressure, and weight, but those with MC were more often female, diabetic, and had history of peripheral vascular disease. Patients with a CD had a lower ischemic event rate suggesting they were a lower risk cohort overall. There were no differences in major bleeding at the access site (0.4% vs 0.5%, P =.588), minor bleeding at the access site (1.9% vs. 3.1%, P =.142) or transfusions (0.8% vs 1.0%, P =.513) between the MC and CD groups, respectively.
Conclusions:
In contemporary percutaneous coronary intervention practice, with appropriate patient selection, a CD can be safely utilized despite aggressive polypharmacy for procedural anticoagulation.
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