AIMS: Although closure devices may be comfortable for patients, the clinical benefits in patients with moderate-to-high risk of bleeding are not yet clear. We compared a closure device with manual compression in moderate- to high-risk bleeding patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: A randomized study was performed to compare a closure device (Angio-Seal, St. Jude Medical, Inc.) with manual compression in 627 patients treated withaspirin, clopidogrel, a glycoprotein IIb/IIIa inhibitor and heparin during PCI. The primary endpoint was the inhospital combined incidence of: 1) severe hematoma > 5 cm at the puncture site or groin bleeding resulting in prolonged hospital stay, transfusion and/or surgical intervention at the puncture site; 2) arteriovenous fistula formation and/or surgical intervention at the puncture site. A total of 313 patients (49.9%) were randomized to the closure device and 314 patients (50.1%) to manual compression. The combined primary endpoint was 2.6% in the closure device group compared to 4.5% in the manual compression group (p = 0.195). In the predefined subgroup of patients with a history of hypertension, however, the combined primary endpoint (0.8% vs. 7.2%; p = 0.008) was significantly reduced after use of the closure device. CONCLUSION: This trial did not show the superiority of using a closure device over manual compression in patients treated with triple antiplatelet therapy who underwent PCI. The fact that patients with a history of hypertension had a benefit from a closure device merits further investigation.
RCT Entities:
AIMS: Although closure devices may be comfortable for patients, the clinical benefits in patients with moderate-to-high risk of bleeding are not yet clear. We compared a closure device with manual compression in moderate- to high-risk bleedingpatients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: A randomized study was performed to compare a closure device (Angio-Seal, St. Jude Medical, Inc.) with manual compression in 627 patients treated with aspirin, clopidogrel, a glycoprotein IIb/IIIa inhibitor and heparin during PCI. The primary endpoint was the inhospital combined incidence of: 1) severe hematoma > 5 cm at the puncture site or groin bleeding resulting in prolonged hospital stay, transfusion and/or surgical intervention at the puncture site; 2) arteriovenous fistula formation and/or surgical intervention at the puncture site. A total of 313 patients (49.9%) were randomized to the closure device and 314 patients (50.1%) to manual compression. The combined primary endpoint was 2.6% in the closure device group compared to 4.5% in the manual compression group (p = 0.195). In the predefined subgroup of patients with a history of hypertension, however, the combined primary endpoint (0.8% vs. 7.2%; p = 0.008) was significantly reduced after use of the closure device. CONCLUSION: This trial did not show the superiority of using a closure device over manual compression in patients treated with triple antiplatelet therapy who underwent PCI. The fact that patients with a history of hypertension had a benefit from a closure device merits further investigation.
Authors: Michael J Thibert; Christopher B Fordyce; John A Cairns; Ricky D Turgeon; Martha Mackay; Terry Lee; Wendy Tocher; Joel Singer; Michele Perry-Arnesen; Graham C Wong Journal: CJC Open Date: 2021-02-16