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


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.


CONCLUSIONS
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.
Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands.
Renicus S
RS
Hermanides
Jan Paul
JP
Ottervanger
Jan-Henk E
JH
Dambrink
Menko Jan
MJ
de Boer
Jan C A
JC
Hoorntje
A T Marcel
AT
Gosselink
Harry
H
Suryapranata
Arnoud W J
AW
Van't Hof
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D001164:Arteriovenous Fistula / Q000453:epidemiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000187:drug effects / Q000502:physiology; D005260:Female; D005263:Femoral Artery / Q000187:drug effects / Q000502:physiology; D006406:Hematoma / Q000453:epidemiology / Q000517:prevention & control; D006470:Hemorrhage / Q000453:epidemiology / Q000517:prevention & control; D006488:Hemostasis, Surgical / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000494:pharmacology; D011312:Pressure; D011446:Prospective Studies; D012039:Regional Blood Flow / Q000187:drug effects / Q000502:physiology; D016896:Treatment Outcome; D058106:Wound Closure Techniques / Q000295:instrumentation*
D010975:Platelet Aggregation Inhibitors