Randomized clinical trial on short-time compression with Kaolin-filled pad: a new strategy to avoid early bleeding and subacute radial artery occlusion after percutaneous coronary intervention.
BACKGROUND
Despite the increasing use of transradial techniques for cardiac percutaneous procedures, none of the strategies commonly utilized for hemostasis has been able to reduce the occurrence of radial artery occlusion (RAO). The aim of this study was to evaluate the occurrence of 24-hour RAO and the rate of bleeding of a novel hemostatic device for radial closure after percutaneous interventions, in adjunct to short-time compression.


METHODS
Once the radial access was obtained, patients were randomized to 3 different strategies of radial closure: a short compression with the QuikClot® Interventional™ pad (Z-Medica Corporation, Wallingford, CT, USA) (15 minutes, group 1), a short compression (15 minutes, group 2), and a conventional prolonged compression (2 hours, group 3) both without QuikClot® utilization.


RESULTS
Fifty patients in group 1, 20 in group 2, and 50 in group 3 were enrolled. The three groups were homogenous for baseline and procedural characteristics. None of patients in group 1 developed RAO, 1 (5%) occurred in group 2, and 5 (10%) in group 3 (P = 0.05). Active bleeding after compression removal occurred in 10 patients (20%) in group 1, 18 (90%) in group 2, and 1 (2%) in group 3 (P < 0.001). Among patients in group 1, at univariate analysis, the predictors of acute bleeding resulted in chronic therapy with clopidogrel (Odds Ratio 28.78, 95% Confidence Intervals 4.79-172.82, P < 0.001) and high levels of activated clotting time (ACT) at the time of sheath removal (OR 1.02, 95% CI 1.00-1.03, P = 0.009). At ROC analysis, the cutoff value of ACT for the risk of bleeding with a sensitivity of 80% and specificity of 75% was 287 seconds.


CONCLUSIONS
Early sheet removal and short-time compression with QuikClot® Interventional™ can reduce the rate of RAO after diagnostic or interventional procedures especially in patients not on double antiplatelet therapy.
Politi
Luigi
L
Interventional Cardiology, Policlinico Hospital, University of Modena and Reggio Emilia, Modena, Italy.
Aprile
Alessandro
A
Paganelli
Catia
C
Amato
Andrea
A
Zoccai
Giuseppe B
GB
Sgura
Fabio
F
Monopoli
Daniel
D
Rossi
Rosario
R
Modena
Maria G
MG
Sangiorgi
Giuseppe M
GM
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D000930:Antidiarrheals / Q000627:therapeutic use; D001157:Arterial Occlusive Diseases / Q000517:prevention & control*; D001780:Blood Coagulation Tests; D016001:Confidence Intervals; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D019934:International Normalized Ratio; D007616:Kaolin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011312:Pressure; D017534:Radial Artery / Q000293:injuries / Q000473:pathology*; D012307:Risk Factors; D012680:Sensitivity and Specificity; D013997:Time Factors; D014654:Vascular Patency
D000930:Antidiarrheals; D007616:Kaolin