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.
Politi L, Aprile A, Paganelli C, Amato A, Zoccai GB, Sgura F, Monopoli D, Rossi R, Modena MG, Sangiorgi GM. Interventional Cardiology, Policlinico Hospital, University of Modena and Reggio Emilia, Modena, Italy.
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(R) 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(R) 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(R) Interventional can reduce the rate of RAO after diagnostic or interventional procedures especially in patients not on double antiplatelet therapy.
J Interv Cardiol. 2010 Aug 29. [Epub ahead of print]