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.

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 (TM) 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 (TM) can reduce the rate of RAO after diagnostic or interventional procedures especially in patients not on double antiplatelet therapy. (J Interven Cardiol 2011;24:65-72).