Archivos de cardiología de México
Print version ISSN 1405-9940
RAMIREZ-GUTIERREZ, Álvaro Eduardo et al. Randomized, controlled trial, to assess the efficacy of two vascular compression techniques in reducing complications at vascular access sites after therapeutic or diagnostic catheterization. Arch. Cardiol. Méx. [online]. 2012, vol.82, n.2, pp.105-111. ISSN 1405-9940.
Objective: To compare the incidence of hemostatic failure and rate of vascular events during and after vascular compression using two different techniques. Methods: Patients were randomized to mechanical or manual compression after a therapeutic or diagnostic catheterization procedure. Results: One hundred patients were enrolled in the mechanical compression group (group one) and 112 patients in the manual compression group (group two). Failed hemostasis was observed in 48% of patients in group 1 and 19.7% in group two (p<0.001). A tendency towards a greater incidence for hematoma (>4cm) formation was found on ultrasound follow-up in group 1 (11.4% vs 4.6%, p=0.062). Logistic regression analysis found that the only independent factors for hemostatic failure were: use of mechanical compression device (OR 4.34, 95% CI 2.24-8.43, p<0.001) and age greater than 61 years (OR 2.44, 95% CI 1.3-4.7, p=0.008). A body mass index <26 was found to reduce the risk for hemostatic failure (OR 0.84, 95% CI 0.78-0.94, p=0.001). Conclusion: After introducer sheath removal, manual compression is superior to mechanically-assisted hemostasis in avoiding hemostatic failure at vascular access site. This study was not able, however, to show the superiority of either method to reduce the rate of vascular complications due to the small sample size of patients enrolled at the time of early study termination for safety reasons.
Keywords : Clinical trial; Introductor; Compressor; Manual compression; Mexico.