OBJECTIVE: To test the non-inferiority in bleeding and/or hematoma after sheath removal with either three or six hours of restriction, and to compare back pain and satisfaction between these groups.
METHODS: The Randomized Controlled Trial (RCT) enrolled 378 patients who underwent PCI via femoral artery post procedure who were admitted at the cardiac care unit or at the intermediate cardiac care ward, between July 2012 and June 2014. After sheath removal, the experimental group (n=182) was restricted to complete bed rest for three hours, whereas six hours for the control group (n=196). Z-test for non-inferiority as a test for bleeding and/or hematoma of 90% CI and a p-value<0.05 was considered statistically significant. The primary outcome was bleeding and/or hematoma, the secondary outcomes were back pain and satisfaction.
RESULTS: There were no significant differences in bleeding and/or hematoma (p-value=0.429, 90%CI:-0.92-2.38). Mean potential of bleeding and/or hematoma was 0.54. Restriction for 3 hours can reduce back pain by relative risk reduction 92.1%, back pain scores 4 to10 were significantly different (p=0.001), in control group than experimental group (0.5%, n=1, 6.8%, n=13), respectively. Patient’s satisfaction levels 4 to 5 were significantly different (p=0.001), in experimental group than control group (58.1%, n=108, 35.9%, n=69), respectively.
CONCLUSION: Reduction of six hours to three of hours restriction after sheath removal in PCI patients does not increase risk of bleeding and/or hematoma and reduces back pain with more patient satisfaction. increase in heart and a chronic rise in splenic neutrophils and monocytes. Mechanistic studies show that eosinophil IL4 and the cationic protein mEar1 play a role in preventing H2O2 and hypoxia-induced cardiomyocyte death in mice and humans, as well as TGF-induced cardiac fibroblast Smad 2/3 activation and TNF-induced neutrophil adhesion on the heart endothelial cell monolayer. In vitro-cultured eosinophils from WT mice or recombinant mEar1 protein efficiently cure aggravated cardiac dysfunctions in eosinophil-deficient dblGATA mice, but not eosinophils from IL4-deficient animals. Eosinophils play a cardioprotective role in post-MI hearts, according to this study.
