Possible Effects Of Plasma Troponin I, Creatine Kinase MB And Myoglobin Using Fragmin And Unfractionated Heparin In Elective Percutaneous Coronary Intervention

Objective: Coronary heart disease (CHD) is one of the usual diseases disturbing wrinkly and elderly people, and recognized as the first killer. Recently, in the treatment of Percutaneous Coronary Intervention (PCI), as a popular treatment to CHD, anticoagulation is a very important step. Generally, Unfractionated Heparin (UFH) is used as the first choice of anticoagulation. However, the sensitiveness and metabolism of UFH differ with different patients. Entering into the blood, UFH integrates with kinds of Plasma protein, making itself less active in anticoagulatory activity; at the same time, UFH may integrate with endothelial cells and macrophage, making it even harder for us to test its pharmacodynamics and pharmacokinetics. Low Molecular Weight Heparin (LMWH) is now used as a substitution of UFH in the treatment of anticoagulation. Few LMWH integrates with macrophage and endothelial cell, and it seldom fuses with plasma protein, making itself surviving the attack of platelet factor 4. All these advantages make LMWH the first choice in the treatment of anticoagulation instead of UFH. Many prospective, controlled clinical trials have investigated the use of LMWH vs. UFH in the treatment of PCI. PCI treatment might cause the by-effect of elevation of cTnI and CK-MB in certain patients, therefore, anticoagulant is presenting to the patients in order to alleviate the damage caused by PCI operation.The research focuses on influence of LMWH vs. UFH on the elevation of cTnI, CK-MB and MYO in the treatment of PCI, probing into the possibility and stability of large scale use of LMWH instead of UFH in the treatment of PCI.Methods: From May 2006 to November 2007, 106 patients with CHD who were planned to undergo elective PCI were enrolled into this study. The 106 patients were randomized to UFH group (54 cases) and LMWH group (52 cases); the age of the subjects is between 37-77, with an average age of 56.29±9.92. Before the treatment of PCI, all the subjects take a regular use of Aspirin 75-150mg once a day, Clopidogrel 75 mg once a day, a regular use of 5000 IU Dalteparin subcutaneously once every 12 hours. Subcutaneous Fragmin (5000 IU,q12 h) given to both groups last at least 3 days until 12 hours before PCI. In the UFH group, patients were given UFH 5000 IU firstly before selective coronary angiography, additional 5000 IU was given before PCI procedure. In the LMWH group, patients received dalteparin 10000 IU before PCI. For patients with a transradial approach, the sheath was withdrawn immediately after PCI; for patients with a transfemoral approach, the sheath was withdrawn about 4 hours after the procedure. Blood samples were collected respectively before the treatment and 20 hours after PCI for the test of the changes of cTnI, CK-MB and MYO of the subjects.Statistical analysis, because this was a pilot study, it was not adequately powered to detect statistical significance in clinical end points. However, we estimated a priori that randomization of 106 patients overall would provide feasibility data for design of larger studies. All data are expressed as mean value±SD or frequency (%), unless otherwise stated. Analyses of outcome variables (individual or composite) were performed on an intention-to-treat basis using 2-tailed independent t test for continuous variables and either theχ2 test or Fisher exact test for noncontinuous variables.Results: Before the PCI, cTnI were normal in UFH group and LMWH group (<1.00 ng/ml). The incidence of total cTnI≥1.00 ng/ml was 37.03% in the UFH group and 30.77% in the LMWH group after PCI. There were no significant difference between the two groups (P=0.634). The incidence of total cTnI≥3.00 ng/ml was 11.11% in the UFH group and 7.69% in the LMWH group. There were no significant difference between the two groups (P=0.787).Before the PCI, CK-MB were normal in UFH group and LMWH group (<5.00ng/ml). The incidence of total CK-MB≥5.00 ng/ml was 57.40% in the UFH group and 44.23% in the LMWH group after PCI. There were no significant difference between the two groups (P=0.245). The incidence of total cTnI≥15.00 ng/ml was 22.22% in the UFH group and 11.54% in the LMWH group. There were no significant difference between the two groups (P=0.228).Before the PCI, MYO were normal in UFH group and LMWH group (<70.00 ng/ml). The incidence of total MYO≥70.00 ng/ml was 1.85% in the UFH group and 3.84% in the LMWH group after PCI. There were no significant difference between the two groups (P=0.228).With the UFH group, after the subcutaneous 10000 IU was finished, blood test of the plasma anti-Xa level was conducted respectively at 10min, 20min, and 1huor, with the result listed correspondingly as 0.32±0.14 IU/ml, 0.74±0.15IU/ml and 0.82±0.12IU/mlWith the LMWH group, after the subcutaneous 10000 IU was finished, blood test of the plasma anti-Xa level was conducted respectively at 10min, 20min, and 1huor, with the result listed correspondingly as 0.28±0.12 IU/ml,0.67±0.15 IU/ml and 0.72±0.12 IU/ml.Conclusions: In this pilot, randomized comparison of Fragmin with UFH in patients undergoing elective PCI is at least as safe and efficacious as UFH; these data form the basis for further evaluation of Fragmin in a larger number of patients in this setting.