The Study Of Different Antithrombotic Treatment At Different Times On Patients Implanted CIED After DES Implantation

Objectives:1. To investigate the safety and efficacy during perioperative period of cardiovascular implantable electronic devices( CIED) at different times with different antithrombotic treatments for patients with dual antiplatelet therapy(DAPT) after coronary drug-eluting stents( DES) implantation. 2. To evaluate the perioperative safety and efficiency of tirofiban for patients undergoing emergency operation of CIED after implantation of drug-eluting stent. 3. To explore the method of perioperative antiplatelet for patients with long-term aspirin therapy during perioperative period of CIED implantation. 4. The Logistic analysis was used to analyze the bleeding events during the implantation of CIED, and to explore the risk factors of bleeding. Methods: 1. 105 patients who implanted CIED with dual antiplatelet therapy(DAPT) after coronary stenting admitted to our hospital from January 2009 to January 2015 were enrolled in the study. According to the time of implanting CIED after coronary stenting, the patients were divided into 3 groups:Dual antiplatelet therapy(DAP)group: implanting CIED within 3 months after coronary stenting, continuous aspirin and clopidogrel therapy during perioperative period; Low molecular weight heparin(LMWH)bridging group: implanting CIED after coronary stenting 3 to 6 months, aspirin and clopidogrel interruption 5 days instead of subcutaneous injection of enoxaparin(1mg/kg) per 12 hours; Asprin alone group: implanting CIED after coronary stenting 6 months, clopidogrel interruption 5 days and asprin continuous. Oral DAPT was returned after surgery 12-24 hours according to the patients’ condition. MACE and bleeding complications were observed for up to 3months after operations. 2. A total of 22 patients who having taken(DAPT) drugs(clopidogrel and aspirin) within 6 month after DES and undergoing emergency implantation of CIED in our department were recruited in this study. Clopidogrel is discontinued 3-5 days before the operation and instead of tirofiban intravenous infusion of 0.4 ug/( kg.min) over 30 min, followed by 0.1 mg /(kg.min). The infusion was stopped 4 h before surgery; The tirofiban dose was reduced by 50% if creatinine clearance was <30 ml /min and the infusion was stopped 8 h before surgery. Clopidogrel was returned using a loading dose of 300 mg(four tablets) and then continued at a once daily dose of 75 mg after CIED implantation 12-24 hours according to the bleeding condition. Asprin was continued throughout the perioperative period. Close postoperative monitoring is performed, A 12-lead ECG was recorded every morning during the CCU stay and 6 h or more after any suspicious symptoms or ECG signs of ischeamia. Blood test for CK-MB were collected every day, In the case of an increase in CK-MB levels, further samples were collected at 6-8 h intervals until the values had normalized.During the period of tirofiban intravenous infusion,blood routine were checked every 6-8hours.Thrombotic and bleeding complications were studied for up to 3months after the bridged procedure. 3. 112 patients who implanted CIED with long-term aspirin therapy admitted to our hospital were enrolled in the study at the same period.The patients were divided into 3 groups : Group A: Continuous aspirin therapy during perioperative period; Group B: Aspirin interruption 3-5days before operation. Group C: Aspirin interruption 3-5days instead of subcutaneous injection of enoxaparin(1mg/kg) per 12 hours, asprin was returned after CIED implantation 12-24 hours. The incidences of the errhysis, pocket hemorrhage, pouch infection,the main adverse cardiovascular events( MACE) and hospitalizations were observed for up to 3months. Results: 1. There were no pouch infection and major adverse cardiac events during perioperative period of and 3months after CIED implantation. The incidence of pocket hemorrhage and errhysis in the bridging group was significantly higher than that of DAP group and asprin group(16.7%、8.0%、1.8% χ2=10.431,P=0.005 and 29.2%、 12.0%、7.1% χ2=6.321,P=0.042 respectively). There were 3 patients had severe bleeding. The hospitalization time of the bridging group was 11.5days slightly higher than the other two groups. Compared with asprin group, the incidence of hematoma of the DAP group was significantly higher(8.0% vs 1.8% P<0.05). The incidence of errhysis DAP group and asprin group was 12.0% vs 7.1% respectively(P>0.05), there were no serious bleeding events in the two groups, the incidence of hematoma and errhysis of asprin group was lowest. LMWH bridging therapy and DAPT significantly increased the incidence of bleeding after implantation of the device. Low body mass index, LVEF and elderly patients are independent risk factors of postoperative bleeding. 2. 19 cases were implanted DDD, 2cases were implanted VVI, one patient was implanted ICD. The average time of operation was 70.3min, the mean time for bridging with tirofiban was approximately 95.3hours.There were no MACE during perioperative period and 3months after procedure. 2 cases happened symptom of angina, 5(22.7%) cases occurred bleeding events, 1 pocket hematoma, 4cases errhysis, 1 patient occurred thrombocytopenia.the lowest value of platete was 8×10 9/L. we stopped tirofiban immedately and gave dexamethasone 10 mg intravenous, after the treatment the count of platete was recovered gradually and there was no sequelae. There were no serious bleeding events during peri-operative period. 3. The occurrence of errhysis of Group A,Group B and Group C were 5.6 percent, 7.1 percent and 23.5 percent respectively(F=6.258 P=0.044),The occurrence of hematomas of Group C was 17.6 percent,much higher than that of Group A(2.8 percent) and Group B(2.4 percent),(F=7.361 P=0.025); The hospitalizations of Group B and Group C were 10.5days,11.6days respectively and longer than that of Group A(7.5days), p<0.001. No major adverse cardiac event and pouch infections was obersved among 3 groups, Only 1 patient in Group C occurred subarachnoid hemorrhage, we stopped asprin and gave arterial embolization treatment, the patient recovered and there was no sequelae. Low body mass index and elderly patients are independent risk factors of postoperative bleeding. LMWH bridging therapy significantly increased the incidence of bleeding after implantation of CIED. Conclusion: 1. For the patients with DAPT, LMWH bridging therapy increases the incidence of the errhysis, pocket hematoma and serious bleeding events; The incidence of hematoma of the DAPT was higher than that of asprin group; The time of CIED implantation can be as long as 6 months later. 2. The use of tirofiban as bridging therapy undergoing emergency operation of CIED after implantation of drug-eluting stent seems safe and efficiency in our small study population. There was no incidence of MACE within 3 months after procedure. Although there were some cases occurred pocket hematoma and errhysis,there were no serious bleeding events during peri-operative period. 3. For the patients with long-time single aspirin treatment, continuous aspirin therapy does not increases the risk of hemorrhage. LMWH bridging therapy increases the incidence of pocket hemorrage and prolongs hospitalizations. 4. Low body mass index and elderly patients are independent risk factors of postoperative pocket hematoma and errhysis.