A Comparative Study Of The Clinical Effects Of Two Different Thrombus Aspirators In Percutaneous Coronary Intervention

Objective:The aim of our study was to investigate the effectiveness,various operating performance and safety of Apt thrombus aspiration device and Export AP during percutaneous coronary intervention in patients with severe thrombus loading in acute coronary syndrome and to provide guidance for the interventional therapy of coronary artery.Methods:From July 2015 till September 2016,171 patients with ACS undergoing manual aspiration thrombectomy and PCI in the China–Japan union hospital of JILIN university were selected in our study.According to the type of thrombus aspiration devices,patients were divided into two groups,the apt thrombus aspiration device was used as a test group and the Export AP was used as a control group.Baseline data and PCI-related data were collected from two groups of patients to compared for baseline data.During PCI,evaluate the performance of the aspiration catheter in the treatment of thefirst target vessel,and record the immediate surgical results,the duration of the aspiration catheter,the investigator's evaluation of the use of the device,complications,and correlation with the aspiration catheter.Results:1.In terms of baseline analysis,Subjects in the test group and control group in age,gender,past medical history,Admission diagnosis,preoperative antiplatelet comparison,preoperative platelet count,preoperative coagulation parameters,preoperative risk score(GRACE,TIMI,Killip),thrombus aspiration catheter treatment of the first target vascular lesion,target vessel thrombosis type,target Thrombus burden,balloon preexpansion,stent placement,balloon dilatation,intraoperative heparin dosage,intraoperative contrast agent dosage and postoperative TIMI flow were not statistically significant.2.In terms of curative effect analysis,the immediate success rate of operation was not worse than that of the control group.The two groups were in aspiration catheter operation time,aspiration catheter X-ray fluoroscopy time and display effect,aspiration catheter operation performance(push performance,superiority and inferior performance of the body,performance of the head,withdrawal of the integrity of the body and the presence or absence of Adherent thrombus,stability of lesions delivered to lesions,damage to blood vessels,irritation of blood vessels at head end,friction with guide catheter,friction with guide wire,the smoothness of the withdrawal),the sealing performance at each link and the overall performance score of the aspiration catheter were no statistical difference.3.In terms of the safety analysis results,there were 27 adverse events in the test group including 7 serious adverse events and 33 adverse events in the control group including8 serious adverse events.There was no statistical difference in the total number of adverse events(including serious adverse events)and serious adverse events between the two groups.All adverse events were positively related to the test product.There was no statistical difference between the two groups in terms of adverse events(including serious adverse events),test products,interventional devices other than the tested products,surgical operations,and disease relatedness.Conclusion:In patients diagnosed with acute coronary syndromes and undergoing emergency PCI,the Apt thrombus aspiration device and Export AP were used for thrombus aspiration.This study shows that the Apt thrombus aspiration device is not inferior in terms of effectiveness,and there is no significant difference in safety and performance.The Apt thrombus aspiration device is suitable for percutaneous coronary intervention.