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Coronary disease is one of the highest mortality diseases in the world,and interventional therapy has been the best treatment choice for its low risks,high efficiency,less wound and rapid recovery after the operation.Thrombus aspiration catheter is one of the most important equipment in the interventional therapy instrument of coronary disease.This paper is based on the demand of clinical and market,designed and manufactured aspirated catheter for the treatment of coronary thrombosis.Through the performance comparison of the material,confirmed the main material quality of thrombus aspiration catheter and its organization.We also made the appraisement for the function of the material and the main performance of the thrombus aspiration catheter.The experiment turned out that our catheter performance is stable and also with highly reliable,which is absolutely fit for the using requirements of the clinical.

Objective: To investigate the effect of thrombus aspiration during primary percutaneous coronary intervention (PPCI) in patients with ST-segment elevation myocardial infarction (STEMI). Methods: This retrospective study included 321 STEMI patients who underwent PPCI at Beijing Chaoyang hospital from January 2013 to March 2014. Patients were divided into the PPCI group (189 cases) and the PPCI plus thrombus aspiration group (132 cases). Baseline and perioperative clinical data, procedural characteristics were collected, and primary endpoint events including all-cause death, re-myocardial infarction, and coronary revascularization and secondary endpoint events including cardiac death, recurrent angina, target lesion revascularization, and stent thrombosis were recorded during the follow-up. Results: There were no significant difference between PPCI group and PPCI plus aspiration group in age ((59.8±12.5) years old vs. (58.3±14.4) years old, P= 0.060) and male ratio (82.5% (156/189) vs. 82.6% (109/132), P= 0.993). The number of disease vessels (1.59±0.81 vs. 1.47±0.70, P= 0.039) and the prevalence of left anterior descending as infarction related artery (52.3% (69/132) vs. 38.6% (73/189), P= 0.022) were significantly higher in the PPCI plus aspiration group than that in the PPCI group.The symptom onset time (3.0 (2.0,4.8) hours vs. 4.0 (2.0,7.0) hours, P= 0.027) and myocardial ischemia time (3.9 (2.7,6.2) hours vs. 4.7 (2.9,7.9) hours, P= 0.022) were significantly in the PPCI plus aspiration group than in the PPCI group. The percent of thrombolysis in myocardial infarction (TIMI) thrombosis score≥ grade 4 (92.4% (122/132) vs. 75.1% (142/189), P< 0.001)and postoperative TIMI flow grade 3 (70.5% (93/132) vs. 60.8% (115/189), P= 0.003) was significantly higher in the PPCI plus aspiration group than in the PPCI group. The PPCI group patients were followed up for (31.6±7.5) months, and PPCI plus aspiration group patients were followed up for (32.2±6.7) months ( P= 0.466). During the follow-up period, there was no significant difference in the incidence of primary endpoint events between the PPCI plus aspiration group and the PPCI group (17.1% (22/129) vs. 16.9% (31/184), P= 0.962). Recurrent angina was more frequent in the PPCI plus aspiration group than in the PPCI group (25.6% (33/129) vs. 16.3% (30/184), P= 0.044). There was no significant difference in cardiac death (3.1% (4/129) vs. 3.3% (6/184), P= 1.000), target lesion revascularization (3.9% (5/129) vs. 3.3% (6/184), P= 0.765), and stent thrombosis (3.1% (4/129) vs. 2.7% (5/184), P= 1.000) between the PPCI plus aspiration group and the PPCI group. Multivariate Cox regression analysis showed that the number of diseased vessels ( RR= 1.901, 95 %CI 1.217-2.970, P= 0.005) and postoperative TIMI flow grade ( RR= 0.455, 95 %CI 0.221-0.934, P= 0.032) were the risk factors for coronary revascularization after PPCI. The number of diseased vessels was a risk factor for major endpoint events after PPCI ( RR= 1.421, 95 %CI 1.017-1.986, P= 0.040). Conclusion: The incidence of clinical events is similar in patients with STEMI treated with PPCI alone or PPCI plus aspiration.

Objective: To explore the impact of intracoronary bolus administration of tirofiban combined with nitroprusside through thrombus aspiration catheter or thrombus aspiration alone on myocardial reperfusion and major adverse cardiovascular events rate in acute anterior myocardial infarction patients with heavy thrombosis burden., Methods: Ninety consecutive acute anterior myocardial infarction patients with heavy thrombosis burden [(59.8 ± 11.5) years old] were randomly assigned to thrombus aspiration group (Group A, n = 30), thrombus aspiration and intracoronary tirofiban bolus (25 µg/kg prior to the first balloon inflation,Group B, n = 30), thrombus aspiration and intracoronary tirofiban combined with nitroprusside bolus (200 µg prior to the first balloon inflation, Group C, n = 30) with random number table. Baseline clinical data, angiographic features before and after percutaneous coronary intervention (PCI) and major adverse cardiovascular events after PCI between 3 groups were compared., Results: The baseline clinical data and angiographic features among 3 groups were similar (all P > 0.05) . The time of pain to balloon was (5.5 ± 3.8) hours. After primary PCI, myocardial tissue perfusion was significantly better in Group C than in Group A and Group B: TMP grade < 3 [10.0% (3/30) vs. 40.0% (12/30) and 33.3% (10/30), P < 0.01 and P < 0.05]. Left ventricular ejection fraction at 5 to 7 days after PCI also tended higher in Group C than in the other 2 groups (P = 0.05). One patient died of heart failure at 7th day after PCI in Group A, and no patient died in Group B and C. Thirty days after PCI, there was no re-myocardial infarction and target vessel revascularization event among 3 groups. The bleeding complication rate during 30 days follow-up was similar among 3 groups (P > 0.05) ., Conclusion: Intracoronary bolus application of tirofiban combined with nitroprusside through thrombus aspiration catheter after thrombus aspiration is associated with an improvement of myocardial reperfusion without increasing bleeding complication and other adverse cardiovascular events rate compared with thrombus aspiration alone in patients with acute anterior myocardial infarction and heavy thrombosis burden undergoing primary PCI.

Objective: To investigate whether thrombus aspiration plus intra-infarct-related artery bolus administration of tirofiban via the aspiration catheter is superior to thrombus aspiration alone in improving myocardial perfusion in patients with ST-elevation myocardial infarction (STEMI) undergoing primary angioplasty., Methods: In this single center retrospective study, 108 patients with STEMI who underwent angioplasty after thrombus aspiration plus intra-infarction related artery 500 µg tirofiban administration, with subsequent 12-hour intravenous infusion of 0.1 µg×kg(-1)×min(-1) after angioplasty (thrombus aspiration + tirofiban group) and 108 matched control patients with STEMI who underwent angioplasty after thrombus aspiration (thrombus aspiration group). The primary end points included thrombolysis in myocardial infarction (TIMI) flow immediately after angioplasty, complete ST-segment elevation resolution (> 70%) at 90 minutes after angioplasty and the peak of creatine kinase-MB (CK-MB) and troponin I (TnI). The secondary end points were the left ventricular ejection fraction (LVEF) in the hospital and at 9 months follow-up as well as major adverse cardiac events (MACE: cardiac death, target vessel revascularization, re-infarction) at 9 months and any bleeding events., Results: Baseline characteristics of the two groups were well-balanced. The TIMI 3 flow rate (97.22% vs. 87.04%, P = 0.011) and the complete ST-segment resolution rate (66.67% vs. 50.91%, χ(2) = 6.129, P = 0.047)were significantly higher in the thrombus aspiration + tirofiban group than in the thrombus aspiration group. The peak of CK-MB (83.9 U/L vs. 126.1 U/L, P = 0.034) and TnI (42.7 ng/ml vs. 72.5 ng/ml, P = 0.029) were significantly lower in the thrombus aspiration + tirofiban group than in the thrombus aspiration group. LVEF in the hospital favored thrombus aspiration + tirofiban the group (45.7% ± 10.8%, 42.9% ± 9.9%, t = 1.99, P = 0.049). There was a tendency to decreased MACE rate at 9-month follow-up, which favored thrombus aspiration + tirofiban the group (logrank χ(2) = 2.865, P = 0.09). Bleeding events were similar between the two groups., Conclusion: Thrombus aspiration plus intra-infarct-related artery bolus administration of tirofiban in patients with STEMI undergoing primary angioplasty may improve myocardium perfusion, attenuate myocardial ischemia and result in a better clinical prognosis compared to thrombus aspiration alone.

Objective: To retrospectively evaluate the efficacy of stent-delayed implantation in patients with acute myocardial infarction (AMI) with high thrombus burden after thrombus extraction was performed., Methods: Of 186 consecutive AMI patients, 56 were included according to thrombus score(TS)>or=2, and then were divided into 2 groups based on the thrombus score after thrombus extraction was executed: the stent-direct implantation group (TS=0 or 1)and the stent-delayed implantation group (TS>or=2) even if 3 times thrombus extraction were given. Thrombolysis in myocardial infarction(TIMI)flow grade and TIMI myocardial perfusion (TMP) were used to assess the coronary artery flow and myocardial perfusion,respectively., Results: TIMI score in the stent-direct implantation group was lower than that in the stent-delayed implantation group. There was no significant difference(P=0.07). TMP score in the stent-direct implantation group was significantly lower than that in the stent-delayed implantation group (P<0.05)., Conclusion: Stent-delayed implantation can remarkably improve myocardial perfusion in AMI patients with high thrombus burden after thrombus extraction and intensive anti-thrombosis therapy is administrated.

Objective: To evaluate the effect of aspiration of coronary thrombus upon the outcome of in-hospital primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) patients., Methods: A total of 202 AMI patients undergoing primary PCI and receiving aspiration thrombectomy catheter during from December 2007 to November 2008 were enrolled into the study group. And 148 receiving only routine PCI but with similar coronary angiography and basic characteristics were enrolled into the control group. The immediate and in-hospital outcomes were compared between two groups., Results: There were no significant baseline differences between two groups. Compared with the control group, no-reflow/slow flow (3.5% vs 8.8%, P = 0.038), acute and subacute stent thrombosis (0.5% vs 4.7%, P = 0.011), heart failure (11.4% vs 19.6%, P = 0.035), re-infarction (1.0% vs 6.1%, P = 0.010), in-hospital mortality (3.5% vs 8.8%, P = 0.038), peak level of serum CK-MB (152.0 U/L +/- 73.6 U/L vs 171.0 U/L +/- 71.2 U/L, P = 0.015) and TnI (44.7 microg/L +/- 31.2 microg/L vs 51.9 microg/L +/- 33.6 microg/L, P = 0.041) decreased in the study group. However, stent was directly implanted (44.1% vs 24.3%, P = 0.002), TIMI flow grade 3 was obtained (90.1% vs 81.8%, P = 0.027) and faster ST segment resolution (67.8% vs 53.4%, P = 0.008) improved in the study group., Conclusion: Application of thrombus aspiration in patients with acute myocardial infarction is effective to decrease no-reflow/slow flow and achieve a better clinical prognosis during hospitalization.

Vulnerable plaque rupture is the main cause of acute coronary syndrome (ACS), a representative cardiovascular thrombotic disease. Considering that the Western medical pathogenetic recognition on vulnerable plaque inflammatory reaction and thrombus formation is similar to the etiopathogenesis and clinical characteristics of toxin and stasis as well as the clinical manifestation of toxic-stasis in TCM, the authors believe that it is necessary to expand the previous TCM thinking on taking blood stasis as the main etiopathogenesis for ACS to that ACS is caused by the toxic-stasis induced vulnerable plaque rupture. Therefore to make sense, depending evidence-based medical principle, the relationship between toxic-stasis and vulnerable plaque forming and rupturing, and to form the clinical norm for diagnosis and treatment of toxic-stasis should be helpful for the prevention and control of ACS.

Objective: To determine risk factors and evaluate the efficacy of emergent PCI for acute or subacute coronary in-stent thrombosis., Methods: Baseline and follow-up data of 6977 patients who underwent stent implantation in our institution between January 2000 and May 2006 were analyzed., Results: Of 6977 patients, acute or subacute coronary in-stent thrombosis was confirmed in 52 (0.75%) patients by coronary angiogram. The in-stent thrombosis occurred between 30 minutes to 20 days post PCI (mean 3.6 +/- 4.2 days). Predictive factors for in-stent thrombosis showed by multivariate analysis were AMI, B2/C type lesions, multi-vessel diseases, heart failure and target lesions on left anterior descending artery (LAD). Among these 52 patients, 43 presented recurrent chest pain or ST elevation AMI, 6 suffered from cardiac arrests, 1 manifested hypotension and 2 showed no typical clinical symptoms and were diagnosed during scheduled PCI for other diseased vessels. Emergent coronary angiogram evidenced total thrombotic occlusion in 48 patients and 70% - 95% thrombotic stenosis in 4 patients. All 52 patients were treated with emergent PCI. Forty-seven patients survived and 5 patients died (mortality 9.6%)., Conclusion: The risk of developing in-stent thrombosis was higher in patients with AMI, B2/C type lesions, multi-vessel diseases, heart failure and target lesions on LAD. Emergent PCI is the most effective method for treating in-stent thrombosis and should be carried out as early as possible in order to improve outcomes of this severe complication post stenting.