| Objective:This study was designed using randomized controlled trial, by comparing the revascularization, myocardial perfusion, platelet aggregation inhibition, ventricular systolic and diastolic function, bleeding complications and major adverse cardiac events (MACE) occurrence between delayed PCI combined with platelet glycoprotein IIb/IIIa blockade tirofiban and selective PCI therapies in acute myocardial infarction (AMI) patients, to explore the clinical effects and safety of the delayed PCI combined with tirofiban, so as to perform an earlier PCI for the AMI patients who missed the emergency time window, open the infarct-related artery (IRA) as soon as possible, restore the forward blood flow, reduce the infarction area,rescue the dying myocardia, protect cardiac function,and then, improve the prognosis.Methods: 80 patients with first AMI (59 males, 21 females, age: 53.34±6.75) were enrolled into study from Oct 2007 - Oct 2008. These patients had myocardial infarction within 24 hours to 7 days.And they had no hemodynamic obstacles and ischemia manifestations.All patients had similar features: persistent angina for more than 30 minutes, the cardiac enzyme peak was 3 folds of normal range, positive troponin and/or ECG showed ST segment elevation beyond 2 leads or new left bandle branch block. However, patients with bleeding diathesis, thrombocy- topenia,administration of thrombolytic agents within 24 hours,mechanical complications, major surgery or trauma (within 3 months), once stroke and known contraindi- cations of anticoagulation therapy were excluded. 80 cases were randomly allocated into two groups, the delayed PCI group (n=38, 27 males, 11 females, age: 53.26±7.02) and the control group (n=42, 32 males, 10 females, age: 52.76±5.76). In delayed PCI group, Tirofiban was administered as following, 10μg/kg over 3 minutes as a bolus, followed by 0.15μg/kg/min administration before CAG. The patients were then transferred to the catherlab at once and CAG was conducted. If the stenosis of IRA was higher than 70%,PCI was performed. In control group, the patients received routinely clopidogrel, aspirin and low molecular heparin. Then, 7-10 days after infarction, PCI was done to deal with infarct-related artery. Both groups were given standard treatment of anticoagulation, antiplatelet, lipid-lowering,and suppression of remodeling. The clinical information including age, gender, risk factors, angina before AMI, location of AMI, distribution of lesions, platelet aggregation rate, heart function, the hemorrhage events and MACE in hospital were collected. QCA was used to analyze the coronary artery situation (the artery stenosis larger than 70% was defined as positive), and TMP was used to analyze the lesion and reperfusion of the IRA. The patients information in-hospital and on the 90th day after PCI were compared, including left ventricular end-diastolic volume (LVEDV) , end-systolic volume (LVESV),left ventricular ejection fraction (LVEF) and major adverse cardiac events (MACE, including death, re-infarction, target vessel re-reconstruction). SAS 8.0 statistics software was used for data analysis. The numerical variables were presented as mean±SD, categorical data was presented as percentage with absolute numbers. Differences between group means were assessed with the t test. TheΧ2 analysis or the Fisher exact test was used to test differences between proportions. Statistical significance was set as P <0.05.Result:There were no significant differences in age, gender, risk factors, pre-angina, the location of the AMI, heart function between two groups. The delayed PCI group had a greater percentage of TIMI 1 flow of IRA than control group before PCI (44.74%, 17/38 vs 21.43%, 9/42,P<0.05); 3 cases had total occlusion, the ratio was significantly lower than control group (7.89%, 3/38 vs 28.57%, 12/42, P<0.05). No significant differences were found in TIMI 2 and TIMI 3 level comparison. The percentage of TIMI 0 flow of IRA after the guild wire first crossing was lower in delayed PCI group (5.26%, 2/38 vs 23.81%, 10/42, P<0.05), and there were no significant differences in TIMI 1-3 levels. The percentage of TIMI 3 flow in delayed PCI group after stenting was higher than control group (92.11%, 35/38, vs 71.43%, 30/42, P<0.05). The CTFC was fewer in the delayed PCI group (24.90±3.33 vs 31.52±2.12, P<0.05) after stenting. The percentage of TMP beyond 2 grade was higher in the delayed PCI group (76.32%, 29/38 vs 52.38%, 22/42, P<0.05). There was no significant difference in the left ventricular function LVEDVI,LVESVI,LVEF between two groups(82.16±14.84vs84.69±15.31,42±19.14 vs 43.48±21.49,52.87±14.6%vs 50.19±13.5%,P>0.05)。And there was no significant difference in LVEF after 3 months of PCI (59.79±12.4%vs56.5±11.9%,P>0.05)。The LVEDVI,LVESVI of both groups were lower than before,LVEF was higher in 3 months later。The platelet aggregation rate in the delayed PCI group was lower after tirofiban administration for 0.5, 2, 6, 12 and 48 hours. After 7 days, no significant difference was found in the platelet aggregation rate. There was no significant difference in hemorrhage events and MACE between two groups. But the delayed PCI group had more bleeding cases than control group with application of tirofiban. (7.89%, 3/38, vs2.38%, 1/42, P>0.05).Conclusions:1. There was no significant difference in effects and safety of AMI treamtment between delayed PCI combined with platelet glycoprotein IIb/IIIa blockade tirofiban tirofiban therapy and selective PCI。2. The delayed PCI combined with tirofiban therapy on AMI does not increase the incidence of MACE after PCI.3. Tirofiban may increase coronary blood flow, improve tissue-level perfusion and preserve the heart function.4.The delayed PCI combined with tirofiban may not increase obviously the hemorrhage events.
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