| ObjectiveIn this randomized perspective parallel comparison study, in order to assess the efficacy of Tenecteplase(TNK-tPA) for thrombolysis therapy of acute ST-segment elevation myocardial infarction(ASTEMI), the infarction related coronary artery patency rate and myocardial tissue perfusion of infarction area assessed by coronary angiography(CAG) 90 minutes and indirect indexes of coronary artery recanalization after infusion of TNK-tPA or recombinant tissue-type tissue plasminogen activator(r-tPA). Acute complications and adverse events after administration of the two medicines were observed for evaluating the safety of TNK-tPA for ASTEMI thrombolysis and providing evidence for its clinic use.MethodsFrom May, 2005 to February, 2007, 33 patients from our hospital who had diagnosed ASTEMI according to the ACC/AHA criteria without thrombolysis contraindication were randomized to TNK-tPA group and r-tPA group(TNK-tPA group 17 patients, r-tPA group 16 patients). Inclusion criterias;(1)18-70years old, male or female;(2)persistent angina for more than 30 minutes;(3)symptom onset within 12 hours;(4)greater or equal to 0.1 mv ST-segment elevation in two or more limb leads or greater or equal to 0.2 mv ST-segment elevation in two or more contiguous precordial leads. Exclusion criterias:(1)age>70 years old;(2)history of hemorrhagic apoplexy or ischemic stroke within 12 months;(3)major surgery,significant trauma on head or other positions;(4)definite ulceration history, gastro intestinal tract genitourinary system hemorrhage within 4 weeks;(5)active bleeding or definite hemorrhagic disease constitution;(6)uncontrolled hypertension(i.e., systolic pressure greater or equal to 180 mmHg and/or diastolic pressure greater or equal to 110mmHg);(7)cardiac shock,long time resuscitation(>10 minutes) or trauma;(8)reinfarction at the same area.After assignment to TNK-tPA group, 20mg TNK-tPA was administrated within 5-10 seconds. while in r-tPA group, r-tPA was administrated by accelerate program(total 50mg). First 8mg i.v. uniformitly, then 42mgⅣdrop persistently over a 90 min period.300mg aspirin and clopidogrel oral or chewable before thrombolysis,followed by a daily dose of 300mg aspirin and 75mg clopidogrel after discharge a daily oral dose of 100-300mg aspirin. Heparin must be used to all the patients. A 70U/kg heparin bolus was given before TNK-tPA or r-tPA was infusing for anti-coagulation treatment(total dose≤5000IU) 1000IU/h heparin wasⅣdrop after thrombolysis within 15 min,(total 24 hours),adjusted the dose of heparin by APTT,then changed to LMWH(low molecule weight heparin) subcurtaneous injection twice a day.CAG were performed at 90 min to confirm infarction location, IRA and the extent of stenosis.IRA flow was evaluated by TIMI grades,myocardial tissue reperfusion was evaluated by TMP(TIMI myocardial perfusion) grades.To the patients without CAG,colledted the indirect indexes of patency rate:(1)ST-segment of ECG depressed≥50% within 2 hours after thrombolysis in any 30 min period.(2)chest pain relieved within 2 hours after thrombolysis.(3)temporal accelerated idioventricular rhythm, A-V block or bundle branch block defluxion, articulo sinus bradycardia,S-A or A-V block or hypotension condition in patients with inferoposterior infarct within 2 hours.(4)pesk value of CK and CK-MB aheaded, within 14 hours. Having more than 2 items can be considered recanalization,except(2)plus(3).Acute complications and adverse events were recored during 30 days after thrombolysis.All data was analyzed with SPSS12.0 statistic software.Statistical significance was determined by P value<0.05.ResultsThere was no significant difference about age,sex,CHD risk factors,angina before infarction,infarction lacation,Kllip grade and the mean interval from onset to thrombolysis beween the two groups.Except 1 patient of TNK-tPA group died at 40 min due to cardiac rupture,the other 10 patients in TNK-tPA group were performed CAG 90 min after thrombolysis,TIMI 2 flow(6 patients), TIMI 3 flow(2 patients).7 patients didn't receive CAG(4 patients recanalized,3 patients not evaluated by the indirect indexes).There were 12 patients recanalization in this group(70.59%).11 patients in r-tPA group were performed CAG 90 min after thrombolysis,TIMI 2 flow(1 patiens),TIMI 3 flow(4 patients).5 patients didn't performed CAG(4 patients recanalized,1 patients not evaluated by the indirect indexes).There were 9 patients recanalization in this group(56.25%).There was no difference in IRA distribution between the two groups,the IRA repatency rate(70.59% vs 56.25%χ~2=0.24,P=0.62). The acute complications during 30-day period after thrombolysis include serious arrhythmias(include reperfusion arrhythmia)(29.41% vs25%χ~2=0.00,P=1.00),heart failure KillipⅢor KillipⅣ(29.41%vs25%,χ~2=0.00,P=1.00),IRA reoccluded(5.88% vs 0,P=1.00) and death(5.88% vs 0,P=1.00),have no significant difference between the two groups.The bleeding complication of TNK-tPA group were slightly less(5.88% vs 25.00%χ~2=1.09,P=0.30),but this difference was not statistically significant.(one patient ulemorrhagia in TNK-tPA group;one patient,one patient left forearm congestion, one patient ulemorrhagia,one patient blood urine from micro. in r-tPA group,but they all took a favorable turn without blood transfusion.there was no intracranial hemorrhage in the two groups)Conclutions1,20mg TNK-tPA proved to be as effective as 50mg r-tPA for ASTEMI in the infarction relately coronary artery patency rate. 2,The safety of TNK-tPA thrombolysis therapy is at about the same level of that of r-tPA,not associate with exessess mortality and complications of arrhythmia,heart failure and hemorrhage.3,TNK-tPA is a thrombolytic medicine which was used easily and didn't need continous infusion. |
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