Streptokinase-induced hypotension has no detrimental effect on patients with thrombolytic treatment for acute myocardial infarction. A substudy of the Romanian Study for Accelerated Streptokinase in Acute Myocardial Infarction (ASK-ROMANIA).

UNLABELLED: The Streptokinase (SK) regimen (1.5 MU/60 minutes) has remained unchanged for the past 20 years in patients with ST-segment elevation acute myocardial infarction (STEMI) due to fear of hypotension (a specific effect of this thrombolytic agent) and of hemorrhagic complications. OBJECTIVE: To evaluate the influence of the Streptokinase-induced hypotension (SK-hTA) on the rate of coronary reperfusion (CR), incidence of cardiogenic shock (CS), 30-day mortality and incidence of stroke in patients (pts.) with STEMI. The SK-hTA was defined as decrease of the systolic blood pressure with at least 20% within the first 20 min. after the start of the SK infusion. METHODS: A group of 837 pts. (age 20-90) with thrombolytic treatment, with three "accelerated" SK regimens within the first 6 hours after the onset of STEMI and enrolled in the Romanian open, prospective, non-randomised study for accelerated SK in STEMI (ASK-ROMANIA) have been included. The SK regimens consisted in infusing of the standard dose of 1.5 M.U. either in 30 min. (regimen SK1.5/30, 173 pts).) or in 20 min. (regimen SK1.5/20, 377 pts.) or of the half dose (0.75 M.U.) in 10 min. followed by a new infusion of 0.75 M.U. after 50 min. only if no bed-side signs of CR have been recorded (regimen SK 0.75/10, 287 pts.). The speed of the SK infusion was maintained in all pts. experiencing SK-hTA. All pts. received aspirin and heparin or enoxaparin if not contraindicated. Three noninvasive CR criteria have been used: 1. Rapid cessation of the chest pain. 2. Rapid decrease of the ST segment elevation by more than 50% of the initial value. 3. Rapid increase of the CK and CK-MB with a peak within the first 12 hrs. RESULTS: SK-hTA appeared in 372 pts. (44.55%) at 9+/-5 min after the start of the SK infusion. In this subgroup the rate of CR was 74.46%, non-significantly higher than the one of 68.81% registered in pts. without SK-hTA (p=0.071). SK-hTA disappeared in all patients after 16+/-6 minutes without a specific therapy. Fourteen pts. with SK-hTA (3.76%) and 16 pts. without SK-hTA (3.44%) developed CS after thrombolysis ( non-significant difference). The global in-hospital mortality was 10.21% in pts. with SK-hTA and 9.89% in pts. without this side effect (non-significant difference). The incidences of hemorrhagic and ischemic strokes were 0.26% (1 patient) respectively 0.52% (2 pts.) in the SK-hTA subgroup and 0.43% (2 pts.) respectively 0.64% (3 pts.) in the subgroup without SK-hTA. CONCLUSIONS: 1. Despite a very high incidence (44.55%) the SK-hTA has not a detrimental effect in pts. treated with accelerated SK regimens for STEMI. 2. Streptokinase can be rapidly administered without an increased risk.

Double bolus of 0.75 MU streptokinase plus enoxaparin versus front-loaded alteplase plus unfractionated heparin in ST-segment elevation myocardial infarction.

OBJECTIVE: To compare the efficacy and safety of an accelerated streptokinase regimen (double bolus of 0.75 MU in 10 min) in combination with enoxaparin (SK0.75Enox regimen) with the one of the front loaded alteplase (t-PA 100 mg/90 min) plus heparin (the t-PAHep regimen) in patients (pts.) with ST-segment elevation acute myocardial infarction (STAMI). METHODS: One hundred seventy three pts. (age 18-74) treated within the first 6 hrs. after the onset of STAMI with the above two mentioned thrombolytic regimens were included. 1. The group SK0.75Enox (102 pts.) received an i.v. bolus of 40 mg Enox followed by 0.75 MU SK in 10 min. A second bolus of 0.75 MU SK would be administrated only if no bed-side signs of coronary reperfusion (CR) were detected within the next 50 min. After thrombolysis Enox was administered 1 mg/kg bodyweight every 12 hrs. for 5-7 days. 2. The group t-PAHep (71 pts.) received 15 mg oft-PA in bolus followed by 50 mg in 30 min and 35 mg within the next 60 min; t-PA was followed by heparin 1000 u/hour for the next 48-72 hours. All the patients received aspirin. Three noninvasive CR criteria were used: 1. Rapid cesation of the chest pain. 2. Rapid decrease of the ST segment elevation by more than 50% from the initial value. 3. Rapid increase of the CK and CK-MB with a peak within the first 12 hrs. RESULTS: Two patients (2.85%) from the t-PAHep group had non-fatal stroke (one haemorrhagic, one ischemic). No other major haemoragical events were registered in both groups. During the thrombolytic infusion hypotension appeared more frequently in the SK0.75Enox group (31.4%) than in the t-PAHep one (8.5%) (p>0.0001) but without any consequence regarding the patients' outcome. The ratio of CR was 78.4% in the SK0.75Enox group and 70.4% in the t-PAHep one (p = 0.308). In-hospital reocclusion appeared in 4 pts. from the t-PAHep group (5.7%) but in none in the SK0.75Enox one. Six pts. (5.9%) from the SK0.75Enox group and 5 pts. from the t-PA one (7.04%) died within the first 30 days after the onset of STAMI (p = 0.993). CONCLUSIONS: The combination SK0.75Enox is at least as safe and efficacious as the t-PAHep one.

Accelerated streptokinase--a new thrombolytic regimen in acute myocardial infarction.

Efficiency and safety of an accelerated regimen of streptokinase (1.5 M.U. over 20 min., 109 patients) has been compared with the standard regimen (1.5 M.U. over 60 min, 119 patients) in 218 patients admitted within the first 6 hours after the onset of the symptoms of acute myocardial infarction. Using the noninvasive criteria we found a coronary reperfusion rate of 77.04% in patients belonging to the accelerated regimen group and this value was significantly higher than the one of 57.14% registered in the standard group. No major hemorrhagic events were registered in both groups. Although the hypotension appeared to be more frequent in patients in whom the accelerated regimen was used, however this side effect proved to be transient and well controlled using the rapid infusion of natrium chloride solution. In conclusion, the accelerated regimen of streptokinase is safe and followed by a higher rate of coronary reperfusion as compared to the standard one.