Saruplase is a safe and effective thrombolytic agent; Observations in 1698patients: Results of the PASS study

Saruplase (unglycosylated human-type high molecular weight single-chain uro kinase-type plasminogen activator) was given to 1698 patients in the open-l abel Practical Applicability of Saruplase Study (PASS), which assessed the safety and efficacy of saruplase in the treatment of acute myocardial infar ction. Thirty-seven hospitals in Europe participated in the study. All pati ents received 20 mg saruplase as a bolus followed by an infusion of 60 mg s aruplase over 1 hour. Prior to the infusion of saruplase, 62% of the patien ts received a bolus of 5000 U of heparin, and after saruplase a 24-hour int ravenous infusion of heparin was given to 95% of patients. The mean age of the patients was 59 years and 80.1% were male. The median delay from the on set of chest pain to the start of saruplase infusion was 145 minutes. Acute angiography was performed in 8 of the participating 37 centers in 350 pati ents (20.6%), on average 85 minutes (median) after the start of the sarupla se infusion. TIMI 3 flow was obtained in 186 patients (53.1%) and TIMI 2 fl ow in 61 patients (17.4%). Patency rates were similar for patients with ant erior and inferior infarction. ECG signs suggestive of reperfusion were see n in 63% of the patients. In-hospital mortality was low (92 patients; 5.4%) , and nonfatal recurrent myocardial infarction was seen in 60 patients (3.5 %). Severe bleeding complications occurred in 92 patients (5.4%), 21 of who m (1.2%) needed a blood transfusion. An intracerebral hemorrhage was observ ed in eight patients (0.5%), and seven patients (0.4%) suffered from a thro mboembolic stroke. At discharge 85.9% of the patients were in NYHA function al class I. One-year mortality was low (142 patients; 8.4%). Mortality was high in patients with TIMI 0 or 1 flow at the acute angiography who did not undergo rescue PTCA (9/39; 23.1%), lower in patients with TIMI 0 or 1 flow followed by successful rescue PTCA (7/64; 10.9%), and low in patients with TIMI 2 flow (1/61; 1.6%) or with TIMI 3 flow (2/186; 1.1%). Patency rates and (bleeding) complications did not differ between patients with a body we ight greater than or less than 70 kilograms. No antibodies against saruplas e were detected in samples from 455 patients. In conclusion, it can be stat ed that saruplase, given in combination with aspirin and intravenous hepari n, can be given safely and effectively to patients with acute myocardial in farction.