| Patency trials with reteplase (r-PA): what do they tell us? | |
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MedLine Citation:
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PMID: 8990406 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Thrombolytic therapy has been shown to reduce mortality and morbidity after acute myocardial infarction. Therapeutic benefit seems to be directly correlated with completeness of reperfusion (Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow) of the infarct-related coronary artery, as well as the timeliness of reperfusion. To determine which regimen of reteplase (r-PA), a deletion mutant of wild-type tissue plasminogen activator (t-PA), is most effective for clinical thrombolysis, several reteplase regimens were compared with the most successful standard regimens of recombinant t-PA (alteplase) in 2 large-scale, randomized studies. All patients received aspirin and intravenous heparin. In the Reteplase Angiographic Phase II International Dose Finding Trial (RAPID-1), results in 606 randomized patients showed that a 10 + 10 U double bolus of reteplase was more effective than a 15 U single bolus, a 10 + 5 double bolus, or conventional alteplase (100 mg over 3 hours). In the Reteplase versus Alteplase Patency Investigation During Acute Myocardial Infarction (RAPID-2) trial, results in 324 patients showed that significantly more patients achieved patency of the infarct-related artery (TIMI grade 2 or 3 flow) at 90 minutes with reteplase (10 + 10 U double bolus) than with accelerated alteplase (100 mg over 90 minutes): 83.4% versus 73.3%, respectively (p = 0.03). The incidence of complete patency (TIMI grade 3 flow) at 90 minutes was likewise greater with reteplase than with accelerated alteplase (59.9% vs 45.2%, respectively; p = 0.01). At 60 minutes, the incidence of TIMI grade 2 or 3 flow was also significantly higher with reteplase than with alteplase (81.8% vs 66.1%, respectively; p = 0.01), as was the incidence of TIMI grade 3 flow (51.2% vs 37.4%, respectively; p < 0.031). The 35-day mortality rate was 4.1% for reteplase and 8.4% for alteplase (p = not significant). Reteplase and alteplase did not differ significantly with regard to the occurrence of severe bleeding (12.4% vs 9.7%, respectively) or hemorrhagic stroke (1.2% vs 1.9%, respectively). The results of these trials show that reteplase, given as a 10 + 10 U double bolus, achieves significantly higher rates of early reperfusion of the infarct-related coronary artery and is associated with significantly fewer acute coronary interventions when compared with front-loaded alteplase. The benefits of reteplase are achieved without any apparent increased risk of complications. |
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Authors:
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C Bode; T K Nordt; K Peter; R W Smalling; M S Runge; W Kübler |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Review |
Journal Detail:
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Title: The American journal of cardiology Volume: 78 ISSN: 0002-9149 ISO Abbreviation: Am. J. Cardiol. Publication Date: 1996 Dec |
Date Detail:
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Created Date: 1997-02-06 Completed Date: 1997-02-06 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0207277 Medline TA: Am J Cardiol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 16-9 Citation Subset: AIM; IM |
Affiliation:
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Medizinische Klinik III (Kardiologie, Angiologie und Pulmonologie, Heidelberg, Germany. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Cerebral Hemorrhage
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chemically induced Clinical Trials, Phase II as Topic Coronary Circulation Coronary Vessels / drug effects, pathology Drug Administration Schedule Fibrinolytic Agents / administration & dosage, adverse effects, therapeutic use* Hemorrhage / chemically induced Humans Incidence Myocardial Infarction / drug therapy, pathology Plasminogen Activators / administration & dosage, adverse effects, therapeutic use* Randomized Controlled Trials as Topic* Recombinant Proteins / administration & dosage, adverse effects, therapeutic use Survival Rate Thrombolytic Therapy* Tissue Plasminogen Activator / administration & dosage, adverse effects, therapeutic use Treatment Outcome Vascular Patency / drug effects |
| Chemical | |
Reg. No./Substance:
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0/Fibrinolytic Agents; 0/Recombinant Proteins; 133652-38-7/reteplase; EC 3.4.21.-/Plasminogen Activators; EC 3.4.21.68/Tissue Plasminogen Activator |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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