Document Detail


Patency trials with reteplase (r-PA): what do they tell us?
MedLine Citation:
PMID:  8990406     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
C Bode; T K Nordt; K Peter; R W Smalling; M S Runge; W Kübler
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Review    
Journal Detail:
Title:  The American journal of cardiology     Volume:  78     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  1996 Dec 
Date Detail:
Created Date:  1997-02-06     Completed Date:  1997-02-06     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  16-9     Citation Subset:  AIM; IM    
Affiliation:
Medizinische Klinik III (Kardiologie, Angiologie und Pulmonologie, Heidelberg, Germany.
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MeSH Terms
Descriptor/Qualifier:
Cerebral Hemorrhage / 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:
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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