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Would tirofiban have been shown non-inferior to abciximab had the TENACITY trial not been terminated for financial reasons?
MedLine Citation:
PMID:  23379785     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To investigate whether tirofiban would have been non-inferior to abciximab had the trial completed enrollment and place the termination of this trial in a broader research ethics context.
BACKGROUND: TENACITY was terminated by the sponsor for financial reasons. At the time, event rates for the 2 treatment arms were unknown.
METHODS: TENACITY was designed to compare tirofiban with abciximab in approximately 8,000 patients; however, enrollment was terminated after 383 (4.8%) patients. The primary end-point was a composite of 30-day death, myocardial infarction, and urgent target vessel revascularization. Non-inferiority was defined as the likelihood that tirofiban would preserve at least 50% of the ability of abciximab to reduce the primary end-point at 30 days, based on abciximab's demonstrated ability to reduce such events by 43% (relative risk, 0.573; 95% confidence interval [CI], 0.507-0.648; P < 0.001). To determine the probability of non-inferiority given the patients already enrolled, a Bayesian approach was used.
RESULTS: The primary composite end-point occurred in 8.8% of patients randomized to abciximab versus 6.9% receiving high-bolus-dose tirofiban (odds ratio, 0.77; 95% CI, 0.37-1.64). The estimated conditional power for the test that tirofiban would be non-inferior to abciximab if all patients been enrolled is 93.7%. Using the estimated predictive power method, the likelihood was 84.8%.
CONCLUSIONS: TENACITY was well powered to identify non-inferiority with tirofiban versus abciximab, and the patients enrolled strengthened the probability that this would have been the outcome had the trial been completed. When a clinical trial is terminated solely for financial reasons, it is incumbent upon the sponsor to provide proper patient follow-up and publication of the findings.
Peter B Berger; Judson B Williams; Vic Hasselblad; Karen Chiswell; Karen S Pieper; Robert M Califf
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2013-02-05
Journal Detail:
Title:  Journal of interventional cardiology     Volume:  26     ISSN:  1540-8183     ISO Abbreviation:  J Interv Cardiol     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-04-05     Completed Date:  2014-01-09     Revised Date:  2014-11-05    
Medline Journal Info:
Nlm Unique ID:  8907826     Medline TA:  J Interv Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  123-30     Citation Subset:  IM    
Copyright Information:
© 2013, Wiley Periodicals, Inc.
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MeSH Terms
Acute Coronary Syndrome / drug therapy*,  mortality,  surgery
Antibodies, Monoclonal / adverse effects,  therapeutic use*
Early Termination of Clinical Trials / economics*
Immunoglobulin Fab Fragments / adverse effects,  therapeutic use*
Middle Aged
Myocardial Infarction / epidemiology,  etiology*
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use*
Stents / adverse effects*
Survival Rate
Treatment Outcome
Tyrosine / adverse effects,  analogs & derivatives*,  therapeutic use
Grant Support
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Immunoglobulin Fab Fragments; 0/Platelet Aggregation Inhibitors; 144494-65-5/tirofiban; 42HK56048U/Tyrosine; X85G7936GV/abciximab

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