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To the Editor: The clinical trial comparing unfractionated and low-molecular-weight heparin for the treatment of VTE by Dr Kearon and colleagues¹ lacks an important component recommended by the CONSORT statement: a justification for the chosen noninferiority margin.² The authors' assertion of noninferiority of unfractionated heparin is called into question by this omission, combined with the enrollment of fewer patients than planned, as well as recent reports of a trend in favor of low-molecular-weight heparin compared with intravenous unfractionated heparin.^3-4

Although the superiority of low-molecular-weight heparin cannot be excluded, the data suggest limits of the potential cost-effectiveness of this treatment. With a cost differential of $675 estimated by the authors and a maximum risk difference of 3.3%, the cost per event prevented is at least $20 000. Therefore, the decision to use unfractionated heparin can perhaps be better justified by cost-effectiveness arguments than by claiming that clinical noninferiority has been rigorously established.

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Jonathan Lee Edwards, MD, MA
jedwards@barbhosp.com
Department of Family Practice
Barberton Hospital
Barberton, Ohio

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