To the Editor: In their study of the effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction, the OASIS-6 (Organization for the Assessment of Strategies for Ischemic Syndromes) Trial Group1 reported higher bleeding rates in patients treated with placebo than in patients treated with fondaparinux. This finding is difficult to explain2 and may be due to one of the many cointerventions.
Open-label low-molecular-weight heparin (LMWH) was given to significantly fewer patients in the fondaparinux group compared with the control group (5.3% vs 6.3%, P = .02). The choice of nonstudy anticoagulants seems to have been left to the discretion of the treating physicians, rather than defined by explicit criteria. Blinding likely does not work well with fondaparinux and similar anticoagulants, which are administered by subcutaneous injection. Large cutaneous hematomas may mark the injection sites of anticoagulants. Because the absence of hematoma may suggest placebo, it is possible that for such patients the physicians may have administered LMWHs more liberally.
Therefore, we suspect that bleeding rates were higher in those OASIS patients receiving nonstudy LMWHs compared with patients without such heparin treatment. The authors did not report whether they assessed blinding efficacy.3 - 4 Assessment of blinding efficacy to judge the degree of performance bias4 is particularly important when multiple nonstudy interventions are used, as in acute myocardial infarction.
Financial Disclosures: None reported.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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