COMMANDER HF trail - How data can be twisted to create a positive spin: Prof. Sundeep Mishra
M3 India Newsdesk Nov 17, 2018
Prof Sundeep Mishra throws light on yet another study presented at the recent annual AHA Session 2018 in Chicago, the COMMANDER HF trial.
COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure) was a large RCT that was conducted to test the hypothesis that the direct factor Xa inhibitor rivaroxaban could reduce the rate of primary outcome, a composite of death, myocardial infarction (MI), or stroke. It enrolled 5022, mostly high-risk patients with recent symptom of exacerbation / worsening of ischemic heart failure (HF), with a left ventricular ejection fraction of 40% or less, and elevated natriuretic peptides but with no history of atrial fibrillation (AF).
It enrolled rather sick patients, ≈ 50% were in New York Heart Association functional class 3 or 4. The addition of rivaroxaban at a dose of 2.5 mg twice daily to standard care, including clinically selected antiplatelet therapies, was not associated with a significantly lower rate of the composite primary outcome. Furthermore, the secondary outcomes of cardiovascular (CV) mortality and HF hospitalization were also found neutral. The rivaroxaban group had 20% numerical increase in the risk for the primary safety end point of "fatal bleeding or bleeding into a critical space with potential for permanent disability," but it was not statistically significant (95% CI, 0.43 - 1.49). Thus this trial essentially was a failure.
However, in a new twist to the older version data presented in the recent annual AHA Session 2018 in Chicago revealed that while rivaroxaban therapy did not stem the progression of HF there was a 17% reduction in risk (P = .013) for a thrombo-embolic composite end point (MI, ischemic stroke, sudden or un-witnessed death, pulmonary embolism, or symptomatic deep venous thrombosis) over a median 21 months. The spin-masters proposed that while the primary end point was unaffected by NOAC treatment because mortality in the trial "was driven by events that were not influenced by rivaroxaban," despite the drug's beneficial effect on MI and stroke.
Dr Greenberg went to the extent of saying that "I think we studied the wrong population here, in that we looked at worsening heart failure, where there's so much else going on that outcomes are heart-failure-driven. We really almost missed that signal."
This trial is another example of how data can be twisted to create a positive spin.
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