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Comment & Response
February 20, 2019

Evaluating Treatment Effect of Transcatheter Interatrial Shunt Device Using Heart Failure Event Rates

Author Affiliations
  • 1Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts
  • 2Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts
JAMA Cardiol. 2019;4(3):299. doi:10.1001/jamacardio.2019.0001

To the Editor Shah et al1 conducted an important study to evaluate the 1-year safety and patency of the interatrial shunt device (IASD) compared with a sham control treatment. The IASD appears to be safe with respect to various clinical end points. For one of the key outcomes, heart failure (HF) events requiring intravenous treatment, the authors reported the cumulative incidence of HF events over the first year of the trial in Figure 2B.1 The HF event rates at the end of follow-up were 19% in the IASD arm and 41% in the control arm (log-rank P = .08). The authors also stated that Figure 2B1 shows that there was a longer time from randomization to first HF event in the IASD arm (mean [SD] time, 178 [47] days) vs the control arm (mean [SD] time, 70 [83] days).