September 11th, 2014

Race and Ethnicity Do Not Affect the Benefits of Device Therapy in Heart Failure

CardioExchange’s Harlan M. Krumholz interviews Boback Ziaeian, lead author of an observational study exploring the benefits of guideline-recommended cardiac resynchronization therapy and ICD therapy in heart failure patients, according to race and ethnicity. The study is published in JACC.

Krumholz: Please briefly describe your study and its main findings.

Ziaeian: We used the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF) to analyze the 2-year survival benefits of an implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) in select racial and ethnic groups. In a real-world outpatient population, we found no evidence that patients’ race or ethnicity affects their response to device therapy. Estimates of the degree of benefit were consistent among racial and ethnic subgroups and across prior randomized trials.

Krumholz: Why do you think the benefit of these devices in racial and ethnic minority groups have been questioned?

Ziaeian: The under-representation of women and minority groups in large randomized controlled trials is often highlighted as a criticism of the external validity of published trials. Clinical trials have historically over-represented white men at the expense of other groups. Despite the lack of a physiologic or well-grounded theory for why minorities may not derive a benefit similar to the one for white patients, these ideas persist. Furthermore, physicians and researchers often misinterpret subgroup analyses by focusing on the p-values for each subgroup rather than statistical tests for interactions.

Krumholz: What is it like for a fellow to be participating in research? Getting an article published in JACC is great.

Ziaeian: As a cardiology fellow in UCLA’s Specialty Training and Advanced Research (STAR) Program, it is an honor to publish my first JACC article on an important clinical issue for heart failure patients. Cardiovascular outcomes research is central to illuminating the gaps in our knowledge and provides clarity or, in some situations, further doubt on recommended clinical practices.

The STAR Program provides me with the educational foundation (through doctoral training at UCLA Fielding School of Public Health) and time to participate in research activities, as well as invaluable mentorship from Dr. Gregg Fonarow. This particular paper had 3 rounds of “revise and resubmit” during a 6-month period before final acceptance. Young investigators must appreciate the importance of addressing reviewers’ concerns, providing additional analyses, and rewriting the initial manuscript. Perseverance and acceptance of criticism are essential to the peer-review process.

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