January 2, 2013 – Positive results seen in clinical trials are not always as significant when applied to standard clinical practice, which is why the new study results are important for clinicians.
Numerous clinical trials have demonstrated that implantable cardioverter defibrillators (ICDs) significantly improve survival rates for people who have a history of heart failure and/or a heart attack and are at risk for sudden cardiac death. But a new study also found similar benefits in real-world settings, indicating that ICDs are a good therapy choice for many patients.
Study results were published in the January 2 issue of the Journal of the American Medical Association. The DCRI’s Sana Al-Khatib, MD, MHS, was the lead author (pictured).
Positive results seen in clinical trials are not always as significant when applied to standard clinical practice, where patients are often sicker than patients enrolled in trials and care is not as standardized as it is in trials. The new DCRI-led study used data from a national ICD registry to compare results of more than 5300 regular (non-trial) patients with results of more than 1500 patients enrolled in two large ICD trials. The Centers for Medicare & Medicaid Services require that all patients who receive an ICD for primary prevention must be enrolled in the national registry.
For this study, researchers included patients from the registry who were clinically similar to the patients enrolled in the trials. The oldest and sickest patients in the registry were excluded from the study. Patients from the registry and patients enrolled in the trials who received ICDs had similar two- and three-year survival rates. Researchers were able to demonstrate that regular patients who don’t receive the close monitoring provided in clinical trials have similar survival to patients receiving an ICD in the trials.
However, excluding older and sicker patients than those who were enrolled in the trials left researchers unable to understand how the outcomes of all real-life patients compare to those of trial participants. Even without this information, the new study results should offer providers confidence that using ICDs is associated with improved survival and, consequently, should continue to be used to prevent sudden cardiac death.
Other DCRI study authors include Anne Hellkamp; Daniel Mark, MD; Kevin Anstrom, PhD; Hussein Al-Khalidi, PhD; Lesley Curtis, PhD; Eric Peterson, MD, MPH; Gillian Sanders; Nancy Clapp-Channing; and Kerry Lee, PhD.