What the trial was testing
The REGROUP enrolled 1,150 patients with heart failure. The study was sponsored by VA Office of Research and Development and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
Researchers followed patients through treatment and into recovery, tracking the outcomes that mattered most for the disease being studied.
What the results showed
15.5% of open-harvest patients and 13.9% of endoscopic-harvest patients had major heart events—no significant difference.
The New England journal of medicine · 2019 · NCT01850082
These findings — that no meaningful difference in death, heart attack, or repeat procedures between the two harvesting methods — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 1,150 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with heart failure, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Both vein-harvesting techniques are widely used and FDA-cleared for bypass surgery. If you're having bypass, ask your surgeon which method they use and why. Endoscopic harvest may lower leg wound infections slightly, but overall heart outcomes appear similar.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open heart failure trials
Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients
There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac MRI technique, called native T1 mapping, may provide a solution to this. To assess the accuracy of this novel technique in dialysis patients, it is essential to undertake a study which compares native T1 mapping to actual levels of scarring in the hearts of patients on dialysis.
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with reduced ejection fraction (HFrEF).