Preliminary results from the BIO-LIBRA study, assessing the outcomes of device-treated ventricular arrhythmias or mortality in patients with non-ischaemic cardiomyopathy (NICM) being treated with implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation therapy defibrillators (CRT-Ds) along with guideline-directed medical therapy (GDMT) for heart failure, were presented at the Heart Rhythm Society 2023 annual meeting (19–21 May, New Orleans, USA).
Results suggest that women with NICM, especially those with a CRT-D, had a significantly lower rate of ventricular tachycardia (VT), ventricular fibrillation (VF) or death events compared to men. According to researchers, the enrolment model used in the trial, which yielded a near gender balance, could provide an important benchmark for future device trials.
For patients with NICM, physicians often consider cardiac rhythm devices to help improve heart function, relieve symptoms, and treat arrhythmias. The researchers state that while ICDs and CRT-Ds are common treatment options for heart failure patients, there is not a lot of recent data collected on the impact of ICDs on NICM patients and enrolment of women in device trials is historically low (<30%).
The BIO-LIBRA study, a multicentre, prospective, observational study, enrolled 1,000 patients at 48 enrolling sites across the USA. Patients were implanted with Biotronik ICDs or CRT-Ds with home monitoring to be uniformly assessed for the primary endpoint of device- treatment VT or VF. Secondary endpoints included all-cause mortality, VT or VF, cardiac death and sudden cardiac death by sex and by device type.
To address the lack of diverse enrolment, the authors created the BIO-LIBRA model, which champions female recruitment at each site and includes a variety of tools like patient and coordinator talking points, tailored patient education materials and key consenting tips for women shared at investigator meetings and in newsletters at enrolling sites in the country. The study successfully recruited 475 of 1,000 (47.5%) female patients, exceeding the enrolment goal of 40% women. Additionally, 30% of the enrolled subjects were non-white and 10% self-reported their ethnicity as Hispanic/Latino.
Preliminary findings from follow-up of all subjects showed women with NICM, especially those with a CRT-D, had a significantly lower rate of VT/VF/death events compared to men. The authors report that novel guideline-directed medical therapy with angiotensin receptor blocker/neprilysin inhibitors (ARNI) was high, 42%, and sodium-glucose cotransporter-2 (SGLT2) inhibitors increased over time, suggesting ongoing therapy optimisation in patients with implanted medical devices.
“This pioneering BIO-LIBRA model will pave the path for future medical device studies, transforming the way women and minorities are enrolled in clinical studies,” said Valentina Kutyifa (University of Rochester Medical Center, Rochester, USA. “The study also sheds new light on the intricate, interconnected relationship between sex, race, and device type on patient outcomes and offers a more balanced picture of NICM patients. We hope these findings will help close this knowledge gap and shape future research and interventions that will improve health outcomes for all—no matter your race or sex.”
The authors assert that the results of the BIO-LIBRA study will inform future scientific consensus and guideline documents regarding the role of ICD therapy in both men and women with a non-ischaemic cause of heart failure. The authors also added that a long-term, three-year follow-up of the enrolled subjects is currently underway.