touchCARDIO coverage of data from BIO LIBRA presented at Heart Rhythm 2025:

Transcript:

Introduction

Welcome everyone. I’m Dr Valentina Kutyifa from the University of Rochester Medical Center in Rochester, New York. I’m a Professor of Medicine here at the University of Rochester, and today I’m going to talk about the BIO LIBRA study.

What was the background and rationale for the BIO LIBRA study?

The BIO LIBRA study focuses on patients with non-ischaemic cardiomyopathy and why we know that, patients with non-ischaemic cardiomyopathy benefit from the implantation of the ICD [implantable cardioverter-defibrillator].

Many of these studies were conducted several decades ago. Since then, there has been significant changes in medical management of these patients, but we have no data of how patients with a contemporary medication and management would do today, and that’s exactly the reason, we designed the BIO LIBRA study.

What were the main aims of BIO LIBRA? Can you describe the trial design?

BIO LIBRA is an investigator-initiated, multicenter, one-arm, single-arm clinical trial that enrolled 1,000 with non-ischaemic cardiomyopathy from the United States. We have identified 50 centers enrolling non-ischaemic cardiomyopathy patients that were representative of all the different regions of the United States.

The study cohort included both patients with an implanted ICD and also patients who received the cardiac resynchronization therapy device.

And in this particular study, we had a focus on sex-specific differences.

So we asked the sites to enroll at least 40% women in the trial, preferably more. And this was highlighted in all of the study meetings, and special attention was paid to this particular matter.

What were the primary and secondary endpoints, and what were the key findings?

So in BIO LIBRA, the primary endpoint was ventricular arrhythmias or all-cause mortality as a combined endpoint, as both of these events are particularly relevant to patients with non-ischaemic cardiomyopathy.

We had a secondary endpoint that was looking at VT or VF alone and all-cause mortality alone as well. And all of the analysis was performed by sex and by device type of an ICD or CRTD [cardiac resynchronization therapy device] as well. We also looked at sudden cardiac deaths and cardiac mortality and, again, looking at these events by sex and device type.

We had several really important findings in this study.

First, you know, just highlighting the characteristics of the patient populations. At the end of the trial, we succeeded to enroll 485 women out of the 1,000 patients. So achieving 48, almost 49% enrollment of women in the study. So this was particularly relevant because it allowed us to provide a well-powered analysis on sex-specific differences in the study.

About half of our patients had an implanted ICD and the other half had an implanted CRTD.

The main findings were that when we looked at the clinical outcomes of VT/VF [ventricular tachycardia/ventricular fibrillation] or DAS by sex, we found that women had a significantly lower rate of VT/VF or death at 3 years, with a 3 year event rate of, I believe, 17% as compared to 28% in males; so quite a big difference. Women had about half the number of events as compared to men. And this finding was also significant after adjustment for differences between men and women.

We also looked at the differences by the implanted device. When we looked at this, we found that the patients who were implanted with a cardiac resynchronization therapy device had also a significantly lower rate of VT/VF or death as compared to patients with an implanted ICD. And this is particularly relevant as we know CRT has been shown to significantly reduce these events.

And one of the most interesting and surprising findings were that we found something that we call an interaction between sex and device type – so the different patients of different sexes and different devices behaved very differently.

And when we looked at the four groups – women with a CRTD, women with an ICD, men with a CRTD and men with an ICD – we again found relevant differences.

Specifically, we found that women with an implanted CRTD had the lowest rate of ventricular arrhythmias or death, and, you know, followed by all of the other groups. So we have been able to identify a particularly low risk cohort in our study.

How should the BIO LIBRA trial’s findings reshape our approach to risk stratification and device selection in clinical practice?

Excellent question, thank you. Well, I want wanted to highlight two major findings of our study. The first one was that again, this is the first prospective study looking at events rates in a non-ischaemic cardiomyopathy patient cohort with contemporary medical therapy.

And, we actually had a relatively high rate of events in this patient population, so high residual risk. These were patients who had an ICD or CRTD device, but yet, over 3 years, they had a 21% rate of residual, you know, risk of VT/VF or death, which is quite high, and a 14% residual risk of VT/VF over 3 years as well. So patients with non-ischaemic cardiomyopathy remain at a high risk of ventricular arrhythmia events, even with contemporary medication and advanced device therapy.

The second important finding was that I mentioned, you know, looking at different sexes and the type of the device, we have been able to identify cohorts that were particularly low risk – these were women with the CRTD – and some other cohorts that might be higher risk.

You know, keep in mind, this study was not a randomized trial, so we cannot truly talk about device benefit, but these findings might be especially relevant, as we are managing these patients in everyday clinical practice.

Disclosures: Valentina Kutyifa has been a consultant for ZOLL and Biotronik, received grant/research support from Biotronik, Boston Scientific, Spire, NIH and ZOLL, and honoraria from ZOLL.

This content has been developed independently by Touch Medical Media for touchCARDIO and is not affiliated with Heart Rhythm 2025. Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. No endorsement of unapproved products or unapproved uses is either made or implied by mention of these products or uses by Touch Medical Media or any sponsor. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.

Interviewer/Editor: Heather Hall, Managing Editor

Cite: Kutyifa V. BIO LIBRA: ICD versus CRTD in Non-ischaemic Cardiomyopathy Outcomes by Sex. touchCARDIO, July 3 2025.

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