Abbott has announced results of the landmark GUIDE-HF clinical trial, a 1,000 patient randomised study designed to assess the benefits of the CardioMEMS HF System in people living with NYHA Class II, III and IV heart failure.
Data adjusted for the impact of COVID-19 show a strong reduction in a composite endpoint of heart failure hospitalisations, emergency visits and death in a broad range of patients, suggesting new benefits from the CardioMEMS device.
CardioMEMS is currently approved for use in NYHA Class III patients with a prior heart failure hospitalisation within the last year. The GUIDE-HF study examined an expanded patient population, including patients with NYHA Class II and Class IV heart failure, to evaluate the device in patients in earlier or later-stage disease progression.
GUIDE-HF is one of many large trials conducted amid the COVID-19 pandemic, when healthcare systems experienced significant disruption. Heart failure patients are at a heightened risk of COVID-19 and, as a result, experienced changes to their care management and hospitalisation during the pandemic.
An analysis of the full one-year dataset, of which 28% of the follow-up data was collected during COVID-19, showed CardioMEMS-guided patients had a lower composite endpoint rate of total heart failure events and death compared to the study’s control group, which was not statistically significant. In an analysis of data adjusted for the impact of COVID-19 (captured prior to March 13, 2020—the date the US national emergency was declared), CardioMEMS demonstrated a significant 19% reduction in the study’s composite endpoint and a 28% reduction in heart failure hospitalisations.
The results of GUIDE-HF were presented at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual) and simultaneously published in The Lancet. Based on the strength of the GUIDE-HF data, Abbott has filed a premarket approval (PMA) supplement with the US Food and Drug Administration (FDA) for consideration of an expanded indication for the CardioMEMS device.
The CardioMEMS HF System includes a small sensor the size of a paperclip that, once placed in the pulmonary artery during a minimally invasive procedure, monitors for pressure changes that indicate worsening heart failure even before patients feel symptoms. The CardioMEMS sensor connects to a system that remotely provides daily pressure readings to a patient’s clinical team, allowing physicians to make therapy changes to combat worsening heart failure.
“The two most important strategies in treating heart failure are helping doctors stay ahead of the condition as it progresses and keeping people stable and out of the hospital and emergency room. The GUIDE-HF trial shows that Abbott’s CardioMEMS device has a role in both,” said Philip B Adamson, chief medical officer of Abbott’s heart failure business. “This tiny cardiac sensor, coupled with the increased improvements in informed telemedicine, can have a tremendous impact on helping people at all stages of heart failure live their healthiest lives.”
Though not designed to assess the benefits of CardioMEMS in specific patient sub-groups, when adjusted for the impact of COVID-19, the GUIDE-HF study suggests potential benefits of the device in new groups of patients, including:
- Patients in earlier stages of heart disease. GUIDE-HF data suggests better outcomes in Class II patients when their therapy is guided by pulmonary pressure monitoring, with a 34% reduction in heart failure hospitalisations, emergency visits and death.
- Specific patient groups. GUIDE-HF also demonstrated a relative risk reduction for both women (33%) and African American patients (41%), two patient segments disproportionately impacted by effects of heart failure.
- Patients at risk of potential hospitalisation. GUIDE-HF showed a 25% reduction in hospitalisation or emergency department visits in patients without a prior heart failure hospitalisation but who undergo blood tests that show elevated levels of a biomarker known as B-type Natriuretic Peptide (BNP), which indicates worsening heart failure.
“Clinicians have seen first-hand the importance of CardioMEMS in helping them proactively manage heart failure to keep patients out of the hospital, and the GUIDE-HF trial showed the device provides benefits for more patients than ever before,” said JoAnn Lindenfeld, primary investigator for the GUIDE-HF trial and director of advanced heart failure at Vanderbilt University Medical Center, Nashville, USA. “Even with the disruptions that we saw as a result of the COVID-19 pandemic, this trial was still able to show significant reductions in heart failure hospitalisations and reduced emergency visits with pulmonary pressure sensor monitoring.”
Prior clinical and real-world evidence, including the landmark CHAMPION study, has shown substantial benefits of CardioMEMS, including reduced heart failure hospitalisation, positive economic impact and reduction in pulmonary artery pressures—which physicians use to assess their patients’ heart failure. GUIDE-HF built upon these prior studies by expanding the patient population (Class II–IV and patients with elevated BNP or NT-proBNP levels), while also broadening the primary endpoint to include hospitalisation, visits to emergency departments or outpatient urgent care centres and death.
The GUIDE-HF study included a randomised arm of 1,000 patients and a single arm of up to an additional 2,600 patients that is currently enrolling for a total of 3,600 patients across 118 centres in North America. All patients received a CardioMEMS device, but therapy for patients in the control arm was not guided by the device.