The US Patient-Centered Outcomes Research Institute (PCORI) has announced the approval of funding awards totalling more than US$165 million for new patient-centred, comparative clinical effectiveness research (CER), with US$57 million being committed to two studies specifically focused on heart health.
The first of these two studies is being led by scientists at the University of Rochester Medical Center (URMC; Rochester, USA) and has received US$27 million in PCORI funding. This large study will compare two commonly prescribed ‘beta blockers’—carvedilol and metoprolol succinate—in patients with heart failure and implantable cardioverter defibrillators (ICDs).
“A cornerstone of treatment for heart failure is the use of beta blockers,” said Mehmet Aktas (URMC, Rochester, USA), principal investigator (PI) of the study. “Carvedilol and metoprolol succinate are the main types of beta blockers that are prescribed for 90% of people with this condition to improve survival. However, no one has ever studied the differences in outcomes for these two drugs in patients with heart failure who receive implantable cardioverter defibrillators.”
As noted in a URMC press release, this study is the first large-scale, head-to-head comparison of two heart failure drugs, and it hopes to improve physicians’ ability to provide optimal heart failure management for the millions of people living with this disease. The five-year study will enrol 2,000 patients at 100 sites across the USA to determine if carvedilol provides additional benefits versus metoprolol.
“Whether we find that both drugs are equally effective, or that carvedilol is superior, it is a win for patients and providers,” Aktas added. “We’ll come away with knowledge that will inform and improve how we treat patients.”
A second large-scale study, dubbed ‘RAPTOR-CIED’, is set to receive US$30 million from the PCORI as it seeks to compare different methods for monitoring pacemakers and ICDs that use wireless remote monitoring. The study will be led by a team from Beth Israel Deaconess Medical Center’s Richard A and Susan F Smith Center for Outcomes Research (Boston, USA) in close partnership with Harvard T H Chan School of Public Health’s CAUSALab (Boston, USA).
“This funding award aligns with the Smith Center’s mission to lead innovative research that improves clinical care and outcomes for cardiovascular patients,” said Daniel Kramer (Harvard Medical School, Boston, USA), who will lead the RAPTOR-CIED project. “Modern pacemakers and ICDs collect and transmit enormous amounts of data to clinical sites. While this can be very helpful, we need better strategies for managing this deluge of information. Our project has the potential to change practice for a large and growing patient population with these devices.”
In the study, Kramer and colleagues will compare two strategies for managing patients living with pacemakers and ICDs. Current practice involves annual in-office device evaluations and wireless remote monitoring transmissions from patients’ devices—which include frequent scheduled transmissions, patient-initiated transmissions, and alert transmissions sent automatically. This standard strategy is effective, but imposes many burdens on patients related to time, cost and complexity. An alternative strategy of remote monitoring alone with focus on automatic alerts may be just as safe while reducing burdens on patients and clinical teams, and this is the approach being evaluated in RAPTOR-CIED, as stated in a Beth Israel Deaconess Medical Center press release.
Also among a total of 10 CER studies awarded part of the PCORI’s US$165 million funding contribution are three more that will evaluate the effectiveness of telehealth interventions to treat Type 2 diabetes, chronic low back pain and opioid use disorder. Another three will study in vitro fertilisation, antibiotics for young children with mild pneumonia, and treatments for inflammatory myelitis and optic neuritis. A further two are set to compare strategies to treat urinary incontinence during vaginal prolapse repair procedures, and evaluate approaches to address the social needs of patients managing multiple chronic conditions.
“These latest PCORI-funded comparative clinical effectiveness research studies will generate evidence for various care approaches, including virtual delivery methods, when managing conditions such as diabetes, heart conditions and other health concerns affecting patients across the nation,” said Nakela Cook, PCORI’s executive director. “Through research approaches that will engender trust and trustworthiness, the findings of these studies will offer valuable insights for patients and those who care for them to make better-informed healthcare decisions.”
