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ABBOTT LABORATORIES

(ABT)
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Abbott Announces Results of the GUIDE-HF Clinical Trial

08/27/2021 | 08:46am EDT

Abbott announced results of the GUIDE-HF clinical trial, a 1,000 patient randomized 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 hospitalizations, 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 hospitalization 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 hospitalization during the pandemic. An analysis of the full one-year data set, 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 U.S. national emergency was declared), CardioMEMS demonstrated a significant 19% reduction in the study's composite endpoint and a 28% reduction in heart failure hospitalizations. The results of GUIDE-HF were presented at the ESC Congress 2021 (organized by the European Society of Cardiology) 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 U.S. 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. 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 hospitalizations, 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 hospitalization. GUIDE-HF showed a 25% reduction in hospitalization or emergency department visits in patients without a prior heart failure hospitalization but who undergo blood tests that show elevated levels of a biomarker known as B-type Natriuretic Peptide (BNP), which indicates worsening heart failure.


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Financials (USD)
Sales 2021 41 861 M - -
Net income 2021 6 575 M - -
Net Debt 2021 8 432 M - -
P/E ratio 2021 34,3x
Yield 2021 1,34%
Capitalization 225 B 225 B -
EV / Sales 2021 5,57x
EV / Sales 2022 5,73x
Nbr of Employees 109 000
Free-Float 88,8%
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Robert B. Ford President, CEO, Chief Operating Officer & Director
Robert Emmett Funck Chief Financial Officer & Executive VP-Finance
Miles D. White Executive Chairman
Sabina Ewing Chief Investment Officer, VP-Business & Technology
Roxanne Schuh Austin Independent Director
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