A high-intensity treatment strategy for heart failure reduces the risk of death or hospital readmission

A high-intensity treatment strategy for heart failure reduces the risk of death or hospital readmission

Rapidly increasing drug doses after hospitalization for acute heart failure resulted in a lower risk of death or readmission for heart failure within the first six months after discharge compared to usual care, according to a scientific research presentation presented today at the American Heart Association's Scientific Sessions 2022. The meeting, held November 5-7 Held in person in Chicago and virtually in 2022, it is a premier global exchange on the latest scientific advances, research and evidence-based clinical practice updates in cardiovascular science.

Every year millions of people worldwide are hospitalized for acute heart failure. There is a 20% risk of rehospitalization and a 5% risk of death within one month of hospital discharge, and a 60% risk of rehospitalization and a 25% risk of death within one year of discharge. Despite this increased risk, research suggests that many patients with heart failure are not closely monitored after hospital discharge and may not be treated with full doses of all guideline medications.

The American Heart Association and the European Society of Cardiology both recommend that patients hospitalized with acute heart failure should receive optimal doses of three major classes of heart failure medications (beta-blockers, renin-angiotensin inhibitors/angiotensin receptor-neprilysin inhibitors, and Aldosterone inhibitors). ) and regular follow-up visits after discharge. However, low implementation of guideline-adherent medical therapies has been a major problem for decades, and previous studies have found that optimal doses of these medications are administered to only 1% of patients with heart failure in the United States. Some studies also suggest that women are less likely than men to receive optimal therapy.”

Alexandre Mebazaa, M.D., Ph.D., lead researcher on the study and professor of anesthesiology and critical care at the Université de Paris and chair of the Department of Critical Care at the Assistance Publique Hôpitaux de Paris, both in Paris, France

The STRONG-HF trial (Safety, Tolerability and Efficacy of Rapid Optimization, supported by NT-proBNP testinG, of Heart Failure Therapies) is the first trial designed to follow people with heart failure after hospital discharge with more frequent follow-up visits and a comprehensive clinical examination and laboratory tests to assess whether rapid optimization of oral medications for heart failure improves clinical outcomes. Medication optimization involves providing the maximum recommended dose and the most tolerated combination of guideline-recommended medications to reduce the risk of death and additional hospitalizations.

This multicenter study was conducted at nearly 90 sites worldwide between 2018 and 2022 and included more than 1,000 people hospitalized for acute heart failure. Participants had an average age of 63 years, 61% were male, and 77% were white. Almost 30% of patients had diabetes (with and without insulin dependence) and over 40% had atrial fibrillation.

Study participants were randomized to receive either usual care (536 people) or high-intensity care (542 people) shortly before their hospital discharge. Patients admitted to the usual care group were discharged and treated according to local medical standards, with follow-up care and heart failure medication management provided by the patient's primary care physician and/or cardiologist. They were first evaluated by the study team 90 days after their hospital discharge.

In the high-intensity care group, participants initially received 50% of the maximum recommended dose of three oral heart failure medications before hospital discharge. Their doses were increased to 100% of the recommended dose two weeks after discharge. The study team closely monitored the high-intensity group for the first 6 weeks to make sure it was safe to increase their doses. They were followed at 1, 2, 3, and 6 weeks with a physical examination and blood tests to measure renal function, sodium, potassium, glucose, hemoglobin, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). a marker of heart failure and congestion.

Mebazaa said: "Some heart failure therapies can cause unwanted side effects such as reduced blood pressure, reduced heart rate, worsening kidney function or increased fluid retention. We started treatment with half the recommended dose of each of the three standard heart failure drug classes while patients were still in the hospital so we could ensure they received the lower doses tolerated, and to determine whether it is safe to increase the dose of each medication after discharge.”

The study aimed to compare the rates of death or re-hospitalization between the two groups 180 days after hospital discharge.

An interim analysis conducted after the 90-day follow-up period found that the high-intensity strategy significantly improved outcomes compared to usual care:

• Eine erneute Aufnahme aufgrund von Herzinsuffizienz oder Tod jeglicher Ursache trat bei 15 % der Personen in der Gruppe mit hochintensiver Versorgung auf, im Vergleich zu 23 % der Patienten in der Gruppe mit Standardversorgung. Dieser Unterschied war statistisch signifikant.
• Blutdruck, Puls, Klasse der New York Heart Association (NYHA) und NT-proBNP-Werte verbesserten sich stärker in der Gruppe mit hochintensiver Pflege.
• Die selbstberichtete Lebensqualität der Patienten verbesserte sich in der Gruppe mit hochintensiver Pflege im Vergleich zur Gruppe mit normaler Pflege signifikant, mit einer durchschnittlich 3,5 Punkte höheren Punktzahl auf einem Fragebogen zur Beurteilung der gesundheitsbezogenen Lebensqualität.
• Behandlungsbedingte Nebenwirkungen traten bei 41 % der Gruppe mit hoher Intensität und 29 % der Gruppe mit der üblichen Behandlung auf, jedoch waren schwerwiegende unerwünschte Ereignisse ähnlich – 16 % in der Gruppe mit hoher Intensität und 17 % in der Gruppe mit der üblichen Behandlung.
• Tödliche unerwünschte Ereignisse traten bei 4 % der Gruppe mit hoher Intensität und 6 % der Gruppe mit der üblichen Behandlung auf.
• Diese Ergebnisse wurden sowohl bei Patienten mit reduzierter als auch erhaltener linksventrikulärer Ejektionsfraktion (LVEF) beobachtet; Die Ejektionsfraktion ist ein Maß für die Kontraktionsfähigkeit des Herzens.

After reviewing these results, the study's data and safety monitoring board recommended early termination of the study on the grounds that it would be unethical to withhold the intensive treatment from both current and future study participants.

“The high-intensity care strategy required an average of five visits within three months of discharge, compared to one visit for usual care,” Mebazaa said. "Other studies of appropriate size and power have examined intensive follow-up, but there were no effects on mortality rates or hospital readmissions. More follow-up visits alone do not appear to be effective without rapidly increasing guideline medications to maximum tolerated doses."

He added: "Patients in the intensive care group also reported improved quality of life, suggesting that this treatment strategy has benefits beyond mortality and hospital readmissions."

There are several limitations to the study, including changing from 90-day to 180-day follow-up to increase enrollment due to the low event rate. However, a statistical analysis showed that the results are the same even if participants who registered before the change were removed from the analysis. Second, the study was stopped early due to the large benefit to participants in the high-intensity group, suggesting that it would be unethical to continue placing patients in the usual care group. Third, this study was not blinded, which may have influenced the study team's perception. Fourth, the causes of hospitalizations were not investigated by the entire team. Finally, the study was designed before a fourth class of heart failure drugs, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, were approved to treat heart failure, and these drugs were used late in the study and were not prescribed to most patients.

Source:

American Heart Association

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