ACC 2022|Professor Li Liwen: DIAMOND Trial brings good news for HFrEF patients to reduce hyperkalemia caused by taking RAASi

*For medical professionals only

“img class=”responsive ” sizes=”(min-width: 320px) 320px, 100vw” src=”https://mmbiz.qpic.cn/mmbiz_png/Or5ialKAVHBjj9KeHXecssZZlKphAZd0SuCDhFIblGGu5VD7wXg3ibubKXe79P17dgCGkzd8rNibZvZNIwiaur8g3A/640″ >2022The 71st ACC Annual Meeting in Washington, D.C., USA on April 3rd ,Professor Javed Butler from the University of Mississippi,introduced Results of the DIAMOND Trial (Patiromer for the management of hyperkalemia in patients with HFrEF receiving renin-angiotensin-aldosterone system antagonists).

Research Brief

The DIAMOND Trial enrolled 1640 HFrEF patients with hyperkalemia or a history of hyperkalemia, age 67±10 years old.

Patients received an RAASi-optimized regimen including a mineralocorticoid receptor antagonist (MRA) and Patiromer. Randomized, double-blind assignment in a 1:1 ratio to receive either Patiromer or placebo.

K+ between the two groups during the trial The mean difference in concentration from baseline.

Secondary endpoints of the study included the first occurrence of hyperkalemia (K+ span> >5.5mmol/L), time to reduce the target dose of MRA (spironolactone/eplerenone 50mg/day), investigator-reported Hyperkalemia adverse events (first/recurrent), hyperkalemia-related clinical events (CV death, CV hospitalization, serum K+ >6.5mmol/L, 6.0-6.5mmol/L, 5.0-6.0mmol/L Incidence) and the “win rate” points used by RAASi across the board.

K+ The levels of span> increased by 0.03mmol/L and 0.13mmol/L respectively compared with the baseline, P<0.001. Among the preset secondary endpoints, Patiromer was favored.

Primary endpoint

secondary >

Research Reviews

1. The pathophysiological mechanism of HFrEF is cardiac remodeling due to excessive neuroendocrineactivation, renin–< /span>Angiotensinaldosterone receptor antagonist(RAASi) is the cornerstone of improvingHFrEF, howeverRAASi’s side effect is blood lossK+ is elevated, especially in older patients with concurrent chronic kidney disease (CKD) and/or diabetes Hyperkalemia is more likely to occur.

In addition to causing neuromuscular symptoms, hyperkalemia can lead to malignant arrhythmia, sudden death, etc., and further aggravate kidney damage. Hyperkalemia is an important reason for the reduction or interruption of RASSi therapy in patients with HFrEF. How to follow the guidelines to optimize the RASSi treatment plan for HFrEF patients and maintain blood flowK+The level is in the normal range to avoid hyperkalemia, which has always been concerned by clinicians.

2. Patiromer is a non-absorbable spherical organic polymer that binds the entire gastrointestinal Potassium in the tract, but mainly acts on the distal colon where the concentration of free potassium is highest. As a back-exchange ion to prevent Na+< in patients with underlying heart or kidney disease who are at greater risk of volume overload /span> load increased. Patiromer improves serum potassium levels and reduces RAASi-induced hyperkalemia, optimizes RAASI treatment in patients, and achieves guideline-recommended doses, but in patients with HFrEF, Patiromer has limited previous evidence.

3. DIAMOND Trial confirms the efficacy of Patiromer in HFrEF with hyperkalemia sex and safety. The study was initiated on April 25, 2019, and the primary endpoint of the original design was CV death or hospitalization for heart failure.

Howeverdue to the COVID-19 pandemic, subject enrollment has been slow, hospitalization patterns have changed, study drug supply has been hampered, laboratory testing has Due to other uncontrollable factors, the researchers changed the primary endpoint on June 24, 2021 to: at the end of the study, blood >K+Change from baseline. From the “hard endpoint” of the original design to a “surrogate endpoint”, although the investigators still established CV death, CV death, CV Hospitalizations, occurrences of different levels of hyperkalemia, use of RAASi, etc., and applying new statistical “win rate” scores: 1. Patients during follow-up: no death/CV hospitalization (2 points), CV hospitalization (1 point) , death (0 points); 2. Taking drugs ACEI/ARB/ARNi, MRA, BB according to >50% target dose (2 points), >0-50% target dose (1 point), 0% target dose (0% score), calculate the score, compare the difference between the treatment group and the placebo group, and judge whether there is a statistically significant difference. However, currently only a few studies have adopted the “win rate” method. Whether it can be widely recognized still needs more clinical studies to confirm.

4. Previous HARMONIZE studies have suggested that sodium zirconium cyclosilicate is effective in patients with heart failure combined with high Kalemia treatment is beneficial. Guidelines and consensus recommend that as long as patients use RASSi, they should consider using sodium zirconium cyclosilicate at the same time to prevent hyperkalemia. DIAMOND Trial conclusion suggests that the application of Patiromer in HFrEF patients can reduce the incidence of hyperkalemia, effectively maintain the target dose of RASSi and MRA, and add a new treatment method.

Source:

Patiromer For The Management Of Hyperkalemia In Subjects Receiving Reninangiotensin-aldosterone System Inhibitor Medications For Heart Failure With Reduced Ejection Fraction: Results From The DIAMOND Trial.ACC.22

Expert Profile

Liwen Li

Chief Physician, MD, Master Student Instructor, Guangdong Provincial People’s Hospital, Guangdong Provincial Institute of Cardiovascular Diseases, Director of the Department of Cardiology, Director of the Heart Failure Center. FESC, FACC.

He is currently a member of the Metabolic Cardiovascular Disease Group of the Cardiovascular Branch of the Chinese Medical Association, a member of the Standing Committee of the Heart Failure Professional Committee of the Chinese Medical Doctor Association, and a member of the Heart Failure Branch of the Chinese Medical Doctor Association Cardiovascular Medicine Branch. Member of the study group, chairman of the Heart Failure and Metabolic Cardiovascular Disease Special Committee of the Guangdong Women’s Physician Association, deputy director of the Heart Failure Professional Physician Branch of the Guangdong Medical Doctor Association, and deputy group of the Heart Failure Group of the Cardiovascular Disease Branch of the Guangdong Medical Association Chairman, Vice Chairman of the Cardiovascular Disease Professional Committee of the Guangdong Provincial Health Management Association, Vice Chairman of the Cardiovascular Disease Prevention Professional Committee of the Guangdong Provincial Association of Integrative Chinese and Western Medicine, etc.

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