On April 2-4, 2022, the Annual Meeting of the American College of Cardiology (ACC2022) was successfully held in Washington, D.C. The ACC Annual Conference is an interactive debate and discussion of the world's leading cardiovascular experts, bringing together nearly 20,000 experts and scholars from all over the world, bringing us an academic feast.
ACC2022 attracted much attention with the "Featured Clinical Research (FCR)" session. At the FCR, Professor Gerasimos Filippatos, former President of the European Heart Failure Association and Director of the Heart Failure Center at Attikon University Hospital in Greece, presented the results of a subgroup analysis of arteriosclerotic cardiovascular disease (ASCVD) in the nonelidone large FIDELITY study. As a newly listed cardiovascular and kidney chronic disease management treatment drug in many regions around the world, nonelidone has been highly concerned by cardiovascular experts around the world with its superior pharmacological properties and cardiac and kidney benefit results. This time, the subgroup analysis of the FIDELITY study showed that regardless of whether the patients had a history of ASCVD or not, compared with placebo, non-nelidone significantly reduced the risk of cardiovascular and renal adverse events in patients with type 2 diabetes mellitus (T2D) and chronic kidney disease (CKD), delayed disease progression, and improved patients' cardiovascular and renal outcomes.
Expert Profiles
Professor Chen Jiyan
- Doctor of Medicine Doctoral Supervisor
- Chief Physician, Department of Cardiology, Guangdong Provincial People's Hospital
- Director of Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention and Treatment
- Member of the American College of Cardiology
- Member of the European College of Cardiology
- Vice President of cardiovascular physician branch of Chinese Medical Doctor Association
- Vice Chairman of China Cardiovascular Health Alliance
- Vice-President of the Board of Governors of the Asian Society of Cardiology
- Vice President of APCTO CLUB
- Chairman of Guangdong Interventional Cardiology Society
- Chairman of cardiovascular disease branch of Guangdong Medical Association
- President of the Macau Greater Bay Area Heart Research Association
Clinical attention should be paid to the comprehensive management of chronic diseases in patients with high risk of cardiovascular diseases
Cardiovascular disease is the first major type of disease that seriously threatens the health of mainland residents, and is the first cause of death of mainland residents¹. Moreover, the prevalence and mortality rate of cardiovascular diseases in the mainland are still in a continuous upward stage, and we have not yet seen a downward inflection point, and the prevention and treatment of cardiovascular diseases still has a long way to go. Attaching importance to the comprehensive management of cardiovascular risk factors, attaching importance to the long-term prognosis of the heart and kidneys, and preventing problems before they occur are the keys to improving the current situation of cardiovascular disease prevention and treatment in mainland China.
Both diabetes and CKD are independent risk factors for cardiovascular events. The data showed that patients with diabetes had a 2-4-fold increased risk of cardiovascular events compared with non-diabetic populations²², and if combined with CKD (either a decrease in eGFR or an increase in urine protein), the risk of cardiovascular events was further increased by 1-3 times³⁻⁴. Therefore, patients with T2D and CKD are at high risk of cardiovascular disease, and attention should be paid to risk factor control and long-term cardiovascular and renal protection in such patients.
FIDELITY studies ASCVD subgroup analysis
FIDELITY Research ⁵ is a pre-set meta-analysis study based on FIDELIO Research ⁶ and FIGARO Research ⁷, the results of which were published in the journal Eur Heart J in 2021. Fidelity findings showed that non-nerolidone significantly reduced the risk of cardiovascular complex endpoint events in patients with T2D and CKD by 14% compared with placebo (HR-0.86; 95%CI: 0.78-0.95; P=0.0018), significantly reduced the risk of renal compound endpoint events by 23% (HR=0.77; 95%CI: 0.67-0.88; P=0.0002）。 The SUBgroup analysis of THE FIDELITY study ASCVD published at the 2022ACC to assess the effect of ASCVD history on the efficacy and safety of nonelidone, including a total of 13026 patients with T2D with CKD (UACR≥30-<300 mg/g, and eGFR ≥25-≤90 mL/min/1.73 m² or UACR ≥300-≤5000 mg/g, and eGFR ≥ 25 mL/min/1.73 m²), of which 5935 cases (45.6%) had a history of ASCVD at baseline.
The results of the ASCVD subgroup analysis showed:
1. Patients with a baseline history of ASCVD have a higher risk of cardiovascular events than those without a history
The analysis found that patients with a baseline history of ASCVD had a twice the risk of cardiovascular complex events (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) than those without a history (HR=2.09; 95% CI: 1.89-2.30), as shown in Figure 1.
In addition, there was a compound event of cardiovascular death or hospitalization for heart failure in patients with a history of ASCVD (HR=2.12; 95% CI: 1.88-2.40) and all-cause death (HR=1.72; The incidence of 95% CI: 1.52 to 1.94) was also significantly higher than in those without history. There was no significant difference in the incidence of renal compound endpoint events (HR=0.96; 95%CI: 0.83-1.10）。
Figure 1. Cumulative incidence of cardiovascular complex events in patients with or without a history of ASCVD
2. The cardiovascular benefit of nonelidone is not affected by baseline history of ASCVD, but patients with a history of ASCVD may benefit better
The results showed that noneligone significantly reduced the risk of cardiovascular compound endpoint events in patients with T2D and CKD compared with placebo and were not affected by a prior history of ASCVD, but those with a history of ASCVD were particularly beneficial. Compared with placebo, noneliglione significantly reduced the risk of cardiovascular complex events by 17% in patients with a history of ASCVD (RR= 0.83; 95%CI: 0.74-0.94), see Figure 2.
In addition, nonelidone significantly reduced the risk of cardiovascular death or heart failure hospitalization complex event by up to 18% compared with placebo (RR 0.82; 95% CI: 0.71-0.94), significantly reducing the risk of all-cause death by 15% (RR=0.85; 95%CI: 0.74-0.99), see Figure 3.
In addition, noneliglione renal benefit is not affected by baseline history of ASCVD. Fenailidone significantly reduced the risk of renal complex events by up to 29% compared with placebo (RR=071; 95% CI: 0.57-0.88), which significantly reduced the risk of renal complex events in patients without a history of ASCVD by up to 19% (RR=081; 95% CI: 0.68-0.97), see Figure 3.
Figure 2. The cardiovascular benefit of nonelidone is not affected by a history of ASCVD
Figure 3. The cardiovascular and renal benefits of nonelidone are not affected by a history of ASCVD
In terms of safety, the incidence of nonneeridone hyperkalemia-associated discontinuation was low (0.2% and 0.1%) in patients with and without a history of ASCVD, with no significant difference from placebo.
Conclusion
Both diabetes mellitus and CKD are independent risk factors for cardiovascular events, and clinical attention should be paid to long-term cardiac and renal protection in patients with diabetes mellitus and CKD. The 2022 AHA Scientific Statement also includes noneligilone as a key advance in improving cardiovascular and renal outcomes in patients with diabetes mellitus and chronic kidney disease. The publication of the results of the ASCVD subgroup analysis of the FIDELITY study further enriched the evidence-based medicine of non-nailidone, and provided new ideas and inspiration for cardiovascular risk management and prevention in high-risk patients.
bibliography:
1. China Cardiovascular Health and Disease Report Writing Group. Chinese Journal of Circulation. 2021; 36(6): 521-545.
2. Consensus expert group on multidisciplinary diagnosis, treatment and management of diabetic nephropathy. Chinese Journal of Clinicians. 2020; 48(5): 522-527.
3. Microvascular Complications Group, Diabetes Branch of Chinese Medical Association. Chinese Journal of Diabetes. 2019; 11(1): 15-27.
4. Maryam Afkarian, et al. J Am SocNephrol. 2013 Feb; 24(2): 302-8.
5. Rajiv Agarwal, et al. Eur Heart J. 2021 Nov 22; ehab777.
6. George L Bakris, et al. N Engl J Med. 2020 Dec 3; 383(23): 2219-2229.
7. Bertram Pitt, et al. N Engl J Med. 2021 Dec 9; 385(24): 2252-2263.
Fetish