Real world effectiveness of PCSK-9 inhibitors combined with statins versus statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease in China(RWE-PCSK study)

BACKGROUND The efficacy and safety of proprotein convertase subtilisin/kexin type 9(PCSK-9) inhibitors were confirmed by several clinical trials, but its effectiveness in routine clinical practice in China has not been evaluated. This study aims to describe the real world effectiveness of PCSK-9 inhibitors combined with statins compared with statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease(ASCVD).METHODS This is a multi-center observational study, enrolled patients from 32 hospitals who underwent percutaneous coronary intervention(PCI) from January to June in 2019. There are 453 patients treated with PCSK-9 inhibitors combined with statins in PCSK-9 inhibitor group and 2,610 patients treated with statins-based lipid lowering therapies in statins-based group. The lipid control rate and incidence of major adverse cardiovascular events(MACE) over six months were compared between two groups.A propensity score-matched(PSM) analysis was used to balance two groups on confounding factors. Survival analysis using Kaplan-Meier methods was applied for MACE.RESULTS In a total of 3,063 patients, 89.91% of patients had received moderate or high-intensity statins-based therapy before PCI, but only 9.47% of patients had low-density lipoprotein cholesterol(LDL-C) levels below 1.4 mmol/L at baseline. In the PSM selected patients, LDL-C level was reduced by 42.57% in PCSK-9 inhibitor group and 30.81%(P < 0.001) in statins-based group after six months. The proportion of LDL-C ≤ 1.0 mmol/L increased from 5.29% to 29.26% in PCSK-9 inhibitor group and 0.23% to 6.11% in statins-based group, and the proportion of LDL-C ≤ 1.4 mmol/L increased from 10.36% to 47.69% in PCSK-9 inhibitor group and 2.99% to 18.43% in statins-based group(P < 0.001 for both). There was no significant difference between PCSK-9 inhibitor and statins-based treatment in reducing the risk of MACE(hazard ratio = 2.52, 95% CI: 0.49-12.97, P = 0.250).CONCLUSIONS In the real world, PCSK-9 inhibitors combined with statins could significantly reduce LDL-C levels among patients with very high risk of ASCVD in China. The long-term clinical benefits for patients received PCSK-9 inhibitor to reduce the risk of MACE is still unclear and requires further study.

Consensus of Chinese Specialists on Diagnosis and Treatment of Resistant Hypertension

INTRODUCTION Resistant hypertension has become a challenge in the treatment of hypertension.As the population continues to age and obesity,sleep apnea hypopnea syndrome,and chronic kidney disease increase in incidence,resistant hypertension has become an increasingly common issue in clinical practice.Failure to control blood pressure can impair target organs such as the heart,brain,and kidney,facilitating the occurrence of clinical cardiovascular events.

Age, estimated glomerular filtration rate and ejection fraction score predicts contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease： insight from the TRACK-D study

Background The occurrence of contrast induced acute kidney injury （CIAKI） has a pronounced impact on morbidity and mortality.The aim of the present study was to appraise the diagnostic efficacy of age,estimated glomerular filtration rate （eGFR） and ejection fraction （AGEF） score （age/EF（％）＋1 （if eGFR was ＜60 ml·min-1·1.73 m2）） as an predictor of CIAKI in patients with diabetes mellitus （DM） and concomitant chronic kidney disease （CKD）.Methods The AGEF score was calculated for 2 998 patients with type 2 DM and concomitant CKD who had undergone coronary/peripheral arterial angiography.CIAKI was defined as an increase in sCr concentration of 0.5 mg/dl （44.2 mmol/L） or 25％ above baseline at 72 hours after exposure to the contrast medium.Post hoc analysis was performed by stratifying the rate of CIAKI according to AGEF score tertiles.The diagnostic efficacy of the AGEF score for predicting CIAKI was evaluated with receiver operating characteristic （ROC） analysis.Results The AGEF score ranged from 0.49 to 3.09.The AGEF score tertiles were defined as follows：AGEFlow ≤0.92 （n=1 006）; 0.92 ＜AGEFmid ≤1.16 （n=1 000）,and ACEFhigh ＞1.16 （n=992）.The incidence of CIAKI was significantly different in patients with low,middle and high AGEF scores （AGEFlow=1.1％,AGEFmid=2.3％ and AGEFhigh=5.8％,P ＜0.001）.By multivariate analysis,AGEF score was an independent predictor of CIAKI （odds ratio=4.96,95％ CI：2.32-10.58,P ＜0.01）.ROC analysis showed that the area under the curve was 0.70 （95％ CI：0.648-0.753,P ＜0.001）.Conclusion The AGEF score is effective for stratifying risk of CIAKI in patients with DM and CKD undergoing coronary/peripheral arterial angiography.