Efficacy and safety of sacubitril/valsartan in chronic Type B aortic dissection combined with mild hypertension.

BACKGROUND: Optimal antihypertensive medication for chronic Type B aortic dissection remains undecided. This study compared the efficacy and safety of sacubitril/valsartan with valsartan to determine suitable antihypertensive drug combinations. METHODS: In this single-center, open-label, randomized, controlled trial, patients with chronic Stanford type B aortic dissection and mild hypertension were randomized to receive sacubitril/valsartan 100/200 mg or valsartan 80/160 mg. The primary endpoint was the reduction in mean sitting systolic blood pressure (msSBP) at Week 8 in patients with sacubitril/valsartan versus valsartan. Key secondary endpoints included changes in 1) mean sitting diastolic blood pressure (msDBP); 2) pulse pressure; and 3) mean ambulatory blood pressure for 24-hour, daytime, and nighttime. Safety assessments included adverse events and serious adverse events. This trial was registered with the Chinese Clinical Trial Registry, identifier: ChiCTR2300073399. RESULTS: A total of 315 patients completed the study. Sacubitril/valsartan provided a significantly greater reduction in msSBP than valsartan at Week 8 (between-treatment difference: -5.1 mm Hg [95% confidence interval (CI) -5.8 to -4.5], P < 0.001). Reductions in msSBP, msDBP, and pulse pressure as well as the mean ambulatory blood pressure for 24-hour, daytime, and nighttime, were significantly greater in sacubitril/valsartan compared with valsartan (all P < 0.001). No excessive episodes of adverse events occurred in the sacubitril/valsartan group. CONCLUSION: Sacubitril/valsartan and valsartan reduced BP compared with baseline values. However, sacubitril/valsartan improved blood pressure control to a greater extent than valsartan. It may offer a new treatment option for patients with mild hypertension and chronic Type B aortic dissection.

The Impact of Contrast-Associated Acute Kidney Injury on All-Cause Mortality in Older Patients After Coronary Angiography:A 7.5-year Follow-Up.

Older patients (≥75 years) after coronary angiography constitute an increasing proportion, but only limited data are available regarding the prognosis of geriatric contrast-associated acute kidney injury (CA-AKI). Patients (≥75 years) undergoing coronary angiography between December 2010 and September 2013 were consecutively enrolled. CA-AKI was defined as an increase in serum creatinine of 25% or .5 mg/dL from the baseline within 48-72 h of contrast exposure. All-cause mortality was assessed during median 7.5 years (interquartile range [IQR] 6.7-8.7 years) follow-up period. In total, 571 patients aged >75 years undergoing coronary angiography were enrolled in a single center study; 82 (14.4%) patients had CA-AKI. The all-cause mortality during the median 7.5 years follow-up period was 22.0% in patients with CA-AKI and 13.1% in patients without CA-AKI (P = .015). After adjusting for potential confounding factors, the multivariable analysis indicated that CA-AKI was related to an increased risk of all-cause mortality during the median 7.5-year follow-up (hazard ratio [HR]: 2.46; 95% CI: 1.29-4.7; P = .006). CA-AKI is a significant and independent predictor of long-term mortality for patients aged over 75 years who underwent coronary angiography.

Cardiopulmonary prognosis of prophylactic endotracheal intubation in patients with upper gastrointestinal bleeding undergoing endoscopy.

BACKGROUND: It is controversial whether prophylactic endotracheal intubation (PEI) protects the airway before endoscopy in critically ill patients with upper gastrointestinal bleeding (UGIB). The study aimed to explore the predictive value of PEI for cardiopulmonary outcomes and identify high-risk patients with UGIB undergoing endoscopy. METHODS: Patients undergoing endoscopy for UGIB were retrospectively enrolled in the eICU Collaborative Research Database (eICU-CRD). The composite cardiopulmonary outcomes included aspiration, pneumonia, pulmonary edema, shock or hypotension, cardiac arrest, myocardial infarction, and arrhythmia. The incidence of cardiopulmonary outcomes within 48 h after endoscopy was compared between the PEI and non-PEI groups. Logistic regression analyses and propensity score matching analyses were performed to estimate effects of PEI on cardiopulmonary outcomes. Moreover, restricted cubic spline plots were used to assess for any threshold effects in the association between baseline variables and risk of cardiopulmonary outcomes (yes/no) in the PEI group. RESULTS: A total of 946 patients were divided into the PEI group (108/946, 11.4%) and the non-PEI group (838/946, 88.6%). After propensity score matching, the PEI group (n=50) had a higher incidence of cardiopulmonary outcomes (58.0% vs. 30.3%, P=0.001). PEI was a risk factor for cardiopulmonary outcomes after adjusting for confounders (odds ratio [OR] 3.176, 95% confidence interval [95% CI] 1.567-6.438, P=0.001). The subgroup analysis indicated the similar results. A shock index >0.77 was a predictor for cardiopulmonary outcomes in patients undergoing PEI (P=0.015). The probability of cardiopulmonary outcomes in the PEI group depended on the Charlson Comorbidity Index (OR 1.465, 95% CI 1.079-1.989, P=0.014) and shock index >0.77 (compared with shock index ≤0.77 [OR 2.981, 95% CI 1.186-7.492, P=0.020, AUC=0.764]). CONCLUSION: PEI may be associated with cardiopulmonary outcomes in elderly and critically ill patients with UGIB undergoing endoscopy. Furthermore, a shock index greater than 0.77 could be used as a predictor of a worse prognosis in patients undergoing PEI.

Changes of cardiac output and velocity time integral in blood return at the end of renal replacement therapy predict fluid responsiveness in critically Ill patients with acute circulatory failure.

OBJECTIVES: To observe if blood return, also defined as the blood infusion test (BIT) could predict fluid responsiveness in critically ill patients with acute circulatory failure and renal replacement therapy (RRT). METHODS: This was a single-center, prospective, diagnostic accuracy study. Before BIT, the passive leg raise test (PLRT) was performed to record the change of cardiac output (ΔCO) by pulse contour analysis, and ΔCO > = 10% was defined as the fluid responder. Meanwhile, the change in velocity time integral (ΔVTI) was recorded by ultrasound. Later, the ΔCO and ΔVTI during BIT were recorded 5-10 min after PLRT. The receiver-operating characteristic curves of ΔCO and ΔVTI of BIT were performed in predicting the fluid responder defined by PLRT. RESULTS: A total of 43 patients with acute circulatory failure undergoing RRT were enrolled in the present study, and 25 patients (58.1%) were recognized as responders during PLRT. According to the receiver-operating characteristic curves, the cutoff value of ΔCO was 10% and ΔVTI was 9% during BIT with the area under curve of 0.96 and 0.94, respectively. CONCLUSIONS: BIT in RRT could identify fluid responsiveness in critically ill patients with shock. TRIAL REGISTRATION: ChiCTR-DDD-17010534. Registered on 30/01/2017 (retrospective registration).

Hydration for prevention of kidney injury after primary coronary intervention for acute myocardial infarction: a randomised clinical trial.

OBJECTIVE: To evaluate the efficacy of aggressive hydration compared with general hydration for contrast-induced acute kidney injury (CI-AKI) prevention among patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). METHODS: The Aggressive hydraTion in patients with STEMI undergoing pPCI to prevenT Contrast-Induced Acute Kidney Injury study is an open-label, randomised controlled study at 15 teaching hospitals in China. A total of 560 adult patients were randomly assigned (1:1) to receive aggressive hydration or general hydration treatment. Aggressive hydration group received preprocedural loading dose of 125/250 mL normal saline within 30 min, followed by postprocedural hydration performed for 4 hours under left ventricular end-diastolic pressure guidance and additional hydration until 24 hours after pPCI. General hydration group received ≤500 mL 0.9% saline at 1 mL/kg/hour for 6 hours after randomisation. The primary end point is CI-AKI, defined as a >25% or 0.5 mg/dL increased in serum creatinine from baseline during the first 48-72 hours after primary angioplasty. The safety end point is acute heart failure. RESULTS: From July 2014 to May 2018, 469 patients were enrolled in the final analysis. CI-AKI occurred less frequently in aggressive hydration group than in general hydration group (21.8% vs 31.1%; risk ratio (RR) 0.70, 95% CI 0.52 to 0.96). Acute heart failure did not significantly differ between the aggressive hydration group and the general hydration group (8.1% vs 6.4%, RR 1.13, 95% CI 0.66 to 2.44). Several subgroup analysis showed the better effect of aggressive hydration in CI-AKI prevention in male, renal insufficient and non-anterior myocardial infarction participants. CONCLUSIONS: Comparing with general hydration, the peri-operative aggressive hydration seems to be safe and effective in preventing CI-AKI among patients with STEMI undergoing pPCI.

Clinical Characteristics and Long-Term Prognosis of Elderly Valvular Heart Disease Patients with Diabetes Mellitus: Five-Year Experience from a Single-Center Study of Southern China.

BACKGROUND: Diabetes mellitus (DM) is a prognostic marker in elderly patients with cardiovascular diseases, but its predictive value in elderly valvular heart disease (VHD) patients is unclear. This study aimed to investigate the effect of DM on the long-term outcome of elderly VHD patients. METHODS: This single-center, observational study enrolled patients aged 65 and older consecutively with confirmed VHD using echocardiography. Patients, divided into the DM group and non-DM group, were followed up for major adverse cardiac and cerebrovascular events (MACCEs), including all-cause death, ischemic stroke, and heart failure rehospitalization. RESULTS: Our study consisted of 532 patients over a median follow-up of 52.9 months. Compared with the non-DM group (n = 377), the DM group (n = 155) had higher incidences of ischemic stroke (25.2% vs. 13.5%, P=0.001), heart failure rehospitalization (37.4% vs. 20.7%, P < 0.001), and MACCEs (60.0% vs. 35.8%, P < 0.001). After adjustment of confounders by the multivariable cox regression, DM appeared as an independent predictor for MACCEs (adjusted hazard ratio, aHR: 1.88; 95% confidence interval 1.42-2.48; P < 0.001). In the subgroup analysis of VHD etiology and functional style, conversely, DM was a protective factor for MACCEs in the patients with rheumatic VHD compared with those without rheumatic VHD (aHR: 0.43 vs. 2.27, P=0.004). CONCLUSIONS: DM was an independent predictor for ischemic stroke and heart failure rehospitalization in elderly VHD patients undergoing conservative treatment.

Nutritional screening based on objective indices at admission predicts in-hospital mortality in patients with COVID-19.

BACKGROUND: Could nutritional status serve as prognostic factors for coronavirus disease 2019 (COVID-19)? The present study evaluated the clinical and nutritional characteristics of COVID-19 patients and explored the relationship between risk for malnutrition at admission and in-hospital mortality. METHODS: A retrospective, observational study was conducted in two hospitals in Hubei, China. Confirmed cases of COVID-19 were typed as mild/moderate, severe, or critically ill. Clinical data and in-hospital death were collected. The risk for malnutrition was assessed using the geriatric nutritional risk index (GNRI), the prognostic nutritional index (PNI), and the Controlling Nutritional Status (CONUT) via objective parameters at admission. RESULTS: Two hundred ninety-five patients were enrolled, including 66 severe patients and 41 critically ill patients. Twenty-five deaths were observed, making 8.47% in the whole population and 37.88% in the critically ill subgroup. Patients had significant differences in nutrition-related parameters and inflammatory biomarkers among three types of disease severity. Patients with lower GNRI and PNI, as well as higher CONUT scores, had a higher risk of in-hospital mortality. The receiver operating characteristic curves demonstrated the good prognostic implication of GNRI and CONUT score. The multivariate logistic regression showed that baseline nutritional status, assessed by GNRI, PNI, or CONUT score, was a prognostic indicator for in-hospital mortality. CONCLUSIONS: Despite variant screening tools, poor nutritional status was associated with in-hospital death in patients infected with COVID-19. This study highlighted the importance of nutritional screening at admission and the new insight of nutritional monitoring or therapy.

Erratum to microRNA-188 aggravates contrast-induced apoptosis by targeting SRSF7 in novel isotonic contrast-induced acute kidney injury rat models and renal tubular epithelial cells.

[This corrects the article DOI: 10.21037/atm.2019.07.20.].

Predictive Value of Hypoalbuminemia for Contrast-Associated Acute Kidney Injury: A Systematic Review and Meta-Analysis.

Contrast-associated acute kidney injury (CA-AKI) is a major adverse complication of intravascular administration of contrast medium. Current studies have shown that hypoalbuminemia might be a novel risk factor of CA-AKI. This systematic review and meta-analysis was performed to evaluate the predictive value of hypoalbuminemia for CA-AKI. Relevant studies were identified in Ovid-Medline, PubMed, Embase, and Cochrane Library up to December 31, 2019. Two authors independently screened studies, consulting with a third author when necessary to resolve discrepancies. The pooled odds ratio (OR) was calculated to assess the association between hypoalbuminemia and CA-AKI using a random-effects model or fixed-effects model. Eight relevant studies involving a total of 18 687 patients met our inclusion criteria. The presence of hypoalbuminemia was associated with an increased risk of CA-AKI development (pooled OR: 2.59, 95% CI: 1.80-3.73). Hypoalbuminemia is independently associated with the occurrence of CA-AKI and may be a potentially modifiable factor for clinical intervention. This systematic review and meta-analysis was registered in PROSPERO (CRD42020168104).

The role of the plasma glycosylated hemoglobin A1c/Apolipoprotein A-l ratio in predicting cardiovascular outcomes in acute coronary syndrome.

BACKGROUND AND AIMS: Glucose and lipid metabolism are major prognostic indicators of coronary heart disease. The ratio of plasma glycosylated hemoglobin A1c (HbA1c) to apolipoprotein A-l (ApoA-l) is an indirect measure of insulin resistance. The study aimed to evaluate whether the HbA1c/ApoA-1 ratio can predict the prognosis in patients with the acute coronary syndrome (ACS). METHODS AND RESULTS: A total of 476 ACS patients diagnosed by coronary angiography were enrolled in this longitudinal, observational, retrospective study. Plasma HbA1c, fasting blood glucose and lipid profile were measured. Patients were stratified according to the tertiles of HbA1c/ApoA-l levels. Cox proportional hazard model was used to examine the predictive value of HbA1c/ApoA-l for study endpoints. The association between the Log HbA1c/ApoA-l ratio and major adverse cardiovascular events (MACEs) was estimated using multiple logistic regression. Baseline characteristics showed a mean age of 66 ± 8 years, and 52.5% were hypertensive, 26.8% diabetic, and 54.5% current or prior smokers. During a mean follow-up period of 22.3 ± 1.7 months, 59 deaths occurred. After adjusting for age, gender, smoking, hypertension, diabetes, and coronary artery disease severity, patients in the highest HbA1c/ApoA-l ratio tertile had a 4.36-fold increased risk of mortality compared with those in the lowest tertile. The multivariate logistic regression showed that the Log HbA1c/ApoA-l ratio was associated with MACEs (Odds ratio 2.95, p = 0.013). CONCLUSION: After adjusting for traditional cardiovascular risk factors and ACS severity scores, the HbA1c/ApoA-1 ratio remained an independent predictor of all-cause mortality and MACEs in the ACS patients undergoing angiography.

Impact of contrast-induced acute kidney injury on the association between renin-angiotensin system inhibitors and long-term mortality in heart failure patients.

INTRODUCTION: Renin-angiotensin system inhibitors (RASi) reduce mortality among heart failure (HF) patients, but their effect among those complicating contrast-induced acute kidney injury (CI-AKI) remains unexplored. We aimed to investigate whether the relationship between RASi prescription at discharge and mortality differs between HF patients with or without CI-AKI following coronary angiography (CAG). METHODS: About 596 HF patients from an observational cohort were divided into a CI-AKI group (n = 104) and a non-CI-AKI group (n = 492) based on whether they had CI-AKI following CAG. The endpoint was all-cause mortality. Multivariable Cox regression was performed in each group to explore the associations between RASi at discharge and mortality. RESULTS: During the median follow-up time of 2.26 (1.70; 3.24) years, higher mortality rate was observed in the CI-AKI group compared to the non-CI-AKI group (18.3% vs 8.9%, p = 0.002). Among HF patients with CI-AKI, after adjusting for confounding factors, the association was not significant between RASi prescription at discharge and mortality (HR: 0.39, 95%CI: 0.12-1.31, p = 0.128), while it was among those without CI-AKI (HR: 0.39, 95%CI: 0.18-0.84, p = 0.016). CONCLUSION: RASi prescription at discharge for HF patients complicating CI-AKI tended to be ineffective, while it benefited those without CI-AKI. Further randomized evidence is needed to confirm this trend.

Characteristics and requirements of hypertensive patients willing to use digital health tools in the Chinese community: a multicentre cross-sectional survey.

BACKGROUND: Digital health tools (WeChat or mobile health apps) provide opportunities for new methods of hypertension management for hypertensive patients. However, the willingness of these patients to use social media and mobile health apps for hypertension management remains unclear. This study explored the characteristics and requirements of patients willing to use digital health (WDH) tools to manage hypertension. METHODS: From February to March 2018, we administered questionnaires to 1089 patients with hypertension at eight Chinese primary medical units. We assessed independent risk factors of WDH and requirement among WDH patients. RESULTS: Overall, 43% (465/1089) of participants were WDH patients, who were younger (58 ± 12 vs 61 ± 13 years) and had a greater proportion of employed individuals (31% vs 14%) and higher education levels (65% vs 52%) than the non-WDH patients (all P < 0.0001). After adjusting for other risk factors, higher education (OR: 0.52; 95% CI: 0.34-0.79), good medicine adherence (OR: 1.5; 95% CI: 1.0-2.3) and blood pressure self-monitoring (OR: 1.6; 95% CI: 1.2-2.3) remained significantly associated with WDH (all P < 0.05). WDH patients responded that digital health tools should try to provide a platform for blood pressure monitoring (42%), medication reminders (41%), hypertension knowledge (39%) and doctor-patient communication (32%). CONCLUSION: Our survey suggested that among hypertensive patients, willingness to use digital health tools was significantly associated with education, medicine adherence and blood pressure self-monitoring. Digital health tool developers and researchers should pay particular attention to recruiting older, less educated and unemployed patients with less willingness and who are less technologically savvy and research the requirements of WDH patients (blood pressure monitoring, medication reminders, and knowledge education) in the future.

A prediction model of contrast-associated acute kidney injury in patients with hypoalbuminemia undergoing coronary angiography.

BACKGROUND: Risk stratification is recommended as the key step to prevent contrast-associated acute kidney injury (CA-AKI) among at-risk patients following coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). Patients with hypoalbuminemia are prone to CA-AKI and do not have their own risk stratification tool. Therefore, this study developed and validated a new model for predicting CA-AKI among hypoalbuminemia patients CAG/PCI. METHODS: 1272 patients with hypoalbuminemia receiving CAG/PCI were enrolled and randomly allocated (2:1 ratio) into the development cohort (n = 848) and the validation cohort (n = 424). CA-AKI was defined as an increase of ≥0.3 mg/dL or 50% in serum creatinine (SCr) compared to baseline in the 48 to 72 h after CAG/PCI. A prediction model was established with independent predictors according to stepwise logistic regression, showing as a nomogram. The discrimination of the new model was evaluated by the area under the curve (AUC) and was compared to the classic Mehran CA-AKI model. The Hosmer-Lemeshow test was conducted to assess the calibration of our model. RESULTS: Overall, 8.4% (71/848) patients of the development group and 11.2% (48/424) patients of the validation group experienced CA-AKI. A new nomogram included estimated glomerular filtration rate (eGFR), serum albumin (ALB), age and the use of intra-aortic balloon pump (IABP); showed better predictive ability than the Mehran score (C-index 0.756 vs. 0.693, p = 0.02); and had good calibration (Hosmer-Lemeshow test p = 0.187). CONCLUSIONS: We developed a simple model for predicting CA-AKI among patients with hypoalbuminemia undergoing CAG/PCI, but our findings need validating externally. TRIAL REGISTRATION: http://www.ClinicalTrials.gov NCT01400295 , retrospectively registered 21 July 2011.

The relationship between hyperuricemia and contrast-induced acute kidney injury undergoing primary percutaneous coronary intervention: secondary analysis protocol for the ATTEMPT RESCIND-1 study.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) contributes toward unfavorable clinical outcomes after primary percutaneous coronary intervention (pPCI). We will assess whether hyperuricemia is an independent predictor of CI-AKI and outcomes in patients undergoing pPCI. METHODS/DESIGN: Our study is a secondary analysis for the database from ATTEMPT study, enrolling 560 ST-segment elevation myocardial infarction (STEMI) patients undergoing pPCI. Patients will be divided into 2 groups according to the admission serum uric acid (SUA) level. Hyperuricemia will be defined as a SUA level > 7 mg/dL (417 mmol/L) in males and > 6 mg/dL (357 mmol/L) in females. The primary endpoint was CI-AKI, defined as > 25% or 0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 h post-procedurally. Multivariate analyses for CI-AKI and long-term mortality will be performed using the logistic regression and Cox regression analyses, respectively. DISCUSSION: This study will determine the predictive value of hyperuricemia for the development of CI-AKI and outcomes in patients with STEMI undergoing pPCI. We predict that hyperuricemia will be associated with a risk of CI-AKI in patients with pPCI. Furthermore, after adjusting for other variables, long-term mortality after pPCI may be higher in those with hyperuricemia than in those with normouricemia. Results of this study may provide scientific evidence for the effect of hyperuricemia on CI-AKI and long-term outcomes, thereby offering the potential possibility of lowering SUA on the development of CI-AKI and outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02067195, Registered on 20 February 2014.

Patient-level and system-level barriers associated with treatment delays for ST elevation myocardial infarction in China.

OBJECTIVE: This study aims to understand the current ST elevated myocardial infarction (STEMI) treatment process in Guangdong Province and explore patient-level and system-level barriers associated with delay in STEMI treatment, so as to provide recommendations for improvement. METHODS: This is a qualitative study. Data were collected using semistructured, face-to-face individual interviews from April 2018 to January 2019. Participants included patients with STEMI, cardiologists and nurses from hospitals, emergency department doctors, primary healthcare providers, local health governors, and coordinators at the emergency medical system (EMS). An inductive thematic analysis was adopted to generate overarching themes and subthemes for potential causes of STEMI treatment delay. The WHO framework for people-centred integrated health services was used to frame recommendations for improving the health system. RESULTS: Thirty-two participants were interviewed. Patient-level barriers included poor knowledge in recognising STEMI symptoms and not calling EMS when symptoms occurred. Limited capacity of health professionals in hospitals below the tertiary level and lack of coordination between hospitals of different levels were identified as the main system-level barriers. Five recommendations were provided: (1) enhance public health education; (2) strengthen primary healthcare workforce; (3) increase EMS capacity; (4) establish an integrated care model; and (5) harness government's responsibilities. CONCLUSIONS: Barriers associated with delay in STEMI treatment were identified at both patient and system levels. The results of this study provide a useful evidence base for future intervention development to improve the quality of STEMI treatment and patient outcomes in China and other countries in a similar situation.

Population attributable risk estimates of risk factors for contrast-induced acute kidney injury following coronary angiography: a cohort study.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is a common complication with poor outcomes following coronary angiography (CAG) or percutaneous coronary intervention (PCI). However, no study has explored the population attributable risks (PARs) of the CI-AKI risk factors. Therefore, we aimed to identify the independent risk factors of CI-AKI and estimate their PARs. METHODS: We analyzed 3450 consecutive patients undergoing CAG/PCI from a prospective cohort in Guangdong Provincial People's Hospital. CI-AKI was defined as a serum creatinine elevation ≥50% or 0.3 mg/dL from baseline within the first 48 to 72 h after the procedure. Independent risk factors for CI-AKI were evaluated through stepwise approach and multivariable logistic regression analysis, and those that are potentially modifiable were of interest. PARs of independent risk factors were calculated with their odds ratios and prevalence among our cohort. RESULTS: The overall incidence of CI-AKI was 7.19% (n = 248), which was associated with increased long-term mortality. Independent risk factors for CI-AKI included heart failure (HF) symptoms, hypoalbuminemia, high contrast volume, hypotension, hypertension, chronic kidney disease stages, acute myocardial infarction and age > 75 years. Among the four risk factors of interest, the PAR of HF symptoms was the highest (38.06%), followed by hypoalbuminemia (17.69%), high contrast volume (12.91%) and hypotension (4.21%). CONCLUSIONS: These modifiable risk factors (e.g., HF symptoms, hypoalbuminemia) could be important and cost-effective targets for prevention and treatment strategies to reduce the risk of CI-AKI. Intervention studies targeting these risk factors are needed.

Clinical features of severe patients infected with 2019 novel coronavirus: a systematic review and meta-analysis.

BACKGROUND: 2019 novel coronavirus disease (COVID-19) has posed significant threats to public health. To identify and treat the severe and critical patients with COVID-19 is the key clinical problem to be solved. The present study aimed to evaluate the clinical characteristics of severe and non-severe patients with COVID-19. METHODS: We searched independently studies and retrieved the data that involved the clinical characteristics of severe and non-severe patients with COVID-19 through database searching. Two authors independently retrieved the data from the individual studies, assessed the study quality with Newcastle-Ottawa Scale and analyzed publication bias by Begg's test. We calculated the odds ratio (OR) of groups using fixed or random-effect models. RESULTS: Five studies with 5,328 patients confirmed with COVID-19 met the inclusion criteria. Severe patents were older and more common in dyspnea, vomiting or diarrhea, creatinine >104 µmol/L, procalcitonin ≥0.05 ng/mL, lymphocyte count <1.5×109/L and bilateral involvement of chest CT. Severe patents had higher risk on complications including acute cardiac injury (OR 13.48; 95% CI, 3.60 to 50.47, P<0.001) or acute kidney injury (AKI) (OR 11.55; 95% CI, 3.44 to 38.77, P<0.001), acute respiratory distress syndrome (ARDS) (OR 26.12; 95% CI, 11.14 to 61.25, P<0.001), shock (OR 53.17; 95% CI, 12.54 to 225.4, P<0.001) and in-hospital death (OR 45.24; 95% CI, 19.43 to 105.35, P<0.001). Severe group required more main interventions such as received antiviral therapy (OR 1.69; 95% CI, 1.23 to 2.32, P=0.001), corticosteroids (OR 5.07; 95% CI, 3.69 to 6.98, P<0.001), CRRT (OR 37.95; 95% CI, 7.26 to 198.41, P<0.001) and invasive mechanical ventilation (OR 129.35; 95% CI, 25.83 to 647.68, P<0.001). CONCLUSIONS: Severe patients with COVID-19 had more risk of clinical characteristics and multiple system organ complications. Even received more main interventions, severe patients had higher risk of mortality.

Post-PCI acute heart failure is an independent predictor of long-term mortality in patients with chronic kidney disease.

BACKGROUND: This study aimed to clarify the association of post-percutaneous coronary intervention (PCI) acute heart failure (AHF) with all-cause long-term mortality in patients with chronic kidney disease (CKD). METHODS: In this prospective, observational study, 610 patients with CKD and coronary artery disease (CAD) undergoing PCI were included in the final analysis. Patients were divided to the non post-PCI AHF group (n = 557) and the post-PCI AHF group (n = 53). The diagnosis of post-PCI AHF was based on symptoms, prior cardiovascular history, and potential cardiac and noncardiac precipitants. RESULTS: The overall incidence of post-PCI AHF was 53/610 (8.7%). The incidence of all-cause long-term mortality was significantly higher in the post-PCI AHF group than in the non post-PCI AHF group (50.9% vs 23.2%, P < .01). The median follow-up period was 7.3 years (interquartile range: 3.7-8.4). After adjusting for left ventricular ejection fraction <40% at discharge, CKD stage, acute myocardial infarction, age and smoking, post-PCI AHF was the strongest predictor of all-cause long-term mortality (hazard ratio: 8.08; 95% CI: 3.04-21.48; P < .01). CONCLUSIONS: In patients with CKD and CAD undergoing PCI, post-PCI AHF is the strongest predictor of all-cause long-term mortality.

Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.

BACKGROUND: The ATTEMPT study is a multicenter, randomized controlled trial which is investigator-based and open label in nature. For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group). To improve the quality of the study's analysis and to minimize analysis bias based on the study's findings. METHODS: The design of the statistical analysis plan (SAP) was created by chief investigators and statisticians and received permission from the aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) management committee. Treatment allocation and research data were reviewed by the Data Safety and Monitoring Committee and researchers were kept blind. We produced data shells based on a pre-existing published protocol and produced detailed descriptions of statistical analyses. This study includes primary, secondary and safety endpoints. Relevant statistical comparisons were planned and discussed in a transparent manner. They are publicly available, verifiable and were determined prior to the data collection process being completed. RESULTS: We developed a SAP for the ATTEMPT study and an outline and list of mock tables were also created. We produced descriptions of analyses of baseline characteristics, patient care approaches, efficacy measures, and outcomes. This study defined five previously specified subgroups and compared the statistics of groups within these subgroups. CONCLUSIONS: This SAP has been developed for the ATTEMPT study and has high-quality standards of internal validity to minimize analysis bias. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02067195.