Safety and efficacy of paclitaxel-coated balloons in treating dysfunctional arteriovenous fistulae

A recent study has shown that paclitaxel-coated balloons (AcoArt Orchid) exhibited improved primary patency rates when treating stenotic lesions in dysfunctional hemodialysis arteriovenous (AV) fistulae when compared to plain balloon angioplasty. This study’s findings were published in the Clinical journal of the American Society of Nephrology. 

This study was a prospective, multicenter, randomized controlled trial that included 244 patients who had ≥50% venous stenosis of the AV fistula and exhibited symptoms suggesting notable hemodynamic changes. Following a successful predilation using a high-pressure balloon (residual stenosis ≤30%), patients were randomly assigned to receive either the paclitaxel-coated balloon or the uncoated control balloon in a 1:1 ratio. The primary efficacy outcome was evaluated at 6 months, and safety assessment was conducted within 30 days of the procedure. Additionally, the 12-month results were also analyzed.

The drug-coated balloon (DCB) group achieved a primary target lesion patency rate of 91% (106/116), while the plain balloon catheter group had a rate of 67% (79/118), resulting in a difference of 24.63%. In terms of the secondary efficacy end point, the DCB group had a primary target lesion patency rate of 66% (74/112) at 12 months, whereas the plain balloon catheter group had a rate of 46% (52/112). Throughout the 12-month period following the index procedure, the DCB group required a mean number of 0.39 reinterventions per patient to maintain target lesion patency, compared to 0.77 reinterventions per patient in the plain balloon catheter group.

It can be concluded that the AcoArt Orchid DCB demonstrated better primary patency rates when compared to plain balloon angioplasty in the treatment of stenotic lesions in dysfunctional hemodialysis AV fistulae at both 6 and 12 months. Additionally, it necessitated fewer repeated interventions and exhibited comparable safety over the course of one year.

Sodium bicarbonate is an effective alternative to classic heparin as a lock solution for non-tunneled dialysis catheters

According to a recent study, sodium bicarbonate has comparable efficacy to classic unfractionated heparin in the prevention of catheter lumen thrombosis. Additionally, it serves as a cost-effective alternative that can be utilized in cases where heparin is not recommended. This study’s findings were published in the journal, International urology and nephrology.

In the prospective trial, 426 patients were assigned to four groups. : femoral bicarbonate (n = 100), femoral heparin (n = 113), jugular bicarbonate (n = 113), and jugular heparin (n = 113), Patients were allocated to receive either 8.4% sodium bicarbonate or heparin (5000 IU/ml) in a consecutive manner. Information on basic characteristics, catheters, dialysis sessions, and complications was collected.

The mean time to the last effective dialysis treatment for those on heparin was 10.7 ± 12.1 days compared to 11.5 ± 10.8 days for the bicarbonate group. Among the 25 (5.9%) patients who faced blood flow issues, 13 were in the heparin group and 12 were in the bicarbonate group. Out of these 25 cases, only 12 individuals (7 in the heparin group and 5 in the bicarbonate group) experienced catheter dysfunction.

The above study showed that sodium bicarbonate is as effective as classic unfractionated heparin in the prevention of catheter lumen thrombosis. It also provides a cost-effective alternative for cases where heparin is not suitable.

Renal relapse in ANCA-associated vasculitis can be predicted by the presence of CD4 + T cells in the urine

A recent study demonstrated that urinary CD4 + T-cell counts have the potential to identify individuals with antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis who are at a significant risk of experiencing renal relapse within a 6-month period. This study’s findings were published in the Journal of the American Society of Nephrology.

The PRE-FLARED was a prospective multicenter biomarker study that enrolled 102 individuals with ANCA-associated vasculitis in remission. This study aimed to predict the occurrence of renal relapse by quantifying the levels of urinary CD4 + T-cell subsets through flow cytometry at the baseline, and then monitoring the clinical outcomes during a six-month follow-up period.

Out of the total participants, 2 had non-renal flares, 10 experienced renal relapses, and 90 remained in stable remission. Patients who relapsed had a significantly higher median baseline urinary CD4 + T-cell count compared to those in remission. The analysis of urinary CD4 + T-cell counts using receiver operating characteristic curve showed an area under the curve value of 0.88 for predicting renal flares, hematuria, proteinuria, and outperforming ANCA titers. With a cutoff of 490 CD4 + T cells per 100 ml urine, the sensitivity and specificity in identifying patients with future renal flares were 60% and 97.8%, respectively. Combining urinary CD4 + T-cell counts with proteinase-3 ANCA levels in a post hoc analysis suggested improved predictive performance in the PR3 + subgroup. Additionally, the number of urinary CD4 + T cells demonstrated a limited correlation with a decline in glomerular filtration rate (GFR) and an increase in proteinuria over the follow-up period.

According to the above study, urinary CD4+ T-cell counts could be used to detect individuals with ANCA-associated vasculitis who face a considerable risk of renal relapse within six months. The incorporation of these counts with ANCA levels has been shown to enhance the accuracy of relapse prediction.

Roxadustat is more beneficial than rHuEPO in facilitating the regression of left ventricular hypertrophy in haemodialysis patients

A recent study found that roxadustat is more beneficial than recombinant human erythropoietin (rHuEPO) in reducing left ventricular hypertrophy (LVH) in haemodialysis (HD) patients. This study’s results were published in the Journal of Internal Medicine. 
In this prospective, multi-centre, randomized trial, 114 participants were enrolled and randomized to either the roxadustat group or the rHuEPO group in a 1:1 ratio. The dosage of both treatment regimens was adjusted to achieve a haemoglobin level of 10.0-12.0 g per dL for the patients. The primary endpoint of the study was to evaluate the change in left ventricular mass index (LVMI, g/m2) measured through echocardiography from the beginning to the end of the 12-month period.
The median duration of dialysis was 33 months and the roxadustat group showed a decrease in LVMI from 116.18 ± 27.84 to 110.70 ± 25.74 g/m2. On the other hand, the rHuEPO group experienced an increase in LVMI from 109.35 ± 23.41 to 114.99 ± 28.46 g/m2. Notably, there was a significant difference in the change of LVMI between the two groups [-5.48 (-11.60 to 0.65) versus 5.65 (0.74 to 10.55)]. The roxadustat group exhibited superior changes in left ventricular mass, 6-minute walk test and the end-diastolic volume. 
Thus, it can be concluded that in HD patients, roxadustat proves to be more advantageous than rHuEPO in regression of LVH.
 

Inorganic nitrate reduces contrast-induced nephropathy following coronary angiography for acute coronary syndromes

A recent study demonstrated that for patients at risk of renal injury undergoing coronary angiography for acute coronary syndromes (ACS), a short (5-day) regimen of once-daily inorganic nitrate resulted in decreased contrast-induced nephropathy (CIN), enhanced kidney outcomes at 3 months, and reduced major adverse cardiovascular events (MACE) at 1 year when compared with individuals who received a placebo. This study’s results were published in the European Heart Journal.

The NITRATE-CIN trial was a double-blind, randomized, placebo-controlled trial that included a total of 640 patients. These patients were randomized to receive either once daily potassium nitrate (n= 319; 12 mmol) or placebo (n= 321; potassium chloride) capsules for a period of 5 days. The primary endpoint of the trial was the incidence of CIN based on KDIGO criteria. Secondary outcomes measured included kidney function (eGFR) at 3 months, rates of procedural myocardial infarction, and MACE at 12 months.

Inorganic nitrate treatment led to a significant decrease in the rates of CIN compared to the placebo (9.1% vs 30.5%). This difference remained even after adjusting for baseline creatinine levels and diabetes status. Additionally, the use of inorganic nitrate exhibited positive outcomes in secondary outcomes, including a lower incidence of procedural myocardial infarction (2.7% vs 12.5%), improved renal function at 3 months (between-group change in estimated glomerular filtration rate of 5.17), and a reduced occurrence of MACE at 1 year (9.1% vs. 18.1%) compared to the placebo group.

Thus, it can be concluded that a 5-day regimen of once-daily inorganic nitrate may be beneficial for patients undergoing coronary angiography for ACS. This treatment resulted in a decrease in CIN, improved kidney outcomes at 3 months, and reduced MACE at 1 year compared to those who received a placebo.