Dataset Information

Rosuvastatin Failed to Improve Arteriovenous Fistula Patency for Hemodialysis in Diabetic Patients - A Randomized Clinical Trial.

ABSTRACT:

Background

Very limited therapeutic strategies exist to prevent the primary failure of arteriovenous (AV) fistulas in patients with diabetes.

Objectives

To investigate whether rosuvastatin could improve the primary patency of AV fistulas in diabetic patients with stage 5 chronic kidney disease (CKD).

Methods

This was a double-blind randomized clinical trial. From July 2012 to September 2018, patients aged between 18 and 65 years with type 2 diabetes and stage 5 CKD were randomized to receive placebo or rosuvastatin (5 mg/day) for 7 days prior to the creation of an AV fistula on the forearm until the 21^st day after surgery. Patients were followed up for 180 days after the operation. The primary composite endpoint was the development of fistula immaturity or stenosis. The secondary endpoints were changes in inflammatory markers, oxidative stress, and occurrence of postoperative complications.

Results

A total of 60 patients were enrolled in the study. Rosuvastatin resulted in a 20% reduction in total cholesterol from postoperative day 0 to 28 (p = .0006). The overall rate of AV fistula failure (immaturity or stenosis) was 30%, with no significant difference between patients receiving rosuvastatin and those receiving the placebo (33.3% vs. 26.7%, p = .5731). Although not statistically significant, the administration of rosuvastatin might have increased the incidence of postoperative complications (2.99 vs. 2.39 event rate per 1000 patient-days; odds ratio, 1.33; p = .5986).

Conclusions

Rosuvastatin showed no significant beneficial effects on the primary patency of AV fistulas in diabetic patients with stage 5 CKD, but might have been associated with the risk of drug-related complications.

SUBMITTER: Roan JN

PROVIDER: S-EPMC7814325 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Rosuvastatin Failed to Improve Arteriovenous Fistula Patency for Hemodialysis in Diabetic Patients - A Randomized Clinical Trial.

Roan Jun-Neng JN Lin Wei-Hung WH Tsai Meng-Ta MT Kuo Te-Hui TH Lin Ting-Wei TW Chen Di-Yung DY Fang Shih-Yuan SY Hsieh Ya-Ping YP Li Chung-Yi CY Lam Chen-Fuh CF

Acta Cardiologica Sinica 20210101 1

<h4>Background</h4>Very limited therapeutic strategies exist to prevent the primary failure of arteriovenous (AV) fistulas in patients with diabetes.<h4>Objectives</h4>To investigate whether rosuvastatin could improve the primary patency of AV fistulas in diabetic patients with stage 5 chronic kidney disease (CKD).<h4>Methods</h4>This was a double-blind randomized clinical trial. From July 2012 to September 2018, patients aged between 18 and 65 years with type 2 diabetes and stage 5 CKD were ran ...[more]

PMID: 33488024

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Project description:Rationale & objectiveThe current clinical guidelines for vascular access do not have specific recommendations for older hemodialysis patients. Our study aimed to determine the association of age with arteriovenous fistula (AVF) placement, maturation, and primary and secondary patency loss among older hemodialysis recipients.Study designRetrospective cohort study.Setting & participantsA US national cohort of incident hemodialysis patients 67 years or older (N = 43,851) assembled from the US Renal Data System.ExposureAge at dialysis initiation.OutcomesAVF placement, maturation, primary patency loss, and abandonment.Analytical approachCause-specific and subdistribution proportional hazards models were used to examine the association of age and AVF outcomes, with kidney transplantation, peritoneal dialysis, and death treated as competing events. Age cutoff was identified by restricted cubic splines. We compared crude and inverse probability-weighted cumulative incidence functions using Gray's test.ResultsAs compared with those aged 67-<77 years, patients 77 years or older had significantly lower probabilities of AVF placement (adjusted cause-specific HR [cHR], 0.96 [95% CI, 0.92-0.99]; adjusted subdistribution HR [sHR], 0.92 [95% CI, 0.89-0.95]; Gray's test P < 0.001) and maturation (adjusted cHR, 0.95 [95% CI, 0.91-0.99]; adjusted sHR, 0.93 [95% CI, 0.90-0.97]; P < 0.001). However, age was not associated with AVF primary (adjusted cHR, 1.05 [95% CI, 1.00-1.11]; adjusted sHR, 1.04 [95% CI, 0.99-1.09]; P = 0.09) or secondary (adjusted cHR, 1.06 [95% CI, 0.94-1.20]; adjusted sHR, 1.05 [95% CI, 0.93-1.18]; P = 0.4) patency loss.LimitationsReliance on administrative claims to ascertain AVF outcomes.ConclusionsThe likelihood of AVF maturation is an important consideration for vascular access planning. Age alone should not be the basis for excluding older dialysis patients from AVF creation because maintenance of fistula patency was not reduced with older age despite a modest reduction in fistula maturation.

Project description:BackgroundRegional anesthesia improves short-term blood flow through arteriovenous fistulas (AVFs). We previously demonstrated that, compared with local anesthesia, regional anesthesia improves primary AVF patency at 3 months.MethodsTo study the effects of regional versus local anesthesia on longer-term AVF patency, we performed an observer-blinded randomized controlled trial at three university hospitals in Glasgow, United Kingdom. We randomly assigned 126 patients undergoing primary radiocephalic or brachiocephalic AVF creation to receive regional anesthesia (brachial plexus block; 0.5% L-bupivacaine and 1.5% lidocaine with epinephrine) or local anesthesia (0.5% L-bupivacaine and 1% lidocaine). This report includes findings on primary, functional, and secondary patency at 12 months; reinterventions; and additional access procedures (primary outcome measures were previously reported). We analyzed data by intention to treat, and also performed cost-effectiveness analyses.ResultsAt 12 months, we found higher primary patency among patients receiving regional versus local anesthesia (50 of 63 [79%] versus 37 of 63 [59%] patients; odds ratio [OR], 2.7; 95% confidence interval [95% CI], 1.6 to 3.8; P=0.02) as well as higher functional patency (43 of 63 [68%] versus 31 of 63 [49%] patients; OR, 2.1; 95% CI, 1.5 to 2.7; P=0.008). In 12 months, 21 revisional procedures, 53 new AVFs, and 50 temporary dialysis catheters were required. Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon. Results were robust after extensive sensitivity and scenario analyses.ConclusionsCompared with local anesthesia, regional anesthesia significantly improved both primary and functional AVF patency at 1 year and is cost-effective.Clinical trial registry name and registration numberLocal Anaesthesia versus Regional Block for Arteriovenous Fistulae, NCT01706354.

Project description:BackgroundIt is unclear whether surgical placement of an arteriovenous (AV) fistula (AVF) confers substantial clinical benefits over an AV graft (AVG) in older adults with end-stage kidney disease (ESKD). We report vascular access outcomes of a pilot clinical trial.Study designPilot randomized parallel-group open-label trial.Setting & participantsPatients 65 years and older with ESKD and no prior AV access receiving maintenance hemodialysis through a tunneled central venous catheter referred for AV access placement by their treating nephrologist.InterventionParticipants were randomly assigned in a 1:1 ratio to surgical placement of an AVG or AVF.OutcomesIndex AV access primary failure, successful cannulation, adjuvant interventions and infections.ResultsOf 122 older adults receiving hemodialysis and no prior AV access surgery, 24% died before (n = 18) or were too sick for (n = 11) referral for a permanent AV access. Of 46 eligible patients, 36 (78%) consented and were randomly assigned to AVG (n = 18) and AVF (n = 18) placement, of whom 13 (72%) and 16 (89%) underwent index AV access surgical placement, respectively. At a median follow-up of 321.0 days, primary AV access failure was noted in 31% in each group. The proportion of patients with successful cannulation was 62% (8 of 13) in the AVG and 50% (8 of 16) in the AVF group; median times to successful cannulation were 75.0 and 113.5 days, respectively. Endovascular procedures were recorded in 38% and 44%, and surgical reinterventions, in 23% and 25%, respectively. AV access infection was seen in 3 (23%) and 2 (13%) patients, respectively.LimitationsSmall sample size precludes statistical inference.ConclusionsAlmost one-quarter of older adults with incident ESKD and a central venous catheter as primary access were not referred for AV access placement due to medical reasons. Based on these limited results, there is little reason to favor either an AVF or AVG in this population until results from a larger randomized clinical trial become available.FundingGovernment funding to an author (Dr Murea is supported by National Institutes of Health∖National Institute on Aging grant 1R03 AG060178-01).Trial registrationNCT03545113.

Project description:ObjectiveThis study analyzed the long-term arteriovenous fistula (AVF) patency rate and its determinants in patients undergoing maintenance hemodialysis.MethodsGeneral data and laboratory examinations of hemodialysis patients were collected retrospectively. The primary patency time, primary functional patency time, cumulative patency time, cumulative functional patency time, and temporary central venous catheterization (CVC) time were counted. Cox regression was used to analyze the relationships between different factors and AVF survival time. Kaplan-Meier survival analysis was used to analyze the primary patency, primary functional patency, cumulative patency, and cumulative functional patency rates between different groups.ResultsA total of 174 patients were included (mean age 58.38 ± 15.35 years), 57 women (32.76%) and 68 diabetics (39.08%). Univariate and multivariate Cox regression showed a correlation between UCR and AVF primary patency time, primary functional patency time, cumulative patency time, and cumulative functional patency time (HR 1.127, 1.116, 1.127, 1.115, 1.088, 1.075, 1.087, 1.013; 95%CI 1.055-1.204, 1.043-1.194, 1.055-1.204, 1.042-1.194, 1.022-1.158, 1.006-1.149, 1.021-1.157, 1.004-1.147; p < 0.001, 0.001, <0.001, 0.002, 0.008, 0.033, 0.009, 0.039, respectively). Duration of temporary CVC was also correlated (HR 1.013, 1.013, 1.013, 1.014, 1.008, 1.008, 1.008, 1.008; 95%CI 1.007-1.018, 1.008-1.019, 1.008-1.019, 1.009-1.020, 1.004-1.012, 1.004-1.012, 1.004-1.012, 1.004-1.012; p < 0.001, <0.001, <0.001, <0.001, <0.001, <0.001, <0.001, <0.001, respectively). Female sex was correlated with the primary patency time and the primary functional patency time (HR 1.755, 1.765, 1.767; 95%CI 1.028-2.997, 1.034-3.014, 1.021-3.057; p = 0.039, 0.037, 0.042, respectively), but not with the cumulative patency time and the cumulative functional patency time, the primary patency rate and primary functional patency rate of AVF were higher in male than in female patients (χ2 = 4.439, 4.531; p = 0.035, 0.033, respectively). The primary patency rate, primary functional patency rate, cumulative patency rate, and cumulative functional patency rate of AVF with UCR > 10.11 group are lower than those with UCR ≤ 10.11 (χ2 = 10.745, 10.712, 4.605, 4.472; p = 0.001, 0.001, 0.032, 0.034, respectively). The group of DTCP ≤ 42 days is better than DTCP > 42 days (χ2 = 6.014, 6.055, 8.572, 8.461; p = 0.014, 0.014, 0.003, 0.004, respectively).ConclusionWomen with high UCR values at the beginning of dialysis and a long duration of temporary CVC have a poor long-term survival rate of AVF. Therefore, UCR can be used as an indicator to predict the long-term survival rate of AVF. Simultaneously, clinicians should remove the temporary catheter as early as possible if conditions permit it.

Dataset Information

Rosuvastatin Failed to Improve Arteriovenous Fistula Patency for Hemodialysis in Diabetic Patients - A Randomized Clinical Trial.

Background

Objectives

Methods

Results

Conclusions

Publications

Rosuvastatin Failed to Improve Arteriovenous Fistula Patency for Hemodialysis in Diabetic Patients - A Randomized Clinical Trial.

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