Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone.

PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS: LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Preliminary evaluation of a new index to predict the outcome of a spontaneous breathing trial.

BACKGROUND: The available predictors of spontaneous-breathing-trial (SBT) success/failure lack accuracy. We devised a new index, the CORE index (compliance, oxygenation, respiration, and effort). OBJECTIVE: To compare the CORE index to the CROP index (compliance, rate, oxygenation, and pressure), airway-occlusion pressure 0.1 s after the start of inspiratory flow (P(0.1)), and rapid shallow breathing index (RSBI) for predicting SBT success/failure in a critical care environment. METHODS: With 47 mechanically ventilated patients recovering from respiratory failure, of various causes, we prospectively examined the SBT success/failure prediction accuracy and calculated receiver operating characteristic curves, sensitivity, specificity, and likelihood ratios of CORE, CROP, P(0.1), and RSBI. RESULTS: The specificities were CORE 0.95, P(0.1) 0.70, CROP 0.70, and RSBI 0.65. The sensitivities were CORE 1.00, CROP 1.00, P(0.1) 0.93, and RSBI 0.89. The areas under the receiver operating characteristic curve were CORE 1.00 (95% CI 0.92-1.00), CROP 0.91 (95% CI 0.79-0.97), P(0.1) 0.81 (95% CI 0.67-0.91), and RSBI 0.77 (95% CI 0.62-0.88). The positive likelihood ratios were CORE 20.0, CROP 3.3, P(0.1) 3.1, and RSBI 2.5. The negative likelihood ratios were CORE 0.0, CROP 0.0, P(0.1) 0.1, and RSBI 0.2. CONCLUSIONS: The CORE index was the most accurate predictor of SBT success/failure.