Rheumatoid arthritis is not generally considered to be a risk factor for venous thromboembolism (VTE), although abnormalities of coagulation factors have been found in patients with rheumatoid arthritis. Sparse data in a few patients suggest that patients with rheumatoid arthritis may have higher rates of VTE. The purpose of this investigation was to determine if the incidences of pulmonary embolism (PE) and deep venous thrombosis (DVT) are increased in hospitalized patients with rheumatoid arthritis. The number of patients discharged from non-Federal short-stay hospitals throughout the United States from 1979 through 2005 with a discharge code for rheumatoid arthritis was obtained from the National Hospital Discharge Survey (NHDS). Among hospitalized patients with rheumatoid arthritis who did not have joint surgery, 41,000 of 4,818,000 (0.85%) had PE compared with 3,366,000 of 891,055,000 (0.38%) among patients who did not have rheumatoid arthritis and who did not have operations or joint surgery (relative risk = 2.25). Deep venous thrombosis was diagnosed in 79,000 of 4,818,000 (1.64%) patients with rheumatoid arthritis and no joint operation, versus 7,681,000 of 891,055,000 (0.86%) who did not have rheumatoid arthritis or a joint operation (relative risk = 1.90). The relative risk of venous thromboembolism (PE and/or DVT) in these patients was 1.99. The data suggest that rheumatoid arthritis is a risk factor for VTE in hospitalized medical patients. A heightened awareness of the risks for VTE and a lower threshold for evaluation of patients for possible DVT or PE would be appropriate in caring for hospitalized patients with rheumatoid arthritis.
Delayed graft function (DGF) is defined as need for dialysis early posttransplant. DGF is related to ischemia-reperfusion injury (IRI) that diminishes allograft function and may be complement dependent. Here, we investigate the ability of C1 esterase inhibitor (C1INH) to prevent IRI/DGF in kidney transplant recipients. Seventy patients receiving deceased donor kidney transplants at risk for DGF were randomized to receive C1INH 50 U/kg (#35) or placebo (#35) intraoperatively and at 24 hours. The primary end point was need for hemodialysis during the first week posttransplant. Assessments of glomerular filtration rate and dialysis dependence were accomplished. Complications and safety of therapy were recorded. Similar characteristics with no significant differences in cold-ischemia time or risk factors for DGF were seen. C1INH did not result in reduction of dialysis sessions at 1 week posttransplant, but significantly fewer dialysis sessions (P = .0232) were required 2 to 4 weeks posttransplant. Patients at highest risk for DGF (Kidney Donor Profile Index ≥85) benefited most from C1INH therapy. Significantly better renal function was seen at 1 year in C1INH patients (P = .006). No significant adverse events were noted with C1INH. Although the primary end point was not met, significant reductions in need for dialysis and improvements in long-term allograft function were seen with C1INH treatment.
Background and objectivesDelayed graft function is related to ischemia-reperfusion injury and may be complement dependent. We previously reported from a randomized, placebo-controlled trial that treatment with C1 esterase inhibitor was associated with a shorter duration of delayed graft function and higher eGFR at 1 year. Here, we report longer-term outcomes from this trial.Design, setting, participants, & measurementsThis is a post hoc analysis of a phase 1/2, randomized, controlled trial enrolling 70 recipients of deceased donor kidney transplants at risk for delayed graft function (NCT02134314). Subjects were randomized to receive C1 esterase inhibitor 50 U/kg (n=35) or placebo (n=35) intraoperatively and at 24 hours. The cumulative incidence functions method was used to compare graft failure and death over 3.5 years. eGFR slopes were compared using a linear mixed effects model.ResultsThree deaths occurred among C1 esterase inhibitor–treated patients compared with none receiving placebo. Seven graft failures developed in the placebo group compared with one among C1 esterase inhibitor–treated recipients; the cumulative incidence of graft failure was lower over 3.5 years among C1 esterase inhibitor–treated recipients compared with placebo (P=0.03). Although no difference in eGFR slopes was observed between groups (P for group-time interaction =0.12), eGFR declined in placebo-treated recipients (−4 ml/min per 1.73 m2 per year; 95% confidence interval, −8 to −0.1) but was stable in C1 esterase inhibitor–treated patients (eGFR slope: 0.5 ml/min per 1.73 m2 per year; 95% confidence interval, −4 to 5). At 3.5 years, eGFR was 56 ml/min per 1.73 m2 (95% confidence interval, 42 to 70) in the C1 esterase inhibitor group versus 35 ml/min per 1.73 m2 (95% confidence interval, 21 to 48) in the placebo group, with an estimated mean eGFR difference of 21 ml/min per 1.73 m2 (95% confidence interval, 2 to 41 ml/min per 1.73 m2).ConclusionsTreatment of patients at risk for ischemia-reperfusion injury and delayed graft function with C1 esterase inhibitor was associated with a lower incidence of graft failure.
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