Subject(s)
Angiogenesis Inhibitors/therapeutic use , Laser Coagulation/methods , Macular Edema/therapy , Ranibizumab/therapeutic use , Retinal Vein Occlusion/therapy , Adult , Aged , Aged, 80 and over , Combined Modality Therapy , Female , Fluorescein Angiography , Humans , Intravitreal Injections , Macular Edema/etiology , Macular Edema/physiopathology , Male , Middle Aged , Prospective Studies , Retinal Vein Occlusion/complications , Retinal Vein Occlusion/physiopathology , Retreatment , Surgery, Computer-Assisted , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Visual Acuity/physiologyABSTRACT
PURPOSE: To determine whether the efficacy and safety achieved with 2.0 mg intravitreal aflibercept injections (IAIs) for diabetic macular edema (DME) during the phase III VISTA DME trial were maintained with individualized, as-needed treatment. DESIGN: Phase IV, multicenter, open-label extension study. METHODS: Sixty patients completing VISTA DME elected to enter the ENDURANCE extension study. All patients received IAIs in the presence of clinically relevant DME. Patients were observed at 4-, 8-, or 12-week intervals depending on the need for treatment. Main outcome measures were mean IAIs given through month 12 (M12), the proportion of patients receiving no IAIs, and the role of macular laser in decreasing treatment burden among patients requiring ongoing IAIs. RESULTS: A mean of 4.5 IAIs were administered through M12. Eighteen (30%) patients required no IAIs, and among those who met IAI retreatment criteria, a mean of 6.0 IAIs were administered through M12. Best-corrected visual acuity gains achieved during VISTA DME were maintained and stable with individualized dosing during ENDURANCE, fluctuating by <1.5 mean letters from the baseline at all time points. Likewise, mean central retinal thickness remained relatively stable during ENDURANCE. Thirty-seven (62%) patients met macular laser criteria at a mean of 19.5 weeks with no significant difference in the frequency of IAIs before or after macular laser. CONCLUSION: Vision gains achieved during the 3-year VISTA DME trial were maintained through M12 of the ENDURANCE extension study with a reduced treatment frequency, with 30% of patients receiving no IAIs. No significant reduction in IAI frequency was observed after macular laser application.
Subject(s)
Diabetic Retinopathy/complications , Laser Coagulation/methods , Macula Lutea/diagnostic imaging , Macular Edema/drug therapy , Receptors, Vascular Endothelial Growth Factor/administration & dosage , Recombinant Fusion Proteins/administration & dosage , Adult , Aged , Aged, 80 and over , Diabetic Retinopathy/diagnosis , Diabetic Retinopathy/drug therapy , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Humans , Intravitreal Injections , Macular Edema/diagnosis , Macular Edema/etiology , Male , Middle Aged , Retrospective Studies , Time Factors , Tomography, Optical Coherence , Treatment Outcome , Visual AcuityABSTRACT
OBJECTIVE: The relationship between baseline (i.e., pre-injury) blood pressure and trauma outcomes in elderly patients is unknown. We therefore aimed to identify the independent impact of baseline systolic blood pressure (SBP) on inpatient mortality among elderly trauma patients. METHODS: The 2004 to 2014 trauma registries of two Level I Trauma Centers were linked to electronic health records then reviewed to identify patients ≥65 years old with available baseline vital signs. Baseline SBP was defined as mean outpatient SBP within 2 years before injury. Trauma SBP was defined as first SBP reading after presentation for trauma. Baseline and Trauma SBP were classified as Low (<110 mm Hg), Normal (110-139 mm Hg), or High (≥140 mm Hg). Logistic multivariable regression models were constructed to assess the independent impact of Baseline SBP on inpatient mortality, controlling for demographics, comorbidities, injury mechanism/severity, and Trauma SBP. RESULTS: Of 37,494 patient admissions, 4,233 met inclusion criteria. Median age was 81 years; 63.6% were female. Mortality was 5.39%. In unadjusted analyses, mortality rates were 11.01%, 5.28%, and 4.52% in the Low, Normal, and High Baseline SBP groups, respectively (p = 0.001). In multivariable analyses, patients with Low Baseline SBP had significantly increased mortality risk [OR 3.19 (95% CI 1.62-6.26), p = 0.001] compared to patients with Normal Baseline SBP, in particular when they presented with Low Trauma SBP (<110 mm Hg) [OR 6.14 (2.17-17.36), p = 0.001] or Normal Trauma SBP (110-139 mm Hg) [OR 3.87 (1.43-10.45), p = 0.008]. The mortality risk associated with Low Baseline SBP was particularly elevated among patients with a pre-existing diagnosis of hypertension [OR 4.78 (1.97-11.62), p = 0.001]. CONCLUSION: Low baseline pre-injury SBP is independently associated with more than a threefold increase in inpatient mortality among elderly trauma patients and a fivefold increase in mortality risk among patients with pre-existing hypertension. Given that blood pressure control in the elderly offers a long-term survival advantage, the paradoxical finding of decreased survival after trauma warrants further investigation. LEVEL OF EVIDENCE: Prognostic/epidemiologic study, level III.
