Randomized Trial Comparing Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis (PIVOTAL): Study Design and Baseline Data

BACKGROUND: Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown. METHODS: PIVOTAL (Proactive IV irOn Therapy in hemodiALysis patients) is a multicenter, open-label, blinded endpoint, randomized controlled (PROBE) trial. Incident HD adults with a serum ferritin 700 µg/L and/or TSAT ≥40%) or a reactive, low-dose IV iron arm (iron sucrose administered if ferritin <200 µg/L or TSAT < 20%). We hypothesized that proactive, high-dose IV iron would be noninferior to reactive, low-dose IV iron for the primary outcome of first occurrence of nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for heart failure or death from any cause. If noninferiority is confirmed with a noninferiority limit of 1.25 for the hazard ratio of the proactive strategy relative to the reactive strategy, a test for superiority will be carried out. Secondary outcomes include infection-related endpoints, ESA dose requirements, and quality-of-life measures. As an event-driven trial, the study will continue until at least 631 primary outcome events have accrued, but the expected duration of follow-up is 2–4 years. RESULTS: Of the 2,589 patients screened across 50 UK sites, 2,141 (83%) were randomized. At baseline, 65.3% were male, the median age was 65 years, and 79% were white. According to eligibility criteria, all patients were on ESA at screening. Prior stroke and MI were present in 8 and 9% of the cohort, respectively, and 44% of patients had diabetes at baseline. Baseline data for the randomized cohort were generally concordant with recent data from the UK Renal Registry. CONCLUSION: PIVOTAL will provide important information about the optimum dosing of IV iron in HD patients representative of usual clinical practice. TRIAL REGISTRATION: EudraCT number: 2013-002267-25

Mechanical Thrombectomy Using the Solitaire FR system for Occlusion of the Top of the Basilar Artery: Intentional Detachment of the Device after Partial Retrieval

Acute, distal, basilar artery occlusion is a challenging neurovascular emergency. There have been several reports regarding the successful application of the Solitaire FR device for treating this lesion. However, due to the lack of a suitable, balloon-tipped, guiding catheter for the vertebral artery, during this procedure we frequently experience the occurrence of clot fragmentation and distal migration. There may be some technical solutions to solve this problem. The purpose of this report is to present a technical variation of using the Solitaire FR, and which is referred to as the 'intentional device detachment technique.' As a clot tends to re-embolize during its passage through the tortuous cranio-cervical junction level of the vertebral artery or its passage through the tip of the guiding catheter, due to the lack of proximal flow arrest, we thought that not removing the stent segment of the device which is capturing the clot could avoid this problem. We were able to successfully apply this technique in two cases. We believe that this technique can be a possible technical option for using the Solitaire FR device when a patient has little concern regarding the subsequent use of antiplatelets