Stroke in Hemodialysis Patients Randomized to Different Intravenous Iron Strategies: A Prespecified Analysis from the PIVOTAL Trial. Issue 11 (25th November 2021)

• Record Type: Journal Article
• Authors: Mark, Patrick B.; Jhund, Pardeep S.; Walters, Matthew R.; Petrie, Mark C.; Power, Albert; White, Claire; Robertson, Michele; Connolly, Eugene; Anker, Stefan D.; Bhandari, Sunil; Farrington, Kenneth; Kalra, Philip A.; Tomson, Charles R.V.; Wheeler, David C.; Winearls, Christopher G.; McMurray, John J.V.; Macdougall, Iain C.; Ford, Ian
• Other Names: author non-byline.; Winnett Georgia author non-byline.; Akbani Habib author non-byline.; Wessels Julie author non-byline.; Ayub Waqar author non-byline.; Connor Andrew author non-byline.; Brown Alison author non-byline.; Moriarty Jim author non-byline.; Chowdury Paramit author non-byline.; Griffiths Megan author non-byline.; Dasgupta Indranil author non-byline.; Doulton Timothy author non-byline.; Barratt Jonathan author non-byline.; Vilar Enric author non-byline.; Mitra Sandip author non-byline.; Ramakrishna Babu author non-byline.; Nicholas Johann author non-byline.; Ross Calum author non-byline.; Khwaja Arif author non-byline.; Hall Matt author non-byline.; Kirk Adam author non-byline.; Smith Stuart author non-byline.; Jesky Mark author non-byline.; Day Clara author non-byline.; Alchi Bassam author non-byline.; Stratton Jon author non-byline.; Clarke Helen author non-byline.; Walsh Stephen author non-byline.; Brown Rebecca author non-byline.; McCafferty Kieran author non-byline.; Solomon Laurie author non-byline.; Ramadoss Suresh author non-byline.; Ramakrishna Babu author non-byline.; Basanyake Kolitha author non-byline.; Lawman Sarah author non-byline.; Balasubramaniam Gowrie author non-byline.; Banerjee Debasish author non-byline.; Swift Pauline author non-byline.; Wellberry-Smith Matt author non-byline.; Goldsmith Christopher author non-byline.; Ledson Thomas author non-byline.; Mikhail Ashraf author non-byline.; Benzimra Ruth author non-byline.; Bell Samira author non-byline.; Severn Alison author non-byline.; Neary John author non-byline.; Doyle Arthur author non-byline.; Thomson Peter author non-byline.; Shivashankar Girish author non-byline.; Bolton Stephanie author non-byline.; Quinn Michael author non-byline.; Maxwell Peter author non-byline.; Harty John author non-byline.;
• Is Part Of: Kidney360. Volume 2:Issue 11(2021)
• Page Start: 1761
• Page End: 1769
• Publication Date: 2021-11-25
• Subjects: dialysis -- administration -- anemia -- cardiovascular disease -- heart failure -- hemodialysis -- iron -- randomized controlled trials -- renal dialysis -- stroke -- survival; 616.61
• DOI: 10.34067/KID.0004272021
• Languages: English
• ISSNs: 2641-7650

Abstract

Visual Abstract: Abstract : Key Points: In analysis of the PIVOTAL trial, proactive intravenous iron dosing was not associated with increased stroke risk in patients on hemodialysis. Risk factors for stroke included diabetes, prior stroke, higher BP, lower serum albumin, inflammation, and women. Mortality of stroke was high; 58% of patients with a stroke event died during follow-up compared with 23% without a stroke. Background: People with kidney failure treated with hemodialysis (HD) are at increased risk of stroke compared with similarly aged people with normal kidney function. One concern is that treatment of renal anemia might increase stroke risk. We studied risk factors for stroke in a prespecified secondary analysis of a randomized, controlled trial of intravenous iron treatment strategies in HD. Methods: We analyzed data from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial, focusing on variables associated with risk of stroke. The trial randomized 2141 adults who had started HD <12 months earlier and who were receiving an erythropoiesis-stimulating agent (ESA) to high-dose IV iron administered proactively or low-dose IV iron administered reactively in a 1:1 ratio. Possible stroke events were independently adjudicated. We performed analyses to identify variables associated with stroke during follow-up and assessed survival following stroke. Results: During a median 2.1 years of follow-up, 69 (3.2%) patients experienced a first postrandomization stroke. Fifty-seven (82.6%) were ischemic strokes, and 12 (17.4%) were hemorrhagic strokes. There were 34 postrandomization strokes in the proactive arm and 35 postrandomization strokes in the reactive arm (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.44; P =0.66). In multivariable models, women, diabetes, history of prior stroke at baseline, higher baseline systolic BP, lower serum albumin, and higher C-reactive protein were independently associated with stroke events during follow-up. Hemoglobin, total iron, and ESA dose were not associated with risk of stroke. Fifty-eight percent of patients with a stroke event died during follow-up compared with 23% without a stroke. Conclusions: In patients on HD, stroke risk is broadly associated with risk factors previously described to increase cardiovascular risk in this population. Proactive intravenous iron does not increase stroke risk. Clinical Trial registry name and registration number: Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL), 2013-002267-25