K Leslie1, D McIlroy2, J Kasza3, A Forbes3, A Kurz4, J Khan5, C S Meyhoff6, R Allard7, G Landoni8, X Jara9, G Lurati Buse10, K Candiotti11, H-S Lee12, R Gupta13, T VanHelder14, W Purayil15, S De Hert16, T Treschan17, P J Devereaux18. 1. Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia Anaesthesia, Perioperative and Pain Medicine Unit Department of Pharmacology, University of Melbourne, Melbourne, Australia Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia kate.leslie@mh.org.au. 2. Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia. 3. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. 4. Department of Outcomes Research, Cleveland Clinic, Cleveland, USA. 5. Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Canada Departments of Clinical Epidemiology Biostatistics, McMaster University, Hamilton, Canada Department of Anesthesiology, University of Toronto, Toronto, Canada. 6. Department of Anaesthesiology, Herlev Hospital and University of Copenhagen, Herlev, Denmark. 7. Department of Anesthesiology and Perioperative Medicine, Kingston General Hospital and Queen's University, Kingston, Canada. 8. Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute and Vita-Salute University, Milan, Italy. 9. Department of Anesthesiology, Clinica Santa Maria and Universidad de Los Andes, Santiago, Chile. 10. Department of Anaesthesiology, Juravinski Hospital, Hamilton, Canada. 11. Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami, Miami, USA. 12. Department of Anesthesiology, Sultanah Aminah Hospital, Johor Bahru, Malaysia. 13. Department of Medicine, Fortis Escorts Hospital, Jaipur, India. 14. Department of Anesthesia, Hamilton General Hospital, Hamilton, Canada. 15. Department of Anaesthesia, Westfort Hi-tech Hospital, Thrissur, India. 16. Department of Anaesthesiology, Ghent University Hospital, Ghent, Belgium. 17. Department of Anaesthesiology, Duesseldorf University Hospital, Duesseldorf, Germany. 18. Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Canada Departments of Clinical Epidemiology Biostatistics, McMaster University, Hamilton, Canada Department of Medicine, McMaster University, Hamilton, Canada.
Abstract
BACKGROUND: We assessed associations between intraoperative neuraxial block and postoperative epidural analgesia, and a composite primary outcome of death or non-fatal myocardial infarction, at 30 days post-randomization in POISE-2 Trial subjects. METHODS: 10 010 high-risk noncardiac surgical patients were randomized aspirin or placebo and clonidine or placebo. Neuraxial block was defined as intraoperative spinal anaesthesia, or thoracic or lumbar epidural anaesthesia. Postoperative epidural analgesia was defined as postoperative epidural local anaesthetic and/or opioid administration. We used logistic regression with weighting using estimated propensity scores. RESULTS:Neuraxial block was not associated with the primary outcome [7.5% vs 6.5%; odds ratio (OR), 0.89; 95% CI (confidence interval), 0.73-1.08; P=0.24], death (1.0% vs 1.4%; OR, 0.84; 95% CI, 0.53-1.35; P=0.48), myocardial infarction (6.9% vs 5.5%; OR, 0.91; 95% CI, 0.74-1.12; P=0.36) or stroke (0.3% vs 0.4%; OR, 1.05; 95% CI, 0.44-2.49; P=0.91). Neuraxial block was associated with less clinically important hypotension (39% vs 46%; OR, 0.90; 95% CI, 0.81-1.00; P=0.04). Postoperative epidural analgesia was not associated with the primary outcome (11.8% vs 6.2%; OR, 1.48; 95% CI, 0.89-2.48; P=0.13), death (1.3% vs 0.8%; OR, 0.84; 95% CI, 0.35-1.99; P=0.68], myocardial infarction (11.0% vs 5.7%; OR, 1.53; 95% CI, 0.90-2.61; P=0.11], stroke (0.4% vs 0.4%; OR, 0.65; 95% CI, 0.18-2.32; P=0.50] or clinically important hypotension (63% vs 36%; OR, 1.40; 95% CI, 0.95-2.09; P=0.09). CONCLUSIONS:Neuraxial block and postoperative epidural analgesia were not associated with adverse cardiovascular outcomes among POISE-2 subjects.
RCT Entities:
BACKGROUND: We assessed associations between intraoperative neuraxial block and postoperative epidural analgesia, and a composite primary outcome of death or non-fatal myocardial infarction, at 30 days post-randomization in POISE-2 Trial subjects. METHODS: 10 010 high-risk noncardiac surgical patients were randomized aspirin or placebo and clonidine or placebo. Neuraxial block was defined as intraoperative spinal anaesthesia, or thoracic or lumbar epidural anaesthesia. Postoperative epidural analgesia was defined as postoperative epidural local anaesthetic and/or opioid administration. We used logistic regression with weighting using estimated propensity scores. RESULTS: Neuraxial block was not associated with the primary outcome [7.5% vs 6.5%; odds ratio (OR), 0.89; 95% CI (confidence interval), 0.73-1.08; P=0.24], death (1.0% vs 1.4%; OR, 0.84; 95% CI, 0.53-1.35; P=0.48), myocardial infarction (6.9% vs 5.5%; OR, 0.91; 95% CI, 0.74-1.12; P=0.36) or stroke (0.3% vs 0.4%; OR, 1.05; 95% CI, 0.44-2.49; P=0.91). Neuraxial block was associated with less clinically important hypotension (39% vs 46%; OR, 0.90; 95% CI, 0.81-1.00; P=0.04). Postoperative epidural analgesia was not associated with the primary outcome (11.8% vs 6.2%; OR, 1.48; 95% CI, 0.89-2.48; P=0.13), death (1.3% vs 0.8%; OR, 0.84; 95% CI, 0.35-1.99; P=0.68], myocardial infarction (11.0% vs 5.7%; OR, 1.53; 95% CI, 0.90-2.61; P=0.11], stroke (0.4% vs 0.4%; OR, 0.65; 95% CI, 0.18-2.32; P=0.50] or clinically important hypotension (63% vs 36%; OR, 1.40; 95% CI, 0.95-2.09; P=0.09). CONCLUSIONS: Neuraxial block and postoperative epidural analgesia were not associated with adverse cardiovascular outcomes among POISE-2 subjects.
Authors: K Leslie; P Myles; P Devereaux; E Williamson; P Rao-Melancini; A Forbes; S Xu; P Foex; J Pogue; M Arrieta; G Bryson; J Paul; M Paech; R Merchant; P Choi; N Badner; P Peyton; J Sear; H Yang Journal: Br J Anaesth Date: 2013-04-23 Impact factor: 9.166
Authors: P J Devereaux; Homer Yang; Salim Yusuf; Gordon Guyatt; Kate Leslie; Juan Carlos Villar; Denis Xavier; Susan Chrolavicius; Launi Greenspan; Janice Pogue; Prem Pais; Lisheng Liu; Shouchun Xu; German Málaga; Alvaro Avezum; Matthew Chan; Victor M Montori; Mike Jacka; Peter Choi Journal: Lancet Date: 2008-05-12 Impact factor: 79.321
Authors: Carlos E Guerra-Londono; Ann Privorotskiy; Crispiana Cozowicz; Rachel S Hicklen; Stavros G Memtsoudis; Edward R Mariano; Juan P Cata Journal: JAMA Netw Open Date: 2021-11-01