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Effect of aspirin in vascular surgery in patients from a randomized clinical trial (POISE-2)

Biccard BM 1 , Sigamani A 2 , Chan MTV 3 , Sessler DI 4 , Kurz A 5 , Tittley JG 6 Show all authors , Rapanos T 6 , Harlock J 6 , Szalay D 6 , Tiboni ME 7 , Popova E 8 , Vásquez SM 9 , Kabon B 10 , Amir M 11 , Mrkobrada M 12 , Mehra BR 13 , El Beheiry H 14 , Mata E 15 , Tena B 16 , Sabaté S 17 , Zainal Abidin MK 18 , Shah VR 19 , Balasubramanian K 20 , Devereaux PJ 20

Affiliations 

  • 1 Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
  • 2 Narayana Hrudayalaya Limited, Bangalore, India
  • 3 Department of Anaesthetics, Chinese University of Hong Kong, Hong Kong, China
  • 4 Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA
  • 5 Department of General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA
  • 6 Division of Vascular Surgery, McMaster University, Hamilton, Ontario, Canada
  • 7 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  • 8 Biomedical Research Institute (IIB - Sant Pau), Barcelona, Spain
  • 9 Grupo de Cardiología Preventiva Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia
  • 10 Department of Anaesthesiology, Medical University of Vienna, Vienna, Austria
  • 11 Department of Surgery, Shifa International Hospital/Shifa Tameer-e-Millat University, Islamabad, Pakistan
  • 12 Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
  • 13 Mahatma Gandhi Institute of Medical Sciences, Sevagram, India
  • 14 University of Toronto, Trillium Health Partners, Toronto, Ontario, Canada
  • 15 Hospital Universitario La Princesa, Madrid, Spain
  • 16 Department of Anaesthesiology, Hospital Clinic, Barcelona, Spain
  • 17 Department of Anaesthesiology, Fundació Puigvert (IUNA), Barcelona, Spain
  • 18 Department of Anaesthesiology and Intensive Care, Sarawak General Hospital, Kuching, Sarawak, Malaysia
  • 19 Viroc Hospital, Vadodara, India
  • 20 Population Health Research Institute, Hamilton, Ontario, Canada
Br J Surg, 2018 11;105(12):1591-1597.
PMID: 30019751 DOI: 10.1002/bjs.10925

Abstract

BACKGROUND: In the POISE-2 (PeriOperative ISchemic Evaluation 2) trial, perioperative aspirin did not reduce cardiovascular events, but increased major bleeding. There remains uncertainty regarding the effect of perioperative aspirin in patients undergoing vascular surgery. The aim of this substudy was to determine whether there is a subgroup effect of initiating or continuing aspirin in patients undergoing vascular surgery.

METHODS: POISE-2 was a blinded, randomized trial of patients having non-cardiac surgery. Patients were assigned to perioperative aspirin or placebo. The primary outcome was a composite of death or myocardial infarction at 30 days. Secondary outcomes included: vascular occlusive complications (a composite of amputation and peripheral arterial thrombosis) and major or life-threatening bleeding.

RESULTS: Of 10 010 patients in POISE-2, 603 underwent vascular surgery, 319 in the continuation and 284 in the initiation stratum. Some 272 patients had vascular surgery for occlusive disease and 265 had aneurysm surgery. The primary outcome occurred in 13·7 per cent of patients having aneurysm repair allocated to aspirin and 9·0 per cent who had placebo (hazard ratio (HR) 1·48, 95 per cent c.i. 0·71 to 3·09). Among patients who had surgery for occlusive vascular disease, 15·8 per cent allocated to aspirin and 13·6 per cent on placebo had the primary outcome (HR 1·16, 0·62 to 2·17). There was no interaction with the primary outcome for type of surgery (P = 0·294) or aspirin stratum (P = 0·623). There was no interaction for vascular occlusive complications (P = 0·413) or bleeding (P = 0·900) for vascular compared with non-vascular surgery.

CONCLUSION: This study suggests that the overall POISE-2 results apply to vascular surgery. Perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications. Registration number: NCT01082874 ( http://www.clinicaltrials.gov).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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