Evidence map›Paper›PMID 30019751›Full record

Trial reportThe British journal of surgery2018

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

B M Biccard, A Sigamani, M T V Chan, D I Sessler, A Kurz, J G Tittley, T Rapanos, J Harlock, D Szalay, M E Tiboni and 14 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01082874 (A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01082874 phase3completednot on this map

A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2010 to 2015Enrolled10,010ConditionsCardiovascular DiseaseArmsActive Clonidine, Placebo Clonidine, Active ASA, Placebo ASA
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 17 institutions in 10 countries.

B M BiccardDepartment of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.ORCID 0000-0001-5872-8369
A SigamaniNarayana Hrudayalaya Limited, Bangalore, India.ORCID 0000-0002-6927-1947
M T V ChanDepartment of Anaesthetics, Chinese University of Hong Kong, Hong Kong, China.
D I SesslerDepartment of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA.
A KurzDepartment of General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA.
J G TittleyDivision of Vascular Surgery, McMaster University, Hamilton, Ontario, Canada.
T RapanosDivision of Vascular Surgery, McMaster University, Hamilton, Ontario, Canada.
J HarlockDivision of Vascular Surgery, McMaster University, Hamilton, Ontario, Canada.
D SzalayDivision of Vascular Surgery, McMaster University, Hamilton, Ontario, Canada.
M E TiboniDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
E PopovaBiomedical Research Institute (IIB - Sant Pau), Barcelona, Spain.
S M VásquezGrupo de Cardiología Preventiva Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia.
B KabonDepartment of Anaesthesiology, Medical University of Vienna, Vienna, Austria.
M AmirDepartment of Surgery, Shifa International Hospital/Shifa Tameer-e-Millat University, Islamabad, Pakistan.
M MrkobradaDepartment of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
B R MehraMahatma Gandhi Institute of Medical Sciences, Sevagram, India.
H El BeheiryUniversity of Toronto, Trillium Health Partners, Toronto, Ontario, Canada.
E MataHospital Universitario La Princesa, Madrid, Spain.
B TenaDepartment of Anaesthesiology, Hospital Clinic, Barcelona, Spain.
S SabatéDepartment of Anaesthesiology, Fundació Puigvert (IUNA), Barcelona, Spain.
M K Zainal AbidinDepartment of Anaesthesiology and Intensive Care, Sarawak General Hospital, Kuching, Sarawak, Malaysia.
V R ShahViroc Hospital, Vadodara, India.
K BalasubramanianPopulation Health Research Institute, Hamilton, Ontario, Canada.
P J DevereauxPopulation Health Research Institute, Hamilton, Ontario, Canada.
McMaster University · CACleveland Clinic · USPopulation Health Research Institute · CAChinese University of Hong Kong · HKHospital Clínic de Barcelona · ESHospital Universitario de La Princesa · ESInstitut d'Investigacions Biomèdiques de Barcelona · ESMahatma Gandhi Institute of Medical Sciences · INMedical University of Vienna · ATNarayana Health · INPuigvert Foundation · ESSarawak General Hospital · MYShifa Tameer-e-Millat University · PKTrillium Health Centre · CAUniversidad Autónoma de Bucaramanga · COUniversity of Cape Town · ZAWestern University · CA

Funding

CIHR 104026CIHR 116349CIHR 119385
6 · The paper itself

Abstract

backgroundIn 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.

methodsPOISE-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.

resultsOf 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.

conclusionThis 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).

Indexed as

AgedAspirinConstriction, PathologicFemaleHumansMaleMyocardial InfarctionPerioperative CarePlatelet Aggregation InhibitorsPostoperative ComplicationsPostoperative HemorrhageTreatment OutcomeVascular DiseasesVascular Surgical ProceduresAspirinPlatelet Aggregation Inhibitors

Identifiers

PMID30019751
PMCPMC7938845
OpenAlexW2883542287

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.