Evidence map›Paper›PMID 32223318›Full record

Trial reportCirculation2020

Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial.

Deepak L Bhatt, John W Eikelboom, Stuart J Connolly, P Gabriel Steg, Sonia S Anand, Subodh Verma, Kelley R H Branch, Jeffrey Probstfield, Jackie Bosch, Olga Shestakovska and 11 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01776424 (A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease), which is not on this map. Cited by 69 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 6 pooled it
14.4field-weighted citation impact, top 1% 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.

NCT01776424 phase3completednot on this map

A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).

TypeinterventionalSponsorBayerRan2013 to 2021Enrolled27,395ConditionsPrevention & ControlArmsRivaroxaban (Xarelto, BAY59-7939), Aspirin, Aspirin placebo, Rivaroxaban placebo, Pantoprazole
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 6 syntheses or guidelines pooled it, 150 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 14 institutions in 11 countries.

Deepak L BhattBrigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA (D.L.B.).
John W EikelboomPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).
Stuart J ConnollyPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).
P Gabriel StegUniversité de Paris and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).
Sonia S AnandPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).
Subodh VermaDivision of Cardiac Surgery, St Michael's Hospital, University of Toronto, Ontario, Canada (S.V.).
Kelley R H BranchUniversity of Washington Medical Centre, Seattle (K.R.H.B., J.P.).
Jeffrey ProbstfieldUniversity of Washington Medical Centre, Seattle (K.R.H.B., J.P.).
Jackie BoschPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).
Olga ShestakovskaPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).
Michael SzarekState University of New York, Downstate School of Public Health, Brooklyn (M.S.).
Aldo Pietro MaggioniANMCO Research Center, Florence, Italy (A.P.M.).
Petr WidimskýThird Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (P.W.).
Alvaro AvezumHospital Alemão Oswaldo Cruz, São Paulo, Brazil (A.A.).
Rafael DiazEstudios Clínicos Latino América, Rosario, Argentina (R.D.).
Basil S LewisLady Davis Carmel Medical Centre and the Technion-Israel Institute of Technology, Haifa (B.S.L.).
Scott D BerkowitzBayer US LLC, Whippany, NJ (S.D.B.).
Keith A A FoxCentre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).
Lars RydenDepartment of Medicine Solna, Karolinska Institutet, Stockholm, Sweden (L.R.).
Salim YusufPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).
COMPASS Steering Committee and Investigators
Population Health Research Institute · CAKarolinska Institutet · SECharles University · CZKeele University · GBAssociazione Nazionale Medici Cardiologi Ospedalieri · ITBayer (United States) · USHospital Alemão Oswaldo Cruz · BRUniversity of Washington Medical Center · USAssistance Publique – Hôpitaux de Paris · FRBrigham and Women's Hospital · USCarmel Medical Center · ILEstudios Clínicos Latinoamérica · ARSt. Michael's Hospital · CASUNY Downstate Health Sciences University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with established coronary artery disease or peripheral artery disease often have diabetes mellitus. These patients are at high risk of future vascular events.

methodsIn a prespecified analysis of the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies), we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes mellitus versus without diabetes mellitus in preventing major vascular events. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included all-cause mortality and all major vascular events (cardiovascular death, myocardial infarction, stroke, or major adverse limb events, including amputation). The primary safety end point was a modification of the International Society on Thrombosis and Haemostasis criteria for major bleeding.

resultsThere were 10 341 patients with diabetes mellitus and 17 054 without diabetes mellitus in the overall trial. A consistent and similar relative risk reduction was seen for benefit of rivaroxaban plus aspirin (n=9152) versus placebo plus aspirin (n=9126) in patients both with (n=6922) and without (n=11 356) diabetes mellitus for the primary efficacy end point (hazard ratio, 0.74,

conclusionsIn stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral end points in patients with and without diabetes mellitus. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes mellitus, including a 3-fold greater reduction in all-cause mortality. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01776424.

Indexed as

AgedAnticoagulantsAspirinCardiovascular DiseasesDiabetes MellitusDouble-Blind MethodDrug Therapy, CombinationFactor Xa InhibitorsFemaleHumansMaleMiddle AgedPlatelet Aggregation InhibitorsRivaroxabanAnticoagulantsAspirinFactor Xa InhibitorsPlatelet Aggregation InhibitorsRivaroxabananticoagulantscoronary artery diseasediabetes mellitusperipheral artery diseaseplatelet aggregation inhibitors

Identifiers

PMID32223318
PMCPMC7314494
OpenAlexW3013682615

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.