Evidence map›Paper›PMID 34021038›Full record

Trial reportHeart (British Cardiac Society)2021

Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease.

Gilles R Dagenais, Leanne Dyal, Jacqueline J Bosch, Darryl P Leong, Victor Aboyans, Scott D Berkowitz, Deepak L Bhatt, Stuart J Connolly, Keith A A Fox, Eva Muehlhofer and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Heart (British Cardiac Society), 2021. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?Journal of health economics and outcomes research · 2024
    Article
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

15 authors at 8 institutions in 5 countries.

Gilles R DagenaisDepartment of Cardiology, Laval University Heart and Lung Institute, Quebec, Québec, Canada gilles.dagenais@criucpq.ulaval.ca.ORCID 0000-0002-4509-2004
Leanne DyalPopulation Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada.
Jacqueline J BoschPopulation Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada.
Darryl P LeongPopulation Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada.
Victor AboyansDepartment of Cardiology, Dupuytren University Hospital, Limoges, France.
Scott D BerkowitzBayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.ORCID 0000-0002-9428-4408
Deepak L BhattBrigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts, USA.
Stuart J ConnollyPopulation Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada.
Keith A A FoxDepartment of Medicine, University of Edinburgh, Edinburgh, UK.
Eva MuehlhoferBayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.
Jeffrey L ProbstfieldDepartment of Medicine (Cardiology), University of Washington Medical Centre, Seattle, Washington, USA.
Petr WidimskyCardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University Prague, Prague, Czech Republic.
Bernhard R WinkelmannKardiologische Studienpraxis und ClinPhenomics GmbH&Co, Studienzentrum Schaumainkai Frankfurt, Frankfurt, Germany.
Salim YusufPopulation Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada.
John W EikelboomPopulation Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada.
Population Health Research Institute · CABayer (United States) · USBrigham and Women's Hospital · USCharles University · CZEdinburgh College · GBInserm · FRLung Institute · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn patients with chronic coronary or peripheral artery disease enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, randomised antithrombotic treatments were stopped after a median follow-up of 23 months because of benefits of the combination of rivaroxaban 2.5 mg two times per day and aspirin 100 mg once daily compared with aspirin 100 mg once daily. We assessed the effect of switching to non-study aspirin at the time of early stopping.

methodsIncident composite of myocardial infarction, stroke or cardiovascular death was estimated per 100 person-years (py) during randomised treatment (n=18 278) and after study treatment discontinuation to non-study aspirin (n=14 068).

resultsDuring randomised treatment, the combination compared with aspirin reduced the composite (2.2 vs 2.9/100 py, HR: 0.76, 95% CI 0.66 to 0.86), stroke (0.5 vs 0.8/100 py, HR: 0.58, 95% CI 0.44 to 0.76) and cardiovascular death (0.9 vs 1.2/100 py, HR: 0.78, 95% CI 0.64 to 0.96). During 1.02 years after early stopping, participants originally randomised to the combination compared with those randomised to aspirin had similar rates of the composite (2.1 vs 2.0/100 py, HR: 1.08, 95% CI 0.84 to 1.39) and cardiovascular death (1.0 vs 0.8/100 py, HR: 1.26, 95% CI 0.85 to 1.86) but higher stroke rate (0.7 vs 0.4/100 py, HR: 1.74, 95% CI 1.05 to 2.87) including a significant increase in ischaemic stroke during the first 6 months after switching to non-study aspirin.

conclusionDiscontinuing study rivaroxaban and aspirin to non-study aspirin was associated with the loss of cardiovascular benefits and a stroke excess. TRIAL REGISTRATION NUMBER: NCT01776424.

Indexed as

AspirinCoronary DiseaseIschemic StrokeMyocardial InfarctionPeripheral Arterial DiseaseRivaroxabanAgedDrug MonitoringDrug SubstitutionDrug Therapy, CombinationDuration of TherapyFemaleFibrinolytic AgentsHumansMaleMortalityAspirinFibrinolytic AgentsRivaroxabanacute coronary syndromeclinicalcoronary artery diseaseperipheral vascular diseasespharmacologystroke

Identifiers

PMID34021038
PMCPMC8257559
OpenAlexW3161911334

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.