Evidence map›Paper›PMID 32346486›Full record

ArticlePilot and feasibility studies2020

A single-arm feasibility cohort study of rivaroxaban in antiphospholipid syndrome.

Kimberly Legault, Mark Blostein, Marc Carrier, Susan Khan, Sam Schulman, Sudeep Shivakumar, Cynthia Wu, Mark A Crowther

Erratum issued Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02116036 (Rivaroxaban in Antiphospholipid Syndrome Pilot Study), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.7field-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.

NCT02116036 phase4completednot on this map

Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis

TypeinterventionalSponsorSt. Joseph's Healthcare HamiltonRan2014 to 2017Enrolled81ConditionsAntiphospholipid Antibody SyndromeArmsRivaroxaban
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. An Update on Antiphospholipid Syndrome.Current rheumatology reports · 2022
    Review
  7. Review
  8. Review
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Kimberly Legault1Department of Medicine, McMaster University, 1280 Main St. W, Hamilton, ON L8S 4L8 Canada.
Mark Blostein2Department of Medicine, McGill University, 845 Sherbrooke St. W., Montreal, QC, H3A 2T5 Canada.
Marc Carrier3Department of Medicine, University of Ottawa, 75 Laurier Ave E, Ottawa, ON K1N 6N5 Canada.
Susan Khan2Department of Medicine, McGill University, 845 Sherbrooke St. W., Montreal, QC, H3A 2T5 Canada.
Sam Schulman1Department of Medicine, McMaster University, 1280 Main St. W, Hamilton, ON L8S 4L8 Canada.
Sudeep Shivakumar4Department of Medicine, Dalhousie University, 6299 South St, Halifax, NS B3H 4R2 Canada.
Cynthia Wu5Department of Medicine, University of Alberta, 116 St & 85 Ave, Edmonton, AB T6G 2R3 Canada.
Mark A Crowther1Department of Medicine, McMaster University, 1280 Main St. W, Hamilton, ON L8S 4L8 Canada.
McMaster University · CAMcGill University · CADalhousie University · CAUniversity of Alberta · CAUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is uncertainty regarding the safety and effectiveness of direct oral anticoagulant agents in patients with antiphospholipid syndrome (APS). We performed a multicenter feasibility study to examine our ability to identify and obtain consent from eligible APS patients and to obtain 95% adherence with daily rivaroxaban administration, in order to inform and power a larger study. Clinical outcomes of bleeding and thrombosis were also collected.

methodsAPS patients with prior venous thromboembolism (VTE) were recruited over 2 years (Oct 2014-Sept 2016) and followed for ≥ 1 year. Patients were assessed clinically every 3 months and had pill counts performed every 6 months. Numbers of patients fulfilling study criteria, as well as those consenting to participate, were tracked, and percentage adherence based on pill counts was recorded. These data were compared against the feasibility endpoints. Rates of thrombosis and bleeding were calculated. Criterion for feasibility was obtaining consent from 135 of 150 identified APS patients over 2 years.

resultsNinety-six eligible patients were identified, and 14 declined participation. Eighty-two patients were followed for a mean of 19 months, representing 129.8 patient-years. Average rivaroxaban adherence was 95.0%. During follow-up, there were 4 thromboembolic events (2 cerebrovascular and 2 VTE). There were no episodes of major bleeding.

conclusionsAdequately powered comparative trials using patient-important outcomes in APS are unlikely to be successful due to inability to recruit sufficient numbers of study subjects. This study does not reveal a higher than expected risk of recurrent thromboembolic disease compared to historical cohorts; however, this is an uncontrolled study in relatively low-risk APS patients.

trial registrationThe study was registered with clinicaltrials.gov, identifier NCT02116036, April 16, 2014.

Indexed as

Antiphospholipid syndromeFeasibility studiesHemorrhageRivaroxabanThromboembolism

Identifiers

PMID32346486
PMCPMC7183116
OpenAlexW3019320575

What OpenQuestion holds

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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.