Evidence map›Paper›PMID 33247017›Full record

Observational studyBMJ open2020

Bleeding and thrombotic complications during treatment with direct oral anticoagulants or vitamin K antagonists in venous thromboembolic patients included in the prospective, observational START2-register.

Gualtiero Palareti, Emilia Antonucci, Cristina Legnani, Daniela Mastroiacovo, Daniela Poli, Paolo Prandoni, Alberto Tosetto, Vittorio Pengo, Sophie Testa, Walter Ageno and 1 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 12% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Observational
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Anticoagulation Duration After First Venous Thromboembolism: Real-Life Data From the International, Observational WHITE Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Observational
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

11 authors at 6 institutions in 2 countries.

Gualtiero PalaretiFondazione Arianna Anticoagulazione, Bologna, Italy gualtiero.palareti@unibo.it.ORCID 0000-0002-4327-9561
Emilia AntonucciFondazione Arianna Anticoagulazione, Bologna, Italy.
Cristina LegnaniFondazione Arianna Anticoagulazione, Bologna, Italy.
Daniela MastroiacovoDipartimento di Angiologia, Ospedale SS. Filippo e Nicola, Avezzano, Italy.
Daniela PoliSOD Malattie Aterotrombotiche, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy.
Paolo PrandoniFondazione Arianna Anticoagulazione, Bologna, Italy.
Alberto TosettoDivisione di Ematologia, Ospedale San Bortolo, Vicenza, Italy.ORCID 0000-0002-0119-5204
Vittorio PengoThrombosis Research Laboratory, Università di Padova, Padova, Italy.
Sophie TestaCentro Emostasi e Trombosi A O Istituti Ospitalieri di Cremona, Cremona, Italy.
Walter AgenoDipartimento di Emergenza e Accettazione, Centro Trombosi ed Emostasi, Ospedale di Circolo, Università dell'Insubria, Varese, Italy.
START2 Register Investigators
Azienda Ospedaliero-Universitaria Careggi · ITIstituti Ospitalieri di Cremona · ITIstituto di Ematologia di Bologna · ITOspedale San Filippo Neri · ITUniversity of Insubria · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe proportion and characteristics of Italian patients affected by venous thromboembolism (VTE) treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs), and complications occurring during follow-up.

designA prospective cohort of 2728 VTE patients included in the Survey on anticoagulaTed pAtients RegisTer (START2-Register) from January 2014 to June 2018 was investigated. Characteristics of patients, type of treatment and complications occurring during 2962 years of follow-up were analysed.

settingAbout 60 Italian anticoagulation and thrombosis centres participated in the observational START2-Register

participants2728 adult patients with VTE of a lower limb and/or pulmonary embolism (PE), with a follow-up after the initial phase treatment.

interventionsPatients could receive DOACs or VKAs; both prescribed by the National and Regional Health Systems for patients with VTE. OUTCOMES MEASURES: Efficacy: rate of VTE recurrence (all thrombotic complications were also recorded). SAFETY: the rate of major and clinically relevant non-major bleeding events.

resultsAlmost 80% of patients were treated with DOACs. The prevalence of symptomatic PE and impaired renal function was higher in patients receiving VKAs. Duration of anticoagulation was >180 days in approximately 70% of patients. Bleeding events were similar in both treatment groups. The overall eventuality of recurrence was significantly higher in DOAC cohorts versus VKA cohorts (HR 2.15 (1.14-4.06), p=0.018); the difference was almost completely due to recurrences occurring during extended treatment (2.73% DOAC vs 0.49% VKA, p<0.0001). All-cause mortality was higher in VKA-treated (5.9%) than in DOAC-treated patients (2.6%, p<0.001).

conclusionItalian centres treat most patients with VTE with DOACs and prefer VKA for those with more serious clinical conditions. Recurrences were significantly more frequent in DOAC-treated patients due to increased incidence after 180 days of treatment, probably due to reduced adherence to treatment. These results underline the importance of structured surveillance of DOAC-treated patients with VTE to strengthen treatment adherence during extended therapy.

Indexed as

ThrombosisVenous ThromboembolismAdministration, OralAnticoagulantsHemorrhageHumansMaleProspective StudiesVitamin KAnticoagulantsVitamin Kanticoagulationthromboembolismvascular medicine

Identifiers

PMID33247017
PMCPMC7703414
OpenAlexW3107889508

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.