RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate

Ageno, Walter; Casella, Ivan Benaduce; Han, Chee Kok; Raskob, Gary E.; Schellong, Sebastian; Schulman, Sam; Singer, Daniel E.; Kimura, Karen; Tang, Wenbo; Desch, Marc; Goldhaber, Samuel Z.

doi:10.1160/th16-07-0566

Cited by 15 publications

(8 citation statements)

References 31 publications

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“…The rationale and design of the study have been described elsewhere. 11 To minimize the risk of potential selection bias, in the first phase of the study, investigators were encouraged to include consecutive patients with acute VTE irrespective of initial treatment. As such, each patient presenting with a VTE was approached for study enrollment, irrespective of how they were treated and managed.…”

Section: Methods Study Designmentioning

confidence: 99%

Profile of Patients with Isolated Distal Deep Vein Thrombosis versus Proximal Deep Vein Thrombosis or Pulmonary Embolism: RE-COVERY DVT/PE Study

Schellong

Ageno

Casella

et al. 2021

Semin Thromb Hemost

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Isolated distal deep vein thrombosis (IDDVT) is presumed to be more benign than proximal DVT (PDVT) or pulmonary embolism (PE), suggesting a need for different management approaches. This subgroup analysis of the RE-COVERY DVT/PE global, observational study investigated patient characteristics, hospitalization details, and anticoagulant therapy in patients with IDDVT in real-world settings in 34 countries enrolled from January 2016 to May 2017. Data were analyzed descriptively according to the type and location of the index venous thromboembolism (VTE): IDDVT, PDVT ± distal DVT (DDVT), and PE ± DVT. Of the 6,095 eligible patients, 323 with DVT located outside the lower limb and no PE were excluded. Of the remaining 5,772 patients, 17.6% had IDDVT, 39.9% had PDVT ± DDVT, and 42.5% had PE ± DVT. IDDVT patients were younger and had fewer risk factors for VTE than the other groups. Other comorbidities were less frequent in the IDDVT group, except for varicose veins, superficial thrombophlebitis, and venous insufficiency. IDDVT patients were less likely to be diagnosed in an emergency department (22.3 vs. 29.7% for PDVT ± DDVT and 45.4% for PE ± DVT) or hospitalized for VTE (29.2 vs. 48.5% for PDVT ± DDVT and 75.0% for PE ± DVT). At hospital discharge or 14 days after diagnosis (whichever was later), non–vitamin K antagonist oral anticoagulants were the most commonly used anticoagulants (55.6% for IDDVT, 54.7% for PDVT ± DDVT, and 52.8% for PE ± DVT). Although differences in patient characteristics, risk factors, and clinical management were identified, anticoagulant treatment of IDDVT was almost equal to that of PDVT or PE. Prospective studies should investigate whether, in a global perspective, this is an appropriate use of anticoagulants. Trial registration number ClinicalTrials.gov NCT02596230.

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Section: Methods Study Designmentioning

confidence: 99%

Profile of Patients with Isolated Distal Deep Vein Thrombosis versus Proximal Deep Vein Thrombosis or Pulmonary Embolism: RE-COVERY DVT/PE Study

Schellong

Ageno

Casella

et al. 2021

Semin Thromb Hemost

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“…Another example is when a dose regimen that was not studied in the registration trials subsequently became approved by some regulatory authorities, as is the case for dabigatran 110 mg twice daily for VTE. The RE-COVERY study will provide a unique opportunity to validate the justification for this decision (22).…”

Section: Acronym Registration Numbermentioning

confidence: 99%

NOACs for treatment of venous thromboembolism in clinical practice

Schulman

Singer²,

Ageno³

et al. 2017

Thromb Haemost

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SummaryRandomised controlled trials have provided important information on the efficacy and safety of the non-vitamin K antagonist oral anticoagulants (NOACs) for treatment of venous thromboembolism (VTE), leading to registration and increasing use in clinical practice. Many questions remain to be answered, and observational studies are often more suitable for answering "real-world" questions than randomised controlled trials. Patient satisfaction, quality of life, and adherence and persistence in clinical practice with the drug regimen can only be assessed with an open-label design. Evaluation of risk for long-term sequelae of the disease requires much longer follow-up than is possible in registration trials. Treatment patterns and utilisation of health care resources can be assessed from observations in the clinical practice setting. We will review published as well as currently active observational studies with NOACs in VTE, with or without a comparator anticoagulant. These studies are based on cohorts of different sizes, registries, or administrative health care databases. We will also discuss some limitations in analysis and interpretation of observational studies.

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“…The real-world management of acute VTE has been studied by a number of registries on a national (MASTER and SWIVTER II [ 18 , 19 ]), European (PREFER in VTE [ 13 ]) and global (RIETE, GARFIELD-VTE, RE-COVERY and XALIA [ 20 – 23 ]) scale. Such registries are important because they include patients who are usually omitted from clinical trials due to strict inclusion and exclusion criteria, allowing appraisal of treatment regimes in patients with particular characteristics.…”

Section: Discussionmentioning

confidence: 99%

Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

Cohen

Ay²,

Hainaut

et al. 2018

Thrombosis J

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BackgroundVenous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104–183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available.MethodsETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial.ConclusionsETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention.Trial registrationClinicalTrials.gov Identifier: NCT02943993.

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RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate

Cited by 15 publications

References 31 publications

Profile of Patients with Isolated Distal Deep Vein Thrombosis versus Proximal Deep Vein Thrombosis or Pulmonary Embolism: RE-COVERY DVT/PE Study

Profile of Patients with Isolated Distal Deep Vein Thrombosis versus Proximal Deep Vein Thrombosis or Pulmonary Embolism: RE-COVERY DVT/PE Study

NOACs for treatment of venous thromboembolism in clinical practice

Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

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