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Table 3 Differences in design between ETNA-VTE Europe and other important European and global observational acute VTE registries

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

  Study design Geographical scope Patients Agents of interest Primary objective Enrolment period Key outcome measures Status
ETNA-VTE Europe Prospective, single-arm, observational PASS; 18-M FU 310 sites across 8 European countries 2700 edoxaban-treated acute DVT and/or PE in/outpatients across multiple healthcare settings Edoxaban To quantify the real-world, long-term rate of VTE recurrence in patients prescribed edoxaban as part of acute VTE treatment Q4 2016a – Q4 2018 Mortality, recurrent VTE, bleeding events, hepatic events, ADRs, hospitalisation for CV causes, edoxaban adherence/discontinuation O
RIETE [21] Prospective, observational study; 3-M FU 192 sites across 19 countries worldwide (78% of data from weSpain) 6855 acute DVT and/or PE in/outpatients across a range of healthcare settings Standard therapy (pre-DOACs) To improve physician knowledge of the natural history of thromboembolic disease and develop scores to identify patients at high risk of complications March 2001 – Feb 2004 Mortality, recurrent VTE, bleeding events C
XALIA [22, 24] Prospective, observational PASS; 12-M FU Multiple sitesbin 21 countries worldwide 5142 acute DVT (±PE) patients at hospitals or community care centres Rivaroxaban and standard therapy To assess the safety and effectiveness of rivaroxaban for the treatment of symptomatic DVT June 2012 – March 2014 Mortality, recurrent VTE, bleeding events, CV events, treatment satisfaction/adherence/discontinuation, healthcare resource utilisation, TEAEs C
PREFER in VTE [13, 14] Prospective, observational study; 12-M FU 381 sites across 7 European countries 3455 acute DVT and/or PE in/outpatients across a range of healthcare settings DOACs (pre-edoxaban) To explore patient characteristics, VTE management strategies, healthcare resource usage and associated costs Jan 2013 – Jan 2014 Mortality, recurrent VTE, bleeding events, MI, stroke, SE, post- thrombotic syndrome, CV events C
GARFIELD-VTE [20, 25] Prospective, observational study; two sequential cohorts; 3-Y FU 415 sites across 28 countries worldwide 10,878 acute DVT and/or PE in/outpatients across a range of healthcare settings Standard therapy and DOACs To identify regional/temporal treatment variations and assess their impact on clinical/economic outcomes July 2014 – Sept 2016 Mortality, recurrent VTE, bleeding events, post-thrombotic syndrome, chronic thromboembolic pulmonary hypertension, healthcare resource utilisation O
RE-COVERY [23, 26] Prospective, observational PASS; 12-M FU ~17b sites in 5 countries worldwide ~ 8000 acute DVT and/or PE patients Dabigatran and VKA To characterise the VTE patient population and compare the safety and effectiveness of dabigatran to VKA Nov 2015 – Dec 2018 Mortality, recurrent VTE, bleeding events O
  1. Legend: Y, year; M, month; DVT, deep vein thrombosis; FU, follow-up; PE, pulmonary embolism; DOAC, direct oral anticoagulant; VTE, venous thromboembolism; TIA, transient ischaemic attack; PASS, post-authorisation safety study; Q4, fourth quarter; MI, myocardial infarction; SE, systemic embolism; CV, cardiovascular; VKA, vitamin-K antagonist, C, completed; O, ongoing, TEAE, treatment-emergent adverse events. Important differences are highlighted in bold. aSwiss sites: February 2015. bPrecise number unknown
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Thrombosis Journal

ISSN: 1477-9560

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