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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 2016aQ4 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