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

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 2016^a – 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 sites^bin 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

~17^b 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