Thromb Haemost 2018; 118(02): 320-328
DOI: 10.1160/TH17-08-0598
Coagulation and Fibrinolysis
Schattauer GmbH Stuttgart

Predictors of Post-Thrombotic Ulcer after Acute DVT: The RIETE Registry

Jean-Philippe Galanaud
,
Laurent Bertoletti
,
Maria Amitrano
,
Carmen Fernández-Capitán
,
José María Pedrajas
,
Vladimir Rosa
,
Manuel Barrón
,
Alicia Lorenzo
,
Olga Madridano
,
Isabelle Quéré
,
Susan R. Kahn
,
Paolo Prandoni
,
Manuel Monreal
,
for the RIETE registry investigators
Further Information

Publication History

29 August 2017

23 November 2017

Publication Date:
29 January 2018 (online)

Abstract

In patients with deep-vein thrombosis (DVT) in the lower limbs, venous ulcer is the most debilitating and end-stage clinical expression of the post-thrombotic syndrome (PTS). To date, risk factors for PTS-related ulcer in DVT patients have not been identified.

We used the international observational RIETE registry to assess the evolution of PTS signs and symptoms during a 3-year follow-up period and to identify independent predictors of PTS ulcer at 1 year in patients with acute DVT.

Among 1,866 eligible patients, cumulative rates of PTS ulcer at 1, 2 and 3 years were 2.7% (n = 50), 4.3% (n = 54) and 7.1% (n = 60), respectively. The proportion of patients with PTS symptoms at 1, 2 or 3 years remained stable (≈40%), while the proportion of patients with PTS signs increased slightly over time (from 49 to 53%). Prior history of venous thromboembolism (VTE) (odds ratio [OR] = 5.5 [2.8–10.9]), diabetes (OR = 2.3 [1.1–4.7]), pre-existing leg varicosities (OR = 3.2 [1.7–6.1]) and male sex (OR = 2.5 [1.3–5.1]) independently increased the risk of PTS ulcer at 1 year. Obesity also increased the risk but failed to reach statistical significance (OR = 1.8 [0.9–3.3]). DVT treatment characteristics (duration or drug) did not influence the risk.

Our results evidence that after acute DVT, pre-existing leg varicosities, prior venous thromboembolism, diabetes and male gender independently increased the risk for PTS ulcer. This suggests that clinicians should consider strategies aimed to prevent ulcers in high-risk DVT patients, such as preventing VTE recurrence, use of stockings in those with pre-existing venous insufficiency, careful monitoring of diabetic patients and encouraging weight loss in obese patients.

Role of the Funding Source

The funding sources had no involvement in the design of the study; the collection, analysis and interpretation of data; the writing of the report; or the decision to submit the manuscript for publication.


Authors' Contributions

Study concept and design: J.-P.G., M.M.


Acquisition of data; analysis and interpretation of data; statistical analysis:


All authors


Drafting of the manuscript: J.-P.G.


Critical revision of the manuscript for important intellectual content: All authors


Study supervision: J.-P.G., M.M.


The corresponding author, J.-P.G., had full access to all the data in the study and had final responsibility for the decision to submit for publication.


Addendum

Coordinator of the RIETE Registry: Dr. Manuel Monreal (Spain)


RIETE Steering Committee Members: Dr. Hervè Decousus (France)


Dr. Paolo Prandoni (Italy)


Dr. Benjamin Brenner (Israel)


RIETE National Coordinators: Dr. Raquel Barba (Spain)


Dr. Pierpaolo Di Micco (Italy)


Dr. Laurent Bertoletti (France)


Dr. Inna Tzoran (Israel)


Dr. Abilio Reis (Portugal)


Dr. Marijan Bosevski (R. Macedonia)


Dr. Henri Bounameaux (Switzerland)


Dr. Radovan Malý (Czech Republic)


Dr. Philip Wells (Canada)


Dr. Peter Verhamme (Belgium)


RIETE Registry Coordinating Center: S & H Medical Science Service


Members of the RIETE Group: SPAIN: Adarraga MD, Aibar MA, Alcalde-Manero M, Alfonso M, Arcelus JI, Ballaz A, Barba R, Barrón M, Barrón-Andrés B, Bascuñana J, Blanco-Molina A, Braun B, Cañas I, Casado I, Chic N, del Pozo R, del Toro J, Díaz-Pedroche MC, Díaz-Peromingo JA, Domínguez V, Falgá C, Fernández-Aracil C, Fernández-Capitán C, Fidalgo MA, Font C, Font L, Gallego P, García MA, García-Bragado F, Gavín O, Gómez C, Gómez V, González J, González-Marcano D, Grau E, Grimón A, Guirado L, Gutiérrez J, Hernández-Comes G, Hernández-Blasco L, Jara-Palomares L, Jaras MJ, Jiménez D, Joya MD, Llamas P, Lobo JL, López P, López-Jiménez L, López-Reyes R, López-Sáez JB, Lorente MA, Lorenzo A, Luque JM, Madridano O, Marchena PJ, Martín-Martos F, Monreal M, Nieto JA, Nieto S, Núñez A, Núñez MJ, Odriozola M, Otalora S, Otero R, Pedrajas JM, Pérez-Ductor C, Peris ML, Pons I, Porras JA, Reig O, Riera-Mestre A, Riesco D, Rivas A, Rodríguez M, Rodríguez-Dávila MA, Rosa V, Ruiz-Artacho P, Ruiz-Giménez N, Sahuquillo JC, Sala-Sainz MC, Sampériz A, Sánchez R, Sánchez-Martínez R, Sanz O, Soler S, Suriñach JM, Tolosa C, Torres MI, Trujillo-Santos J, Uresandi F, Usandizaga E, Valero B, Valle R, Vela J, Vicente MP, Vidal G, Xifre B, BELGIUM: Verhamme P, BRAZIL: Yoo HHB, CANADA: Wells P, CZECH REPUBLIC: Hirmerova J, Malý R, ECUADOR: Salgado E, FRANCE: Bertoletti L, Bura-Riviere A, Farge-Bancel D, Hij A, Mahé I, Merah A, Moustafa F, ISRAEL: Braester A, Brenner B, Tzoran I, ITALY: Amitrano M, Antonucci G, Barillari G, Bilora F, Bortoluzzi C, Brandolin B, Bucherini E, Ciammaichella M, Dentali F, Di Micco P, Duce R, Giorgi-Pierfranceschi M, Grandone E, Imbalzano E, Lessiani G, Leopardi N, Mastroiacovo D, Pace F, Parisi R, Pellegrinet M, Pesavento R, Pinelli M, Poggio R, Prandoni P, Quintavalla R, Rocci A, Tiraferri E, Tonello D, Tufano A, Visonà A, LATVIA: Gibietis V, Skride A, Vitola B, REPUBLIC OF MACEDONIA: Bosevski M, Zdraveska M, SWITZERLAND: Bounameaux H, Mazzolai L.