Incidence and predictors of post-thrombotic syndrome in patients with proximal DVT in a real-world setting: findings from the GARFIELD-VTE registry
Paolo Prandoni, Sylvia Haas, Meg Fluharty, Sebastian Schellong, Harry Gibbs, Eric Tse, Marc Carrier, Barry Jacobson, Hugo Ten Cate, Е. П. Панченко, Peter Verhamme, Karen S. Pieper, Gloria Kayani, Lord Ajay Kakkar, the GARFIELD-VTE investigators, N.A. Nik Abdullah, Akihiko Abiko, Juan Carlos Abril, David Acevedo, Taylan Adademir, David Adler, Walter Ageno, Giancarlo Agnelli, Mostafa Shawky Ahmed, Ahmet Aksoy, Serir Aktoğu, Gholam Ali, Raz Alikhan, Gregory Allen, Pantep Angchaisuksiri, Sevestre Antoinette, Amy Arouni, Addala Azeddine, T. Md. Azim, Wilfried De Backer, Yohan Balthazar, Soo‐Mee Bang, Martin Banyai, О. Л. Барбараш, Marcelo Barrionuevo, M. Bary, Bektaş Battaloǧlu, Willem A. Bax, Terriat Béatrice, Steffen Behrens, Dmitry Belenky, Juan Benitez, Mario A Berli, Peuch Bernadette, Andrea Berni, Michiel Van Betsbrugge, Adriaan Beyers, Abraham F. Bezuidenhout, Claude Luyeye Bidi, Peter Baron von Bilderling, L Binet, Tina Biss, Luis Blasco, Erwin Blessing, Peter Blombery, Julio Bono, Karin A. Boomars, Juree Boondumrongsagoon, Lohana Borges, Manuel Monreal Bosch, Louis Botha, Henri Bounameaux, Tim Boussy, Margaret Bowers, Mikhail Boyarkin, Cornelia Brauer, Kate Burbury, Hana Burianová, Yuriy Burov, Cas Cader, Reto Canevascini, Luc Capiau, Roberto Cappelli, Boulon Carine, Marc Carrier, A. T. O. Abdool Carrim, Patrick Carroll, T Smith Casabella, Hugo Ten Cate, Marco Cattaneo, Vladimir Cech, Luis Cervera, Seung Cha, Joseph Chacko, Kuan‐Chang Chang, Kanchana Chansung, Ting Chao, Anoop Chauhan, Sunee Chayangsu, Mariam Chetanachan, Lee Ping Chew, Chern En Chiang, Kuan‐Ming Chiu, Won‐Il Choi, Ponchaux Christian
Abstract
Although substantial progress has been made in the pathophysiology and management of the post-thrombotic syndrome (PTS), several aspects still need clarification. Among them, the incidence and severity of PTS in the real world, the risk factors for its development, the value of patient's self-evaluation, and the ability to identify patients at risk for severe PTS. Eligible participants (n = 1107) with proximal deep-vein thrombosis (DVT) from the global GARFIELD-VTE registry underwent conventional physician's evaluation for PTS 36 months after diagnosis of their DVT using the Villalta score. In addition, 856 patients completed a Villalta questionnaire at 24 months. Variable selection was performed using stepwise algorithm, and predictors of severe PTS were incorporated into a multivariable risk model. The optimistic adjusted c-index was calculated using bootstrapping techniques. Over 36-months, 27.8% of patients developed incident PTS (mild in 18.7%, moderate in 5.7%, severe in 3.4%). Patients with incident PTS were older, had a lower prevalence of transient risk factors of DVT and a higher prevalence of persistent risk factors of DVT. Self-assessment of overall PTS at 24 months showed an agreement of 63.4% with respect to physician's evaluations at 36 months. The severe PTS multivariable model provided an optimistic adjusted c-index of 0.68 (95% CI 0.59-0.77). Approximately a quarter of DVT patients experienced PTS over 36 months after VTE diagnosis. Patient's self-assessment after 24 months provided added value for estimating incident PTS over 36 months. Multivariable risk analysis allowed good discrimination for severe PTS.