Incidence and predictors of post-thrombotic syndrome in patients with proximal DVT in a real-world setting: findings from the GARFIELD-VTE registry
Authors: Prandoni Paolo , Haas Sylvia , Fluharty Meg E. , Schellong Sebastian , Gibbs Harry , Tse Eric , Carrier Marc , Jacobson Barry , ten Cate Hugo , Panchenko Elizaveta , Verhamme Peter , Pieper Karen , Kayani Gloria , Kakkar Lord A. ,   the GARFIELD-VTE investigators, Abdullah Nik , Abiko Akihiko , Abril Juan , Acevedo David , Adademir Taylan , Adler David , Ageno Walter , Agnelli Giancarlo , Ahmed Mostafa , Aksoy Ahmet , Aktogu Serir , Ali Gholam , Alikhan Raz , Allen Gregory , Angchaisuksiri Pantep , Antoinette Sevestre , Arouni Amy , Azeddine Addala , Azim Tarek , Backer Wilfried , Balthazar Yohan , Bang Soo , Banyai Martin , Barbarash Olga , Barrionuevo Marcelo , Bary Mostafa , Battaloglu Bektas , Bax W. , Béatrice Terriat , Behrens Steffen , Belenky Dmitry , Benitez Juan , Berli Mario , Bernadette Peuch , Berni Andrea , Betsbrugge Michiel , Beyers Adriaan , Bezuidenhout Abraham , Bidi Claude , Bilderling Peter , Binet Laure , Biss Tina , Blasco Luis , Blessing Erwin , Blombery Peter , Bono Julio , Boomars Karin , Boondumrongsagoon Juree , Borges Lohana , Bosch Manuel , Botha Louis , Bounameaux Henri , Boussy Tim , Bowers Margaret , Boyarkin Mikhail , Brauer Cornelia , Burbury Kate , Burianova Hana , Burov Yuriy , Cader Cas , Canevascini Reto , Capiau Luc , Cappelli Roberto , Carine Boulon , Carrier Marc , Carrim Abu , Carroll Patrick , Casabella Tomas , Cate Hugo , Cattaneo Marco , Cech Vladimir , Cervera Luis , Cha Seung , Chacko Joseph , Chang Kuan , Chansung Kanchana , Chao Ting , Chauhan Anoop , Chayangsu Sunee , Chetanachan Mariam , Chew Lee , Chiang Chern , Chiu Kuan , Choi Won , Christian Ponchaux , Christophe Brousse , Christophe Seinturier , Chunilal Sanjeev , Clark Amanda , Colak Abdurrahim , Correa João , Cosmi Benilde , Cosmi Franco , Coufal Zdenek , Creagh Desmond , Cristina Leone , Cuneo Carlos , Dalmau Garcia , Damien Garrigues , D’Angelo Armando , Darius Harald , Datta Sudip , Dees Adriaan , Dessoki Mohamed , Diaz Carlos , Diaz Enrique , Dogan Emre , Dominique Brisot , Dominique Elkouri , Dominique Stephan , Donders Servaas , Dorokhov Dmitry , Duchateau Johan , Duda Norberto , Eddie Grace , Elali Hallah , ElDin Hesham , Elisa Chevrier , Emmanuel Messas , Erdelyi Barbara , Erdkamp Frans , Esheiba Ehab , Esperón Guillermo , Essameldin Sherif , Everington Tamara , Faghih Markus , Falanga Anna , Fedele Jose , Ferkl Richard , Fernandez Alberto , Fernandez Manuel , Ferrini Piera , Ferroni Fabian , Filho Jose , Fixley Mark , Fletcher John , Flores Oscar , Francis Couturaud , Francois Bergmann , Franow Hendrik , Gad Amr , Gaffar Mohamed , Gaffney Mary , Gal Gregoire , Galvar Javier , Galvez Angel , Gamba Marco , Gan Gin , Gerdes Victor , Gerofke Hagen , Gibbs Harry , Gogia Harinder , Gordeev Ivan , Goto Shinya , Griffin Sam , Gris Christina , Grochenig Ernst , Gujral Jaspal , Gur Ozcan , Gurbuz Orcun , Gustin Michel , Guzman Luis , Ha Chung , Haddad Ghassan , Hagemann Dirk , Hainaut Philippe , Hameed Muhammad , Hart Terence , Hasanoglu Hatice , Hashas Erman , Haverkamp Wilhelm , Helene Desmurs , Henry Fitjerald , Herdy Artur , Herreweghe Rika , Hirano Masao , Ho Prahlad , Ho Wai , Hollanders Geert , Homza Miroslav , Horacek Thomas , Hsia Chien , Huang Chien , Huang Chi , Huang Chun , Humphrey Julian , Hunt Beverley , Husin Azlan , Hwang Hun , Iamsai Piriyaporn , Ibarra Manuel , Imberti Davide , Isabelle Mahe , Isbir Selim , Jacobson Barry , Jansky Petr , Jiang Weihong , Jimenez David , Jing Zhicheng , Jing Zhicheng , Joh Jin , Kamalov Gadel , Kanda Junji , Kanemoto Masashi , Kanitsap Nonglak , Kanko Muhip , Karaarslan Kemal , Kassis Jeannine , Kato Atsushi , Kazakov Andrey , Keeling David , Keim Reinhold , Kelly Allan , Khan Mohamed , Kho Bonnie , Khotuntsov Alexey , Kim Ho , Kim Igor , Kim JangYong , Kim Jin , Kim Moo , Kim Yang , Kiris Ilker , Klamroth Robert , Kleiban Andres , Klein Garry , Kondo Katsuhiro , Koretzky Martin , Korte Wolfgang , Koto Modise , Koura Firas , Kovacs Michael , Krasavin Vladimir , Krichell Alan , Kroeger Knut , Kroening Ralf , Krupicka Jiri , Kubat Emre , Kucera Dusan , Kuki Shintaro , Kuo Jen , Kvasnicka Jan , Kwok Chi , Kwon JiHyun , Lai Wen , Lang Pavel , Lara Jose , Lastuvka Jiri , Lawall Holger , Leahy Michael , Lee Jae , Lee Moon , Leon Raul , Léopold Siwe , Levy Michael , Libov Igor , Lin Wei , Lockman Ann , Lodigiani Corrado , Looi Irene , López Luciano , Loualidi Ab , Lunn Charles , Luo Canhua , Luvhengo Thifhelimbilu , Maasdorp Shaun , MacCallum Peter , Machowski Andrew , Majumder Mujibur , Makruasi Nisa , Malek Wagih , Manuel Kubina , Marchena Pablo , Marino Javier , Martinez Rafael , Matsuoka Shunzo , Mazzone Antonino , McRae Simon , Mellor Stuart , Mendes Robert , Merli Geno , Mestre Antoni , Michèle Escande , Middeldorp Saskia , Miranda Raimundo , Mohamed Ahmed , Mohamed Monniaty , Moia Marco , Møller Dorthe , Motte Serge , Moustafa Moustafa , Mumoli Nicola , Mun Yeung , Munch Michael , Muntaner Juan , Mustafa Bisher , Mutirangura Pramook , Myriam Martin , Na Sang , Nagib Mohamed , Nakamura Hiroaki , Nakamura Mashio , Nakazawa Satoshi , Nam Seung , Natha Bhavesh , Nicolas Falvo , Nielsen Jørn , Norasetthada Lalita , Nordin Nordiana , Numbenjapon Tontanai , Nyvad Ole , Ohler Hans , Ohnuma Yasushi , Olsen Michael , Onodera Tomoya , Opitz Christian , Oropallo Alisha , Otero Remedios , Oto Oztekin , Paez Jorge , Panchenko Elizaveta , Paredes Félix , Park Jin , Park Yong , Paruk Nishen , Patanasing Siriwimon , Paul Guillot , Pauw Michel , Peromingo Jose , Petrov Dmitry , Pharr Walter , Plassmann Georg , Platt George , Podpera Ivo , Poirier Germain , Poli Daniela , Porreca Ettore , Prisco Domenico , Prosecky Robert , Pumprla Jiri , Raedt Herbert , Ratsela Rapule , Raymundo Selma , Reyes Raquel , Reynolds Tim , Ria Luigi , Rojnuckarin Ponlapat , Roux Dirk , Salem Ayman , Santoro Rita , Saraiva Jose , Sathar Jameela , Savas Ismail , Schellong Sebastian , Schiavi Lilia , Schmidt Andor , Schmidt Renate , Schroe Herman , Schul Marlin , Schwencke Carsten , Scott David , Shah Gaurand , Shibata Yoshisato , Shih Jhih , Shim Hyeok , Sholkamy Sherif , Shyu Kou , Singh Rupesh , Singh Suaran , Skowasch Dirk , Slocombe Alison , Smith Clifford , Sokurenko German , Soliman Mosaad , Solymoss Susan , Song Ik , Sonkin Igor , Souto Joan , Spacek Rudolf , Staroverov Ilya , Staub Daniel , Striekwold Harry , Stuecker Markus , Subbotin Yuriy , Suchkov Igor , Sun Shenghua , Surinach Jose , Suwanban Tawatchai , Svatopluk Koscál , Svobodova Jaromira , Tahar Mersel , Takeuchi Kensuke , Tanabe Yasuhiro , Tenorio Isabel , Testa Sophie , Theodoro Daniel , Tian Hongyan , Tick Lidwine , Timmermans Luc , Ting Seng , Tiraferri Eros , Toh Cheng , Toh See , Tolstikhin Vladimir , Toro Jorge , Toro Jorge , Tosetto Alberto , Toufek Berremeli , Trimarco Bruno , Tse Eric , Tseng Wei , Turker Hatice , Ueng Kwo , Usandizaga Esther , Vandenbosch Kristel , Vanwelden Jan , Verhamme Peter , Vesely Jiri , Vesti Beatrice , Viboonjuntra Pongtep , Vilamajo Oscar , Vleeschauwer Philippe , Wang Haofu , Wang Shenming , Ward Chris , Watanabe Akinori , Watt Simon , Welker James , Wells Rachel , Wern Kwan , Westendorf Jan , White Richard , Wilson Benedicte , Wong Lily , Wong Raymond , Wongkhantee Somchai , Wu Chau , Wu Chih , Wu Cynthia , Yang Jinghua , Yang Zhenwen , Yang Zhongqi , Yavuz Celal , Yeo Erik , Yhim Ho , Yiu Kai , Yoshida Shuichi , Yoshida Winston , Zaidman Cesar , Zateyshchikov Dmitry , Zeller Thomas , Zemek Stanislav , Zhang Lei , Zhang Weihua , Zhu Hong , Zidan Hesham , Zidel Brian , Zrazhevskiy Konstantin , Zubareva Nadezhda 
Published: November 2023

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.