Functional limitations three and twelve months after venous thromboembolism: Results from a prospective cohort study

Introduction Venous thromboembolism (VTE) is associated with various long-term complications, including a decline in physical functioning. We aimed to investigate the association of clinical parameters at VTE diagnosis with functional limitations three and twelve months after diagnosis.

Method We conducted a prospective cohort study of VTE patients at a tertiary care center, excluding patients with cancer, pregnant patients, and patients in the postpartum period. Functional limitations were assessed with the post-VTE functional status (PVFS) scale (ranging from 0 to 4, with higher values indicating more limitations) within the first 21 days of diagnosis, after three and twelve months (prospectively), and one month before diagnosis (retrospectively). Twelve-month follow-up was only performed in patients remaining on anticoagulation. We fitted two separate proportional odds logistic regression models for the 3- and 12-month follow-ups and computed odds ratios (ORs) with 95% bootstrap percentile confidence intervals (CI) to describe the association of clinical parameters at the time of VTE diagnosis with functional limitations three and twelve months after VTE.

Results We included 307 patients with a median (interquartile range, IQR) age of 55.6 (43.7-65.7) years, of whom 128 (41.7%) were women. The median (IQR) PVFS scale grade before diagnosis and at baseline were 0 (0-0) and 2 (2-3), respectively. About 49% of patients had pulmonary embolism, 62% had unprovoked VTE, 28% had a history of VTE, 24% had a history of cardiovascular or pulmonary disease, and 49% were active or current smokers. After a median (IQR) follow-up time of 13.4 (12.9-16.0) weeks, 269 patients reported a median (IQR) PVFS scale grade of 1 (0-2) ([Fig. 1]). Compared to their pre-VTE functional status, 123 (45.7%) returned to their status or improved, while 146 (54.3%) had more functional limitations. Female sex (OR, 2.15, 95% CI, 1.26-4.14), higher BMI (OR, 1.05, 95% CI, 1.00-1.10), functional limitations at diagnosis, and older age were associated with increased odds for more limitations at the three-month follow-up ([Fig. 2]). After a median (IQR) follow-up time of 55.9 (53.1-62.6) weeks, 124 patients had a median (IQR) PVFS scale grade of 1 (0-2) ([Fig. 1]). Compared to their pre-VTE functional status, 56 (45.2%) returned to their status or improved, while 68 (54.8%) had more functional limitations. Female sex (OR, 4.29, 95% CI, 1.57-15.83), history of cardiovascular or pulmonary disease (OR, 2.62, 95% CI, 1.03-7.85), and functional limitations at baseline were associated with increased odds for reporting a higher PVFS scale grade twelve months after VTE ([Fig. 2]).

Fig. 1  Change in functional limitations over time; Alluvial plot showing absolute number of patients per category of functional limitations. The upper panel depicts change in functional limitations from one month before venous thromboembolism diagnosis over the time of diagnosis to three months after diagnosis, the lower panel from one month before over the time of diagnosis to twelve months afterwards.

Fig. 2  Odds ratios and 95% bootstrap confidence intervals (CIs) for model 1 and 2; Model 1 refers to the three-month follow-up, model 2 to the twelve-month follow-up.; ^a95% bootstrap percentile confidence intervals were calculated with 500 resamples. ^bAge was modelled as a continuous variable using restricted cubic splines with four knots at the 5^th, 35^th, 65th, and 95^th percentile. Odds ratios for age are presented for 10^th, 25^th, 50^th, 75^th, and 95^th percentile of patients with outcome data available for 3-month follow-up (n=275), with the 10^th percentile as reference.

Conclusion Patients with VTE had a considerable degree of functional limitations three and twelve months after VTE diagnosis and did not return to their pre-VTE functional status. We identified clinical parameters associated with functional limitations which could help in early identification of patients at risk for increased functional limitations after VTE.

 

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Conflict of Interest

This project was supported by a GTH Early Career Research Grant. SB reports institutional grants or contracts from Bayer, INARI, Boston Scientific, Medtronic, Bard, Sanofi, and Concept Medical; payment or honoraria from INARI, Boston Scientific, Penumbra, and Concept Medical; and support for attending meetings and/or travel from Bayer and Sanofi. FAK received research support from Bayer, BMS, BSCI, MSD, Leo Pharma, Actelion, The Netherlands Organisation for Health Research and Development, The Dutch Thrombosis Association, The Dutch Heart Foundation, and the Horizon Europe Program, all paid to his institution and outside the current work. CA reports honoraria for lectures from Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi, and participation in advisory boards for Bayer, Boehringer Ingelheim, Daiichi Sankyo, and BMS/Pfizer outside the current work. DS, SN, GH, DK, OS, IP, and BW have no conflicts of interest to declare with regard to the present study.

Publikationsverlauf

Artikel online veröffentlicht:
26. Februar 2024