Jean-Philippe Galanaud1,2, Marc Righini3, Lorris Le Collen1, Aymeric Douillard4, Helia Robert-Ebadi3, Daniel Pontal1, David Morrison5, Marie-Thérèse Barrellier6, Antoine Diard7, Hervé Guénnéguez8, Dominique Brisot9, Pascale Faïsse10, Sandrine Accassat11, Myriam Martin12, Aurélien Delluc13,14, Susan Solymoss15, Jeannine Kassis16, Marc Carrier14, Isabelle Quéré1, Susan R Kahn10. 1. Department of Vascular Medicine, Montpellier University Hospital and University of Montpellier, Montpellier, France. 2. Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada. 3. Division of Angiology and Hemostasis, Faculty of Medicine, Geneva University Hospital, Geneva, Switzerland. 4. Clinical Research and Epidemiology Unit, University Hospital, Montpellier, France. 5. Department of Medicine and Lady Davis Institute, Jewish General Hospital, Montreal, QC, Canada. 6. Vascular Medicine Unit, Caen University Hospital, Caen, France. 7. Vascular Medicine Office, Langoiran, France. 8. Clinique Mégival, St Aubin sur Scié, France. 9. Vascular Medicine Unit, Clinique du Parc, Castelnau Le Lez, France. 10. Vascular Medicine Physician, Alès, France. 11. Clinical Investigation Centre, Saint Etienne University Hospital, Saint Etienne, France. 12. Vascular Medicine Physician, Annecy, France. 13. Department of Medicine, Brest University Hospital, Brest, France. 14. Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada. 15. Division of Hematology, St Mary's Hospital, Montreal, QC, Canada. 16. Division of Hematology, Hôpital Rosemont-Maisonneuve, Montréal, QC, Canada.
Abstract
BACKGROUND: After a proximal lower limb deep vein thrombosis (DVT; involving popliteal veins or above), up to 40% of patients develop postthrombotic syndrome (PTS) as assessed by the Villalta scale (VS). Poor initial anticoagulant treatment is a known risk factor for PTS. The risk of developing PTS after isolated distal DVT (infra-popliteal DVT without pulmonary embolism), and the impact of anticoagulant treatment on this risk, are uncertain. METHODS: Long-term follow-up of CACTUS double-blind trial comparing 6 weeks of s.c. nadroparin (171 IU/kg/d) versus s.c. placebo for a first symptomatic isolated distal DVT. At least 1 year after randomization, patients had a PTS assessment in clinic or by phone using the VS. RESULTS: After a median follow-up of 6 years, PTS was present in 30% (n = 54) of the 178 patients who had a PTS assessment. PTS was moderate or severe in 24% (n = 13) of cases. There was no statistically significant difference in prevalence of PTS in the nadroparin versus placebo groups (29% versus 32%, P = .6), except in patients without evidence of primary chronic venous insufficiency (9% versus 24%, P = .04). Rates of venous thromboembolism recurrence during follow-up in the nadroparin and placebo groups were, respectively, 8% (n = 7) and 14% (n = 13; P = .2). CONCLUSION: After a first isolated distal DVT, the risk of PTS is substantial but much lower than that reported after proximal DVT. Anticoagulation with nadroparin doesn't provide any clear benefit to prevent PTS, except in patients without preexisting chronic venous insufficiency. Anticoagulation might be associated with a lower risk of venous thromboembolism recurrence.
RCT Entities:
BACKGROUND: After a proximal lower limb deep vein thrombosis (DVT; involving popliteal veins or above), up to 40% of patients develop postthrombotic syndrome (PTS) as assessed by the Villalta scale (VS). Poor initial anticoagulant treatment is a known risk factor for PTS. The risk of developing PTS after isolated distal DVT (infra-popliteal DVT without pulmonary embolism), and the impact of anticoagulant treatment on this risk, are uncertain. METHODS: Long-term follow-up of CACTUS double-blind trial comparing 6 weeks of s.c. nadroparin (171 IU/kg/d) versus s.c. placebo for a first symptomatic isolated distal DVT. At least 1 year after randomization, patients had a PTS assessment in clinic or by phone using the VS. RESULTS: After a median follow-up of 6 years, PTS was present in 30% (n = 54) of the 178 patients who had a PTS assessment. PTS was moderate or severe in 24% (n = 13) of cases. There was no statistically significant difference in prevalence of PTS in the nadroparin versus placebo groups (29% versus 32%, P = .6), except in patients without evidence of primary chronic venous insufficiency (9% versus 24%, P = .04). Rates of venous thromboembolism recurrence during follow-up in the nadroparin and placebo groups were, respectively, 8% (n = 7) and 14% (n = 13; P = .2). CONCLUSION: After a first isolated distal DVT, the risk of PTS is substantial but much lower than that reported after proximal DVT. Anticoagulation with nadroparin doesn't provide any clear benefit to prevent PTS, except in patients without preexisting chronic venous insufficiency. Anticoagulation might be associated with a lower risk of venous thromboembolism recurrence.
Authors: Behnood Bikdeli; César Caraballo; Javier Trujillo-Santos; Jean Philippe Galanaud; Pierpaolo di Micco; Vladimir Rosa; Gemma Vidal Cusidó; Sebastian Schellong; Meritxell Mellado; María Del Valle Morales; Olga Gavín-Sebastián; Lucia Mazzolai; Harlan M Krumholz; Manuel Monreal Journal: JAMA Cardiol Date: 2022-08-01 Impact factor: 30.154