Background: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) characterised by chronic complaints such as oedema and skin changes including; venous ectasia, varicose veins, redness, eczema, hyperpigmentation, and in severe cases fibrosis of the subcutaneous adipose in the affected limb. These chronic complaints are the effects of venous outflow restriction that can cause symptoms such as heaviness, itching, pain, cramps, and paraesthesia. Twenty to fifty percent of people with DVT develop post-thrombotic complications. Several non-pharmaceutical measures are used for prevention of PTS during the acute phase of DVT. These include elevation of the legs and compression therapy. There have been limited studies regarding the effectiveness of compression therapy for prevention or treatment of PTS. As a result, clinicians and guidelines differ in their assessment of compression therapy during treatment of DVT and in the treatment of PTS. This is an update of a review first published in 2003. Objectives: To assess the effectiveness of compression therapy for treatment of post-thrombotic syndrome, including elastic compression stockings and mechanical devices compared with no intervention, placebo and with each other. Search methods: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries on 2 July 2018. Selection criteria: We included trials that evaluated compression therapy for the treatment of PTS. The primary outcomes were severity of PTS and adverse effects. There were no restrictions on date or language. Two review authors (SA, DNK) independently assessed whether potentially relevant studies met the inclusion criteria. Data collection and analysis: One review author extracted and summarised data and one review author (DNK) verified them. We resolved disagreements by discussion. We assessed methodological study quality with the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of the evidence supporting the outcomes assessed in this review. Main results: We identified four trials, with 116 participants, investigating the effectiveness of compression therapy for treatment of PTS. The methodology used by each trial was too heterogeneous to perform a meta-analysis, so we reported our findings narratively. Two trials studied the effect of graduated elastic compression stockings (GECS) on improvement of PTS symptoms. One study reported beneficial haemodynamic effects, while the other found no benefits on PTS severity compared to placebo (very low-certainty evidence). There was very limited evidence available for adverse effects and quality of life (QoL). The two studies did not report on compliance rates during the study period. Two trials studied the effects of intermittent mechanical compression devices. Both reported improvement in PTS severity (low-certainty evidence). Improvement of the severity of PTS was defined by treatment 'success' or 'failure'. Only one study comparing compression devices evaluated adverse effects and QoL. Although 9% of the participants experienced adverse effects such as leg swelling, irritation, superficial bleeding, and skin itching (moderate-certainty evidence), QoL was improved (moderate-certainty evidence). Studies did not assess compliance using intermittent mechanical compression devices. None of the studies evaluated patient satisfaction. Authors' conclusions: There is very low-certainty evidence regarding the use of GECS for treatment of PTS as assessed by two small studies of short duration. One study reported beneficial haemodynamic effects, while one found no benefits on PTS severity compared to control/placebo stockings. There is very limited evidence for adverse effects, patient satisfaction, QoL, and compliance rates. There is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studies of short duration. There is moderate-certainty evidence of improved QoL but possible increased adverse effects related to compression device use owing to small studies of short duration. High-certainty evidence to support the use of compression therapy in prevention of PTS is lacking and any conclusions drawn from current evidence should be interpreted with care. Further research is needed to assess whether compression can result in long-term reduction and relief of the symptoms caused by PTS, or prevent deterioration and leg ulceration.
BACKGROUND: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) that is characterised by chronic pain, swelling, and skin changes in the affected limb. One of every three people with DVT will develop post-thrombotic complications within five years. Several non-pharmaceutical measures are used for prevention of post-thrombotic syndrome during the acute phase of DVT. These include elevation of the legs and compression therapy. Clinicians and guidelines differ in their assessment of the utility of compression therapy for treatment of DVT. This is an update of a review first published in 2003.
OBJECTIVES: To determine relative effectiveness and rate of complications when compression therapy is used in people with deep vein thrombosis (DVT) for prevention of post-thrombotic syndrome (PTS).
SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist (CIS) searched the Cochrane Vascular Specialised Register (20 March 2017) and CENTRAL (2017, Issue 2). The CIS also searched trial registries for details of ongoing or unpublished studies.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of compression therapy, such as bandaging and elastic stockings, in people with clinically confirmed DVT. The primary outcome was the occurrence of PTS.
DATA COLLECTION AND ANALYSIS: Two review authors (DK and EvL) identified and assessed titles and abstracts for relevance, and a third review author (DA) verified this assessment independently. Review authors imposed no restrictions on date or language of publications. Three review authors (DA, DK, EvL) used data extraction sheets to independently extract study data. We resolved disagreements by discussion.
MAIN RESULTS: We identified 10 RCTs with a total of 2361 participants that evaluated compression therapy. The overall methodological quality of these trials was low. We used only five studies in meta-analysis owing to differences in intervention types and lack of data. Three studies compared elastic compression stockings (pressure of 30 to 40 mmHg at the ankle) versus no intervention. Two studies compared elastic compression stockings (pressure 20 to 40 mmHg) versus placebo stockings. Overall, use of elastic compression stockings led to a clinically significant reduction in the incidence of PTS (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.38 to 1.01; P = 0.05; 1393 participants; 5 studies; low-quality evidence); no reduction in the incidence of severe PTS (RR 0.78, 95% CI 0.53 to 1.15; P = 0.21; 1224 participants; 4 studies; low-quality evidence); and no clear difference in DVT recurrence (RR 0.94, 95% CI 0.69 to 1.28; 1212 participants; 4 studies; P = 0.69; low-quality evidence). We did not pool data on the incidence of pulmonary embolism because this information was poorly reported, but we observed no differences between groups included in individual studies (low-quality evidence).Two studies evaluated effects of compression in the acute phase versus no compression treatment and found no differences in the incidence of PTS (RR 0.76, 95% CI 0.49 to 1.16; P = 0.2; 101 participants). One study reported that thigh-length stockings did not provide better protection against development of PTS than knee-length stockings (RR 0.92, 95% CI 0.66 to 1.28; P = 0.6; 267 participants). Another trial reported that wearing compression stockings for two years seemed to be superior to wearing them for one year in terms of PTS incidence.Two of the 10 included studies described patient satisfaction and quality of life (moderate-quality evidence), using different measurement systems. The first study showed significant improvement in well-being and DVT-related quality of life with compression treatment (P < 0.05) compared with bed rest, and the second study showed no differences in quality of life scores between compression and placebo groups. Four studies poorly reported side effects (low-quality evidence) that included itching, erythema, and other forms of allergic reaction and described no serious adverse events. Compliance with wearing of compression stockings was generally high but varied across studies.
AUTHORS' CONCLUSIONS: Low-quality evidence suggests that elastic compression stockings may reduce the occurrence of PTS after DVT. We downgraded the quality of evidence owing to considerable heterogeneity between studies and lack of or unclear risk of blinding due to clinical assessment scores. No serious adverse effects occurred in these studies. Large randomised controlled trials are needed to confirm these findings because of current lack of high-quality evidence and considerable heterogeneity.
CONTEXTE: La cicatrisation des ulcères de jambe veineux est améliorée par l'utilisation d'un bandage de compression, mais certains ulcères veineux ne cicatrisent pas, et certaines personnes sont inaptes à un traitement par compression. La pentoxifylline, un médicament qui améliore la circulation sanguine, a été utilisée pour traiter les ulcères de jambe veineux.
OBJECTIFS: Évaluer les effets de la pentoxifylline (oxpentifylline ou Trental 400) pour le traitement des ulcères de jambe veineux, comparativement à un placebo ou à d'autres traitements, en la présence ou en l'absence d'un traitement de compression.
STRATÉGIE DE RECHERCHE DOCUMENTAIRE: Pour cette cinquième mise à jour, nous avons effectué des recherches dans le registre spécialisé du groupe Cochrane sur les plaies et contusions (recherche datant du 20 juillet 2012) ; (The Cochrane Library 2012, numéro 7) ; Ovid MEDLINE (2010 à la 2ème semaine de juillet 2012) ; Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 19 juillet, 2012) ; Ovide EMBASE (de 2010 à la 28ème semaine de 2012) et EBSCO CINAHL (2010 au 13 juillet 2012).
CRITÈRES DE SÉLECTION: Essais randomisés comparant la pentoxifylline à un placebo ou un autre traitement en la présence ou en l'absence de compression, chez les personnes souffrant d'ulcères de jambe veineux.
RECUEIL ET ANALYSE DES DONNÉES: Un auteur de la revue a extrait et résumé les données des essais éligibles à l'aide d'un formulaire de codage. Un autre auteur de la revue a vérifié l'extraction des données, de manière indépendante.
RÉSULTATS PRINCIPAUX: Aucun nouvel essai n'a été identifié pour cette mise à jour. Nous avons inclus douze essais impliquant 864 participants. La qualité des essais était variable. Onze essais ont comparé la pentoxifylline à un placebo ou à l'absence de traitement. La pentoxifylline est plus efficace que le placebo en termes de cicatrisation complète ou d'amélioration significative de l'ulcère (RR = 1,70, IC à 95 % de 1,30 à 2,24). La pentoxifylline plus compression est plus efficace que le placebo plus compression (RR = 1,56, IC à 95 % de 1,14 à 2,13). La pentoxifylline en l'absence de compression semble être plus efficace que le placebo ou l'absence de traitement (RR = 2,25, IC à 95 % de 1,49 à 3,39).Il y a eu davantage d'effets indésirables signalés chez les personnes recevant de la pentoxifylline (RR = 1,56, IC à 95 % de 1,10 à 2,22). Près de trois quarts (72 %) des effets indésirables signalés étaient gastro-intestinaux.
CONCLUSIONS DES AUTEURS: La pentoxifylline est un complément efficace au bandage de compression pour le traitement des ulcères veineux et peut s'avérer efficace en l'absence de compression. La majorité des effets indésirables ont été des troubles gastro-intestinaux.
Post-thrombotic syndrome (PTS) is a long-term complication of deep-vein thrombosis (DVT), manifesting as swelling, pain, edema, venous ectasia, and skin induration of the affected limb. PTS has been estimated to affect 23-60% of individuals with DVT, frequently occurring within 2 years of the DVT episode. Symptomatic DVT, post-operative asymptomatic DVT, and recurrent DVT are all risk factors for the development of PTS. Treatment of PTS is often ineffective and treatment-related costs represent a healthcare burden. Therefore, prevention of DVT is essential to reduce PTS, and thus improve outcomes and reduce overall healthcare costs. Although recommended by guidelines, appropriate DVT prophylaxis remains considerably underused. This review evaluates the incidence, risk factors, and economic impact of PTS. Increasing the awareness of PTS, and the methods to prevent this complication may help reduce its incidence, improve long-term outcomes in patients, and decrease resulting costs associated with treatment.
SUMMARY: The post-thrombotic syndrome (PTS) is increasingly recognized to be a common and important complication of deep venous thrombosis (DVT). Because there is no 'gold standard' objective test to establish its presence, PTS is diagnosed primarily on the basis of the presence of typical symptoms and clinical signs in a limb that was affected by DVT. As a wide variety of definitions of PTS have been used by researchers, it is difficult to compare data across studies and to formally combine data in meta-analyses. In a step towards standardization of the measurement of PTS in clinical studies, available scales and evidence to support their utility to diagnose PTS and to classify its severity were reviewed and discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis (Vienna, July 2008).
This chapter about treatment for venous thromboembolic disease is part of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh risks, burden, and costs. Grade 2 suggests that individual patient values may lead to different choices (for a full understanding of the grading, see "Grades of Recommendation" chapter). Among the key recommendations in this chapter are the following: for patients with objectively confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE), we recommend anticoagulant therapy with subcutaneous (SC) low-molecular-weight heparin (LMWH), monitored IV, or SC unfractionated heparin (UFH), unmonitored weight-based SC UFH, or SC fondaparinux (all Grade 1A). For patients with a high clinical suspicion of DVT or PE, we recommend treatment with anticoagulants while awaiting the outcome of diagnostic tests (Grade 1C). For patients with confirmed PE, we recommend early evaluation of the risks to benefits of thrombolytic therapy (Grade 1C); for those with hemodynamic compromise, we recommend short-course thrombolytic therapy (Grade 1B); and for those with nonmassive PE, we recommend against the use of thrombolytic therapy (Grade 1B). In acute DVT or PE, we recommend initial treatment with LMWH, UFH or fondaparinux for at least 5 days rather than a shorter period (Grade 1C); and initiation of vitamin K antagonists (VKAs) together with LMWH, UFH, or fondaparinux on the first treatment day, and discontinuation of these heparin preparations when the international normalized ratio (INR) is > or = 2.0 for at least 24 h (Grade 1A). For patients with DVT or PE secondary to a transient (reversible) risk factor, we recommend treatment with a VKA for 3 months over treatment for shorter periods (Grade 1A). For patients with unprovoked DVT or PE, we recommend treatment with a VKA for at least 3 months (Grade 1A), and that all patients are then evaluated for the risks to benefits of indefinite therapy (Grade 1C). We recommend indefinite anticoagulant therapy for patients with a first unprovoked proximal DVT or PE and a low risk of bleeding when this is consistent with the patient's preference (Grade 1A), and for most patients with a second unprovoked DVT (Grade 1A). We recommend that the dose of VKA be adjusted to maintain a target INR of 2.5 (INR range, 2.0 to 3.0) for all treatment durations (Grade 1A). We recommend at least 3 months of treatment with LMWH for patients with VTE and cancer (Grade 1A), followed by treatment with LMWH or VKA as long as the cancer is active (Grade 1C). For prevention of postthrombotic syndrome (PTS) after proximal DVT, we recommend use of an elastic compression stocking (Grade 1A). For DVT of the upper extremity, we recommend similar treatment as for DVT of the leg (Grade 1C). Selected patients with lower-extremity (Grade 2B) and upper-extremity (Grade 2C). DVT may be considered for thrombus removal, generally using catheter-based thrombolytic techniques. For extensive superficial vein thrombosis, we recommend treatment with prophylactic or intermediate doses of LMWH or intermediate doses of UFH for 4 weeks (Grade 1B).
BACKGROUND: Post-thrombotic syndrome (PTS) is a chronic complication of deep venous thrombosis (DVT).
OBJECTIVES: To determine the risk of PTS after DVT and to assess risk factors for PTS.
METHODS: Patients were recruited from the Multiple Environmental and Genetic Assessment (MEGA) study of risk factors for venous thrombosis. Consecutive patients who suffered a first DVT of the leg were included in a follow-up study. All patients completed a questionnaire and DNA was obtained. PTS was ascertained in a structured interview using a clinical classification score.
RESULTS: The 1-year cumulative incidence of PTS was 25% and 7% for severe PTS. Elastic compression stockings were prescribed in 1412 (85%) patients. The majority used their stockings every day. Women were at an increased risk compared with men [risk ratio (RR) 1.5, 95% confidence interval (CI) 1.3-1.8]. Similarly, obese patients had a 1.5-fold increased risk of PTS compared with normal weight patients (RR 1.5, 95% CI 1.2-1.9), with a 1-year cumulative incidence of 34% compared with 22%. Patients who already had varicose veins had an increased risk (RR 1.5, 95% CI 1.2-1.8) of PTS. DVT in the femoral and iliac vein was associated with a 1.3-fold increased risk of PTS compared with popliteal vein thrombosis (RR 1.3, 95% CI 1.1-1.6). Patients over 60 years were less likely to develop PTS than patients below the age of 30 (RR 0.6, 95% CI 0.4-0.9). Malignancy, surgery, minor injury, plaster cast, pregnancy or hormone use did not influence the risk of PTS neither did factor (F)V Leiden nor the prothrombin 20210A mutation.
CONCLUSIONS: PTS is a frequent complication of DVT, despite the widespread use of elastic compression stockings. Women, obese patients, patients with proximal DVT and those with varicose veins have an increased risk of PTS, whereas the elderly appeared to have a decreased risk.
Background: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) characterised by chronic complaints such as oedema and skin changes including; venous ectasia, varicose veins, redness, eczema, hyperpigmentation, and in severe cases fibrosis of the subcutaneous adipose in the affected limb. These chronic complaints are the effects of venous outflow restriction that can cause symptoms such as heaviness, itching, pain, cramps, and paraesthesia. Twenty to fifty percent of people with DVT develop post-thrombotic complications. Several non-pharmaceutical measures are used for prevention of PTS during the acute phase of DVT. These include elevation of the legs and compression therapy. There have been limited studies regarding the effectiveness of compression therapy for prevention or treatment of PTS. As a result, clinicians and guidelines differ in their assessment of compression therapy during treatment of DVT and in the treatment of PTS. This is an update of a review first published in 2003. Objectives: To assess the effectiveness of compression therapy for treatment of post-thrombotic syndrome, including elastic compression stockings and mechanical devices compared with no intervention, placebo and with each other. Search methods: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries on 2 July 2018. Selection criteria: We included trials that evaluated compression therapy for the treatment of PTS. The primary outcomes were severity of PTS and adverse effects. There were no restrictions on date or language. Two review authors (SA, DNK) independently assessed whether potentially relevant studies met the inclusion criteria. Data collection and analysis: One review author extracted and summarised data and one review author (DNK) verified them. We resolved disagreements by discussion. We assessed methodological study quality with the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of the evidence supporting the outcomes assessed in this review. Main results: We identified four trials, with 116 participants, investigating the effectiveness of compression therapy for treatment of PTS. The methodology used by each trial was too heterogeneous to perform a meta-analysis, so we reported our findings narratively. Two trials studied the effect of graduated elastic compression stockings (GECS) on improvement of PTS symptoms. One study reported beneficial haemodynamic effects, while the other found no benefits on PTS severity compared to placebo (very low-certainty evidence). There was very limited evidence available for adverse effects and quality of life (QoL). The two studies did not report on compliance rates during the study period. Two trials studied the effects of intermittent mechanical compression devices. Both reported improvement in PTS severity (low-certainty evidence). Improvement of the severity of PTS was defined by treatment 'success' or 'failure'. Only one study comparing compression devices evaluated adverse effects and QoL. Although 9% of the participants experienced adverse effects such as leg swelling, irritation, superficial bleeding, and skin itching (moderate-certainty evidence), QoL was improved (moderate-certainty evidence). Studies did not assess compliance using intermittent mechanical compression devices. None of the studies evaluated patient satisfaction. Authors' conclusions: There is very low-certainty evidence regarding the use of GECS for treatment of PTS as assessed by two small studies of short duration. One study reported beneficial haemodynamic effects, while one found no benefits on PTS severity compared to control/placebo stockings. There is very limited evidence for adverse effects, patient satisfaction, QoL, and compliance rates. There is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studies of short duration. There is moderate-certainty evidence of improved QoL but possible increased adverse effects related to compression device use owing to small studies of short duration. High-certainty evidence to support the use of compression therapy in prevention of PTS is lacking and any conclusions drawn from current evidence should be interpreted with care. Further research is needed to assess whether compression can result in long-term reduction and relief of the symptoms caused by PTS, or prevent deterioration and leg ulceration.
