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.
BACKGROUND: Here, we update an earlier systematic review on the preventive efficacy of active compression stockings in patients with diagnosed proximal deep venous thrombosis (DVT) by including the results of recently published trials. The aims are to synthesize the results of the original studies, and to identify details to explain heterogeneous results.
METHODS: We searched the Cochrane Library, PubMed, Scopus, and Medline for original studies that compared the preventive efficacy of active compression stockings with placebo or no compression stockings in patients with diagnosed proximal DVT. Only randomized controlled trials (RCTs) were included.
RESULTS: Five eligible RCTs with a total of 1393 patients (sample sizes ranged from 47 to 803 patients) were included. In three RCTs, patients started to wear compression stockings, placebo stockings or no stockings within the first three weeks after the diagnosis of DVT. The results of two RCTs indicate a statistically significant reduction in post-thrombotic syndrome (PTS) of 50% or more after two or more years. The result of one RCT shows no preventive effect of compression stockings at all. Due to the heterogeneity of the study results, we refrained from pooling the results of the RCTs. In a further RCT, randomization to groups with and without compression stockings took place six months after the diagnosis of DVT, and in another RCT, only patients with the absence of PTS one year after the diagnosis of DVT were analyzed. One RCT revealed a significant reduction in symptoms, whereas another RCT failed to show any benefit of using compression stockings.
CONCLUSIONS: At this time, it does not seem to be justifiable to entirely abandon the recommendations regarding compression stockings to prevent PTS in patients with DVT. There is evidence favoring compression stockings, but there is also evidence showing no benefit of compression stockings.
OBJECTIVE: We conducted a systematic review and meta-analysis to address benefits and harms of using elastic compression stockings after lower-extremity deep vein thrombosis.
METHODS: We searched 7 electronic databases through January 15, 2015, including randomized controlled trials (RCTs)/quasi-randomized trials reporting on elastic compression stocking efficacy on postthrombotic syndrome incidence, recurrent venous thromboembolism, mortality, and acute pain after deep vein thrombosis. Two reviewers independently screened records, extracted data, assessed risk of bias, and assessed confidence in effect estimates using Grading of Recommendations Assessment, Development, and Evaluation methodology. We applied random-effects meta-analysis models.
RESULTS: We included 5 RCTs (n = 1418) reporting on postthrombotic syndrome. The hazard ratio (HR) for postthrombotic syndrome with elastic compression stockings was 0.69 (95% confidence interval [CI], 0.47-1.02). We have very low confidence in this estimate due to heterogeneity and inclusion of unblinded studies at high risk of bias. Excluding high risk of bias studies, a single large RCT at low risk of bias provided moderate-quality evidence of no effect on postthrombotic syndrome (HR 1.00; 95% CI, 0.81-1.24). Moderate-quality evidence including all 5 studies suggests no effect of elastic compression stockings on recurrent venous thromboembolism (relative risk [RR] 0.88; 95% CI, 0.63-1.24) or mortality (RR 1.00; 95% CI, 0.73-1.37, 5 studies). Moderate-quality evidence from one large RCT does not suggest effect on acute pain after deep vein thrombosis.
CONCLUSIONS: The highest-quality evidence available suggests no effect of elastic compression stockings on postthrombotic syndrome or pain relief, from a single large RCT. However, results for preventing postthrombotic syndrome differ substantially across studies, and future guideline updates should reflect uncertainty about treatment effects. Elastic compression stockings are unlikely to prevent death or recurrent venous thromboembolism.
OBJECTIVE: The present meta-analysis aimed to evaluate the efficacy and safety of compression stockings for postthrombotic syndrome (PTS) prevention in patients with deep venous thrombosis (DVT).
METHODS: Randomized controlled trials (RCTs) regarding the use of compression stockings for prevention of PTS were identified from the Medline, PubMed, and Embase databases as well as the Cochrane library. The resulting manuscripts were analyzed according to the criteria in the Cochrane Handbook for Systematic Reviews of Interventions.
RESULTS: Six RCTs involving 1465 patients with DVT were included. The meta-analysis indicated no statistical differences between the compression stocking and the control groups in PTS incidence, using either the Villalta scale (odds ratio [OR], 0.63; 95% confidence interval [CI], 0.23-1.74) or the Ginsberg scale (OR, 1.13; 95% CI, 0.72-1.77). Based on the Villalta scale categorization, there were no differences in the incidence of mild-moderate PTS (OR, 0.71; 95% CI, 0.36-1.41) or incidence of severe PTS (OR, 0.68; 95% CI, 0.15-3.11). The difference in the recurrence of venous thromboembolism (OR, 0.89; 95% CI, 0.61-1.30) was also not significant. In the 3 RCTs that reported side effects of compression stockings, they were primarily related to discomfort, including itching, erythema, and rash.
CONCLUSION: The present meta-analysis has indicated that compression stockings may not prevent PTS, as determined by either the Villalta or the Ginsberg scale, in patients with DVT. However, owing to the limited number of trials, the evidence is not strong enough to draw a reliable conclusion. Further larger, randomized, double-blind, placebo-controlled, multicenter trials are needed.
Although compression therapy has been widely used after deep vein thrombosis (DVT), its efficacy in prevention of postthrombotic syndrome (PTS) remains disputable. We aimed to update the meta-analysis to comprehensively evaluate the effect of compression therapy on the prevention of PTS in adult patients after DVT.PubMed, Embase, and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) evaluating the preventive effect of compression therapy on PTS in adult patients after DVT were included. The primary outcome was the incidence of PTS. All meta-analyses were performed using random-effects models regardless of the heterogeneity. Subgroup and sensitivity analysis were also performed to examine the robustness of the pooled effects according to our predesigned plan. Potential publication bias was assessed.Eight RCTs with 1598 patients were included. Overall, compression therapy could significantly reduce the incidence of PTS (estimate 0.68, 95% confidence interval [CI] 0.52-0.90; P = 0.007). However, it was only associated with a reduction in the incidence of mild/moderate PTS (relative risk [RR] 0.66, 95% CI 0.46-0.93; P = 0.019) but not in the incidence of severe PTS (RR 0.64, 95% CI 0.27-1.50; P = 0.31). Additionally, compression therapy failed to reduce the incidence of recurrent venous thromboembolism (RR 0.91, 95% CI 0.65-1.27; P = 0.58), the incidence of ulceration (RR 0.74, 95% CI 0.36-1.53; P = 0.42), or mortality (RR 0.99, 95% CI 0.72-1.37; P = 0.96). No publication bias was observed.Current evidence still supports compression therapy to be a clinical practice for prophylaxis of PTS in adult patients after DVT. However, our findings should be cautiously interpreted because of heterogeneity and hence more large-scale and well-designed RCTs are still warranted.
Le syndrome post-thrombotique (PTS) est un fréquent, complication chronique de la TVP. L'efficacité et la sécurité des traitements disponibles ne sont pas connus. L'objectif de cette étude était d'examiner systématiquement la littérature pour évaluer si pharmacologiques et les thérapies de compression sont efficaces et sûrs pour le traitement du SPT.
MÉTHODES: Nous avons cherché à identifier les essais contrôlés randomisés (ECR) via une recherche sur PubMed, des études mentionnées dans les publications incluses, et des études citées littérature pertinente.
RÉSULTATS: Un total de 121 titres ont été examinés, 12 publications en texte intégral ont été évalués pour l'inclusion, et sept ECR, dont 703 patients ont été sélectionnés pour l'inclusion. Quatre essais ont évalué l'efficacité des médicaments, y compris rutosides, hidrosmin et Defibrotide, et quatre essais de compression évalué thérapies pour le traitement du PTS. Systèmes pour le diagnostic et la classification de la sévérité PTS varient selon les études. Trois des quatre essais de thérapie de drogue ont rapporté une amélioration modérée des symptômes PTS sélectionnés, des changements mineurs dans le mollet et la cheville circonférence, et certains effets sur la cicatrisation de l'ulcère. Deux études de bas de contention n'ont pas fait état des avantages. Deux études qui ont évalué les dispositifs de compression rapportés amélioration des scores de symptômes PTS, l'une d'entre elles fait état d'une amélioration de la qualité de vie partition.
CONCLUSIONS: Il existe des preuves limitées et de faible qualité pour l'efficacité de rutosides, hidrosmin, défibrotide, et des bas de compression, mais de qualité moyenne preuves qui appuient l'utilisation de la compression intermittente de fournir au moins à court terme pour soulager la PTS. Des études plus rigoureuses sont nécessaires pour évaluer l'efficacité à court et à long terme et la sécurité des traitements STP.
OBJECTIF: Déterminer l'efficacité des bas de compression veineuse ou de bandages de compression sur la réduction du syndrome post-thrombotique chez les patients présentant une thrombose veineuse profonde. MÉTHODES: Nous avons tenté d'identifier tous les essais publiés dans toutes les langues identifiées par PubMed à Juin 2009. La méta-analyse a été effectuée. RÉSULTATS: Sur la base de 5 essais randomisés de patients atteints de thrombose veineuse profonde comparant le traitement par compression veineuse à des contrôles, d'intensité légère à modérée syndrome post-thrombotique s'est produite dans 64 des 296 (22%) traités avec la compression veineuse, comparativement à 106 de 284 (37% ) chez les témoins (risque relatif = 0,52). Syndrome post-thrombotique sévère a eu lieu dans 14 des 296 (5%) traités, comparativement à 33 sur 284 (12%) des contrôles (risque relatif = 0,38). Tout syndrome post-thrombotique s'est produite dans 89 des 338 (26%) traités, comparativement à 150 de 324 (46%) des contrôles (risque relatif = 0,54). CONCLUSION: la compression veineuse a réduit l'incidence du syndrome post-thrombotique, en particulier le syndrome post-thrombotique. De compression veineuse chez les patients présentant une thrombose veineuse profonde semble être indiqué à cet effet. Il y avait, cependant, de grandes variations dans le type de bas utilisé, l'intervalle de temps entre le diagnostic et à l'application des bas, et la durée du traitement. Une enquête plus poussée, par conséquent, est nécessaire.
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.
