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 The CIS also searched trial registries for details of ongoing or unpublished studies.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.
CONTEXTE: Jusqu'à 50% des patients développent un syndrome post-thrombotique (PTS) après leur première thrombose veineuse profonde proximale (TVP). Cette méta-analyse a pour but d'évaluer l'efficacité des bas de compression graduée (GCS) dans la prévention de PTS.
Méthode: Medline, Embase, Cochrane Database of Systematic Reviews, et ClinicalTrials.gov ont été fouillés par voie électronique de la création à Janvier 2015 pour des études portant sur l'effet de GCS dans la prévention de PTS. Tous les essais contrôlés randomisés ont été considérés pour l'inclusion s'ils ont comparé l'efficacité de GCS (30-40 mmHg à la cheville) avec un placebo ou pas de bas chez les adultes avec une nouvelle proximale inférieure DVT du membre. évaluation méthodologique, en utilisant le risque Cochrane de Bias Tool, et l'extraction des données a été effectuée par deux examinateurs indépendants. L'effet de GCS a été exprimée comme la différence de risque (DR).
RÉSULTATS: Un total de 686 articles ont été projetés. Trois essais contrôlés randomisés compris des 1.177 patients étaient admissibles pour l'inclusion. PTS développé dans 49-70% des patients de contrôle à 5 ans. hétérogénéité statistique élevée a été observée entre les essais (tous PTS: I (2) = 0,94; PTS sévères: I (2) = 0,79). La différence de risque de l'incidence PTS entre le contrôle et les bras GCS variait de 0% à 39% entre les essais. Dans les essais avec une prévalence de base de PTS plus, une tendance visuelle vers plus d'avantages avec GCS a été noté.
CONCLUSION: L'incertitude en raison de la variabilité et de l'hétérogénéité d'échantillonnage était trop élevé pour conclure en faveur ou contre un effet de porter des bas de compression dans la prévention PTS. Un effet peut être présent pour des valeurs plus élevées de risque de base. Une preuve supplémentaire est nécessaire. l'histoire de l'article.
AIM: The aim of this review is to try to explain the controversy by critical analysis of previously published randomized controlled trials on the value of elastic compression stockings in the treatment of acute proximal deep vein thrombosis in prevention of post-thrombotic syndrome, which forms the scientific basis for our present management.
METHODS: A research was made through Medline and Embase databases to identify relevant original articles, not abstracts, with the following keywords: post-thrombotic syndrome, deep venous thrombosis, venous thromboembolism, compression stockings, prevention and compliance.
RESULTS: We identified five randomized controlled trials (RCTs) before the SOX trial including 798 patients with acute proximal deep vein thrombosis. Brandjes (1997): at two years' follow-up, elastic compression stockings reduced post-thrombotic syndrome by 50%; Ginsberg (2001): no difference in post-thrombotic syndrome with or without elastic compression stockings after more than two years' follow-up; Partsch (2004): elastic compression stockings with routine above knee and early ambulation reduced the incidence and severity of post-thrombotic syndrome after two years' follow-up; Prandoni (2004) showed significantly less post-thrombotic syndrome after elastic compression stockings for two years with a five-year follow-up; Aschwanden (2008) showed no difference with elastic compression stockings after three years' follow-up.
CONCLUSION: Prescription of elastic compression stockings for the prevention of post-thrombotic syndrome is now in doubt. Immediate compression after diagnosis of acute deep vein thrombosis to prevent swelling and reduce pain, permitting early ambulation in combination with adequate anticoagulation has proven benefit, although a secondary analysis of the SOX trial refutes this belief. Continued long-term compression treatment is questioned. Two major questions remain: Is the lack of positive outcome on the development of post-thrombotic syndrome after proximal deep vein thrombosis due to the fact that there were a few patients with iliofemoral extension in the quoted randomized controlled trials who may benefit from prolonged medical compression treatment? Compliance is the major issue, and the two randomized controlled trials with excellent control of compliance showed significant reduction in the rate of post-thrombotic syndrome, but we know that in daily practice the adherence is closer to Kahn's data.
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.
INTRODUCTION: Le pourcentage de temps dans la plage INR cible de 2,0 à 3,0 (TTR) chez les patients traités par antivitamines K varie considérablement selon les études de l'efficacité des anticoagulants nouveaux. Afin d'évaluer correctement la qualité du contrôle anticoagulant dans les prochaines études coût-efficacité et les registres de la vie réelle de cette revue systématique rapporte un point de repère de TTR pour différentes durées de traitement chez les patients présentant la maladie thromboembolique veineuse et discute des façons de calculer TTR.
MÉTHODES: Medline et Embase ont cherché des études publiées entre Janvier 1990 et mai 2012. Des essais contrôlés randomisés et les études de cohortes rapports du TTR chez les patients ayant une thromboembolie veineuse confirmée objectivement traités par antivitamines K (AVK) étaient admissibles. Dupliquer les rapports, les études ne rapportant INR au cours du traitement initial ou d'un traitement AVK moins de 3 mois ont été exclus. Trois auteurs ont évalué les essais pour l'inclusion et extrait les données indépendamment. Les divergences ont été résolues par la discussion entre les examinateurs. Une méta-analyse a été réalisée en calculant une moyenne pondérée, en fonction du nombre de participants dans chacune des études, pour chaque période de temps dans laquelle le TTR a été mesurée depuis la confirmation du diagnostic de MTEV.
RÉSULTATS: Quarante études ont été incluses (26 064 patients). Les moyennes pondérées des TTR étaient 54,0% dans le premier mois depuis le début du traitement, 55,6% dans les mois 1 à 3, 60,0% dans les 2 à 3 mois, 60,0% dans les mois 1 à 6 + et 75,2% dans les mois à 4 à 12 +. Cinq études ont rapporté TTR dans les classes. L'INR dans ces études était ≥ 67% du temps dans l'intervalle thérapeutique dans 72,0% des patients.
CONCLUSION: Rapporté qualité du traitement AVK est fortement dépendante de la période de temps depuis le début du traitement, avec TTR allant d'environ 56% dans les études, y compris le 1 (er) mois à 75% dans les études excluant les 3 premiers mois.
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.
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.
