Does prescription of medical compression prevent development of post-thrombotic syndrome after proximal deep venous thrombosis?

Abstract

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.

Keywords

Post-thrombotic syndrome compression stockings compliance deep vein thrombosis venous syndromes

Introduction

Medical compression was considered effective by level 1 evidence in preventing post-thrombotic syndrome (PTS) after proximal deep venous thrombosis (DVT) until the recent publication of a randomized controlled trial (RCT) conducted by a North American group headed by a recognized epidemiologist and angiologist.¹

The aim of this review is to try to explain the resulting controversy by identifying bias or inclusion criteria differences in RCTs published on the topic, with inclusion of other pertinent articles on medical compression appropriate to the subject.

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, compliance.

Results

We identified six RCTs.^1–6

The Brandjes RCT (Table 1)

This monocentric study was limited to patients presenting with “proximal” vein thrombosis involving the popliteal vein or above irrespective of concomitant calf-vein thrombosis, with a very good adherence to custom-made knee length stockings. It is worth noting that there were no cases with iliac vein thrombus; perhaps, a distinction between femoral and common femoral veins was not yet established when this article was published in 1997. The outcome was evaluated by using a personal system close to Villalta scale including both symptoms and signs in which patients presenting PTS were classified in two groups: moderate to mild PTS and severe PTS. PTS developed usually within two years of the acute thrombotic episode.

Table 1.

Brandjes RCT.

Article	Type of study Patients #	Type of compression or no compression	FU duration	Date of initial compression	Adherence to treatment criteria	Type of assessment	Outcome
Brandjes et al.²	Single centre 194	CS Knee-length, custom made 40 mm Hg (Gr 1 #96) vs. No compression (Gr 2 #98)	2 Y	2–3 W after DVT	Always 76% Usually 16.7% Never or occasionally 7.3%	Brandjes Scoring system – Mild to moderate – Severe	Gr. 1 Moderate or Mild 20% Severe 11% P < 0.001 Gr. 2 Moderate or Mild 47% Severe 23%

CS: compression stockings; DVT: deep venous thrombosis; W: week; Y: year; FU: follow-up.

There was a significant difference at two-year follow-up (FU) between the stocking group compared to patients without compression in terms of mild or moderate PTS and severe PTS. The authors concluded that approximately 70% of patients with symptomatic proximal DVT will develop a PTS in absence of compression. The use of compression stockings reduces the rate of PTS by about 50%. In summary, this trial shows that in patients compliant with compression and presenting proximal DVT (93% in this series), compression is efficient.

Ginsberg’s RCT (Table 2)

Table 2.

Ginsberg RCT.

Article	Type of study Patients #	Type of compression or no compression	FU duration	Date of compression	Adherence to treatment criteria	Type of assessment	Outcome
	Study 1 Single centre Asymptomatic patients with no deep venous valve incompetence #120	No compression	55 M (mean)	No compression		Global rating questionnaire at base line and 3-M interval.	Presence of PTS 5%
Ginsberg et al.³	Study 2 Single centre Asymptomatic patients with venous valve incompetence # 47	CS (Gr. 1#24) 20–30 mm Hg BK graduated vs. (Gr. 2#23) Placebo stockings with no hemodynamic effect (1–2 sizes too large)	55 M (mean) 59 M (mean)	Compression at 1 Y	No information	Failure was defined as: – Pain and/or swelling not improved or worse after the first 3-M treatment interval. – Symptomatic deterioration during any 2 consecutive treatment intervals. – Symptoms causing five or more days of work absenteeism or inability to perform housework during 3-M interval. – Venous ulcer	Gr.1 Treatment failure 0% P = NS Gr. 2 Treatment failure 4.3%
	Study 3 Single centre Symptomatic PTS with venous valve incompetence #35	CS 1-year after DVT 30--40 mm Hg (Gr 1# 18) 30–40 mmHg (Gr. 1 #18) BK # 14 AK #4 Placebo stockings (Gr. 2 #17 BK #13 AK #4	28 M (mean) 26 M (mean)				Gr.1 Treatment failure 61% P = NS Gr 2 Treatment failure 59%

AK: above knee; BK: below knee; CS: compression stockings; D: day; DVT: deep venous thrombosis; M: month; PTS: post-thrombotic syndrome; W: week; Y: year; FU: follow-up.

This trial is difficult to analyse as it is divided into three studies, as follows:

A total of 202 patients with “proximal” DVT (popliteal vein or above) were recruited one year after their first episode of DVT. There is no report on the number of cases whose proximal extension of the thrombus was limited to the popliteal vs. the femoral vs. the iliac locations. Nothing is mentioned about how these patients were treated in the acute situation. Apparently, none of these patients had been treated with stockings, when they were recruited after one year.

In study 1, 120 asymptomatic patients without deep venous valve incompetence were followed up (mean 55 months) without any compression treatment. Only 5% developed PTS.

In study 2, the asymptomatic patients with deep valve incompetence were randomized into:

Group 1: active stockings (20–30 mmHg, 24 patients) or Group 2: placebo stockings (one to two sizes too large, 23 patients).

At follow-up (mean 55 months), there was no difference in the outcome in terms of symptoms and ulcer occurrence.

In study 3, the symptomatic patients with or without deep valve incompetence were randomized into: Group 1: active stockings (20–30 mmHg, 18 patients) or Group 2: placebo stockings (one to two sizes too large, 17 patients).

At follow-up (mean 28 months), there was no difference in the outcome in terms of symptoms and ulcer occurrence.

The authors’ conclusions were that after one year most patients do not have PTS and consequently do not require stockings. In patients presenting with PTS the small number of patients is insufficient to draw conclusions, although there was no benefit in those who wore stockings in their study.

Partsch’s RCT (Table 3)

Table 3.

Partsch RCT.

Article	Type of study No. of patients	DVT location	Type of compression	Date of initial compression	FU duration	Compliance	Type of assessment	Outcome
Partsch et al.⁴	Single center 53 included	Iliac extension 30%	Group 1: 11 bed rest, no compression for 9 days; Groups 2 + 3: 26 (13 Unna boot, 13 CS) Early ambulation and compression	As soon as DVT was diagnosed	2 years	Up to the time of FU EC was worn by 73% in group 1 vs. 50% in groups 2 + 3	Villalta score	Group 1: mean score 8.2, 2/11 patients score <5 P < 0.01 Groups 2 + 3: mean score 5.1, 18/26 patients score <5

FU: follow-up; DVT: deep vein thrombosis.

Fifty-three patients presenting proximal DVT were included but DVT anatomic extent was not delineated in the acute phase.⁷ All were treated with low-molecular weight heparin (LMWH) and oral anticoagulation. They were randomized into three groups:

Group 1: bed rest (group 1) and no compression for nine days.

Group 2: early ambulation and compression (half the group thigh-length compression stockings).

Group 3: the other half was treated by Unna boot of the calf with adhesive bandage of the thigh.

After nine days, all patients were encouraged to walk with compression in all groups.

At 2-year FU the proximal extent of the thrombus into the iliac vein was clearly delineated. 37 patients were assessed and 11 had thrombus extension into the pelvis.

According to the authors’ conclusion, in the bed-rest group general well being and quality of life were lower compared to the compression groups; conversely, pain and degree of oedema were greater. There was no relevant difference between groups 2 and 3 (compression groups).

Since long-term compliance with compression was 73% in group 1 (initial bed rest) vs. 50% in groups 2 and 3, compliance with compression could not be discerned to play a role in the development of PTS. Whether it was early ambulation or early compression that was responsible for the benefit is unclear. It is possible that early compression decreased swelling and pain, and facilitated ambulation. The difference in outcome between iliofemoral thrombus extension and more distal localization of the thrombus could not be evaluated due to the small number of patients.

Prandoni’s RCT (Table 4)

The Prandoni single-centre study included 180 symptomatic patients with acute “proximal” DVT treated with unfractionated heparin or LMWH followed by oral anticoagulation for at least three months.

Table 4.

Prandoni RCT.

Article	Type of study Patients #	Type of compression or no compression	FU duration	Date of compression	Adherence to treatment criteria	Type of assessment	Outcome
Prandoni et al.⁵	Single centre 180	CS Knee length, off the rack 30–40 mmHg: #90) vs. No compression Gr. 2: #90)	2 Y	4–10 days (average 1 W after DVT	Adherence 93% of patients wear their compression 80% of daytime hours	Villalta-Prandoni Scale	Villalta score Gr. 1 0–4 73% 5–14 26% ≥ 15 1% CI 0.29–0.84. P = 0.011 Gr. 2 0–4 49% 5–14 46% ≥ 15 5%

CS: compression stockings; D: day; Y: year; DVT: deep venous thrombosis; W: week; FU: follow-up.

Ninety of these patients were randomized for below-knee compression stockings for two years and 90 patients for no compression. FU up to five years showed significantly less PTS in the compression group. It is crucial to point out two important factors:

Compliance was very high in 93% of the patients;

There were no patients with extension of the thrombus into the iliac vein, and the number of patients with extension to the CFV was not reported.

Aschwanden RCT (Table 5)

A total of 169 patients with acute proximal DVT were initially treated by standard anticoagulation and below-knee compression stockings. After six months they were randomized into two groups:

Compression using below-knee stockings;

No compression.

Table 5.

Aschwanden RCT.

Article	Type of study Patients #	DVT location	Type of compression or no compression	FU duration	Date of compression	Adherence to treatment criteria	Type of assessment	Outcome
Aschwanden et al.⁶	Single centre 169	DS examination at 6 M Popliteal 30.9–34.1% Popliteal and Femoral 44.7–52.4% Popliteal, femoral and Iliac 16.7–22%	CS 26.3–36.1 mmHg	Gr. 1 3.2 Y Gr. 2 2.9 Y	CS for 6 months for all patients Exclusion ≥C4. Then Gr. 1 CSvs. Gr 2 no compression	No information on compression adherence for the first 6 M after DVT. After 6 months adherence to compression was 91.6%	– Symptoms – CEAP Classification – Mild or moderate Less than C4 – Severe ≥C4	Gr. 1 Less symptoms the first year CEAP Mild or moderate 20% Severe 0% P = NS Gr. 2 Mild or moderate 13% Severe 0%

CS: compression stockings; Y: year; DVT: deep venous thrombosis; FU: follow-up.

Twenty percent had initially an extension of the thrombus into the iliac vein. Mean FU time for compression group was 3.2 years and for control group 2.9 years. Symptoms were improved in the compression group after one year but not thereafter. No significant difference was found between the two groups in terms of clinical CEAP class after 2 years.

Kahn RCT (Table 6)

In this large multicentre RCT including 806 patients with acute “proximal” DVT, the patients were randomized into one group with elastic compression stockings (ECSs), and one group with placebo stockings. Primary endpoint was the Ginsberg criteria (leg pain and swelling of >1 month duration) and secondary endpoint was the Villalta score. After six months’ FU, there was no difference between the two groups and the authors concluded that ECSs did not prevent the PTS after a first episode of “proximal” DVT. Consequently, they suggested that effectiveness of routine wearing of ECSs after proximal DVT is uncertain.

A flood of criticisms has followed this publication underlining its flaws:

Use of elastic stockings started late, about two weeks after the acute event.

The stocking was sent to the patient by mail and no physician gave instruction to the patient.

The placebo stockings used in the SOX study may have had some therapeutic effect.

The definition of frequent user, three or more days/week is open to criticism.^8,9

The authors replied by rejecting each of these criticisms.¹⁰

Table 6.

Kahn RCT.

Article	Type of study Patients #	Type of compression or no compression	FU duration	Date of initial compression	Adherence to treatment criteria	Type of assessment	Outcome
Kahn SR et al.¹	Multicentre 806	Gr. 1 CS 30–40 mmHg #410 Gr. 2 Placebo #396	2 Y	2--3 W after DVT	Compression adherence 1M 86.4% 3 or more days/W 2Y 55.6% 3 or more days/W	Villalta’s scale Ginsberg’s criteria QoL questionnaire – SF-36 – VEINES-QOL/Sym	Cumulative incidence of PTS Gr. 1 12.7% P = 0.058 Gr. 2 14.2%

FU: follow-up; DVT: deep vein thrombosis; CS: compression stockings; PTS: post-thrombotic syndrome.

Present recommendations from published guidelines

Recommendations for compression treatment in order to prevent PTS following the first episode of proximal DVT was proposed from four societies using the Guyatt’s grade system:

International Compression Club 2011. Grade of recommendation 1A.¹¹

American College of Chest Physicians 2012. We suggest compression stockings to prevent the post-thrombotic syndrome. Grade of recommendation 2B.¹²

Society for Vascular Surgery and American Venous Forum.2012. We recommend that all patients be treated with knee-high compression stockings (30–40 mmHg) for at least two years after early thrombus removal. Grade of recommendation 1C. (JVS 2012).¹³

Society for Vascular Surgery and American Venous Forum 2014. In patients with clinical CEAP C1-4 disease related to prior DVT, we recommend compression, 30 to 40 mmHg, knee or thigh high. Grade of recommendation (Grade 1; Level of Evidence B).

In fact, this recommendation concerns patients presenting with PTS as the CEAP classification of venous disorders is used for selecting patients.¹⁴

American Heart Association 2014. The effectiveness of ECS for PTS prevention is uncertain but application of ECS is reasonable to reduce symptomatic swelling in patients with a diagnosis of proximal DVT. Grade of recommendation 2B; Level of Evidence A.¹⁵

Discussion

In the SVS/AVF guidelines for early thrombus removal (2012), it is recommended to use precise anatomic terminology to characterize the most proximal extent of venous thrombosis as involving the iliofemoral veins, with or without extension into the IVC, the femoral-popliteal veins, or isolated to the calf veins (Grade 1A).¹³ The classification of proximal and distal localization of DVT in the legs used in all quoted RCTs is anatomically non-specific since definition of proximal DVT refers to any DVT that has a proximal extent anywhere from the popliteal vein to the proximal iliac vein. Given the anatomic considerations, it seems obvious we should not put in the same basket a DVT affecting the popliteal or femoral vein with the one involving the iliofemoral axis in terms of possible future development of PTS. Similarly, an isolated femoral vein obstruction cannot be compared to iliofemoral occlusion.

This was pointed out at the 6th Pacific Vascular Symposium.¹⁶ The proximal extent of the thrombus into the iliac vein was reported in only three of the RCT studies and the frequency of extension varied between 12% and 30% in these reports. In two of the RCTs (Brandjes and Prandoni), the reports point out that there was no iliac extension (Table 7).

Table 7.

Top of thrombus.

Article	Iliac vein%	CFV%
Brandjes²	0	?
Prandoni⁵	0	?
Partsch⁴	18–38	?
Aschwanden⁶	20	?
Kahn¹	10.8–12.4	26.7–27.2

With this lack of data concerning the effect of compression in iliofemoral extension of the thrombus, the question arises whether compression may be more important in those with iliac vein involvement than those with more distal thrombosis. Clinical experience leads to the impression that more proximal extent of the thrombus responds to use of compression to limit development of distal skin changes. The question is whether more objective anatomic data will give different results concerning the long-term effect of compression in iliofemoral DVT.

The main problem with compression is compliance to treatment. Middle- or long-term compliance is poorly documented and difficult to assess. Most of the surveys are based on either patient’s reporting, which is not fully reliable, or assessment by healthcare professionals that is variable. Compliance definition is described in different ways: compliant or not compliant; total, partial or never compliant; good, moderate or poor compliant or numbers on hour per day or day per week.

In the Mississippi survey, all classes of patients with chronic venous disease (CVD) were included.¹⁷

In this referral practice, patients had been under the care of primary-care physicians or specialists for variable times before. Only 21% of patients reported using the stockings on a daily basis, 12% used them most days, and 4% used them less often. The remaining 63% did not use the stockings at all or abandoned them after a trial period in the past. It is noteworthy that there was no statistical significant difference between C0s–C2 group and C3–C6 group. The authors concluded that non-compliance is very high in patients with CVD regardless of age, gender, aetiology, duration of symptoms, or disease severity.

The reasons for non-compliance can be classified in two interdependent major categories: wear-comfort factors and intangible sense of restriction imposed by stockings.

Adherence to compression was very high in Brandjes and Prandoni series (Tables 1 and 4). Conversely, in Kahn RCT, compliance was significantly lower (Table 6) and this may explain difference in terms of effectiveness and outcome, but the rate of compression adherence in SOX study looks closer to usual clinical practice.¹⁷

A development may be on the horizon with an implantable device incorporated into the stocking that would record the extent of stocking use each day thereby producing an objective recording of the actual usage. With such a source of data concerning true compliance it could be firmly established that compliance with compression leads to decreased development of PTS.

Clinical tools for assessing PTS

Villalta score.¹⁸

Villalta score has been validated¹⁹ and recommended by Society on Thrombosis and Haemostasis Subcommittee on Control of Anticoagulation.²⁰ However, in this document it was recommended to use Villalta score preferably together with CEAP classification.

Ginsberg measure³

Although the measure does not rate the severity of PTS, it correlates well with QoL scores and identifies more severe PTS than the Villalta scale.²¹

These two clinical measures lack objective studies of the extent of the thrombus and the anatomic involvement of the segments of the veins from the popliteal to the iliac level. It is possible that the addition of these measures would allow an improved correlation of the results of support in limiting long-term complications in the PTS.

Conclusions

To tailor DVT treatment including compression, we need to know which patients are at risk related to DVT location and extent. “Proximal” terminology is not satisfactory because iliac, common femoral, femoral and popliteal veins are classified in the same group and yet we have data supporting that iliofemoral thrombosis are responsible for more severe PTS.^22–24

Obesity and older age increase the risk of developing PTS,¹⁴ and we know that these patients have a poor compliance to compression.

Residual vein thrombosis is a strong determinant of PTS^25–27 as well as early clinical manifestations.²¹

Prescription of medical compression for preventing PTS is now in doubt.

Immediate compression after diagnosis of acute DVT to prevent swelling and reduce pain, permitting early ambulation in combination with adequate anticoagulation has proven benefit although a recent article questions this issue.²⁷

Continued long-term compression treatment is now under debate after the SOX trial publication. Two major questions remain:

1. The lack of positive outcome on the development of PTS after “proximal” DVT due to the fact that there are few patients with iliofemoral extension in the RCTs that may benefit from prolonged medical compression. However, such patients may benefit regarding early symptoms which are a risk factor for PTS.²¹

2. Compliance is the major issue. Two RCTs with excellent control of compliance showed significant reduction in the rate of PTS, but we know that in daily practice the adherence is closer to Kahn’s data.

Efficacy of compression relies also on hemodynamic performance.²⁸

Early thrombus removal in iliofemoral extension seems to be beneficial in small studies.^29–31 Additional scientific evidence is expected from the ongoing ATTRACT trial in the US that should give us guidance in 2016.

Footnotes

Acknowledgement

We appreciate the revision of the manuscript by Robert L Kistner, MD, Honolulu, HI, USA.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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Does prescription of medical compression prevent development of post-thrombotic syndrome after proximal deep venous thrombosis?

Abstract

Aim

Methods

Results

Conclusion

Keywords

Introduction

Methods

Results

The Brandjes RCT (Table 1)

Ginsberg’s RCT (Table 2)

Partsch’s RCT (Table 3)

Prandoni’s RCT (Table 4)

Aschwanden RCT (Table 5)

Kahn RCT (Table 6)

Present recommendations from published guidelines

Discussion

Clinical tools for assessing PTS

Villalta score. 18

Ginsberg measure 3

Conclusions

Footnotes

Acknowledgement

Declaration of Conflicting Interests

Funding

References

Villalta score.¹⁸

Ginsberg measure³