Do Elastic Compression Stockings Lower the Risk of Deep Vein Thrombosis in

People Undertaking Long-Haul Flights?

The Patient:
A male patient approached his GP prior to undertaking a long-haul flight to
Australia. After hearing in the press about the dangers of developing deep vein
thrombosis (DVT) during long flights, he asked the GP if they would recommend
he wear compression stockings to reduce the risk of developing DVT. This paper
aims to analyse a recent trial to determine if wearing elastic compressions socks
decreases the incidence of DVT in persons undertaking long-haul flights versus
those who do not take preventative measures.
The Trial Overview:
The trial in question observed 200 men and women over 50 years old. The
patients were asked to undergo a flight over 8 hours long and asked to return to
the UK within 6 weeks. Half of the patients were given elastic compression
stockings to wear during their journey, while the second half was given no
treatment, acting as a control. The patients were screened for DVT prior to and
following their journey, with the intent of determining if compression stockings
lower the incidence of DVT in the intervention group compared to the control.
Methodology:
The study recruited volunteers by placing advertisements in newspapers and
travel shops. Many of the initially screened patients were also referred to the
study by the Aviation Health Institute. The aim was to recruit healthy individuals
over 50 years of age who intended to fly economy class twice within the space of
6 weeks, with both flights lasting at least 8 hours. The volunteers for the study
were then required to undergo a medical examination and complete a
questionnaire regarding past medical history. Volunteers were excluded if they
had a history of venous thrombosis, cardiovascular or respiratory illness, were
taking anticoagulants, regularly wore compression stockings, or had any other
serious illness. Recruitment for the trial was less than ideal as the recruitment
process relied on two sources, random volunteers and referrals from the aviation
health institute. The nature of these two sources indicates some of the
volunteers may have already been worried about the risk of DVT prior to
participation in the study.
Volunteers who passed initial screening were then observed with duplex
ultrasonography to detect any previous symptomless venous thrombosis. Any
volunteer testing positive during this examination was then excluded. This
examination was done 2 weeks before travel and again 2 days before travel in
the first 30 volunteers in order to determine the incidence of spontaneous DVT
not associated with the flight. This screening process was discontinued for
subsequent patients, with the study citing difficulty for patients to attend the
pre-travel hospital sessions. For the remaining volunteers only one pre-travel
examination was conducted; therefore a true incidence of spontaneous DVT in
the study population is unavailable.
The study group also underwent blood tests to determine full blood and platelet
counts, D-dimer levels, and for mutations in the factor V Leiden (FVL) and
prothrombin G20210A (PGM) genes, two thrombophilic mutations.
The initial 231 volunteers eligible for the study were then randomized via sealed
envelopes. The intervention group received below-knee elastic compression
socks, while the control group received no additional treatment. During the trial
31 participants did not attend the required pre or post travel examinations, and
were subsequently excluded from the study, resulting in a total study population
of 200 people, with 100 in both the intervention and control group. There is no
indication of whether the initial examiners know which patients received
treatment and which do not, and by the nature of the intervention the volunteers
know which group they are in, the study is therefore not completely blinded.
Upon returning to the UK, the volunteers were asked to attend a clinical
examination within 48 hours. The patients were interviewed by research nurses
and completed a questionnaire. The questionnaire included information about
the wearing of stockings during travel. Therefore the nurses conducting the post-
travel examination were aware of which group the passenger was in; this opens
the final examination to the potential for attention bias. Furthermore, the nurses
were required to remove stockings from some passengers, while others removed
the stockings following their flight. This difference in time of patients wearing the
stockings may have affected the final results of the study.
The final duplex ultrasound examination was conducted by a technician who was
unaware of the volunteers group. This was followed by a repeat D-dimer assay.
All statistical analysis was done on an intention-to-treat basis, and therefore
included the 31 volunteers initially randomized, but excluded from the study due
missing pre or post-travel examinations, ill-health, or upgrading to business
class.
Results:
The randomization process resulted in two populations with relatively similar
characteristics (Figure 1). However, the intervention group had a higher
percentage of women than the control (70% vs 53%), and the number of FVL and
PGL mutations varied.
The post-travel examinations determined that 12 of the volunteers had
developed asymptomatic deep vein thrombosis during their period of travel,. All
twelve of these volunteers were from the control non-stocking group (10%: 95%
CI 4.8-16.0 %). Although none of the volunteers in the stocking group developed
a DVT, 4 in the group with varicose veins did develop superficial
thrombophlebitis (SVT) (3%: 95% CI 1.0-8.7 %). Of the volunteers with an FVL
mutation (total 13), 2 developed symptomless DVT, and 1 who developed SVT
was both FVL and PGM positive.
Analysis:
The data above presents an absolute risk reduction (ARR) for the development of
DVT when using compression socks as 0.1, with a number needed to treat (NNT)
analysis indicating 10 patients are required treatment to avoid 1 poor outcome.
Although the study indicates that one in ten passengers over 50 traveling on
long-haul flights develop DVT, the study provides no measure of statistical
significance, likely due to this being a pilot study with a relatively small samples
size. There is also a limited external validity to the general population, as the
study only included those over 50 years old, and with no prior history of a venous
thrombosis or any other risk factor. If there is a link between long-haul flights and
incidence of DVT, which even the study states is currently debated, then it
stands to reason that those most at risk for DVT would be the ones likely to
benefit from intervention. However, the use of compression socks in high risk
populations cannot be advocated from this study.
Furthermore, there are several flaws in the methodology which may have
distorted the true incidence of DVT due to flying in the study group. The study
indicates that all passengers were asked to return to the UK within 6 weeks of
their initial flight. While there is data for the average travel time of the
passengers, there is no data provided for the interval between outgoing and
return flights to the UK. The variance in these figures amongst the study
population may have affected the incidence of DVT, as some passengers may
have developed venous thrombosis during their initial outgoing flight, but this
resolved without problem prior to return. The researchers acknowledge that most
DVTs do resolve over time without complication, with only 10-20% entering more
proximal veins. In addition, the discontinuation of double screening for DVT
before travel did not allow the researchers to determine the incidence of
spontaneous DVT. Therefore it is not possible to distinguish what percent of the
DVTs observed in the population are spontaneous, and which are directly related
to flying.
In terms of screening for DVT, the study was refused use of venography on
participants due to ethical considerations of invasive procedure on those without
symptoms. Duplex ultrasonography was therefore used to determine the
presence of DVT, a process which is thought to have a specificity of 79-99 %.
Therefore it is possible that the screening process may misinterpret the actual
incidence of DVT in the population.
The lack of blinding in the study is also an important issue. Because the
passengers were aware of their treatment (or lack thereof), they may have taken
precautionary measures to avoid a DVT on the flight. The study suggests
patients may have drunk more fluids, and been more active during the flight to
lower their risk of developing a DVt
Considerations for the Patient:
Due to the limitations of the study it is difficult to recommend whether the
patient initially described in this paper should wear compression socks to reduce
his risk of DVT during a long-haul flight. Various factors would be taken into
account, including the patients age, past medical history, and risk factors for
DVT. In addition, the cost and convenience of treatment are relevant factors;
wearing compression socks, a potentially cheap and minimally invasive
intervention, may be recommended more readily than more invasive or
expensive treatments; this would, however, need to be weighed against the
patients risk for superficial thrombophlebitis, as the study indicates a higher risk
with this intervention.