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.
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