Table 24.
—[Section 4.1] Summary of Findings: Elastic Compression Stockings vs No Elastic Compression Stockings to Prevent PTS of the Lega,b,451
| Outcomes | No. of Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute
Effects |
|
| Risk With No Elastic Compression Stockings | Risk Difference With Elastic Compression Stockings (95% CI) | ||||
| PTS |
421 (2 studies), 2 y |
Moderatec due to risk of bias |
RR 0.46 (0.34-0.63)d |
479 per 1,000e,f |
259 fewer per 1,000 (from 177 fewer to 316 fewer)g |
| Recurrent VTE |
374 (2 studies), 5 y |
Moderateh,i due to imprecision |
RR 1.01 (0.61-1.67)d |
210 per 1,000j |
2 more per 1,000 (from 82 fewer to 141 more) |
| QOL not reported | … | … | k | … | |
The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Working group grades of evidence are as follow: High quality, further research is very unlikely to change our confidence in the estimate of effect; moderate quality, further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; low quality, further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate; very-low quality, we are very uncertain about the estimate. See Table 1,3 and 10 legends for expansion of abbreviations.
Prandoni et al202 excluded patients with recurrent ipsilateral DVT, preexisting leg ulcers, or signs of chronic venous insufficiency, bilateral thrombosis, a short life expectancy or a contraindication for use of stockings (eg, advanced-stage peripheral arterial insufficiency). Brandjes et al201 excluded patients with short life expectancy, paralysis of the leg, bilateral thrombosis, leg ulcers, or extensive varicosis.
Brandjes201 used graded elastic compression stockings (40 mm Hg of pressure at the ankle, 36 mm Hg at the lower calf, and 21 mm Hg at the upper calf); stockings were applied 2 to 3 wk after the first episode of proximal DVT. Prandoni et al202 used flat-knitted stockings (30 to 40 mm Hg of pressure at the ankle); stockings were started at hospital discharge, an average of 1 wk after admission. In both studies, stockings were used for 2 y.
Patients were not blinded to the treatment assignment, and outcomes were partly based on subjective report of symptoms.
The effect estimate shown here results from a meta-analysis (Mantel-Haenszel fixed-effects model) of the two relevant trials. A fixed-effects model was chosen because of the small number of studies available.
This estimate is based on the findings of the VETO study.70 This probably underestimates PTS baseline risk given that overall, 52% of patients reported the current use of compression stockings during study follow-up.
In Prandoni et al,202 most events occurred during the first 6 mo. The cumulative incidence of the PTS in the control group was 40% after 6 mo, 47% after 1 y, and 49% after 2 y.
Severe PTS: assuming the same RR of 0.46 and a baseline risk of 8.1% over 2 y, the absolute reduction is 44 fewer severe PTS per 1,000 (from 30 fewer to 53 fewer) over 2 y.
We did not rate down the quality of evidence for recurrent VTE for the lack of blinding because this a more objective outcome than PTS.
CI includes both negligible effect and appreciable benefit or appreciable harm.
This estimate is the mean of two estimates derived from two studies: 12.4% probable/definite VTE (Heit et al165) and 29.1% confirmed VTE (Prandoni et al208).
This is an important outcome that should be considered in future studies.