Table 25.
—[Section 4.2.1] Summary of Findings: Compression Stockings vs No Compression Stockings for Patients With PTSa-c,233,238
| Outcomes | No. of Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute
Effects |
|
| Risk With No Compression Stockings | Risk Difference With Compression Stockings (95% CI) | ||||
| Symptomatic relief treatment successg | 115 (2 studies), 12 to 26 mo | Lowd-f due to risk of bias and imprecision | RR 0.96 (0.70-1.31) | 579 per 1,000 | 23 fewer per 1,000 (from 174 fewer to 179 more) |
|
| |||||
| QOL not reported | … | Not estimable | |||
|
| |||||
| Recurrent VTE not reported | … | Not estimable | |||
|
| |||||
| Ulcerationh not reported | … | Not estimableh | |||
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. CLOTS1 = Clots in Legs or Stocking After Stroke. See Table 1 and 3 legends for expansion of other abbreviations.
Ginsberg et al233 included patients with PTS 1 y after chronic, typical proximal DVT. Frulla et al238 included patients with clinical symptoms and signs suggestive of PTS.
Ginsberg et al233: Graduated compression stockings (30-40 mm Hg, calf or thigh length, depending on symptoms). Patients were encouraged to wear stockings as much as possible during waking hours. Frulla et al238: below-knee graded elastic compression stockings (ECS) (30-40 mm Hg at the ankle). Patients in both study arms received hydroxyethylrutosides (HR) (we considered the ECS 1 HR vs HR comparison).
Ginsberg et al233: placebo stockings (calf or thigh length, depending on symptoms).
Ginsberg et al233: Adequacy of sequence generation and allocation concealment were unclear; patients and outcome assessors were adequately blinded; unclear whether analysis followed the intention-to-treat principle; unclear whether follow-up was complete. Frulla et al238: outcome assessors were blinded; follow-up was complete; intention-to-treat principle was adhered to, but sequence generation and allocation concealment were unclear, and patients were not blinded.
Very small number of patients
Publication bias was not detected but not ruled out given that we identified only one small study partially supported by industry (provision of graduated compression stockings).
Ginsberg et al233 reported treatment failure (defined a priori based on any of five clinical criteria, including symptoms and ulcer development). Treatment success refers to the absence of treatment failure. Frulla et al238 used the Villalta scale.
Indirect evidence from the CLOTS1 trial suggests that compression stockings is associated with an RR of 4 for skin complications.