Table 10.

—[Section 2.9] Summary of Findings: CDT vs No CDT for Extensive Acute DVT of the Leg^a,b,105,106

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With No CDT	Risk Difference With CDT (95% CI)
Mortality	153 (2 studies), 3 mo	Lowc,d due to imprecision	RR 0.14 (0.01-2.71)	39 per 1,000e	34 fewer per 1,000 (from 39 fewer to 67 more)
Nonfatal recurrent VTE	153 (1 study), 3 mo	Lowc,d due to imprecision	RR 0.35 (0-8.09)	48 per 1,000f	31 fewer per 1,000 (from 48 fewer to 340 more)
Nonfatal major bleeding	153 (2 studies), 7 d	Lowc,d due to imprecision	RR 2.00 (0.19-19.46)	29 per 1,0006,7	29 more per 1,000 (from 23 fewer to 535 more)
PTS (complete lysis on venography [Elsharawy et al73]; patency on ultrasound and air plethysmography [Enden et al74])	138 (2 studies), 2 y	Moderatec,g due to indirectness	RR 0.46 (0-0.79)	588 per 1,000h	318 fewer per 1,000 (from 123 fewer to 588 fewer)i
QOL (SF-12, HUI Mark version 2/3 questionnaires)	98 (1 studyj), 16 mo	Lowk,l			See footnotem

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. HUI = Health Utilities Index; SF-12 = Medical Outcomes Survey Short Form-12; VETO = Venous Thrombosis Outcomes. See Table 1 and 3 legends for expansion of other abbreviations.

^aIn selected patients with extensive acute proximal DVT (eg, iliofemoral DVT, symptoms for < 14 d, good functional status, life expectancy ≥ 1 y) who have a low risk of bleeding.

^bAll patients prescribed anticoagulants per protocol, but the intervention group receives CDT in addition to anticoagulation.

^cAllocation was concealed in Enden et al¹⁰⁶ but unclear in Elsharawy et al.¹⁰⁵ Outcome assessor blinded in both studies. Follow-up rates were 87% in Enden et al and 100% in Elsharawy et al. Neither of the studies was stopped early for benefit.

^dCI includes values suggesting both benefit and harm.

^eThree control patients died of cancer.

^fBaseline risks for nonfatal recurrent VTE and for major bleeding derived from Douketis et al.¹⁰⁸

^gSurrogate outcome: absence of patency at 6 mo in Enden et al¹⁰⁶ study; absence of complete lysis at 6 mo in Elsharawy et al¹⁰⁵ study.

^hThis estimate is based on the findings of the VETO study.¹⁰² This probably underestimates PTS baseline risk given that overall, 52% of patients reported the current use of compression stockings during study follow-up.

ⁱSevere PTS: assuming the same RR of 0.46 and a baseline risk of 13.8%,¹⁰² the absolute reduction is 75 fewer severe PTS per 1,000 (from 29 fewer to 138 fewer) over 2 y.

^jCamerota et al.¹⁰⁹

^kParticipation rate was 65%.

^lRecall was used to measure QOL prior to the thrombotic event; we did not consider these measurements.

^mAt the initial follow-up (mean, 16 mo), patients treated with CDT reported a trend toward a higher mental summary scale (P = .087) and improved HUI (P = .078). They reported better overall role physical functioning (P = .046), less stigma (P = .033), less health distress (P = .022), and fewer overall symptoms (P = .006) compared with patients who were treated with anticoagulation alone.