Table 7.

—[Section 2.5.1] Summary of Findings: Fondaparinux vs LMWH for Initial Anticoagulation of Acute DVT^a-c,78

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With LMWH	Risk Difference With Fondaparinux (95% CI)
Mortality	2,205 (1 study), 3 mo	Moderated,e due to imprecision	RR 1.25 (0.8-1.97)	30 per 1,000	7 more per 1,000 (from 6 fewer to 29 more)
Recurrent VTE	2,205 (1 study), 3 mo	Moderated,e due to imprecision	RR 0.96 (0.64-1.45)	41 per 1,000f	2 fewer per 1,000 (from 15 fewer to 18 more)
Major bleeding	2,205 (1 study), 3 mo	Moderated,e due to imprecision	RR 0.93 (0.43-2.03)	12 per 1,000g	1 fewer per 1,000 (from 7 fewer to 12 more)

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 and 3 legends for expansion of abbreviations.

^aAll patients had acute symptomatic DVT.

^bFondaparinux 7.5 mg (5.0 mg in patients weighing < 50 kg and 10.0 mg in patients weighing > 100 kg) SC once daily for at least 5 d and until VKAs induced an INR > 2.0.

^cEnoxaparin 1 mg/kg of body weight SC bid for at least 5 d and until VKAs induced an INR > 2.0.

^dAllocation was concealed. Patients, providers, data collectors, and outcome adjudicators were blinded. Analysis excluded 0.6% of randomized patients. Not stopped early for benefit.

^eCI includes values suggesting no effect and values suggesting either benefit or harm; relatively low number of events.

^fFive fatal VTE in fondaparinux group and five fatal VTE in LMWH group.

^gTwelve patients in the fondaparinux group and 13 in the LMWH group had a major bleeding event during the initial period (7 d). Of these, two in the fondaparinux group and none in the LMWH group were fatal.