Table 5.
—[Section 2.5.1] Summary of Findings: LMWH vs SC UFH for Initial Anticoagulation of Acute VTE70,71,76,77
| Outcomes | No. of Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute
Effects |
|
| Risk With SC UFH | Risk Difference With LMWH (95% CI) | ||||
| All-cause mortality |
1,566 (3 studies), 3 mo |
Moderatea,b due to imprecision |
RR 1.1 (0.68-1.76) |
33 per 1,000c |
3 more per 1,000 (from 11 fewer to 25 more) |
| Recurrent VTE |
1,563 (3 studies), 3 mo |
Moderatea,b due to imprecision |
RR 0.87 (0.52-1.45) |
42 per 1,000c |
5 fewer per 1,000 (from 20 fewer to 19 more) |
| Major bleeding | 1,634 (4 studies), 3 mo | Moderatea,b due to imprecision | RR 1.27 (0.56-2.9) | 16 per 1,000c | 4 more per 1,000 (from 7 fewer to 30 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. SC = subcutaneous. See Table 1 and 3 legends for expansion of abbreviations.
In the two largest trials (Prandoni et al,70 Kearon et al;71 87% of patients), allocation was concealed, outcome adjudicators and data analysts were concealed, analysis was intention to treat, and there were no losses to follow-up.
Precision judged from the perspective of whether SC heparin is noninferior to LMWH. The total number of events and the total number of participants were relatively low.
Event rate corresponds to the median event rate in the included studies.