Table 18.
Outcomes | Illustrative Comparative Risksa (95% CI) |
Relative Effect (95% CI) | No. of Participants (Studies) | Quality of the Evidence (GRADE) | |
Assumed Risk, no VKA | Corresponding Risk, VKA | ||||
Death |
312 per 1,000 |
303 per 1,000 (256-359) |
RR, 0.97 (0.82-1.15) |
1,093 (2) |
Low due to imprecisionb,c |
Symptomatic DVT |
90 per 1,000 |
57 per 1,000 (31-100) |
RR, 0.63 (0.35-1.11) |
1,235 (4) |
Low due to imprecisionb,c |
Major bleeding | 2 per 1,000 | 14 per 1,000 (2-112) | RR, 6.93 (0.86-56.08) | 1,093 (2) | Low due to imprecisionb,c; high-quality evidence in other populations |
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).
We rated down for methodologic limitations. Allocation clearly concealed in three of the four studies. None of studies blinded patients, providers, or data collectors, and three studies blinded outcome adjudicators. Three studies had no problem with incomplete data. The presence of selective reporting was unclear in one study. Two studies clearly used ITT.
Relatively small number of events. CI includes both values suggesting no effect and values suggesting either benefit or harm.