Table 23.

—[Section 3.3] Summary of Findings: Dabigatran vs VKA Therapy for Long-term Treatment of VTE^a-c,343

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With Warfarin	Risk Difference With Dabigatran (95% CI)
Mortality	2,539 (1 study), 6 mo	Moderated,e due to imprecision	HR 0.98 (0.53-1.79)	17 per 1,000	0 fewer per 1,000 (from 8 fewer to 13 more)
Recurrent VTE	2,539 (1 study), 6 mo	Moderated,e due to imprecision	HR 1.01 (0.65-1.84)	19 per 1,000f	0 more per 1,000 (from 7 fewer to 16 more)
Major bleeding	2,539 (1 study), 6 mo	Moderated,e due to imprecision	HR 0.82 (0.45-1.48)	19 per 1,000g	3 fewer per 1,000 (from 10 fewer to 9 more)
Burden of anticoagulation not reported	…	…	…	Warfarin: daily medication, dietary restrictions, frequent blood testing/monitoring, increased hospital/clinic visits	Dabigatran: daily medication, no dietary restrictions, no frequent blood testing/monitoring

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, 3, and 21 legends for expansion of abbreviations.

^aIncluded patients had acute, symptomatic, and objectively verified proximal DVT of the legs or PE.

^bDabigatran 150 mg bid taken orally for 6 mo after an initial treatment with LMWH or IV UFH.

^cWarfarin adjusted to achieve an INR of 2.0 to 3.0 for 6 mo after an initial treatment with LMWH or IV UFH.

^dAllocation was concealed. Patients, providers, data collectors, and outcome adjudicators were blinded. Modified intention-to-treat analysis; 1.1% loss to follow-up. Not stopped early for benefit.

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

^fOne fatal VTE in dabigatran group and three fatal VTE in warfarin group.

^gOne fatal major bleeding in dabigatran group and one fatal major bleeding in warfarin group.