Table 21.

—[Section 3.3] Summary of Findings: Rivaroxaban vs LMWH and VKA Therapy for Acute and Long-term Treatment of VTE^a-c,88

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With LMWH and VKA Therapy	Risk Difference With Rivaroxaban (95% CI)
Mortality	3,449 (1 study), 6-12 mod	Moderatee,f due to imprecision	HR 0.67 (0.44-1.02)	29 per 1,000	9 fewer per 1,000 (from 16 fewer to 1 more)
Recurrent VTE	3,449 (1 study), 6-12 mod	Moderatee,g due to imprecision	HR 0.68 (0.44-1.04)	30 per 1,000h	9 fewer per 1,000 (from 17 fewer to 1 more)
Major bleeding	3,429 (1 study), 6-12 mod	Moderatee,g due to imprecision	HR 0.68 (0.34-1.38)i	11 per 1,000j	4 fewer per 1,000 (from 7 fewer to 4 more)
Burden of anticoagulation not reported	…	…	…	Warfarin: daily medication, dietary restrictions, frequent blood testing/monitoring, increased hospital/clinic visits	Rivaroxaban: 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. HR = hazard ratio. See Table 1 and 3 legends for expansion of other abbreviations.

^aIncluded patients had acute, symptomatic, and objectively verified proximal DVT of the legs (unprovoked, 62%; cancer, 6%; previous, VTE 19%).

^bRivaroxaban 15 mg bid for 3 wk and then 20 mg/d for a total of 3 (12%), 6 (63%), or 12 (25%) mo.

^cEnoxaparin 1 mg/kg bid for ∼8 d and then VKA therapy targeted to an INR of 2.5 for 3, 6, or 12 mo.

^dFollow-up was prespecified to be 3 (12%), 6 (63%), or 12 (25%) mo.

^eAllocation was concealed. Patients, providers, and data collectors were not blinded, but outcome adjudicators were blinded. Intention-to-treat analysis; 1.0% were loss to follow-up. Not stopped early for benefit.

^fCI includes values suggesting benefit or no effect; relatively low number of events.

^gCI includes values suggesting benefit and harm.

^hOne definite or possible fatal VTE in the rivaroxaban group and one in the LMWH/VKA group.

ⁱCalculated from reported data.

^jBleeds contributing to death: one in the rivaroxaban group and five in the warfarin group.