Table 11.

—[Section 4.2] High-Intensity VKA Compared With Moderate-Intensity VKA for Patients With Antiphospholipid Syndrome^136,137

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With Moderate-Intensity VKA	Risk Difference With High-Intensity VKA (95% CI)
Thromboembolism objective confirmation	220 (2 studiesa), 3 y	Very lowb,c due to risk of bias, indirectness, and imprecision	OR 2.33 (0.82-6.66)	Study populationd
				45 per 1,0002	54 more per 1,000 (from 8 fewer to 195 more)
				Lowd
				50 per 1,000a	59 more per 1,000 (from 9 fewer to 210 more)
				Highd
				700 per 1,000a	145 more per 1,000 (from 43 fewer to 240 more)
Major bleeding	220 (2 studiese), 3 y	Moderatef due to imprecision	OR 0.70 (0.23-2.16)	Study population
				64 per 1,000a	18 fewer per 1,000 (from 48 fewer to 64 more)
				Low
				25 per 1,000a	7 fewer per 1,000 (from 19 fewer to 27 more)
				High
				100 per 1,000a	28 fewer per 1,000 (from 75 fewer to 94 more)
Mortality all-cause mortality	220 (2 studies), 3 y	Moderatef due to imprecision	OR 1.51 (0.3-7.72)	18 per 1,000	9 more per 1,000 (from 13 fewer to 107 more)

See Table 1 and 2 legends for expansion of abbreviations.

^aIn the study by Finazzi et al,¹³⁷ three patients with nonembolic arterial thrombosis received, as planned, only aspirin. They had no events and have not been included here.

^bThe study by Finazzi et al¹³⁷ was open label.

^cBoth studies were designed to show superiority of the more intensive regimen, not equivalence. The 95% CI includes both benefit and significant harm.

^dLow of 5% from Schulman et al; high of 70% from Khamashta et al.¹³¹

^eThe types of major hemorrhage were not disclosed.

^fThe 95% CI includes both benefit and significant harm.