Table 4, Clinical evidence summary: VKA versus SAPT in surgical valve replacement - Evidence review for anticoagulant and/or antiplatelet therapy for biological prosthetic valves and after valve repair

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Table 4Clinical evidence summary: VKA versus SAPT in surgical valve replacement

Outcomes	No of Participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95% CI)	Anticipated absolute effects
Outcomes	No of Participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with SAPT	Risk difference with VKA (95% CI)
All-cause mortality at ≤12 months	397 (2 studies) 3-6 months	⊕⊝⊝⊝ VERY LOW^a^,^b^,^c due to risk of bias, indirectness, imprecision	RR 1.22 (0.49 to 3.04)	47 per 1000	10 more per 1000 (from 24 fewer to 96 more)
Health-related quality of life at ≤12 months - not reported	0		Not estimable
Major bleeding at ≤12 months	397 (2 studies) 3-6 months	⊕⊝⊝⊝ VERY LOW^a^,^b^,^d due to risk of bias, indirectness, imprecision	RR 2.94 (0.97 to 8.95)	24 per 1000	47 more per 1000 (from 1 fewer to 191 more)
Minor bleeding at ≤12 months - not measured	0		Not estimable
Arterial thromboembolic events at ≤12 months	397 (2 studies) 3-6 months	⊕⊝⊝⊝ VERY LOW^a^,^b^,^c due to risk of bias, indirectness, imprecision	RR 0.82 (0.37 to 1.76)	63 per 1000	11 fewer per 1000 (from 40 fewer to 48 more)
Hospital re-admission at 12 months	328 (1 study) 6 months	⊕⊝⊝⊝ VERY LOW^b^,^c due to indirectness, imprecision	RR 1.15 (0.67 to 1.97)	130 per 1000	19 more per 1000 (from 43 fewer to 126 more)
Thrombus on imaging at ≤12 months	328 (1 study) 6 months	⊕⊝⊝⊝ VERY LOW^b^,^c due to indirectness, imprecision	Peto OR 0.13 (0 to 6.58)	6 per 1000	10 fewer per 1000 (from 20 fewer to 10 more)^e
All-cause mortality at >12 months - not measured	0		Not estimable
Health-related quality of life at >12 months - not measured	0		Not estimable
Major bleeding at >12 months - not measured	0		Not estimable
Minor bleeding at >12 months - not measured	0		Not estimable
Arterial thromboembolic events at >12 months - not measured	0		Not estimable

a: Downgraded by 1 increment as the majority of the evidence was at high risk of bias
b: Downgraded by 1 increment as one study included people who had a CABG while having the valve replacement surgery. The people in the intervention arm were subsequently given warfarin and aspirin, instead of just warfarin.
c: Downgraded by 2 increments as the confidence interval crossed both MIDs
d: Downgraded by 1 increment as the confidence interval crossed one MID
e: Absolute effect calculated manually using risk difference as zero events in one arm of the study

From: Evidence review for anticoagulant and/or antiplatelet therapy for biological prosthetic valves and after valve repair

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Evidence review for anticoagulant and/or antiplatelet therapy for biological prosthetic valves and after valve repair: Heart valve disease presenting in adults: investigation and management: Evidence review J.

NICE Guideline, No. 208.

National Guideline Centre (UK).

London: National Institute for Health and Care Excellence (NICE); 2021 Nov.

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