Table 7, Clinical evidence summary: DOAC (+ aspirin for 3 months) versus aspirin (+ clopidogrel for 3 months) in biological transcatheter valve implantation - Evidence review for anticoagulant and/or antiplatelet therapy for biological prosthetic valves and after valve repair

Table 7Clinical evidence summary: DOAC (+ aspirin for 3 months) versus aspirin (+ clopidogrel for 3 months) in biological transcatheter valve implantation

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 aspirin (+clopidogrel for 3 months) post TAVI	Risk difference with DOAC (+aspirin for 3 months) (95% CI)
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
All-cause mortality at >12 months - median treatment duration 428 days	1644 (1 study) 428 days	⊕⊕⊝⊝ LOW^a^,^b due to risk of bias, imprecision	RR 1.67 (1.13 to 2.46)	47 per 1000	31 more per 1000 (from 6 more to 69 more)
Health-related quality of life at >12 months - not measured	0		Not estimable
Major bleeding at >12 months - VARC-2 life-threatening, disabling or major bleeding - median treatment 428 days	1644 (1 study) 428 days	⊕⊕⊝⊝ LOW^a^,^b due to risk of bias, imprecision	RR 1.47 (0.94 to 2.29)	38 per 1000	18 more per 1000 (from 2 fewer to 49 more)
Major bleeding at >12 months - BARC type 2, 3 or 5 bleeding - median treatment 428 days	1644 (1 study) 428 days	⊕⊕⊕⊝ MODERATE^a due to risk of bias	RR 1.72 (1.34 to 2.21)	104 per 1000	75 more per 1000 (from 35 more to 126 more)
Major bleeding at >12 months - ISTH major bleeding - median treatment 428 days	1644 (1 study) 428 days	⊕⊕⊝⊝ LOW^a^,^b due to risk of bias, imprecision	RR 1.62 (1.04 to 2.52)	37 per 1000	23 more per 1000 (from 1 more to 56 more)
Minor bleeding at >12 months - TIMI major or minor bleeding - median treatment 428 days	1644 (1 study) 428 days	⊕⊝⊝⊝ VERY LOW^a^,^b^,^c due to risk of bias, indirectness, imprecision	RR 1.73 (1.06 to 2.83)	29 per 1000	21 more per 1000 (from 2 more to 53 more)
Stroke (arterial thromboembolic events) at >12 months - median treatment 428 days	1644 (1 study) 428 days	⊕⊝⊝⊝ VERY LOW^a^,^d due to risk of bias, imprecision	RR 1.19 (0.71 to 2)	31 per 1000	6 more per 1000 (from 9 fewer to 31 more)
Myocardial infarction (arterial thromboembolic events) at >12 months - median treatment 428 days	1644 (1 study) 428 days	⊕⊝⊝⊝ VERY LOW^d^,^e due to risk of bias, imprecision	RR 1.34 (0.72 to 2.49)	21 per 1000	7 more per 1000 (from 6 fewer to 31 more)
Pulmonary embolism (arterial thromboembolic events) at >12 months - median treatment 428 days	1644 (1 study) 428 days	⊕⊝⊝⊝ VERY LOW^d^,^e due to risk of bias, imprecision	OR 1.48 (0.26 to 8.55)	2 per 1000	1 more per 1000 (from 1 fewer to 15 more)
Systemic embolism (arterial thromboembolic events) at >12 months- median treatment 428 days	1644 (1 study) 428 days	⊕⊝⊝⊝ VERY LOW^d^,^e due to risk of bias, imprecision	OR 0.99 (0.06 to 15.85)	1 per 1000	0 fewer per 1000 (from 1 fewer to 15 more)
Hospital readmission at 12 months - not measured	0		Not estimable
Premature study drug discontinuation (withdrawal due to adverse events - thromboembolic, bleeding or other adverse events) at 12 months - median treatment duration 428 days	1644 (1 study) 428 days	⊕⊕⊝⊝ LOW^e due to risk of bias	RR 2.01 (1.6 to 2.54)	111 per 1000	112 more per 1000 (from 67 more to 171 more)
Symptomatic valve thrombosis (thrombus on imaging) at <12 months - median treatment duration 428 days	1644 (1 study) 428 days	⊕⊝⊝⊝ VERY LOW^a^,^d due to risk of bias, imprecision	OR 0.44 (0.13 to 1.54)	9 per 1000	5 fewer per 1000 (from 8 fewer to 5 more)
Need for reintervention at 6-12 months - not measured	0		Not estimable
Need for reintervention at >12 months - not measured	0		Not estimable
Valve degeneration (mean transvalvular gradient) 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 increments as the confidence interval crossed one MID
c: Combines major and minor bleeding rather than reporting minor bleeding events separately
d: Downgraded by 2 increments as the confidence interval crossed both MIDs
e: Downgraded by 2 increments as the majority of the evidence was at very high risk of bias

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

Cover of Evidence review for anticoagulant and/or antiplatelet therapy for biological prosthetic valves and after valve repair

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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