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Mauri et al. Mini-invasive Surg 2022;6:49 https://dx.doi.org/10.20517/2574-1225.2022.34 Page 7 of 13

guideline indications about post-TAVR SAPT .
[1-5]

The GALILEO (global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-
based strategy after transcatheter aortic valve replacement to optimize clinical outcomes) trial investigated
the use of low-dose rivaroxaban (10 mg) plus aspirin vs. DAPT for three months in patients without
indication to OAC undergoing TAVR. The study was prematurely terminated due to the higher risk of all-
cause death, thromboembolic complications, and bleeding (major, life-threatening, or disabling) in patients
[25]
receiving rivaroxaban plus aspirin .

The ATLANTIS (anti-thrombotic strategy to lower all cardiovascular and neurologic ischemic and
hemorrhagic events after trans-aortic valve implantation for aortic stenosis) trial investigated apixaban in
1510 patients undergoing TAVR: comparators were VKA in patients with indication to long-term OAC
(Stratum 1749 patients) and SAPT or DAPT in patients without indication to long-term OAC (Stratum
2751 patients). At one-year follow-up, in Stratum 2, apixaban was not superior to SAPT or DAPT in terms
of primary efficacy and safety outcomes and resulted in higher non-cardiovascular mortality (HR: 0.88) [26,27] .

In a recent study, 94 low-risk patients treated with TAVR and not requiring long-term OAC were
randomized to SAPT or aspirin plus VKA. The primary composite endpoint (HALT, moderately RLM,
valve hemodynamic dysfunction with mean aortic valve gradient ≥ 20 mm Hg, effective orifice area ≤ 1.0
cm , dimensionless valve index < 0.35, moderate-severe aortic regurgitation, stroke, or TIA) was
2
significantly higher in patients receiving only aspirin (26.5% vs. 7.0%; OR: 4.8; P = 0.014), with no
differences in terms of bleeding. These data suggest a potential benefit of OAC in patients at lower risk ,
[28]
but they need to be confirmed in larger studies.

In summary, current evidence does not support the use of OAC (DOAC or VKA) in patients undergoing
TAVR with no preexisting indication.

Patients with indications for long-term OAC
Based on their comorbidities, most patients with AF undergoing TAVR have an indication to receive an
OAC for the value of CHA2DS2-VASc score. The beneficial effect on reduction of peri-procedural
thromboembolic events of OAC is still unknown; however, the continuation of OAC (VKA or DOAC)
[29]
before TAVR was found to be safe in terms of bleeding and vascular complications .

In patients with a pre-procedural indication for OAC, the addition of antiplatelet therapy offers the
theoretical advantage of preventing thrombus formation on struts of bioprosthesis, but several observational
studies showed the safety and efficacy of an OAC-alone strategy, with both VKA and DOAC [Table 4] [30-32] .

Furthermore, the randomized POPular-TAVI trial (Cohort B) that investigated the safety and efficacy of
VKA plus clopidogrel (for three months) versus VKA alone showed a higher rate of nonprocedural bleeding
[33]
in the first group (34% vs. 21.7%; RR: 0.63; P = 0.01) with no benefit on CV death, stroke, or MI .