Table 2.
Overview of completed and ongoing trials investigating different antithrombotic strategies after TAVR.
Trial | Anti-thrombotic strategy | Target population | Study population | Anticipated completion date | Outcome |
---|---|---|---|---|---|
Warfarin and antiplatelet therapy vs. warfarin alone for treating patients with atrial fibrillation undergoing TAVR | VKA vs. VKA + single or double APT | Patients with atrial fibrillation | 621 | Completed | Similar rate of MACE, stroke and death; but significantly higher rate of major or life-threatening bleedings in VKA + APT group (13 months FU) |
ARTE NCT01559298 | ASA + clopidogrel vs. ASA alone | Patients without need for chronic OAC | 222 | Completed | No differences in hemodynamics, MACE, TIA, stroke, and death; less major or life-threatening events in ASA alone group (3 months FU) |
GALILEO NCT02556203 | Rivaroxaban 10 mg + ASA (3 months), followed by rivaroxaban alone vs. DAPT (3 months), followed by ASA alone | Patients without need for chronic OAC | 1644 | 2018 | Stopped prematurely because of increased bleeding and mortality in the rivaroxaban group. |
AUREA NCT01642134 | ASA + clopidogrel vs. VKA | Patients without need for chronic OAC | 124 | 2019 | – |
POPular–TAVI NCT02247128 | ASA + clopidogrel vs. ASA alone, or OAC + clopidogrel vs. OAC alone | All-comers | 1,000 | 2020 | – |
ATLANTIS NCT02664649 | Apixaban vs. standard of care (VKA or SAPT/DAPT) | All-comers | 1,510 | 2020 | – |
AVATAR NCT02735902 | ASA + VKA vs. VKA alone | Patients with underlying indication for chronic OAC | 170 | 2020 | – |
ENVISAGE-TAVI AF NCT02943785 | VKA vs. edoxaban (both with APT if needed) | Patients with atrial fibrillation | 1,400 | 2020 | – |
ADAPT-TAVR NCT03284827 | Edoxaban vs. ASA + clopidogrel (min. 6 months) | Patients without absolute indication for chronic OAC | 220 | 2020 | – |
APT, antiplatelet therapy; ASA, acetylsalicylic acid; DAPT, double antiplatelet therapy; FU, follow-up; MACE, major adverse cardiovascular events; OAC, oral anticoagulant; SAPT, single antiplatelet therapy; TIA, transient ischemic attack; VKA, vitamin-K antagonist.