Table 1. Ongoing trials on the antithrombotic treatment after TAVI.
| Trials | ATLANTIS | AUREA | AVATAR | ENVISAGE-TAVI | GALILEO | POPULAR-TAVI | CLOE |
|---|---|---|---|---|---|---|---|
| ClinicalTrials.gov ID | NCT02664649 | NCT01642134 | NCT02735902 | NCT02943785 | NCT02556203 | NCT02247128 | Announced |
| Patients | 1,510 | 124 | 170 | 1,400 | 1,520 | 1,000 | NA |
| Indication to OAC | Yes | No | Yes | Yes | No | Yes (cohort B) | Yes |
| Comparison | Apixaban vs. SAPT/DAPT (no OAC indication) or VKA (OAC indication) | DAPT vs. VKA | VKA vs. ASA + VKA | Edoxaban vs. VKA. APT per local practice | Rivaroxaban + ASA vs. DAPT for 3 m then rivaroxaban vs. ASA | ASA vs. DAPT (cohort A) or Clop + VKA vs. VKA (cohort B) | ASA vs. DAPT or clop + VKA vs. VKA |
| Follow-up (months) | Up to 13 | 3 | 12 | 36 | Up to 25 | 12 | NA |
| Primary endpoint | Composite of death, MI, stroke, SEE, intracardiac or bioprosthesis thrombus, any DVT or PE, life-threatening or disabling or major VARC-2 bleeding | Prevention of cerebral thromboembolism by the detection of new areas of cerebral infarction by MRI at 3 months | Composite of all-cause death, MI, stroke all causes, valve thrombosis and hemorrhage ≥2 as defined by the VARC-2 | Composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and ISTH major bleeding | Composite of all-cause death and adjudicated any stroke, MI, symptomatic valve thrombosis, PE, DVT, or non-CNS-SE | Freedom of all BARC bleeding at 1 y. The co-primary outcome is freedom of non-procedure related BARC bleeding at 1 y | NA |
ATLANTIS, Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis; APT, antiplatelet therapy; ASA, aspirin; AUREA, Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After TAVI; AVATAR, Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions; BARC, Bleeding Academic Research Consortium; non-CNS-SE, Non-central nervous system-systemic embolism; DAPT, dual antiplatelet therapy; DVT, deep vein thrombosis; ENVISAGE TAVI, Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation; GALILEO, Global Study Comparing a rivaroxaban-based Antithrombotic Strategy to an antiplatelet-based Strategy After Transcatheter aortic valve replacement to Optimize Clinical Outcomes; ISTH, International Society on Thrombosis and Haemostasis; MI, myocardial infarction; MRI, Magnetic Resonance Imaging; NA, not available; OAC, oral anticoagulation; PE, pulmonary embolism; Popular-TAVI, Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation; SEE, systemic embolic events; VARC, Valve Academic Research Consortium; VKA, vitamin K antagonist.