Table 1.
Randomized controlled trials testing antithrombotic treatment strategies in patients treated with transcatheter aortic valve implantation.
| Study Title | Patients Enrolled (n) |
Target Population |
Experimental Treatment |
Control Treatment |
Primary Endpoint (Experimental Group vs. Control Group) |
|---|---|---|---|---|---|
| ARTE | 222 | Patients undergoing TAVI without an indication for OAC | Aspirin + clopidogrel | Aspirin monotherapy | Composite of death, MI, stroke, TIA, or major/life-threatening bleed (at 90-day follow-up (15.3% vs. 7.2%) (OR 95% (CI) = 2.31 (0.95–5.62); p = 0.065) |
| POPular TAVI cohort A | 665 | Patients undergoing TAVI without an indication for OAC | Aspirin monotherapy | Aspirin + clopidogrel | Two primary endpoints: All bleeding (minor, major, life-threatening, or disabling) (15.1% vs. 26.6%) (risk ratio, 0.57; 95% (CI), 0.42 to 0.77; p = 0.001) Non-procedure-related bleeding (including bleeding at the puncture site) (15.1% vs. 24.9%) (risk ratio, 0.61; 95% (CI), 0.44 to 0.83; p = 0.005) |
| POPular TAVI cohort B | 313 | Patients undergoing TAVI with an indication for chronic OAC | VKA or DOAC | OAC + clopidogrel | Two primary endpoints: All bleeding (minor, major, life-threatening or disabling) (21.7% vs. 34.6%) (risk ratio, 0.63; 95% confidence interval (CI), 0.43 to 0.90; p = 0.01) No-procedure-related bleeding (including bleeding at the puncture site) (21.7% vs. 34.0%) (risk ratio, 0.64; 95% (CI), 0.44 to 0.92; p = 0.02) |
| ATLANTIS stratum 1 | 451 | Patients undergoing TAVI with an indication for chronic OAC | Apixaban | VKA | Composite of death, MI, stroke, or TIA, non–central nervous system embolism, pulmonary embolism, intracardiac or valve thrombosis, deep vein thrombosis, and life-threatening, disabling, or major bleeding (22.0% vs. 21.9%) (HR 1.02; 0.69–1.51; p = NS) |
| ENVISAGE-TAVI AF | 1426 | Patients undergoing TAVI with an indication for chronic OAC | Edoxaban | VKA | Composite of all-cause death, MI, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding (17.3% vs. 16.5%) (HR, 1.40; 95% (CI), 1.03 to 1.91; p = 0.93 for noninferiority) |
| GALILEO | 1644 | Patients undergoing TAVI without an indication for OAC | Rivaroxaban + aspirin | Clopidogrel + aspirin | Efficacy outcome: death or thromboembolic event (ie, stroke, MI, symptomatic valve thrombosis, non–central nervous system systemic embolism, pulmonary embolism, or deep vein thrombosis) (12.7% vs. 9.5%) (HR, 1.35; 95% (CI), 1.01 to 1.81; p = 0.04) Safety outcome: major, life-threatening, or disabling bleed (5.6% vs. 3.8%) (HR 1.50 (0.95 to 2.37); 95% (CI)) |
| GALILEO 4D |
231 | Patients undergoing TAVI either native or ViV | Rivaroxaban + aspirin | Clopidogrel + aspirin | ≥1 prosthetic leaflet with >50% RLM, detected on 4D-CT imaging (2.1% vs. 10.9%) (difference, −8.8 percentage points; 95% confidence interval (CI), −16.5 to −1.9; p = 0.01) |
| ADAPT-TAVR trial | 229 | Patients undergoing TAVI without an indication for OAC | Edoxaban | Aspirin + clopidogrel | Incidence of valve leaflet thrombosis detected on 4D-CT imaging (9.8% vs. 18.4%) (absolute difference, −8.5% 95% (CI), −17.8% to 0.8%; p = 0.076) |
| ATLANTIS stratum 2 | 1049 | Patients undergoing TAVI without an indication for OAC | Apixaban | Aspirin and/or clopidogrel | Composite of death, MI, stroke, TIA, non–central nervous system embolism, pulmonary embolism, intracardiac or valve thrombosis, deep vein thrombosis, life-threatening, disabling, or major bleeding (16.9% vs. 19.3%) (HR = 0.88; 95% (CI) (0.66, 1.17); p = 0.57) |