Table 7.
Characteristics and results of the studies comparing Direct oral anticoagulants with vitamin K antagonist oral anticoagulants in AF patients after TAVI.
| Author, Reference |
Study Design | Number of Patients (NOACs/VKAs) |
Results |
|---|---|---|---|
| Jochheim et al. [91] | Prospective Observational Multicenter study DOACs Vs. VKAs |
962 patients included DOACs = 326 VKAs = 636 |
All-cause mortality/MI/CVE DOACs = 63/326 VKAs = 87/636 1.44, CI 95% 1.00–2.07 p = 0.050 |
| All-cause death DOACs = 47/326 VKAs = 70/636 1.36, CI 95% 0.90–2.06 p = 0.136 | |||
| MB DOACs = 67/326 VKAs = 144/636 0.9, CI 95% 0.64–1.26 p = 0.548 | |||
| MACCE DOACs = 30/326 VKAs = 42/636 1.43, CI 95% 0.85–2.43 p = 0.173 | |||
| Kawashima et al. [93] | Prospective observational Multicenter DOACs Vs. VKAs |
403 patients included DOACs = 227 VKAs = 127 |
All-cause mortality 10.3% vs. 23.3%; HR: 0.391, CI 95% 0.204–0.749; p = 0.005 |
| Butt et al. [94] | Retrospective Observational Cohort study DOACs Vs. VKAs |
735 patients included DOACs = 219 VKAs = 516 |
Arterial thromboembolism 1 HR, 1.23; 95% CI, 0.58–2.59 |
| Bleeding HR, 1.14; p = 0.63–2.06 | |||
| All-cause mortality HR, 0.93, 95% CI, 0.61–1.4 | |||
| Van Mieghem et al. [95] |
RCT Edoxaban Vs. VKAs |
1426 patients included Edoxaban = 713 VKAs = 713 |
Composite primary efficacy outcome 2 HR, 1.05, 95% CI, 0.85 to 1.31; p = 0.01 for noninferiority |
| MB HR, 1.40; 95% CI, 1.03 to 1.91 p = 0.93 for noninferiority | |||
| Collet et al. [96] | RCT (stratum 1—with indication for OAC) Apixaban Vs. VKAs |
451 included patients In stratum 1 Apixaban = 223 VKAs = 228 |
Primary efficacy outcome 3 HR, 1.02; 95% CI, 0.68 to 1.51 |
| Primary safety outcome 4 HR, 0.91; 95% CI, 0.52 to 1.60 |
DOACs: direct oral anticoagulants; VKAs: vitamin K antagonist oral anticoagulant; MI: myocardial infarction; CVE: cerebrovascular events; MB: major bleeding; MACCE: major adverse cardiac and cerebrovascular events; RCT: randomized clinical trial; OAC: oral anticoagulant; HR: hazard ratio; CI: confidential interval; 1 composite of ischemic stroke, transient cerebral ischemia, and thrombosis or embolism in peripheral arteries); 2 death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolic event, valve thrombosis, or major bleeding; 3 composite of death, myocardial infarction, stroke or transient ischemic attack, systemic embolism, intracardiac or bioprosthetic thrombosis, deep vein thrombosis or pulmonary embolism, and life-threatening, disabling, or major bleeding over 1-year follow-up; 4 major disabling, or life-threatening bleeding.