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Impact of OAC Type on Outcomes After TAVR
Study Questions:
What is the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR)?
Methods:
The investigators enrolled 962 consecutive patients who underwent TAVR in four tertiary European centers and were discharged on either non–vitamin K oral anticoagulants (NOACs) (n = 326) or vitamin K antagonists (VKA) (n = 636). The primary outcome of interest was the cumulative incidence of ischemic events defined as a nonhierarchical combined endpoint of all-cause mortality, myocardial infarction (MI), and any cerebrovascular event (CVE) at 1-year follow-up. Net adverse clinical event was defined as combined incidence of all-cause death, MI, CVE, or major/life-threatening bleeding complications. By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding.
Results:
The mean age and Society of Thoracic Surgeons (STS) score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range, 3.0-7.3), 52.5% were women, and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, MI, and any cerebrovascular event (CVE) at 1 year after TAVR, was 21.2% with NOACs vs. 15.0% with VKA (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.00-2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium (BARC) bleeds and all-cause mortality were comparable between NOACs and VKA groups: 33.9% vs. 34.1% (HR, 0.97; 95% CI, 0.74-1.26; p = 0.838, IPTW-adjusted) and 16.5% vs. 12.2% (HR, 1.36; 95% CI, 0.90-2.06; p = 0.136, IPT-adjusted), respectively.
Conclusions:
The authors concluded that chronic use of both NOACs and VKA among patients in need of OAC after TAVR was associated with higher risk of ischemic events but comparable 1-year bleeding risk.
Perspective:
This study reports a trend towards higher risk of ischemic events 1 year after TAVR with NOACs compared to VKA. However, among these multimorbid and elderly patients, the risk of bleeding up to 1 year was comparable with both treatment regimens. The higher ischemic event rate observed with NOACs needs further assessment in randomized trials, but for now, use of NOACs after TAVR in patients who need anticoagulation should be discouraged. The ongoing ATLANTIS (NCT02664649) and ENVISAGE-TAVI AF (NCT02943785) trials should provide additional insight on the choice of optimal OAC after TAVR.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Cardiovascular Care Team, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Anticoagulants, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Secondary Prevention, Transcatheter Aortic Valve Replacement, Vascular Diseases, Vitamin K
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