Direct Oral Anticoagulants and Clinical Outcomes Following TAVI

Direct oral anticoagulants (DOACs) can improve clinical outcomes after transcatheter aortic valve implantation (TAVI) in patients with an indication for oral anticoagulation, according to study findings published in Heart.

Investigators sought to compare the efficacy of DOACs vs VKAs after TAVI in a real-world population. The primary outcomes included all-cause mortality and combined cardiac and cerebrovascular events (aortic prosthesis reintervention, transient ischemic attack [TIA], stroke, myocardial infarction, and all-cause mortality in the first year after TAVI).

The investigators conducted an observational study using the German Aortic Valve Registry to enroll 45,598 patients receiving TAVI from 92 hospitals in Germany from January 2011 to December 2019. Among these patients, 16,974 (mean age [SD], 80.7 [5.7] years; 49.3% men) received an anticoagulant (DOAC, n=5641; VKA, n=11,333). Patients were overwhelmingly White (98.8%). There were similar medical histories and comorbidities between the DOAC and VKA treatment groups, except for previous cardiac surgery (15.7% vs 21.5%), atrial fibrillation (49.3% vs 61.1%), and permanent pacemaker (13.2% vs 17.2%). The most common comorbidities were hypertension (91.2% and 89.1%) and congestive heart failure (42.4% each group).

There was a significant increase in DOAC use from 2011 to 2019 (9.4% vs 69.9%). Procedural and postprocedural in-hospital characteristics for DOAC vs VKA revealed small between-group differences (vascular complications, 3.8% vs 2.9%; new-onset atrial fibrillation, 8.0% vs 7.3%; stroke, 1.1% vs 0.9%). Postinterventional days in ICU (mean [SD], 3.12 [4.04] vs 2.92 [3.79]) were slightly more for DOAC and postinterventional days in hospital (9.10 [6.67] vs 11.21 [8.35]) were slightly less for DOAC. There were no significant between-group differences in mean postinterventional aortic valve gradient.

The absolute event rate per 100 person-years for all-cause mortality was 1.7 for DOAC vs 1.9 for VKA during the 1-year follow-up, and the event rate for the combined cardiac and cerebrovascular events was 1.2 for DOAC vs 1.3 for VKA during the 1-year follow-up.

There were no significant between-group differences in all-cause mortality (hazard ratio [HR], 0.95; 95% CI, 0.88-1.01; P =.114) or cardiac and cerebrovascular event-free survival (HR, 0.93; 95% CI, 0.86-1.01; P =.071) after adjustment for baseline confounders.

Overall survival in 5-year follow-up showed subgroup significance in the beneficial effect of DOAC vs VKA among women (P =.046).

Study limitations include use of retrospective data, missing data on adherence and switching of medications during follow-up, and lack of generalizability to other ethnicities/races.

“This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation,” the investigators concluded. “Comparison of VKA versus DOAC treatment was associated with similar outcomes in terms of all-cause mortality and cardiac and cerebrovascular events including TIA, hemorrhagic/ischemic stroke, myocardial infarction, reintervention on the AV [aortic valve], and all-cause mortality, after multivariate adjustment.”

Disclosure: This research was supported by the German Cardiac Society which receives unrestricted grants by medical device companies.