Apixaban in AF Patients After Transfemoral TAVR

Study Questions:

What is the impact of atrial fibrillation (AF) on outcomes associated with transfemoral aortic valve replacement (TAVR)? And, what are the safety and efficacy outcomes associated with apixaban versus vitamin K antagonists in these patients?

Methods:

The authors enrolled 617 patients, 345 (55.9%) of whom were in sinus rhythm and 272 (44.1%) were in AF. Clinical follow-up was performed at 30 days and 12 months. The composite safety endpoints included all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary obstruction, major vascular complications, and valve dysfunction requiring re-intervention.

Results:

Early composite safety endpoints at 30 days were significantly higher in AF versus sinus rhythm patients (23.2% vs. 11.0%, p < 0.01). At 12 months, the composite of all-cause mortality and stroke were higher in AF versus sinus rhythm patients (20.6% vs. 9.7%, p = 0.02), driven largely by higher all-cause mortality (19.1% vs. 7.8%, p = 0.01). Among AF patients, 141 (51.8%) were treated with apixaban and 131 (48.2%) with vitamin K antagonists. Early safety endpoints at 30 days were lower among apixaban-treated patients versus vitamin K antagonist-treated patients (13.5% vs. 30.5%, p < 0.01). Groups were compared using Kaplan-Meier estimates.

Conclusions:

The authors concluded that among TAVR patients, comorbid AF was associated with higher rates of all-cause mortality through 12 months. They also concluded that early safety endpoints were less common for patients treated with apixaban versus vitamin K antagonist medications.

Perspective:

This single-center registry of TAVR patients demonstrated that comorbid AF is associated with higher mortality rates at 30 days and 1 year, as compared with patients in sinus rhythm. While this is not a new finding (Tarantini G, et al., JACC Cardiovasc Interv 2016;9:937-46), the association between use of apixaban and lower rates of 30-day safety endpoints is novel and important. This is not completely unexpected, given the lower rates of bleeding associated with apixaban use versus warfarin in the ARISTOTLE trial (Granger CB, et al., N Engl J Med 2011;365:981-92). This study provides reassuring data on the safety and efficacy of apixaban among patients receiving bioprosthetic TAVR, and should be a consideration for patients with comorbid AF undergoing TAVR procedures.


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