Key result
Anemia was not associated with NACE or major bleeding at 30 days after TAVR, but was associated with a higher risk of major vascular complications (adjusted OR 2.43; 95% CI 1.42-4.16; P=0.001).
Why the study?
Whether periprocedural use of bivalirudin compared with UFH in anemic patients undergoing TAVR impacts outcomes was unknown.
Does periprocedural bivalirudin compared with unfractionated heparin impact 30-day outcomes differently in anemic versus non-anemic patients undergoing TAVR?
RCT (n=802)
randomized
Does periprocedural bivalirudin compared with unfractionated heparin impact 30-day outcomes differently in anemic versus non-anemic patients undergoing TAVR?
Anemia increases the risk of major vascular complications and acute kidney injury after TAVR, but does not modify the comparative safety and efficacy of bivalirudin versus unfractionated heparin.
Anemia flags higher vascular complication risk after TAVR without affecting NACE or bleeding; leaves open whether correction alters outcomes.
Objectives To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). Background Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. Methods The BRAVO‐3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dl in men and <12 g/dl in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all‐cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (Bleeding Academic Research Consortium ≥3b) at 30 days. Results Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30 days between patients with and without anemia, irrespective of the type of anticoagulant used (pinteraction = 0.71 for NACE, pinteraction = 1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42–4.16, p = 0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16–2.59, p = 0.007) compared to non‐anemic patients at 30 days. Conclusions Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH.
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Razuk et al. (2021) conducted an RCT in Severe symptomatic aortic stenosis (n=802). Anemia vs. Absence of anemia was evaluated on Net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding at 30 days (p=0.71 for interaction). Anemia was not associated with NACE or major bleeding at 30 days after TAVR, but was associated with a higher risk of major vascular complications (adjusted OR 2.43; 95% CI 1.42-4.16; P=0.001).
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