Coronary artery disease (CAD) coexists with aortic stenosis in about half the patients who suffer the latter. These patients receiving antiplatelet therapy are at a higher risk of periprocedural bleeding—one of the most frequent complications in patients who undergo transcatheter aortic valve replacement (TAVR).
One way of limiting the risk for bleeding is choosing the right anticoagulant agent during the procedure. Currently, experts recommend using unfractionated heparin. However, a possible alternative that has reduced the risk for bleeding in patients undergoing coronary angioplasty is bivalirudin, a non-reversible short-action direct thrombin inhibitor.
The aim of this multicenter, randomized, controlled, open-label study was to evaluate the impact of CAD on clinical results after TAVR, and to determine whether CAD has an impact on periprocedural anticoagulant therapy using bivalirudin vs. unfractionated heparin.
The primary endpoint (PEP) was a composite of cardiac adverse events (net-adverse clinical effect, NACE) defined as all-cause mortality, acute myocardial infarction (AMI), stroke, and major bleeding (BARC ≥3b) at 30 days after TAVR. The secondary endpoints (SEP) included major adverse cardiac events (MACE) defined as all-cause mortality, AMI, stroke, acute renal failure, major vascular complications, and life-threatening bleeding (according to VARC criteria).
The study randomized 801 patients, 54.6% with CAD and 45.5% free of CAD. Patients were further randomized to bivalirudin and unfractionated heparin. Mean patient age was 82 years, and most subjects were men. CAD patients were more frequently overweight men. They also had higher EUROSCORE log and greater comorbidities, such as anemia, peripheral arterial disease, and low ejection fraction.
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Results showed no differences in terms of NACE (15.3% vs. 14.6%; p = 0.761) or BARC ≥3b bleeding (8.9% vs. 10.2%; p = 0.551) at 30 days for patients with or without CAD. The AMI rate was higher in patients with CAD (p = 0.009), and so was the development of acute renal failure (p = 0.048).
There were no differences either in NACE at 30 days (13.9% vs. 16.8%; odds ratio [OR] = 0.80; 95% confidence interval [CI]: 0.47– 1.35) or BARC ≥3b bleeding (7.2% vs. 10.7%; OR = 0.64, 95% CI: 0.33–1.25) among CAD patients who received bivalirudin or unfractionated heparin. The only finding was an increase in the rate of acute renal failure in patients who received bivalirudin (22.9% vs. 15%; OR = 1.69, 95% CI: 1.03–2.75).
Conclusion
The presence of CAD did not have an impact on NACE or periprocedural bleeding at 30 days after TAVR. There were also no differences between using bivalirudin or unfractionated heparin regardless of the diagnosis of CAD.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO‐3 randomized trial.
Reference: Daniel Feldman MD et al Catheter Cardiovasc Interv. 2023;1–10.
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