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SAN FRANCISCO, CALIF.—Data presented at the TCT 2011 meeting show that dual antiplatelet therapy does not reduce mortality compared with aspirin alone in high-risk patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis.
The results of the study, SAT-TAVI, were presented by Eugenio Stabile, MD, PhD, of Clinica Montevergine, in Italy and showed that TAVR can be performed safely without dual antiplatelet therapy (DAPT). Summarizing his findings, Stabile noted that, aspirin alone “does not increase the rate of combined safety endpoint at 30 days, but is associated with a reduced rate of vascular complications.”
SAT-TAVI included 172 patients with high-risk aortic stenosis, and results included 120 of these patients, who were randomly assigned, 60 in each group, to either aspirin alone or aspirin and a thienopyridine.
Patients received a detailed clinical assessment and serial blood testing. At months 1 and 6, patients underwent a clinical echocardiogram.
Stabile said that at 6 months, all-cause mortality was similar between the two groups at approximately 5%.
Regarding vascular complications, Stabile noted a reductions in major and minor complications with aspirin alone (13% vs. 5%; P=.03), but he said, the study was underpowered to demonstrate this difference.
“When we look at bleeding at 30 days, there is a trend toward major and minor bleeding reductions [with aspirin],” Stabile said. Rates of all bleeding at 30 days were 15% with dual antiplatelet therapy and 10% with aspirin alone respectively (see Figure).
He added that there was also a trend toward reducing the number of transfused blood units with aspirin alone.
Stabile reported that two major strokes—one in each group—occurred during the procedures.
In the United States, trials are ongoing with DAPT for 3 months, then continuing aspirin or clopidogrel. If a patient is on warfarin (Coumadin, Bristol-Myers Squibb), the patient is given one or the other.
Patients were included if they had severe aortic stenosis, defined as having an echo-derived AVA < 0.8 cm2 and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/s. Also, these patients had cardiac symptoms that were defined as NYHA functional class ≥ 2 and were likely to undergo surgery.