ACC.15: TAVR safe and effective in low-risk patients, with caveats

When comparing transcatheter and surgical aortic valve replacements, findings presented at the American College of Cardiology scientific session noted that there were no differences in death, stroke, or MI at one year. However, there were some differences in outcomes, leaving neither on top.

The NOTION (Nordic Aortic Valve Intervention) trial randomized 280 patients between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Patients had severe aortic valve stenosis but were not at high risk.

Hans Gustav Hørsted Thyregod, MD, of The Heart Center at Copenhagen University Hospital in Copenhagen, Denmark, and noted in the paper published concurrently in the Journal of the American College of Cardiology that they had anticipated TAVR would come out a clear winner and did not blind the trial. “It was expected that the lower risk patients would show greater benefit from the less-invasive TAVR procedure than their higher risk counterparts, however the magnitude of this benefit was uncertain,” they wrote.

However, at one-year follow-up neither was superior: composite MI, stroke or mortality was similar between TAVR and SAVR, 13.1 percent and 16.3 percent, respectively. However, among other outcomes, the two diverged. TAVR patients had significantly lower rates of acute kidney injury (0.7 percent vs. 6.7 percent, respectively), cardiogenic shock (4.2 percent vs. 10.4 percent, respectively) and major bleeding (11.3 percent vs. 20.9 percent, respectively). TAVR patients stayed a mean of four days less in the hospital. At 30 days, rates for new or worsening atrial fibrillation were more than three times less among TAVR patients than SAVR, and continued to be significant through one year.

Meanwhile, SAVR patients had the advantage when it came to abnormalities that required a permanent pacemaker at 30 days (SAVR: 1.6 percent vs. TAVR: 34.1 percent) and at one year (2.4 percent vs. 38 percent, respectively). SAVR was also superior to TAVR in New York Heart Association functional class at one year and aortic valve regurgitation.

Thyregod et al wrote that significant changes to TAVR procedures and techniques have occurred since the initial procedure began that may alter results in future studies, including imaging modalities that more clearly provide proper sizing for the valve. They suggested more studies were needed before branching out to include indications for lower risk patients in TAVR.

This study was presented March 16 in San Diego.