Minimally invasive procedures shouldn’t be reserved only for those with limited treatment options, based on two studies that tested a non-surgical procedure in low-risk patients with aortic stenosis. Findings were presented at the American College of Cardiology’s 68th Annual Scientific Session and confirm the benefits of transcatheter aortic valve replacement (TAVR) over surgery in a low-risk population.
TAVR is a minimally invasive procedure used to treat aortic stenosis. Aortic stenosis occurs when the heart’s aortic valve narrows, often causing symptoms like weakness, chest pain and shortness of breath.
TAVR has been shown to relieve symptoms and improve survival in patients with aortic stenosis. Studies also suggest that it’s just as safe, if not more so, than traditional surgery. Since it’s still new, TAVR has typically been reserved for patients who are too risky for surgery. However, experts hope the latest findings may expand its use in a larger group of patients.
Known as the PARTNER 3 and EVOLUT trials, these studies compared TAVR vs. traditional surgery in low-risk patients with severe aortic stenosis. Together, the studies assigned more than 2,300 patients to undergo TAVR or surgery and then tracked outcomes for up to two years.
Key outcomes included stroke, death, rehospitalizations and quality of life, which help measure the treatment’s success.
In the PARTNER 3 trial, researchers found that stroke, death or rehospitalization occurred in 15% of patients undergoing surgery, compared to just 8.5% of patients in the TAVR group after one year. The length of hospital stay was also reduced from seven to three days with TAVR.
In the EVOLUT trial, risk of stroke or death was only 5.3% in the TAVR group compared with 6.7% in the surgery group after two years. Researchers also found that the TAVR group had significantly better quality of life after one month than the surgery group.
Both study findings were published in the New England Journal of Medicine and confirm that TAVR may be better than surgery, even in low-risk patients.
“We’ve now looked at a broad risk spectrum of patients—those at high, intermediate and low surgical risk—and these series of trials have shown that TAVR is better than or as good as surgery in terms of disabling strokes and deaths from all causes,” said Michael J. Reardon, MD, FACC, lead author of the EVOLUT trial. “Given this data, it now seems reasonable to consider moving TAVR in low risk patients to a class I guideline indication on par with surgery for patients with severe aortic stenosis.”
Lead author of the PARTNER 3 trial, Martin B. Leon, MD, FACC, adds, “This is a landmark study because it involves 80 percent of the people who are currently being treated with surgery for aortic stenosis.” According to Leon, most patients who are healthy enough will undergo surgery for aortic stenosis, simply because we have more experience with it. Now that we’ve learned more about TAVR and how it compares to surgery, TAVR may soon become the go-to option for even low-risk patients.
In fact, Reardon noted that PARTNER 3 and EVOLUT are probably the final trials of TAVR vs. surgery, given the positive outcomes of both studies. That’s because once it becomes clear that one treatment is better than another in research, it’s usually time to update guidelines and help patients get the best-possible treatment in a clinical setting.