PARTNER 3 and EVOLUT Confirm Benefits of TAVR Over Surgery in Low-Risk Patients

Outcomes after transcatheter aortic valve replacement (TAVR) were superior or at least as good as those following surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis at low surgical risk, according to results of the PARTNER 3 and EVOLUT trials presented at ACC.19 in New Orleans. Both studies were published simultaneously in the New England Journal of Medicine.

Both studies compared the outcomes of TAVR with those of SAVR in patients with severe aortic stenosis and a low risk of death with surgery. In PARTNER 3, Martin B. Leon, MD, FACC, et al., randomized 1,000 patients to either TAVR with a third-generation balloon-expandable valve or standard SAVR with a bioprosthetic valve. The primary endpoint was the composite of death from any cause, stroke or re-hospitalization at one year after the procedure.

The assigned procedure was performed in 950 patients. Two patients in the TAVR group and four in the surgery group died during the index hospitalization. At one year, the primary endpoint occurred in 8.5 percent of the TAVR group compared with 15.1 percent of the surgery group, meeting the requirements for both noninferiority (p<0.001) and superiority of TAVR vs. surgery (p<0.001).

The Kaplan-Meir analysis of the primary endpoint components with TAVR vs. surgery found mortality rates of 1.0 percent vs. 2.5 percent, stroke rates of 1.2 percent vs. 3.1 percent, and rehospitalization rates of 7.3 percent vs. 11.0 percent, respectively. The length of hospital stay was reduced from seven to three days with TAVR.

“This is a landmark study because it involves 80 percent of the people who are currently being treated ith surgery for aortic stenosis. Our hope was that TAVR would be noninferior or comparable to surgery, and we were surprised to find an almost 50 percent reduction in the primary endpoint, from 15.1 percent in the surgical group to 8.5 percent with TAVR,” said Leon.

In EVOLUT, Michael J. Reardon, MD, FACC, et al. randomized 1,468 patients to TAVR with a self-expanding bioprosthesis compared with surgical replacement. The primary endpoint was the composite of death from any cause or disabling stroke at 24 months.

The as-treated cohort included 1,403 patients. At 24 months, death or disabling stroke occurred in 5.3 percent of the TAVR group compared with 6.7 percent of the surgery group, meeting the prespecified criteria for noninferiority. The mortality rate from any cause was 4.5 percent in both groups. The rate of disabling stroke was 1.1 percent with TAVR vs. 3.5 percent with SAVR.

At 30 days, TAVR was statistically superior to surgery for the secondary combined endpoint of all-cause mortality or disabling stroke (0.8 vs. 2.6 percent). Patients receiving TAVR had significantly better quality of life and hemodynamics at 30 days.

“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,” Reardon said. “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.” Reardon noted that PARTNER 3 and EVOLUT are probably the final trials of TAVR vs. surgery, given the positive outcomes of both studies.

Keywords: ACC19, ACC Annual Scientific Session, Aortic Valve, Aortic Valve Stenosis, Heart Valve Prosthesis, Heart Valve Diseases, Angiography

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