Women have lower one-year mortality rates after TAVR with the Sapien valve

Women undergoing transcatheter aortic valve replacement (TAVR) had a lower mortality rate one year after the procedure compared with men, according to a secondary analysis of the PARTNER (Placement of Aortic Transcatheter Valves) trial.

After adjusting for several variables, the researchers found female sex was independently associated with lower one-year mortality. They also mentioned that women had a higher 30-day incidence of vascular complications and major bleeding.

Lead researcher Susheel Kodali, MD, of Columbia University Medical Center in New York, and colleagues published their results online in the Annals of Internal Medicine on Feb. 22.

“These results, in conjunction with prior published work, indicate that the approach to sex-specific risk in TAVR should be the opposite of that in SAVR [surgical aortic valve replacement], for which female sex is regarded as predictive of adverse prognosis,” they wrote.

Edwards Lifesciences funded this analysis as well as the PARTNER trial. Based on the results of the PARTNER trial, the FDA approved Edwards Lifesciences’ Sapien transcatheter valve. In June, the FDA approved the Sapien 3 for high-risk patients with severe aortic stenosis.

The researchers noted that TAVR is an option for the approximately one-third of patients with aortic stenosis who are deemed to be high-risk or inoperable for SAVR.

For this analysis, they analyzed patients who enrolled in the randomized PARTNER trial as well as those who were part of the randomized and nonrandomized continued access registries. They mentioned the continued access registry was developed to gather real-world safety and efficacy data on the Sapien valve while Edwards Lifesciences awaited the FDA’s approval decision.

The analysis included 2,559 patients who underwent TAVR in the PARTNER trial at 25 sites: 2,000 were in the nonrandomized continued access registry, 40 were in the randomized continued access registry and 519 were in the randomized trial. Of the patients, 47.7 percent were women and 52.3 percent were men. At baseline, women had lower rates of hyperlipidemia, diabetes, smoking and renal disease and higher Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) scores compared with me.

At 30 days, women had a statistically significant higher rate of vascular complications (17.3 percent versus 10.0 percent) and major bleeding (10.5 percent versus 7.7 percent) compared with men. However, at 30 days, women and men had similar rates of all-cause mortality (6.5 percent vs. 5.9 percent), cardiac mortality (4.8 percent vs. 3.9 percent) and the combined end point of death or hospitalization (12.0 percent vs. 12.5 percent).

At one year, the unadjusted all-cause mortality rates were 19.0 percent in women and 25.9 percent in men, while the hospitalization rates were 15.8 percent and 18.9 percent, respectively. The stroke rates were 5.2 percent and 4.5 percent.

Female sex was independently associated with lower one-year mortality based on a multivariable analysis that controlled for the presence of diabetes, oxygen-dependent chronic obstructive pulmonary disease, higher STS-PROM scores, major arrhythmia, renal disease and liver disease.

The researchers cited a few limitations of their analysis, including that measured and unmeasured confounders may have influenced the results. They also mentioned they did not perform bootlegging in the multivariable analysis. Further, the results were based only on the 23 mm and 26 mm Sapien valves, so they may not be generalizable to other valve systems.