TAVR Found to Be Effective Alternative to SAVR in PARTNER 1 Trial
Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis, with similar patient outcomes at five years, according to results from the PARTNER 1 Trial presented on Sunday, March 15 as part of ACC.15 and simultaneously published in the Lancet.
The study, based on 699 patients, 348 of whom were assigned to TAVR and 351 of whom were assigned to SAVR, builds on previous data showing similar surgical outcomes at one year, two years and three years. Overall results showed the mean Society of Thoracic Surgeons (STS) Predicted Risk of Mortality score was 11.7 percent. At five years, risk of death was 67.8 percent in the TAVR group compared with 62.4 percent in the SAVR group (hazard ratio 1.04, 95% CI 0.86–1.24; p=0.76).
In other findings, study investigators, led by Michael Mack, MD, FACC, noted “no structural valve deterioration requiring surgical valve replacement in either group.” Moderate or severe aortic regurgitation occurred in 14 percent of 280 patients in the TAVR group and 1 percent of 228 in the SAVR group, and was associated with increased five-year risk of mortality in the TAVR group.
According to the investigators, it is likely that given the study results patients will undoubtedly choose the less invasive approach. “Some uncertainties remain about outcomes beyond five years (eg, valve durability), but clinical decisions are affected by the way information is presented in terms of probability of survival or death,” they said. “Surgery is associated and often described with a higher short-term probability of discomfort or mortality, and most patients will not consider the likelihood of a long-term benefit but instead choose the less invasive option.”
Meanwhile, a related PARTNER study also published in the Lancet, shows that TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. The study randomly assigned 358 patients to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty.
Finding from the study, showed the risk of all-cause mortality at five years was 71.8 percent in the TAVR group versus 93.6 percent in the standard treatment group. At five years, 42 of 49 survivors in the TAVR group had New York Heart Association class one or two symptoms compared with three of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 1.52 cm² at five years, mean gradient 10.6 mm Hg at five years), with no evidence of structural valve deterioration, the study authors noted.
Moving forward, the authors suggest that “TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status.” However, they point out “that appropriate selection of patients will help to maximize the benefit of TAVR and reduce mortality from severe comorbidities.”
Meanwhile, results from the CoreValve US Pivotal Trial were also presented on Sunday during the LBCT session. The study compared long-term outcomes in TAVR patients who received a self-expanding CoreValve, as opposed to surgical aortic valve replacement (SAVR). The results indicated that high-risk aortic stenosis (AS) patients who had a TAVR with CoreValve had a better survival rate than those who received SAVR. Study investigators emphasized that TAVR with CoreValve should become the standard treatment for AS patients at high-surgical risk.
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