CHICAGO — Compared with a surgical strategy, transcatheter aortic valve replacement (TAVR) using the new generation Sapien 3 device was tied to fewer adverse outcomes in intermediate-risk patients, according to a propensity-score analysis.
At 1 year, the combined rate of all-cause mortality, stroke, and moderate-to-severe aortic regurgitation was lower for intermediate-risk patients who got Sapien 3 versus those getting surgery as part of the PARTNER 2 cohort A study (P<0.001 for superiority).
Individual endpoints driving that difference were an advantage of the Sapien 3 device in mortality (7.4% for TAVR versus 13.0% for surgery, P<0.001 for superiority) and stroke (4.6% versus 8.2%, P=0.004 for superiority), Vinod H. Thourani, MD, of Atlanta’s Emory University Hospital Midtown, and colleagues found.
Moderate or severe aortic regurgitation, in contrast, favored surgery (1.2% versus 1.5% for TAVR, P=0.0149 for superiority).
Presenting at the American College of Cardiology (ACC) 2016 Scientific Sessions and in a report published simultaneously online in The Lancet, Thourani suggested that there is now “strong evidence that in intermediate-risk patients with severe aortic stenosis, Sapien 3 TAVR compared with surgery improves clinical outcomes and is the preferred therapy.”
Ajay J. Kirtane, MD, SM, of New York-Presbyterian/Columbia University Medical Center, told MedPage Today that these findings mean that for intermediate-risk patients with a current generation TAVR device, “we can expect potentially superior outcomes to conventional aortic valve surgery.”
“Traditionally this has been the realm of the surgeons, but at this point I think every patient should be considered for TAVR if they’re in this intermediate-risk cohort,” Kirtane said, calling the combined findings of the present investigation and PARTNER 2A “an impressive package.”
Findings from the PARTNER 2 cohort A showing the non-inferiority of the second-generation Sapien XT device for intermediate-to-high risk patients, especially when performed via transfemoral access, were presented earlier at the same conference.
Thourani’s analysis included 1,078 intermediate-risk recipients of Sapien 3 as an observational cohort within PARTNER 2 compared with surgical arm of the randomized cohort A trial, which comprised 2,032 people. The median age was 82 years for both arms.
As early as 1 month, the TAVR group had the upper hand in having lower rates of all-cause mortality and stroke (3.7% versus 9.7% for surgery). That trend remained intact at 1 year (10.8% versus 18.8%).
“Time-to-event analyses indicated that the benefits of Sapien 3 TAVR occurred in the first few months, suggesting procedure-related effects,” according to the authors.
They cautioned that “each TAVR system is distinct,” however, so “it would be hazardous to generalise these findings to other TAVR systems.” Other limitations to their study included the lack of randomization and analysis of a few select outcomes.
Panel discussant James B. McClurken, MD, of Doylestown Health in Pa., said that TAVR technology is “clearly here to stay.”
What remains to be seen, he suggested, is how paravalvular leak can be minimized in the future. McClurken also questioned the generalizability of the Sapien 3 findings to younger patients. “How much can we move that median age downward?” he asked.
Both SAPIEN 3 and PARTNER 2 were funded by Edwards Lifesciences.
Thourani cited relationships with Abbott Vascular, Boston Scientific, Claret Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical.
Thourani VH, et al “Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis” Lancet 2016; DOI: 10.1016/S0140-6736(16)30073-3.