Acurate neo TAVR system matches Sapien 3 for clinical outcomes at 3 years
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BOSTON — Transcatheter aortic valve replacement with the self-expanding Acurate neo device was similar to the balloon-expandable Sapien 3 device in clinical outcomes at 3 years, according to new data from the SCOPE I trial.
As Healio previously reported, in the main results of SCOPE I, presented at TCT 2019, the Acurate neo device failed to meet noninferiority for the primary safety and efficacy endpoint of a combination of Valve Academic Research Consortium (VARC-2)-derived early safety and clinical efficacy at 30 days. Those results were driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury.
However, “Early differences in procedural and valve performance outcomes between the two devices did not translate into significant differences in clinical outcomes or valve failure at 3 years,” Jonas Lanz, MD, MSc, from the department of cardiology at Bern University Hospital, Bern, Switzerland, said during a press conference at TCT 2022.
The trial included 739 patients (median age, 83 years) with severe symptomatic aortic stenosis at intermediate surgical risk (median Society of Thoracic Surgeons Predicted Risk of Mortality, 3.5%) who were selected for transfemoral TAVR by a heart team. At 3 years, 93% of the cohort was available for follow-up, Lanz said at the press conference.
At 3 years, there were no differences between the groups in all-cause death (HR = 0.98; 95% CI, 0.73-1.33) and all-cause death, stroke or HF hospitalization (HR = 0.92; 95% CI, 0.72-1.18), Lanz said at the press conference.
There were also no differences between the groups in CV death, non-CV death, stroke, disabling stroke, nondisabling stroke, hospitalization for valve-related dysfunction or congestive HF, new-onset atrial fibrillation or flutter, MI and new permanent pacemaker implantation, he said.
Lanz also said that compared with the Sapien 3 valve, the Acurate neo valve had numerically but not significantly lower rates of structural valve deterioration and valve thrombosis, and that there was no difference between the groups in aortic valve reintervention or valve-related death. The lack of difference in 3-year outcomes despite the higher rate of moderate or severe paravalvular regurgitation at 30 days is “not expected but reassuring,” Lanz said at the press conference. “It has been consistently shown that moderate and severe paravalvular leak leads to more hospitalizations and a higher death rate. Why this was not the case in this trial, may potentially be explained by the modest absolute number of patients with moderate or severe paravalvular leak (34) and the fact that 11 patients underwent multiple valve implantation at the time of the procedure or a re-intervention for relevant regurgitation during follow-up in the Acurate neo group. Hence, the patients with most severe regurgitation may have been treated along the way. It also has to be said that we had an elderly population with a rather high mortality rate at 3 years; it was 25%. So these findings might not apply to a lower-risk population with higher life expectancy.”
Since the SCOPE I trial was conducted, the ACURATE neo device has been redesigned with a taller outer sealing skirt in order to reduce the rate of paravalvular aortic regurgitation, Lanz said at the press conference. As Healio previously reported, the new version (Acurate neo2) was associated with less paravalvular aortic regurgitation compared with the original version.
Perspective
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These results were surprising in a good way. The curves seemed to overlap toward the end of the 3-year period. The question is how this translates to clinical practice. In current practice, we have good devices that are frequently used. Which device benefits a certain patient more so than the others? My feeling is that for a majority of patients, there will be multiple available devices that all will be efficacious. There are certain subgroups that might benefit from one or the other. That seems to be a theme for all transcatheter heart valve studies.
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Lanz J, et al. Late-Breaking Clinical Science in Structural Heart Disease: Session II, in Collaboration With The European Heart Journal/Eurointervention. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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