Sapien 3 TAVR On Par with Surgery at 5 Years

Transcatheter aortic valve replacement (TAVR) with the contemporary Sapien 3 device generally held up against surgery in intermediate-risk patients over 5 years, according to a propensity-matched analysis.

Except for differences in stroke types, longer-term clinical outcomes were comparable between 783 matched pairs of patients undergoing TAVR with Sapien 3 and peers receiving surgical aortic valve replacement (SAVR) in the PARTNER II program:

• All-cause death: 39.1% vs 41.3% (HR 0.90, 95% CI 0.77-1.06)
• Any stroke: 13.4% vs 11.4% (HR 1.09, 95% CI 0.80-1.49)
• Disabling stroke: 5.8% vs 7.9% (HR 0.66, 95% CI 0.43-1.00)
• Non-disabling stroke: 6.4% vs 3.5% (HR 1.67, 95% CI 1.01-2.76)
• Rehospitalization: 26.7% vs 25.3% (HR 0.94, 95% CI 0.76-1.16)

Thus, the early benefit of Sapien 3 TAVR with respect to in death or disabling stroke was “somewhat attenuated” by year 5, whereas the difference in non-disabling stroke (modified Rankin Scale scores of 1 or less) appeared to widen over time, reported Susheel Kodali, MD, of New York-Presbyterian/Columbia University Medical Center in New York City, in a presentation at the Transcatheter Valve Therapy (TVT) virtual meeting.

Mean aortic valve gradients were comparable between groups over time. The incidence of moderate or worse paravalvular regurgitation (PVR) was also similar, staying below 1% for either study arm at 5 years, though the proportion of patients classified as having none or trace PVR numerically favored the surgical group.

“These results with Sapien 3 TAVR demonstrating clinical outcomes and valve durability comparable to surgery at 5 years, associated with low PVR, are encouraging and continue to support TAVR as an alternative to surgery,” Kodali concluded.

Sapien 3 is a current-generation balloon-expandable valve that now has the Sapien 3 Ultra as a successor. Recently, the Ultra was shown to lower PVR rates given a new enhanced outer skirt.

Given that patients are more likely to be anticoagulated after SAVR than after TAVR, the increased incidence of non-disabling stroke “maybe related to the treatment of these patients,” suggested TVT discussant Julinda Mehilli, MD, of Ludwig-Maximilians University and the German Heart Center in Munich.

In response, Kodali noted that his group searched and couldn’t find a clear association between anticoagulation and such strokes.

“I’d just be a little careful in this nonrandomized study of trying to make too much of a small stroke difference,” said Gregg Stone, MD, of Mount Sinai Icahn School of Medicine and the Cardiovascular Research Foundation in New York City. The difference may be related to factors such as different adjudication and definitions of disabling versus non-disabling stroke, he said during the discussion.

New permanent pacemaker rates were significantly higher in the 5 years after TAVR (16.2% vs 11.7% after SAVR, OR 0.69, 95% CI 0.52-0.92).

The two approaches otherwise performed similarly when it came to:

• Endocarditis: 2.2% vs 2.4% (OR 1.12, 95% CI 0.58-2.17)
• Reintervention on the aortic valve: 1.3% vs 0.8% (OR 0.60, 95% CI 0.22-1.65)
• Valve thrombosis: 0.8% vs 0.1% (OR 0.17, 95% CI 0.02-1.38)

Kodali emphasized that none of the seven patients who experienced valve thrombosis had a stroke.

Moreover, the 1% reintervention rate “couldn’t be more reassuring” given the competing risk of mortality, commented TVT session moderator Stephan Windecker, MD, of Bern University Hospital in Switzerland.

For the present study, Kodali and colleagues matched intermediate-risk patients who received the Sapien 3 device (in the PARTNER II S3i study) with those who had surgery (in the randomized PARTNER IIA trial). Study participants were all deemed to be at intermediate surgical risk and presented with severe aortic stenosis.

The matched cohort included 1,566 people. Baseline characteristics were similar between TAVR and SAVR arms (age just over 81 on average; 58% men; STS score 5.5%).

Hemodynamic valve deterioration came out to about 0.6% for both groups. Bioprosthetic valve failure reached 0.63% of the TAVR group and 0.37% of the surgical group (P=0.22).

Seeing the “very low” event rates and “good hemodynamics” out to 5 years in an octogenarian population “makes you feel better,” commented Samir Kapadia, MD, of Cleveland Clinic. It’s “a positive feeling you get from reading the data,” he said.

Residual confounding was possible despite propensity matching, Kodali acknowledged. In addition, the PARTNER investigators had not performed systematic neurologic assessments on these patients, and the TAVR group was disproportionately lost to follow-up.

Further follow-up is planned out to 7 and 10 years, Kodali said.