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TAVR vs. Surgical Valve Replacement in Intermediate-Risk Patients
Study Questions:
What are the 1-year outcomes with SAPIEN 3 transcatheter aortic valve replacement (TAVR) in intermediate-risk patients compared with those for similar patients given surgical aortic valve replacement?
Methods:
In the SAPIEN 3 observational study, 1,077 intermediate-risk patients at 51 sites in the United States and Canada were assigned to receive TAVR with the SAPIEN 3 valve (952 [88%] via transfemoral access) between February 17, 2014, and September 3, 2014. In this population, the authors assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then they compared 1-year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between December 23, 2011, and November 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. The investigators did noninferiority (margin 7.5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes.
Results:
At 1-year follow-up of the SAPIEN 3 observational study, 79 of 1,077 patients who initiated the TAVR procedure had died (all-cause mortality 7.4%; 6.5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis, the authors included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both noninferior (pooled weighted proportion difference of –9.2%; 90% confidence interval [CI], –12.4 to –6; p < 0.0001) and superior (–9.2%; 95% CI, –13.0 to –5.4; p < 0.0001) to surgical valve replacement.
Conclusions:
The authors concluded that TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year.
Perspective:
This observational study reports that TAVR with SAPIEN 3 resulted in excellent clinical outcomes after 1-year follow-up, including low rates of death, stroke, and cardiac symptoms. Furthermore, propensity score analysis suggests that comparison of 1-year results of this study with those from the surgery cohort from PARTNER 2A demonstrates that SAPIEN 3 was superior to surgery for death, strokes, and the composite endpoint of death, strokes, and moderate to severe aortic regurgitation combined, and may be the preferred treatment alternative in these patients. Additional prospective randomized trials are indicated to validate these findings before extending the use of TAVR to intermediate- or low-risk patient populations. Although some 5-year data from randomized trials indicate no evidence for premature structural valve deterioration, long-term durability of bioprosthetic transcatheter valves has not been firmly established and needs additional longer-term follow-up data.
Keywords: ACC Annual Scientific Session, Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Risk, Stroke, Stents, Transcatheter Aortic Valve Replacement
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