10-Year PARTNER 2 Outcomes Confirm TAVR Durability Matches Surgery in Intermediate-Risk Aortic Stenosis
核心洞察
The PARTNER 2 trial's 10-year follow-up shows transcatheter aortic valve replacement (TAVR) with SAPIEN 3 (搜索) yields comparable survival and durability to surgical aortic valve replacement (SAVR) in intermediate-risk patients.
At 10 years, rates of death or disabling stroke were similar between TAVR and surgery (TAVR 55.0% vs SAVR 55.8%, p=0.76), with no significant difference in bioprosthetic valve failure.
TAVR was associated with lower rates of new-onset atrial fibrillation and major bleeding, while surgery showed fewer paravalvular leaks and reinterventions.
The long-term durability of transcatheter aortic valve replacement (TAVR) has been a central question since the technology's introduction. Now, 10-year data from the landmark PARTNER 2 trial provide the most comprehensive answer yet: TAVR with the SAPIEN 3 (搜索) valve delivers survival and valve durability outcomes comparable to surgical aortic valve replacement (SAVR) in patients with intermediate-risk aortic stenosis (搜索).
The findings, published in the Journal of the American College of Cardiology, represent the longest randomized follow-up comparing TAVR and surgery in this patient population.
Comparable Survival and Stroke Outcomes at One Decade
In the PARTNER 2 trial, investigators randomized intermediate-risk patients with severe aortic stenosis (搜索) to either TAVR with the SAPIEN 3 (搜索) valve or SAVR. At 10 years, the composite primary endpoint of death or disabling stroke occurred in 55.0% of TAVR patients and 55.8% of SAVR patients (p=0.76), demonstrating no statistically significant difference between the two strategies.
The individual components of the primary endpoint also showed similar rates. All-cause mortality at 10 years was comparable between groups, and rates of disabling stroke were low and not significantly different. These results extend the previously reported 5-year outcomes, which had already suggested equipoise between the two approaches.
Valve Durability: Bioprosthetic Valve Failure Rates
A critical concern with TAVR has been whether transcatheter valves would demonstrate the same long-term durability as surgically implanted bioprosthetic valves. The 10-year PARTNER 2 data address this directly.
Bioprosthetic valve failure—defined as valve-related death, aortic valve reintervention, or severe hemodynamic structural valve deterioration—occurred at similar rates in both groups. The cumulative incidence curves for bioprosthetic valve failure showed no significant separation between TAVR and SAVR over the full decade of follow-up.
Divergent Safety Profiles
While the overall outcomes were comparable, the two approaches demonstrated distinct safety profiles that may inform clinical decision-making. TAVR was associated with significantly lower rates of new-onset atrial fibrillation and major bleeding compared to surgery. These differences reflect the less-invasive nature of the transcatheter approach, which avoids sternotomy and cardiopulmonary bypass.
Conversely, SAVR was associated with lower rates of moderate or severe paravalvular leak and fewer aortic valve reinterventions over the follow-up period. The higher rate of paravalvular leak with TAVR, while improved with newer-generation devices, remains an area for continued technological refinement.
Clinical Implications and Patient Selection
In an accompanying editorial, Dr. Aakriti Gupta of Cedars-Sinai contextualized the findings within the broader TAVR landscape, noting that the 10-year data support TAVR as a reasonable option for intermediate-risk patients. The editorial, titled "TAVR at 10 Years: Which Valve, Which Patient, Which Era?", emphasized that patient-specific factors—including age, frailty, anatomical considerations, and patient preference—should guide the choice between TAVR and SAVR.
A related analysis published alongside the main trial results examined 10-year outcomes specifically with the SAPIEN 3 (搜索) valve, confirming that the newer-generation device maintains its performance advantage over earlier iterations throughout long-term follow-up.
The PARTNER 2 investigators, led by Dr. Vinod H. Thourani, Dr. Tamim M. Nazif, Dr. Martin B. Leon, and Dr. Raj R. Makkar, concluded that these results affirm TAVR as a durable treatment strategy for intermediate-risk patients with severe aortic stenosis (搜索).
The Evolving TAVR Landscape
The 10-year PARTNER 2 results arrive at a time when TAVR has already expanded into low-risk populations based on shorter-term data. These long-term findings provide reassurance that the valve durability concerns that once limited TAVR's adoption have not materialized in a clinically meaningful way over a decade of follow-up.
As noted in a separate review published by Vemulapalli and colleagues, meeting the challenge of 10-year follow-up in transcatheter valve trials is essential for establishing the evidence base that guides clinical practice. The PARTNER 2 investigators' achievement in maintaining long-term follow-up provides a model for future device trials.
For the millions of patients worldwide with severe aortic stenosis (搜索), these data reinforce that both TAVR and SAVR represent excellent treatment options with proven long-term durability, and that the choice between them should be individualized based on each patient's clinical profile and personal preferences.