The SURTAVI trial has become the second major face-off between transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively), after PARTNER 2A, to show parity in 5-year clinical outcomes in patients with severe, symptomatic aortic stenosis at intermediate surgical risk.
The new SURTAVI results, like those from the other trial that used different TAVR valves, offer little to question the previous decade's seismic shift in approaches to aortic valve replacement. For most patients, it's gone from an onerous sternum-splitting surgery with a usually tough recovery to an endovascular procedure followed usually by only a few hospital days.
The noninferiority that TAVR showed at 2 years essentially persisted to 5 years, by which time rates of the primary endpoint, death from any cause or disabling stroke, were 31.3% for TAVR and 30.8% for SAVR (P = .85). The composite's separate component endpoints were also comparable at both 2 and 5 years.
"Forward-flow hemodynamics" reflected in part by aortic valve gradient were significantly better in the TAVR group soon after the procedure, at 2 years, and at 5 years. But mild to severe paravalvular leakage was far more common among the TAVR patients at 5 years, just as it had been at 2 years.
Still, there was no correlation between such paravalvular leaks and 5-year clinical outcomes, reported SURTAVI cochair Nicolas Van Mieghem, MD, PhD, from the Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands, when presenting the study at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held virtually and the more personable, old-fashioned way in Orlando, Florida.
Reintervention was more likely after TAVR than SAVR, but the excess "occurred early after the procedure, and was predominantly because of aortic regurgitation," Van Mieghem said, and "was, in the majority of cases, solved by a redo-TAVR procedure."
New need for a pacemaker implant is a well-recognized early potential complication of TAVR, experienced in SURTAVI by about 26.0% of TAVR patients but only 6.6% of surgical patients in 30 days after their procedure; the difference quite significant at 2 years. The numbers grew to 35.8% and 14.6%, respectively (P < .001) by 5 years.
But there was no group difference in new pacemaker implants in a landmark analysis that started at the 2-year mark, Van Mieghem reported, and the overall excess in pacemaker need didn't track with overall 5-year mortality.
It's reassuring, he said, "that basically a minimally invasive approach performs equally well [to] the more invasive approach out to 5 years, and we're no longer talking about short-term outcome."
Of note, but not unexpectedly, TAVR's advantage over surgery for patient-reported health status narrowed over the first year after the procedures. Mean Kansas City Cardiomyopathy Questionnaire scores, far lower in the SAVR group at 30 days, were about equal for the two groups by 1 year and essentially stayed that way out to year 5.
Still, TAVR provides "added value" with its faster recovery time. "We are still talking about elderly patients," Van Mieghem said. As part of shared decision-making in such cases, "I think it will be quite reasonable to say that most patients would feel and should feel comfortable when they opt for a TAVR procedure for symptomatic severe aortic stenosis."
And "long-term outcomes data from the SURTAVI randomized trial," he concluded in his presentation, are "encouraging for TAVR in younger, healthier patients with aortic stenosis."
But observers caution that even 5 years likely isn't long enough to assess whether TAVR implants are sufficiently durable for many younger patients with longer life expectancies. Long-term durability isn't well understood for TAVR valves, at least much beyond 5 years, but is one of SAVR's strong suits. That's less an issue for older patients. Most SURTAVI participants were in at least their 70s, and the study's mean age was between 79 and 80 years.
"It is reassuring to see these 5-year data that would be helpful in the elderly patients," invited discussant Robert O. Bonow, MD, Northwestern University, Chicago, said after the SURTAVI presentation. But the guidelines already recommend consideration of TAVR in patients older than 75, he noted, "so we do need longer-term data just to be certain that this is going to hold up" beyond 5 years.
"We need to be really cautious in translating these outcomes to 'younger' patients at lower risk. Of the problems that we face, indication creep is close to the top of the list," elaborated Patrick O'Gara, MD, Brigham and Women's Hospital, Boston.
"I think it's not really fair for us to say 60-year-old patients will fare equally well, or that the trade-off between a pacemaker implant and the need for a repeat procedure is perceived the same in folks who are 15 years younger," O'Gara said. But perhaps an 80-year-old would be "more than happy to put up with a pacemaker compared against a median sternotomy."
SURVAVI enrolled a total of 1746 patients for randomization to TAVR or SAVR; 864 and 796 patients, respectively, were available for the reported modified intention-to-treat analysis of those in whom the assigned procedure was attempted. Women made up about 44% of the study population. The TAVR devices were all early-generation self-expanding Medtronic CoreValve (in 84%) and Evolut R (16%) valves.
|SURTAVI Clinical Outcomes, 5-Year Follow-up and Landmark Analysis From 2 to 5 Years|
|Endpoint||TAVR (%)||SAVR (%)||P Value|
|Death from any cause|
|Baseline to 5 y||30.0||28.7||.55|
|From 2 to 5 y||20.9||20.3||.79|
|Baseline to 5 y||11.6||13.6||.16|
|From 2 to 5 y||6.0||5.5||.76|
|Baseline to 5 y||3.5||1.9||.02|
|From 2 to 5 y||1.0||1.3||.60|
|Baseline to 5 y||35.8||14.6||<.001|
|From 2 to 5 y||7.1||5.3||.27|
|*Includes pacemakers at baseline|
Aortic valve mean gradients at 5 years were 8.6 mm Hg for the TAVR device and 11.2 mm Hg for the SAVR prosthesis (P < .001), a superior result for TAVR that may potentially hint at the procedure's longevity vs surgery.
That potential edge for the endovascular procedure was somewhat counterbalanced by a significant excess in paravalvular leakage compared to the SAVR group.
|Rates of Mild, Moderate, or Severe Paravalvular Leakage at 1, 2, and 5-Year Follow-ups in SURTAVI|
|Follow-up||TAVR (%)||SAVR (%)||P Value|
Whereas TAVR in younger patients at intermediate surgical risk may still warrant caution, such use routinely in SURTAVI-like patients in practice seems faite accompli.
"There is very little surgery being done in these patients nowadays," observed surgeon Michael A. Borger, MD, PhD, University of Leipzig and Leipzig Heart Center, Germany, referring specifically to SURTAVI's mean age of about 80 years and mean STS-PROM (Society of Thoracic Surgeons 30-Day Predicted Risk of Mortality) score of about 4.5.
"At least in Germany," Borger said at a media briefing preceding SURTAVI's presentation at TCT 2021, "intermediate-risk patients are all treated with TAVR."
SURTAVI was funded by Medtronic. Van Mieghem discloses receiving grants support or having research contracts for his institution from Abbott Vascular, Medtronic, Boston Scientific, PulseCath BV, Biotronik, Edwards Lifesciences, and Abiomed; receiving consultant fees or honoraria or serving on a speaker's bureau for Boston Scientific; and receiving grant support from and holding research contracts with Daiichi-Sankyo/Eli Lilly. Bonow had no disclosures. O'Gara discloses serving on trial executive committees for Medtronic and Edwards Lifesciences. Borger discloses receiving consultant fees or honoraria or serving on a speakers bureau for Edwards Lifesciences, Medtronic, Abbott Vascular, and CryoLife.
Transcatheter Cardiovascular Therapeutics (TCT) 2021: Late-Breaking Clinical Trials Session 2. SURTAVI: Five-Year Results From a Randomized Trial of TAVR vs SAVR in Patients at Intermediate Surgical Risk. Presented November 5, 2021.
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Cite this: SURTAVI at 5 Years Reinforces TAVR but Was It Long-term Enough? - Medscape - Nov 08, 2021.