TCT2021 | There is no difference in the 5-year results of the SURTAVI of TAVR or SAVR among intermediate-risk patients
Recently, the annual American Transcatheter Cardiovascular Therapeutics Conference (TCT) was held online, and the results of a number of blockbuster studies have been announced one after another. One of the SURTAVI trials on valvular disease research published the results of 5 years. This journal specially invited the researcher Nicolas M. Van Mieghem from the Erasmus University Medical Center in Rotterdam, the Netherlands, to conduct an exclusive interview.
International Circulation: At this TCT conference, you will announce the 5-year results of the SURTAVI trial. Could you share us the main content of the research?
Professor Nicolas M. Van Mieghem: The SURTAVI trial, for the first time, presented its five-year outcome and echocardiography data. SURTAVI is a randomized trial evaluating TAVI or TAVR with a supra-annular self-expanding device versus surgery in patients of intermediate operative risk. It was quite a big trial. Over 1600 patients were randomized 1:1 in a modified intention-to-treat analysis. Basically, in this analysis, every patient where there was an attempted implantation or procedure according to the assigned treatment strategy was included in the study. In general, the mean age was approximately 80 years old, and STS score 4.5. What we saw was that there was no difference whatsoever at five years in the primary composite endpoint of all-cause mortality and disabling stroke. Then, as expected, if you looked at valve performance, the hemodynamic performance of the TAVI valve was superior to surgery. On the other hand, there was more paravalvular leak with the TAVI valve. But we have to bear in mind that the device that was used in the TAVI arm was the CoreValve in 84% of the cases. That is an early generation self-expanding supra-annular functioning valve.
International Circulation:What changes will the results of this study bring to the application of TAVR in patients with intermediate surgical risk?
Professor Nicolas M. Van Mieghem: I think the main message is that SURTAVI is very reassuring when selectingTAVI as a treatment in intermediate-risk patients, who are somewhat younger, and who are obviously at lower risk. Basically, by selecting a TAVI strategy, patients will do well, and will do at least as well as surgery out to five years. So there are no penalties to pay for a strategy selection for TAVI or surgery.
International Circulation: What factors do you think will influence doctors to choose TAVR or SAVR among patients with intermediate surgical risk?
Professor Nicolas M. Van Mieghem: In this day and age, you will also have to bring the patient into the discussion. This is called shared decision-making. You have to inform your patient about this less-invasive option, which is TAVI, and then the more invasive option, which is surgery. At the end of the day, based on SURTAVI, we are now able to say that at least out to five years, there is no difference whatsoever in clinical outcomes.
International Circulation:In the future, what is the application prospect of TAVR in intermediate surgical risk patients with severe aortic stenosis (AS)? Would you please share us your opinions？
Professor Nicolas M. Van Mieghem: Basically, the current guidelines already pencil the future for us, because the current guidelines in Europe and the United States already make the recommendation that TAVI is an OK treatment for patients >75 years of age, regardless of the risk profile. The low-risk trials that only have a follow-up of 1-2 years have already entered the guideline recommendations, but I think what SURTAVI now brings us is a scientific backbone to that recommendation. It is very important to know that there is no durability issue with TAVI, at least with the self-expanding supra-annular functioning device.
International Circulation: At this TCT conference, you will announce the 5-year results of the SURTAVI trial. Could you share us the main content of the research?
Professor Nicolas M. Van Mieghem: The SURTAVI trial, for the first time, presented its five-year outcome and echocardiography data. SURTAVI is a randomized trial evaluating TAVI or TAVR with a supra-annular self-expanding device versus surgery in patients of intermediate operative risk. It was quite a big trial. Over 1600 patients were randomized 1:1 in a modified intention-to-treat analysis. Basically, in this analysis, every patient where there was an attempted implantation or procedure according to the assigned treatment strategy was included in the study. In general, the mean age was approximately 80 years old, and STS score 4.5. What we saw was that there was no difference whatsoever at five years in the primary composite endpoint of all-cause mortality and disabling stroke. Then, as expected, if you looked at valve performance, the hemodynamic performance of the TAVI valve was superior to surgery. On the other hand, there was more paravalvular leak with the TAVI valve. But we have to bear in mind that the device that was used in the TAVI arm was the CoreValve in 84% of the cases. That is an early generation self-expanding supra-annular functioning valve.
International Circulation:What changes will the results of this study bring to the application of TAVR in patients with intermediate surgical risk?
Professor Nicolas M. Van Mieghem: I think the main message is that SURTAVI is very reassuring when selectingTAVI as a treatment in intermediate-risk patients, who are somewhat younger, and who are obviously at lower risk. Basically, by selecting a TAVI strategy, patients will do well, and will do at least as well as surgery out to five years. So there are no penalties to pay for a strategy selection for TAVI or surgery.
International Circulation: What factors do you think will influence doctors to choose TAVR or SAVR among patients with intermediate surgical risk?
Professor Nicolas M. Van Mieghem: In this day and age, you will also have to bring the patient into the discussion. This is called shared decision-making. You have to inform your patient about this less-invasive option, which is TAVI, and then the more invasive option, which is surgery. At the end of the day, based on SURTAVI, we are now able to say that at least out to five years, there is no difference whatsoever in clinical outcomes.
International Circulation:In the future, what is the application prospect of TAVR in intermediate surgical risk patients with severe aortic stenosis (AS)? Would you please share us your opinions？
Professor Nicolas M. Van Mieghem: Basically, the current guidelines already pencil the future for us, because the current guidelines in Europe and the United States already make the recommendation that TAVI is an OK treatment for patients >75 years of age, regardless of the risk profile. The low-risk trials that only have a follow-up of 1-2 years have already entered the guideline recommendations, but I think what SURTAVI now brings us is a scientific backbone to that recommendation. It is very important to know that there is no durability issue with TAVI, at least with the self-expanding supra-annular functioning device.
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