PARTNER 2A, S3i: TAVR reduces cost, improves life expectancy in severe aortic stenosis

David J. Cohen

Patients with severe aortic stenosis and intermediate surgical risk who underwent transcatheter aortic valve replacement with two different valves had lower long-term costs and a greater quality-adjusted life expectancy compared with those who underwent surgical AVR, according to data from two trials presented at TCT 2017.

Perspective from Updesh S. Bedi, MD, FACC, FSCAI

“Taken together with the clinical data that we know, these findings suggest that TAVR should be the preferred strategy for such patients based on both clinical and economic considerations,” David J. Cohen, MD, MSc, professor of medicine at the University of Missouri-Kansas City School of Medicine and director of cardiovascular research at Saint-Luke’s Mid America Heart Institute in Kansas City, Missouri, said during a press conference.

Researchers analyzed data from the PARTNER 2A and SAPIEN 3 Intermediate Risk trials to determine the cost-effectiveness of TAVR compared with surgical AVR in intermediate-risk patients. In the PARTNER 2A trial, about 2,000 patients with severe aortic stenosis were assigned TAVR with a Sapien XT valve (Edwards Lifesciences; n = 994) or surgical AVR (n = 944). The SAPIEN 3 Intermediate Risk trial included 1,077 patients with severe aortic stenosis who underwent TAVR with a Sapien 3 valve (Edwards Lifesciences).

Both groups of patients from the PARTNER 2A trial were compared in one economic analysis. In a second analysis, patients who underwent TAVR in the SAPIEN 3 Intermediate Risk trial were compared with those who underwent surgical AVR in the PARTNER 2A trial. Medicare claim and payment data were used for both analyses.

“Because TAVR is such a Medicare-focused population, virtually all the patients in the trial could be linked with their Medicare claims,” Cohen said.

TAVR vs. surgical AVR

In the PARTNER 2A trial, patients who underwent TAVR had a shorter procedure duration (102 minutes vs. 236 minutes; P < .001), shorter lengths of stay (6.4 days vs. 10.9 days; P < .001) and shorter stays in the ICU (2.4 days vs. 4.6 days; P < .001) compared with those who underwent surgical AVR.

Although the TAVR group had higher procedure costs vs. the surgical AVR group ($38,548 vs. $16,465), patients who underwent TAVR had lower nonprocedural costs ($19,417 vs. $37,409) and lower physician fees ($3,827 vs. $5,421).

“The procedures were substantially more expensive because the valve is so much more expensive; $32,500 for the TAVR valve vs. $5,000 for a surgical valve,” Cohen said.

The total cost for the index hospitalization was $2,888 higher for the TAVR group vs. the surgical AVR group (P = .014).

“TAVR was more expensive, but the difference was much more modest than one might have expected,” Cohen said during the press conference.

At 2 years, the total costs were higher for the surgical AVR group ($114,132) compared with the TAVR group ($107,716), with a difference of $6,416 (P = .01).

The projected lifetime cost difference was $7,949 lower in patients who underwent TAVR compared with surgical AVR. The difference in quality-adjusted life-years was 0.15 years greater in the TAVR group.

“The probability that TAVR is highly cost-effective for this population is essentially 100%,” Cohen said during the press conference.

SAPIEN 3 vs. surgical AVR

Patients who underwent TAVR in the SAPIEN 3 Intermediate Risk trial had a 6.5-day reduction in length of hospital stay and 1-year cost savings of $15,551 compared with patients who underwent surgical AVR (P < .001). The savings were driven by in-hospital cost savings and substantial follow-up cost savings.

The projected life expectancy in the TAVR group was 7.95 years vs. 7.61 years in the surgical AVR group, with a difference in life expectancy of 0.34 years and a difference in QALYs of 0.32.

Patients who underwent TAVR had a greater cost savings ($9,692) and QALYs (0.27 years) compared with those who underwent surgical AVR.

“The results are even more definitive in the SAPIEN 3 Intermediate Risk trial,” Cohen said.

The probability that TAVR is cost-effective at a threshold of $50,000 per QALY was 100%, and the probability that TAVR is economically dominant was 97%.

“The market is already moving this way, so I don’t know that this is going to dramatically change the way people are practicing because the practice is driven right now by the clinical data, which are already good, and by the patient demand, which is high for TAVR,” Cohen said during the press conference. – by Darlene Dobkowski
Reference:

Cohen DJ, et al. Late-Breaking Clinical Trials 2. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.

Disclosure: The PARTNER 2 and SAPIEN 3i trials were funded by Edwards Lifesciences. Cohen reports no relevant financial disclosures.

Perspective

Updesh S. Bedi, MD, FACC, FSCAI

This, a long-term follow up of TAVR vs. surgical AVR, is an important trial. TAVR was performed with the XT system, which is the generation before the Sapien 3, the latest TAVR valve that we’re using currently for the majority of our patients.
There were 2,000 patients enrolled. The mean follow-up was 2 years, and the mean patient age was about 80 years.
Notably, these were intermediate-risk patients, with a 4% to 8% Society of Thoracic Surgeons Predicted Risk of Mortality. Patients with a score of less than 4% could be included if there were coexisting conditions where the surgeon felt that this patient is at intermediate risk.
We saw that in TAVR, the all-cause mortality plus disabling stroke was 19.3% vs. 21.1% in surgical AVR, and this reached statistical significance for noninferiority, but not for superiority.
We did see some important characteristics of TAVR vs. surgical AVR. We saw that all-cause mortality was statistically different. The length of stay was lower with TAVR, 6 days vs. 9 days. The ICU stay was also statistically lower, 2 days vs. 4 days. The vascular complications were higher in the TAVR arm, 7.9% vs. 5%. However, life-threatening or disabling bleeding was significantly higher in the surgical arm; at 30 days, it was 43% vs. 10% in TAVR. Also, atrial fibrillation was higher in the surgical arm, 26% vs. 9% in the TAVR arm. The need for rehospitalization was almost the same.
Paravalvular regurgitation at 2 years was higher in the TAVR arm, 8% vs. 0.6%, but that will keep on improving because the next generation, the Sapien 3, has a skirt around the bottom edge, which has the potential to reduce paravalvular regurgitation.

This is a good trial because it demonstrates that clinically, TAVR is not inferior to surgical AVR. The researchers also did a cost analysis, and it showed that although the upfront costs are higher, it was predominately driven by the cost of the valve. Most of the hospitals paid $32,000 to $33,000 for the TAVR valve vs. approximately $5,000 for the surgical valve. Overall, at 1 year of follow up, the transcatheter strategy saved about $9,000 to $10,000. That demonstrates that the overall cost of care might be lower, although the upfront costs are higher.
The newer-generation valves have reduced stroke rates, pacemaker implantation rates and paravalvular regurgitation rates further.
Boston Scientific and Abbott/St. Jude Medical are working on new valves. Those and other advances could be helpful moving forward.

Updesh S. Bedi, MD, FACC, FSCAI

Assistant Professor, University of Minnesota

Interventional Cardiologist, Regions Hospital, St. Paul, Minnesota

Disclosures: Bedi reports no relevant financial disclosures.