Health care utilization is lower following SURE procedure vs ureteroscopy

Updated data from the ASPIRE trial (NCT04519294) showed that health care consumption (HC) events among patients with urolithiasis were significantly lower at 1 year for those who underwent steerable ureteroscopic renal evacuation (SURE) with the CVAC Aspiration System compared with those who underwent standard ureteroscopy (URS).¹

Data collection in the ASPIRE study remains ongoing.

The updated data were presented at the 41st World Congress of Endourology and Uro-Technology (WCET) in Seoul, South Korea.

“The ASPIRE 1-year data shows significantly lower cumulative incidence of HC events after SURE compared to standard URS,” said presenting author Karen L. Stern, MD, a urologist at Mayo Clinic in Arizona, in a news release on the findings.² “This new data suggests that the new CVAC System may have the potential for a positive clinical and health economic impact in the treatment of urolithiasis.”

Initial 30-day results from the ASPIRE trial were previously presented at the 2024 American Urological Association Annual Meeting in San Antonio, Texas, showing that the trial met its primary end point by demonstrating the non-inferiority of SURE vs URS in stone free rate (P = .027). Overall, treatment with SURE led to greater mean stone clearance (P = .036) and lower mean residual stone volume (P = .012) in patients vs URS, independent of baseline stone volume. Safety was also shown to be comparable between the 2 procedures.³

The current 1-year follow-up analysis of the ASPIRE trial sought to assess the downstream health care burden of the procedures through HC events, defined as any renal event requiring health care resource utilization, including emergency department visits, hospitalization, and retreatment.

Overall, data showed that at 12 months, there were 3 HC events in 2 patients who underwent SURE vs 14 HC events in 9 patients who underwent URS (P = .015). Per Kaplan-Meier estimates, 95.6% of patients who underwent SURE were free of HC events by 12 months, compared with 83.5% of patients who underwent URS.

According to the authors, “These results suggest SURE may have the potential for a positive clinical and health economic impact in the treatment of urolithiasis.”¹

In total, the prospective, multi-center ASPIRE study enrolled 123 adult patients with urolithiasis across 11 institutions in the United States. Patients were eligible for enrollment in the trial if they were candidates for ureteroscopy laser lithotripsy, had at least 1 renal stone, and had 7 to 20 mm of total stone burden. Patients were excluded from the study if they had a body mass index greater then 45; significant comorbidities; bladder, ureteral, or kidney abnormalities; were pregnant; or were unable to meet the treatment and follow-up protocols of the trial.⁴

Those enrolled in the trial were randomly assigned 1:1 to undergo SURE with the CVAC System or standard ureteroscopy with basketing. In total, 101 patients met the criteria for inclusion in the efficacy analysis, comprised of 46 patients who underwent SURE and 55 patients who underwent URS. The patient retention rate at 12-month follow-up was 95%.

Data collection in the ASPIRE study remains ongoing, with stone events and retreatment rates being assessed through 2 years.

Additional data from WCET

Additional data on the CVAC System were presented at the 2024 WCET meeting,² including an initial experience with the device in 50 urologists from 23 institutions. Across 174 procedures, the median stone burden was 15 mm with no stone burden limit. Additionally, 81% of cases achieved at least a 95% stone clearance rate.

The safety and feasibility of the SURE procedure was also assessed in 91 patients who were treated at a single center from January 2022 to August 2023. Overall, the study showed that SURE led to a higher stone-free rate vs URS alone and demonstrated low morbidity even in treating patients with large volume stone disease.

References

1. Stern K, Matlaga B, Mueller T, et al. Healthcare utilization for renal events after steerable ureteroscopic renal evacuation vs ureteroscopy: 1-year results of the Aspire study. Presented at: 2024 World Congress of Endourology and Uro-Technology. Seoul, South Korea. August 12-16, 2024. Abstract MP04-11. https://meetings.association-service.org/docs/wcet/abstracts/abstracts.aspx

2. Calyxo announces new ASPIRE 1-year study results with CVAC System in kidney stone clearance indicating a positive clinical and health economic impact in the treatment of urolithiasis. News release. Calyxo, Inc. August 14, 2024. Accessed August 15, 2024. https://www.businesswire.com/news/home/20240814987943/en/Calyxo-Announces-New-ASPIRE-1-Year-Study-Results-with-CVAC-System-in-Kidney-Stone-Clearance-Indicating-a-Positive-Clinical-and-Health-Economic-Impact-in-the-Treatment-of-Urolithiasis

3. Matlaga B, Mueller T, Johnson B, et al. Prospective, randomized study of steerable ureteroscopic renal evacuation vs ureteroscopy with basketing: 30-day results of the aspire study. J Urol. 2024. Abstract PD10-04. doi:10.1097/01.JU.0001008748.59024.cb.04

4. Comparison of laser lithotripsy with and without steerable ureteroscopic renal evacuation (SURE). ClinicalTrials.gov. Last updated March 6, 2023. Accessed August 15, 2024. https://clinicaltrials.gov/study/NCT04519294