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Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental group) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. The trial was stopped after 210 patients were recruited between November 2013 and June 2017 when funding was interrupted. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils. Safety and other clinical outcomes were similar. Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.

The purpose of this study was to calculate the number needed to treat to save 1 life at 1 year and up to 5 years after vertebral augmentation. A 10-year sample of the 100% US Medicare data base was used to identify patients with vertebral compression fractures treated with nonsurgical management, balloon kyphoplasty, and vertebroplasty. The number needed to treat was calculated between augmentation and nonsurgical management groups from years 1–5 following a vertebral compression fracture diagnosis, using survival probabilities for each management approach. The adjusted number needed to treat to save 1 life for nonsurgical management versus kyphoplasty ranged from 14.8 at year 1 to 11.9 at year 5. The adjusted number needed to treat for nonsurgical management versus vertebroplasty ranged from 22.8 at year 1 to 23.8 at year 5. The authors conclude that the NNT analysis of more than 2 million patients with VCF reveals that only 15 patients need to be treated to save 1 life at 1 year. This has an obvious clinically significant impact and given that all augmentation clinical trials are underpowered to detect a mortality benefit, this large dataset analysis reveals that vertebral augmentation provides a significant mortality benefit over nonsurgical management with a low NNT.