Vertebroplasty Reduces Acute Pain Following Osteoporotic Vertebral Fractures in VAPOUR Study
Joshua A. Hirsch, MD Comments
Vertebroplasty was found safe and effective in reducing acute pain and disability in patients with osteoporotic vertebral fractures within a 6-week period in the randomized controlled Vertebroplasty for Acute Painful Osteoporotic fractures (VAPOUR) trial, published in the October 1 issue of The Lancet.
“These findings are important because, for the first time, vertebroplasty has been demonstrated to reduce pain more effectively than a sham intervention,” said Joshua A. Hirsch, MD, Past President of the Society of NeuroInterventional Surgery and coauthor of a companion commentary in The Lancet. “Moreover, the trial suggests that conservative therapy, including narcotics, bedrest and back braces, are themselves not risk-free. Indeed, in prior open-label trials such as VERTOS 2, vertebroplasty has performed dramatically better than conservative therapy.”
The VAPOUR study included 120 patients with one or two osteoporotic vertebral fractures of less than 6 weeks’ duration and back pain of ≥7 out of 10 on the Numeric Rating Scale (NRS). The participants were randomized to vertebroplasty (n=61) or a placebo intervention with simulated vertebroplasty (n=59).
At 14-days post-intervention, a significantly greater proportion of the patients randomized to vertebroplasty had a NRS score of <4 compared to the placebo group (44% vs 21%). The between- group difference was 23 percentage points (P=0.011). The advantage of vertebroplasty persisted at the 6-month follow-up.
Two people who underwent vertebroplasty had serious adverse events: one patient had a respiratory arrest after administration of sedation before the procedure (this patient was resuscitated and underwent the procedure 2 days later), and one patient sustained a supracondylar humerus fracture when being transferred onto a radiology table.
Implications of the Findings
Two previous randomized controlled trials of vertebroplasty showed no statistically significant benefit to the procedure, noted Drs. Hirsch and Ronil V. Chandra in the commentary that accompanied the article. Based on these 2009 studies, use of vertebroplasty markedly declined in the United States and public funding for the procedure was removed in Australia, he explained.
“Overall, the implications from VAPOUR as a standalone trial are clear: patients with severe pain from a recent osteoporotic fracture appear to benefit from vertebroplasty,” the experts commented. They noted that an additional benefit to the procedure was a reduction in median hospital stay of 5.5 days in those patients enrolled as hospital inpatients (57% of the overall group).
The present study is different from previous trials in many respects, including earlier treatment of fractures, selection of patients with severe pain (Numerical rating scale, NRS ≥7), and a placebo intervention that was closer to a true sham procedure, the experts noted.
In addition, “VAPOUR showed that medical management is not always benign, and can also be associated with risk—two patients in the control group developed spinal cord compression from further collapse and retropulsion of their vertebral compression fractures.”
Limitations of the study, as noted by Drs. Hirsch and Chandra included a potential lack of generalizability to other centers, as the procedures were performed at 4 centers in Australia with the bulk (85%) performed at 1 of those sites.