Terrence Diamond1, William Clark2, Paul Bird3, Peter Gonski4, Elizabeth Barnes5, Val Gebski5. 1. St George and Sutherland Clinical School UNSW, St George Hospital, Sydney, NSW, Australia. terrydiamond@optusnet.com.au. 2. Interventional Radiology, St George Private Hospital, Sydney, NSW, Australia. 3. St George and Sutherland Clinical School UNSW, St George Hospital, Sydney, NSW, Australia. 4. School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia. 5. NHMRC Clinical Trial Centre, University of Sydney, Sydney, NSW, Australia.
Abstract
BACKGROUND: VAPOUR found vertebroplasty (V) more effective than placebo (P) in patients with severe pain and fracture duration less than 6 weeks. Exploratory analysis suggested that benefits were concentrated in the subgroup of patients with fractures ≤ 3-week duration. This difference may account for the three negative blinded trials that included few patients within this fracture time frame. PURPOSE: To assess the safety and efficacy of early vertebroplasty for acute painful vertebral osteoporotic fractures within 3 weeks of fracture onset in the VAPOUR study. METHODS: Spearman's rank log coefficients were calculated to reassess the relationship of pain reduction from vertebroplasty and fracture duration in the VAPOUR trial. We more fully report baseline and outcome data in patients with fractures ≤ 3-week duration. RESULTS: There were 46V and 47P patients with fractures ≤ 3-week duration. Baseline characteristics were similar. In total, 86 patients (41V, 45P) completed the 14-day questionnaire. The proportion of patients with reduction in pain from severe (NRS ≥ 7/10 was an inclusion requirement) to mild (NRS < 4) at 14 days was 21 (51%) V-group and 9 (20%) in the P-group (between-group difference 31 percentage points, 95% CI 12-50; p = 0.002). Early vertebroplasty provided greater reductions in mean NRS pain and Roland-Morris Disability. CONCLUSION: Analysis of this patient subgroup from the VAPOUR trial, in the context of other randomised trial evidence, suggests clinically significant benefits from early vertebroplasty if performed within 3 weeks of fracture. These slides can be retrieved from Electronic Supplementary Material.
RCT Entities:
BACKGROUND: VAPOUR found vertebroplasty (V) more effective than placebo (P) in patients with severe pain and fracture duration less than 6 weeks. Exploratory analysis suggested that benefits were concentrated in the subgroup of patients with fractures ≤ 3-week duration. This difference may account for the three negative blinded trials that included few patients within this fracture time frame. PURPOSE: To assess the safety and efficacy of early vertebroplasty for acute painful vertebral osteoporotic fractures within 3 weeks of fracture onset in the VAPOUR study. METHODS: Spearman's rank log coefficients were calculated to reassess the relationship of pain reduction from vertebroplasty and fracture duration in the VAPOUR trial. We more fully report baseline and outcome data in patients with fractures ≤ 3-week duration. RESULTS: There were 46V and 47P patients with fractures ≤ 3-week duration. Baseline characteristics were similar. In total, 86 patients (41V, 45P) completed the 14-day questionnaire. The proportion of patients with reduction in pain from severe (NRS ≥ 7/10 was an inclusion requirement) to mild (NRS < 4) at 14 days was 21 (51%) V-group and 9 (20%) in the P-group (between-group difference 31 percentage points, 95% CI 12-50; p = 0.002). Early vertebroplasty provided greater reductions in mean NRSpain and Roland-Morris Disability. CONCLUSION: Analysis of this patient subgroup from the VAPOUR trial, in the context of other randomised trial evidence, suggests clinically significant benefits from early vertebroplasty if performed within 3 weeks of fracture. These slides can be retrieved from Electronic Supplementary Material.
Authors: Cristina E Firanescu; Alexander Venmans; Jolanda de Vries; Paul Lodder; Marinus C Schoemaker; Albert J Smeets; Esther Donga; Job R Juttmann; Karen Schonenberg; Caroline A H Klazen; Otto E H Elgersma; Frits H Jansen; Hendrik Fransen; Joshua A Hirsch; Paul N M Lohle Journal: Cardiovasc Intervent Radiol Date: 2022-06-09 Impact factor: 2.797