Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?
Osteoporos Int
; 29(2): 375-383, 2018 02.
Article
em En
| MEDLINE
| ID: mdl-29063215
ABSTRACT
The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients. INTRODUCTION:
BKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients.METHODS:
BKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors.RESULTS:
The cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort.CONCLUSIONS:
Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fraturas da Coluna Vertebral
/
Fraturas por Compressão
/
Vertebroplastia
/
Fraturas por Osteoporose
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Osteoporos Int
Assunto da revista:
METABOLISMO
/
ORTOPEDIA
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Estados Unidos