scholarly journals 111. Duration of Antibiotic Therapy after Debridement and Implant Retention in Patients with Periprosthetic Joint Infections

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S68-S69
Author(s):  
Don Bambino Geno Tai ◽  
Elie Berbari ◽  
Matthew P Abdel ◽  
Brian Lahr ◽  
Aaron J Tande
Keyword(s):  
Lower Risk ◽  
Time Dependent ◽  
Oral Antibiotic ◽  
Material Support ◽  
Joint Infections ◽  
Optimal Duration ◽  
Implant Retention ◽  
Antibiotic Duration ◽  
Time Dependent Analysis

Abstract Background Debridement, antibiotics, and implant retention (DAIR) is appropriate for select acute postoperative and hematogenous periprosthetic joint infections (PJIs). However, the optimal duration of antimicrobial therapy in patients treated with DAIR has not been defined. Therefore, we aimed to identify the ideal duration of parenteral and oral antibiotics after DAIR. Methods We performed a retrospective study of patients >18 years of age with hip or knee PJI managed with DAIR between January 1, 2008, and December 31, 2018, at Mayo Clinic. PJI was defined using criteria adapted from the International Consensus Meeting on PJI. The outcome was defined as either PJI recurrence or unplanned reoperation due to infection. Joint-stratified Cox proportional hazards regression models with time-dependent covariates were used to assess nonlinear effects of antibiotic duration. Hazard ratios were computed based on prespecified time points for comparison, whereas p-values represented the overall effect across the entire range of durations. Results There were 247 unique episodes of PJI in 237 patients during the study period. Parenteral antibiotics were given in 99.2% of cases (n=245). This was followed by chronic oral antibiotic suppression in 92.2% (n=226) with a median duration of 2.2 years (1.0-4.1). DAIR failed in 65 cases over a median follow-up of 4.4 years, with a 5-year cumulative incidence of 28.1%. After adjustment for risk factors, there was no significant association between duration of parenteral antibiotics and treatment failure (p=0.203), with no difference between four versus six weeks (HR 1.11; 95% CI 0.71-1.75) (Figure 1). However, both use and longer duration of oral antibiotic therapy was associated with a lower risk of failure (p=0.006). To account for the possibility that this association was driven by results during early follow-up, conditional analyses at one- and two-year follow-up were performed. Both showed a significantly lower risk for a longer duration of antibiotics (Figure 2). Figure 1. Time-Dependent Analysis of Parenteral Antibiotic Duration Figure 2. Time-Dependent Analysis of Oral Antibiotic Suppression Duration Conclusion After DAIR, efficacy from four weeks of parenteral antibiotics was no different from six weeks when followed by chronic oral antibiotic suppression. Our results could not establish an optimal duration but suggested that continuing suppression portends a lower risk of failure of DAIR. Disclosures Elie Berbari, MD, Uptodate.com (Other Financial or Material Support, Honorary unrelated to this work) Matthew P. Abdel, MD, Stryker and AAOS Board of Directors (Board Member, Other Financial or Material Support, Royalties) Aaron J. Tande, MD, UpToDate.com (Other Financial or Material Support, Honoraria for medical writing)

scholarly journals Multivariable time-dependent analysis of the impact of azacitidine in patients with lower-risk myelodysplastic syndrome and unfavorable specific lower-risk score

2015 ◽  
Vol 39 (1) ◽  
pp. 52-57 ◽  
Author(s):  
Jose Falantes ◽  
Regina García Delgado ◽  
Cristina Calderón-Cabrera ◽  
Francisco J. Márquez-Malaver ◽  
David Valcarcel ◽  
...  
Keyword(s):  
Myelodysplastic Syndrome ◽  
Risk Score ◽  
Lower Risk ◽  
Time Dependent ◽  
The Impact ◽  
Time Dependent Analysis

Prognostic Relevance of the Kinetics of Worsening of Cytopenias in Lower-Risk MDS: A Substudy From the European Leukemianet Low Risk MDS (EUMDS) Registry

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 700-700 ◽  
Author(s):  
Raphael Itzykson ◽  
Alex Smith ◽  
Theo M. de Witte ◽  
Jackie Droste ◽  
Reinhard Stauder ◽  
...  
Keyword(s):  
Lower Risk ◽  
Goodness Of Fit ◽  
Linear Models ◽  
Time Dependent ◽  
Survival Analyses ◽  
Prognostic Relevance ◽  
Registry Entry ◽  
Kinetics Of ◽  
Rbc Transfusion

Abstract Abstract 700 Purpose: Prognosis of lower (IPSS low/int-1) risk MDS is heterogeneous. Current prognostic systems rely on single time point cytopenia values (Hb level, ANC, PLT counts) at diagnosis (classical or revised IPSS [IPSS-R] Greenberg, Blood 2012) or during evolution (time-dependent IPSS/WPSS). Capturing the dynamics of continuous parameters can yield independent prognostic information as exemplified by lymphocyte time doubling in CLL. We analyzed the prognostic relevance of the kinetics of Hb, ANC and PLT in lower-risk MDS patients (pts) included in the prospective EUMDS registry. Methods: Among the first 1000 pts included in the EUMDS registry, those fulfilling the following criteria were analyzed here: a) IPSS low/int-1; b) ≥3 visits (planned every 6 months) with ≥12 months follow-up; c) not treated with hypomethylating agents, G-CSF, hydroxyurea or lenalidomide. Dynamics of Hb, ANC, and PLT were studied by deriving linear models of each variable for each pt. Only pts with ≥3 measures of Hb, ANC and PLT and with stable or worsening corresponding cytopenia (model slope ≤0) were considered in each analysis, regardless of the goodness of fit (R2) of models. Time (T) to lose 1 g/dL of Hb (THb), 1.0 x109/L of ANC (TANC) and 50 x109/L of PLT (TPLT) were derived with the formula: T ∼ 1/slope. All survival analyses were made from the date of registry entry to last follow-up, death, or progression to AML. Unless specified, survival analyses were Cox models using continuous variables accounting for interactions. Results: 530 pts met study inclusion criteria (M/F: 314/216, median age: 73y). WHO diagnosis was 5q- syndrome, RA, RARS, RCMD, RCMD-RS, RAEB-1 and MDS-U in 5, 21, 20, 38, 7, 8 and 2% respectively (resp). IPSS risk was low, int-1 and low/int-1 (cytogenetics not available) in 55%, 38% and 7% resp. At registry entry, median Hb, ANC and PLT were 10.4 g/dL, 2.4 x109/L and 187 x109/L resp. and 23% were RBC transfusion-dependent; 293 received an ESA. The median number of available blood counts was 4 (range 3–9). THb, TANC and TPLT could be determined because of a stable or worsening cytopenia (slope ≤0) in 250/508, 258/495 and 301/509 pts with ≥3 values. There was no significant correlation between the number of values available and the goodness-of-fit (R2) of linear models (all P>0.3). Median THb TANC and TPLT were 23.5 (interquartile range [IQR]: 42.2), 28.7 (IQR: 52.1) and 26.9 (IQR: 49.2) months respectively. Because these figures are derived from linear models, they can be simply rescaled by a proportional extrapolation for daily practice (eg. −1 x109/L ANC at 28.7 months = −0.41 x109/L [12/28.7] at 12 months). THb, TANC and TPLT were not correlated to age, cytogenetic risk, IPSS, IPSS-R or baseline simplified WPSS (Malcovati. Haematologica 2011; all P>0.2). TANC and TPLT (but not THb) were shorter in pts with baseline RBC transfusion dependence (P=.02 and .003, resp.). With a median follow-up of 20.9 months in the 530 pts, 19 patients have progressed (AML: 14, RAEB: 5) and 71 patients have died; 3-year estimates of overall (OS) and progression-free (PFS) survivals were 74.4% and 73.6%. All further analyses are shown for OS and give similar results for PFS. In univariate analysis, longer TANC (hazard ratio [HR] for 6-months increments: 0.88 [95% CI: 0.80–0.97], P=.008) and TPLT (HR: 0.01 [95% CI: 0.001–0.30], P=.007) but not THb (P=.07) were associated with prolonged OS. Pts with a ≥1 x109/L decrease in ANC in less than the median time of 28.7 months (N=129) had a 3-year OS of 66.3% [95% CI: 55.0–79.9%] vs 89.3% [79.7–100%]. Pts with a ≥50 x109/L decrease in PLT in less than the median of 26.9 months (N=151) had a 3-year OS of 59.4% [46.8–75.4%] vs 85.6% [77.5–94.6%] (Figure, both P<10−4). There was no significant difference in the cause of death between those subgroups. In multivariate analysis, the prognostic impact of TANC and TPLT remained independent of baseline IPSS (P=.006 and P=.01 resp.) or IPSS-R (both P=.01), and of simplified time-dependent WPSS (P=.004 and P=.03). A landmark analysis at 2 years, using only retrospective data to derive TANC and TPLT is planned. Conclusion: In lower-risk MDS with stable or worsening cytopenias, kinetics of decline can be approximated to be linear to allow easy prognostic use in clinical practice. Faster decline of ANC and to a lesser extent of PLT counts, but not of Hb level (possibly because of transfusions and use of ESA), is associated with shorter OS and PFS, independently of IPSS, IPSS-R and WPSS. Disclosures: Germing: Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees.

scholarly journals 381. Clinical Outcome of Polymicrobial Prosthetic Joint Infection Managed with Debridement, Antibiotics, and Implant Retention (DAIR)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S198-S198
Author(s):  
Babak Hooshmand ◽  
Dima Youssef ◽  
Kathleen M Riederer ◽  
Susan M Szpunar ◽  
Ashish Bhargava
Keyword(s):  
Joint Infection ◽  
Surgical Site Infections ◽  
International Classification Of Diseases ◽  
Implant Removal ◽  
Suppressive Therapy ◽  
Joint Infections ◽  
Prosthetic Joint ◽  
Prosthetic Joint Infections ◽  
Implant Retention

Abstract Background Polymicrobial (PM) prosthetic joint infections (PJIs) account for 4% to 37% of all PJIs. There is limited literature on surgical debridement, antibiotics and implant retention (DAIR) in PMPJIs. We aimed to assess clinical outcomes of PMPJIs managed with DAIR. Methods A retrospective cohort was studied at three Ascension hospitals in Detroit from January 2012 to December 2018. Cases were identified using the International Classification of Diseases, 9th and 10th Revision code specific for PJIs. Patient’s electronic medical records were reviewed. Results Twenty-six PMPJIs managed with DAIR were identified. Mean age of the infected patients was 66 years. 18 (69%) patients were female and 19 (73%) were caucasians. Infected sites were hip in 15 (58%), knee in 10 (38%) and ankle in 1 (4%) patient. 22 (85%) patients had osteoarthritis, 3 (12%) had diabetes, 3 (12%) were on steroids and 1 (4%) had rheumatoid arthritis. Symptom onset of less than a week was noted in 14 (58%) and 3 or more weeks in 8 (31%) patients. Pain, swelling and drainage were present in 21 (81%), 13 (50%) and 18 (69%) cases. Fever on admission was noted in 7 (27%) patients. 11 (42%) patients were re-admitted in the following 12 months after DAIR. 2 (19%) patients developed superficial surgical site infection (SSI) while 9 (81%) had deep SSI. Implant removal was needed in 6 (55%) patients. 5 (2 superficial and 3 deep) patients required further debridement and antibiotics. 5 (19%) had good outcome with 3–6 months of antibiotics. 3 (12%) patients required long-term chronic suppressive therapy. One patient died from a cardiac event during follow-up. Conclusion In our study, PMPJIs managed with DAIR had high readmission rates and deep surgical site infections. DAIR failure, noted in 23% of our cases, required implant removal within 12 months of follow-up. Disclosures All authors: No reported disclosures.

scholarly journals 403. Clinical Features and Treatment Outcome of Enterobacter Prostethic Joint Infections

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S205-S205
Author(s):  
Dima Youssef ◽  
Babak Hooshmand ◽  
Ashish Bhargava
Keyword(s):  
Clinical Features ◽  
Connective Tissue Diseases ◽  
Surgical Site Infections ◽  
Implant Removal ◽  
Joint Infections ◽  
Prosthetic Joint ◽  
Prosthetic Joint Infections ◽  
Implant Retention ◽  
Surgical History

Abstract Background Enterobacter prosthetic joint infections (PJIs) are rare, occurring mainly in elderly people usually with complex medical and surgical history, and their treatment is usually challenging. Aim of this study is to assess the characteristics and outcomes of Enterobacter PJIs. Methods A retrospective multi-centric cohort was studied at three hospitals from January 2012 to December 2018. Patients with PJIs were identified using ICD codes. Enterobacter PJIs were then identified through reviewing patients’ electronic medical records. Results 13 enterobacter PJIs were identified. 9 (69%) were polymicrobial. Mean age of the patients was 61.7 years, and mean BMI was 34.6 kg/m2. 8 patients (62%) were females, and 8 patients (62%) were Caucasians. Infected sites were: Hip in 5 patients (38%%), knee in 5 patients (38%) and ankle in 3 patients (23%) patients. 9 patients (69%) had osteoarthritis, 3 patients (23%) had diabetes mellitus, and 1 patient (8%) had connective tissue diseases requiring steroids. Most patients (11 out of 13) (85%) presented within 1 week of symptoms onset. Presenting clinical features were pain in 9 patients (69%), drainage in 10 patients (77%), purulence in 7 patients (54%), and fever in 5 patients (38%). 11 patients (85%) were managed with debridement, antibiotics and implant retention (DAIR), and 2 patients (15%) with antibiotics alone. Antibiotics used while managing were as follows: Cefepime n = 6, quinolones n = 2, carbapenems n = 4 and aminoglycosides n = 1. Outcome: 4 patients (31%) developed deep surgical site infections (and two of them required implant removal), 5 patients had no events in 12 months of follow-up, 3 patients (23%) had less than 6 months of follow-up, and one patient died in the hospital due to cardiac failure. Conclusion In our study, most cases of Enterobacter PJIs were polymicrobial. The success rate in monomicrobial infections was 75% while overall it was noted to be 38%. DAIR was associated with high readmission rates and deep surgical site infections (36%). 18% cases managed with DAIR required implant removal. Disclosures All authors: No reported disclosures.

scholarly journals Clinical and Microbiological Characteristics of Bacteroides Prosthetic Joint Infections

2017 ◽  
Vol 2 (3) ◽  
pp. 122-126 ◽  
Author(s):  
Neel Shah ◽  
Douglas Osmon ◽  
Aaron J. Tande ◽  
James Steckelberg ◽  
Rafael Sierra ◽  
...  
Keyword(s):  
Joint Infection ◽  
Significant Proportion ◽  
Resection Arthroplasty ◽  
Joint Infections ◽  
Prosthetic Joint ◽  
Microbiological Characteristics ◽  
Prosthetic Joint Infections ◽  
Implant Retention ◽  
History Of

Abstract. Clinical and microbiological characteristics of patients with Bacteroides prosthetic joint infection (PJI) have not been well described in the literature. The aim of this retrospective cohort study was to assess the outcome of patients with Bacteroides PJI and to review risk factors associated with failure of therapy. Between 1/1969 and 12/2012, 20 episodes of Bacteroides PJI in 17 patients were identified at our institution. The mean age of the patients in this cohort at the time of diagnosis was 55.6 years; 59% (n=10) had knee involvement. Twenty four percent (n=4) had diabetes mellitus, and 24% had a history of either gastrointestinal (GI) or genitourinary (GU) pathology prior to the diagnosis of PJI. Thirty five percent (n=6) were immunosuppressed. The initial medical/surgical strategy was resection arthroplasty (n=9, 50%) or debridement and implant retention (n=5, 28%). Thirty seven percent (n=7) were treated with metronidazole. Eighty percent (n=4) of patients that failed therapy had undergone debridement and retention of their prosthesis, as compared to none of those treated with resection arthroplasty. Seventy percent (n=14) of patient episodes were infection free at their last date of follow up. In conclusion, a significant proportion of patients with Bacteroides PJI are immunosuppressed and have an underlying GI or GU tract pathology. Retention and debridement of the prosthesis is associated with a higher risk of treatment failure.

Control of blood pressure in older patients with heart failure and the risk of mortality: a population-based prospective cohort study

2020 ◽  
Author(s):  
Antonios Douros ◽  
Alice Schneider ◽  
Natalie Ebert ◽  
Dörte Huscher ◽  
Martin K Kuhlmann ◽  
...  
Keyword(s):  
Prospective Cohort ◽  
Older Patients ◽  
Cardiovascular Death ◽  
Population Based ◽  
Time Dependent ◽  
Risk Of Mortality ◽  
Patients With Heart Failure ◽  
All Cause Mortality ◽  
Time Dependent Analysis

Abstract Background treatment goals for blood pressure (BP) lowering in older patients with heart failure (HF) are unclear. Objective to assess whether BP control &lt; 140/90 mmHg is associated with a decreased risk of mortality in older HF patients. Design population-based prospective cohort study. Setting/subjects participants of the Berlin Initiative Study, a prospective cohort of community-dwelling older adults launched in 2009. Clinical information was obtained in face-to-face interviews and linked to administrative healthcare data. Methods Cox proportional hazards models estimated adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) of cardiovascular death and all-cause mortality associated with normalised BP (systolic BP &lt; 140 mmHg and diastolic BP &lt; 90 mmHg) compared with non-normalised BP (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) in HF patients. The primary analysis considered only baseline BP (‘time-fixed’); an additional analysis updated BP during follow-up (‘time-dependent’). Results at baseline, 544 patients were diagnosed with HF and treated with antihypertensive drugs (mean age 82.8 years; 45.4% female). During a median follow-up of 7.5 years and compared with non-normalised BP, normalised BP was associated with similar risks of cardiovascular death (HR, 1.24; 95% CI, 0.84–1.85) and all-cause mortality (HR, 1.16; 95% CI, 0.89–1.51) in the time-fixed analysis but with increased risks of cardiovascular death (HR, 1.79; 95% CI, 1.23–2.61) and all-cause mortality (HR, 1.48; 95% CI, 1.15–1.90) in the time-dependent analysis. Conclusions BP control &lt; 140/90 mmHg was not associated with a decreased risk of mortality in older HF patients. The increased risk in the time-dependent analysis requires further corroboration.

scholarly journals The efficacy of suppressive antibiotic treatment in patients managed non-operatively for periprosthetic joint infection and a draining sinus

2021 ◽  
Vol 6 (7) ◽  
pp. 313-319
Author(s):  
Karel-Jan Dag François Lensen ◽  
Rosa Escudero-Sanchez ◽  
Javier Cobo ◽  
Rihard Trebše ◽  
Camelia Gubavu ◽  
...  
Keyword(s):  
Antibiotic Therapy ◽  
Joint Infection ◽  
Sinus Tract ◽  
Oral Antibiotic ◽  
Curative Surgery ◽  
Joint Infections ◽  
Oral Antibiotic Therapy ◽  
Number Of Patients ◽  
Prosthetic Joint Infections

Abstract. Objectives: Patients with prosthetic joint infections (PJIs) not suitable for curative surgery may benefit from suppressive antibiotic therapy (SAT). However, the usefulness of SAT in cases with a draining sinus has never been investigated. Methods: A multicentre, retrospective observational cohort study was performed in which patients with a PJI and a sinus tract were eligible for inclusion if managed conservatively and if sufficient follow-up data were available (i.e. at least 2 years). SAT was defined as a period of > 6 months of oral antibiotic therapy. Results: SAT was initiated in 63 of 72 (87.5 %) included patients. Implant retention during follow-up was the same in patients receiving SAT vs. no SAT (79.4 % vs. 88.9 %; p=0.68). In total, 27 % of patients using SAT experienced side effects. In addition, the occurrence of prosthetic loosening in initially fixed implants, the need for surgical debridement, or the occurrence of bacteremia during follow-up could not be fully prevented with the use of SAT, which still occurred in 42 %, 6.3 %, and 3.2 % of cases, respectively. However, the sinus tract tended to close more often (42 % vs. 13 %; p=0.14), and a higher resolution of pain was observed (35 % vs. 14 %; p=0.22) in patients receiving SAT. Conclusions: SAT is not able to fully prevent complications in patients with a draining sinus. However, it may be beneficial in a subset of patients, particularly in those with pain or the hindrance of a draining sinus. A future prospective study, including a higher number of patients not receiving SAT, is needed.

scholarly journals Mid-term follow-up results after implementing a new strategy for the diagnosis and management of periprosthetic joint infections

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rares Mircea Birlutiu ◽  
Manuela Mihalache ◽  
Patricia Mihalache ◽  
Razvan Silviu Cismasiu ◽  
Victoria Birlutiu
Keyword(s):  
Joint Infection ◽  
Published Data ◽  
Survival Percentage ◽  
Joint Infections ◽  
Kaplan Meier ◽  
Prosthetic Joint ◽  
Prosthetic Joint Infections ◽  
New Strategy ◽  
Implant Retention

Abstract Background Periprosthetic joint infections (PJIs) represent one of the most serious complications associated with joint replacement surgeries, a complication also of modern orthopedic surgery despite the efforts that occurred in this field. Frequently PJIs lead to prolonged morbidity, increased costs and mortality. Methods We are conducting a single-center observational cohort ongoing study in the Academic Emergency Hospital Sibiu, Romania, study in which sonication of the retrieved and as a rapid method of bacteria detection, molecular identification of bacteria by 16S rRNA beacon-based fluorescent in situ hybridization (bbFISH) are used. Results A total of 61 patients were enrolled in this study. The diagnosis of aseptic loosening was established in 30 cases (49.1%) and the diagnosis of periprosthetic joint infection was established at 31 patients (50.8%). The mean follow-up period in the subgroup of patients diagnosed with periprosthetic joint infections was 36.06 ± 12.59 months (range: 1–54). The 25-months Kaplan-Meier survival rate as the end point, as a consequence of the period of enrollment and a different follow-up period for each type of surgical procedure, was 75% after debridement and implant retention, 91.7% after one-stage exchange, 92.3% after two-stage exchange, and 100% after three-stage exchange. There were no significant differences in survival percentage. Conclusions Our study has good results similar to previously published data. We cannot recommend one strategy of managing prosthetic joint infections over the other. Definitely, there is a need for prospective randomized controlled trials.

scholarly journals Multivariable Time-Dependent Analysis Of The Impact Of 5 Azacitidine In Patients With Lower-Risk Myelodysplastic Syndrome and Unfavorable Specific Lower-Risk Score

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2754-2754
Author(s):  
Jose F Falantes ◽  
Regina García Delgado ◽  
Cristina Calderón ◽  
David Valcarcel ◽  
Julia Montoro ◽  
...  
Keyword(s):  
Clin Oncol ◽  
Lower Risk ◽  
Multivariable Analysis ◽  
Scoring Systems ◽  
Best Supportive Care ◽  
Clinical Parameter ◽  
Time Dependent ◽  
Severe Thrombocytopenia ◽  
The Impact ◽  
Time Dependent Analysis

Abstract Background Specific scoring systems developed for patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) (Garc'a-Manero G et al. Leukemia 2008; Falantes J et al. Clin Lymphoma Myeloma Leuk 2013) are able to identify a significant fraction of pts with a poorer (median OS, 13 months) than expected outcome (Greenberg P et al. Blood 1997). Retrospective data of azacitidine (AZA) in LR-MDS showed hematological improvement and survival when compared to non-responder pts (Lyons R et al. J Clin Oncol 2009; Musto P et al. Cancer 2010). However, the impact of AZA treatment in the group of LR-MDS with poor prognosis by a LR-specific score (LR-S) is uncertain. Aim To evaluate the impact of AZA treatment in LR-MDS pts with more adverse LR-S by multivariable time-dependent analysis. Patients Eighty-eight LR-MDS pts (IPSS Low/Int-1 or <10% bone marrow blast with no unfavorable karyotype according to Schanz J et al. J Clin Oncol 2012) with the most adverse specific LR-S were retrospectively analyzed. Patients were separated in two cohorts: Non-AZA cohort (n=61), that included pts who received only best supportive care (BSC; n=46) or BSC plus erythroid stimulating agents (ESA; n=15) at Hospital Universitario Virgen del Roc'o (Seville, Spain) from 2000-2010 who were the core for the development of the LR specific model, versus AZA-cohort (n=27), that included pts treated with AZA (75 mg/m2/day for 5 or 7 days every 4 weeks subcutaneously) in a compassionate use program in Spain Results Median age was 71 years (range, 48-86). Patients in the AZA cohort were older and included more RAEB-1, transfusion dependent and elevated LR-S pts. Baseline characteristics and differences between cohorts are shown in Table 1. Median time from diagnosis to AZA therapy was 4 months (range, 0.5-21). At last follow-up, 72 pts (81%) had died (Non-AZA cohort: 55/61; 90% and 17/27; 63% in the AZA group). Median OS for the overall series was 18 months. The actuarial probabilities of OS at 1 and 2 years were 62.4% and 45% for AZA and 25.4% and 11% for Non-AZA cohort (P=10-4). In a multivariable analysis including blast % (<4% vs 4-9%), neutropenia (<0.5 vs >0.5x10e9/L), thrombocytopenia (<50 vs >50x10e9/L) and AZA treatment as time-dependent covariate, the later did not significantly influenced OS (HR, 1.502; 95% CI, 0.258-3; P=0.258) and only severe thrombocytopenia (<50x109/L) showed an independent association with OS (HR, 1.690; 95% CI, 1.036-2.756; P=0.03. Table 2). However, a 3-month landmark analysis showed a survival advantage for pts treated with AZA as compared to non-AZA cohort (median OS, 10m [Non-AZA] vs 23 months [AZA]; P=0.019) and estimated OS rate at 12 and 24 months were 31.5% and 5.7% for Non-AZA vs 50.2% and 41.1% for AZA cohort respectively. Progression to acute myeloid leukemia (AML) occurred in 24.6% (Non-AZA) vs 14.8% (AZA)(P=0.19). Conclusion Azacitidine appeared to increase survival in LR-MDS pts within the most adverse LR-S although differences in OS were not statistically significant in a multivariable time-dependent analysis. Larger number of pts and prospective randomized trials are needed to better address this issue. Thrombocytopenia (<50x10e9/L) is confirmed as the most significant clinical parameter with impact on outcome in LR-MDS. Disclosures: Off Label Use: 5 azacitidine. Treatment for lower-risk MDS in Europe.

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