Mateos M.-V.,University of Salamanca |
Hernandez M.-T.,Hospital Universitario Of Canarias |
Giraldo P.,Hospital Universitario Miguel Servet |
De La Rubia J.,San Vicente Martir Catholic University of Valencia |
And 14 more authors.
New England Journal of Medicine | Year: 2013
BACKGROUND: For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. METHODS: In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. RESULTS: After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P = 0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. CONCLUSIONS: Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival. Copyright © 2013 Massachusetts Medical Society.
Garcia-Garcia F.J.,Hospital Virgen Del Valle |
Carcaillon L.,University Paris - Sud |
Fernandez-Tresguerres J.,Complutense University of Madrid |
Alfaro A.,Hospital Virgen Del Valle |
And 3 more authors.
Journal of the American Medical Directors Association | Year: 2014
Objectives: To provide a new instrument to diagnose frailty, the Frailty Trait Scale (FTS), that allows a more precise assessment and monitoring of individuals. Design: Prospective population-based cohort study. Setting: The Toledo Study for Healthy Aging, Spain. Participants: A total of 1972 men and women aged 65 years or older. Measurements: We identified 7 frailty dimensions (energy balance-nutrition, physical activity, nervous system, vascular system, strength, endurance, and gait speed) represented by 12 items. Each item was pondered based on the quintiles of its distribution in the study population. Validity was evaluated by testing its association with factors related to frailty and its predictive value for adverse events. This predictive capacity was further compared with the capacity of 2 well-established frailty models (the frailty phenotype and the Frailty Index). Results: FTS score was associated with several comorbidities and biomarkers classically associated with frailty. The FTS was associated with the incidence of hospitalization and mortality (hazard ratio associated with a score in the highest quartile [versus the first quartile] = 2.3, 95% confidence interval [CI] 1.6-3.4, and 2.5, 95% CI 1.8-3.6, respectively). Compared with Fried et al's definition, the FTS showed a better predictor for hospitalization in persons younger than 80 (area under the curve [AUC] = 0.65 vs 0.62, P = .01), and for mortality in the oldest group (AUC = 0.77 vs 0.72, P = .02). FTS showed similar predictive value to the Frailty Index. Conclusion: FTS associates with many of the factors linked to frailty and has a similar predictive capacity to that provided by the classical instruments. Its characteristics offer some advantages over them, with potential utility in research and clinical practice. © 2014 American Medical Directors Association, Inc.
Dhir V.,Baldota Institute of Digestive science |
Artifon E.L.A.,University of Sao Paulo |
Gupta K.,Cedars Sinai Medical Center |
Vila J.J.,Hospital de Navarra |
And 3 more authors.
Digestive Endoscopy | Year: 2014
Background and Aim Endoscopic ultrasonography-guided biliary drainage (EUS-BD) using expandable biliary metal stents has emerged as an acceptable alternative in patients with failed endoscopic retrograde cholangiopancreatography for malignant biliary obstruction. However, there is no consensus over the preferred access route (transhepatic or extrahepatic), direction of stent insertion (antegrade or retrograde) or drainage route (transluminal or transpapillary) in patients potentially suitable for multiple methods. The present study compares success and complication rates in patients undergoing EUS-BD via different methods. Methods This was a multicenter retrospective analysis. Records of patients who underwent EUS-BD for malignant obstructive jaundice at four centers were entered in a standard database. Success and complications were compared for different techniques. Results Sixty-eight patients were analyzed. EUS-BD was successful in 65 patients (95.6%). There was no significant difference in the success rates of different techniques. Complications wereseen in 14 patients (20.6%) and mortality in three patients (4.4%). Complications were significantly higher for the transhepatic route compared to the transduodenal route (30.5% vs 9.3%, P=0.03). There was no significant difference in complication rates among transluminal and transpapillary stent placements, or direct and rendezvous stenting. Logistic regression analysis showed transhepatic access to be the only independent risk factor for complications (P=0.031, t=2.2). Conclusion EUS-BD can be carried out with high success rates regardless of the choice of access route, stent direction or drainage route. However, complications are significantly higher with transhepatic access. The transduodenal route should be chosen for EUS-guided and rendezvous stent placements, when both routes are available. © 2013 Japan Gastroenterological Endoscopy Society.
Urso S.,Fundacion Jimenez Diaz |
Sadaba J.R.,Hospital de Navarra |
Pettinari M.,Gasthuisberg University Hospital
Interactive Cardiovascular and Thoracic Surgery | Year: 2012
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: In patients undergoing off-pump coronary artery bypass (OPCAB) surgery, does the off-pump to on-pump conversion rate have an impact on post-operative results? Altogether more than 420 papers were found using the reported search, of which 14 randomized controlled trials (RCTs) represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated and ordered according to the sample size. In the 14 RCTs reviewed, the off-pump to on-pump conversion rate incidence ranged from 0 to 13.3%. The most frequent causes of conversion were haemodynamic instability and intramyocardial-coronary target. A low conversion rate (<2%) was reported by five studies. Three of them did not show any difference in terms of mortality between the OPCAB and on-pump groups, one showed better survival of the OPCAB group at 5 years, and one reported better early survival of the OPCAB group. Three of these trials describe a high OPCAB experience and reported that patients undergoing OPCAB had a shorter post-operative stay and lower morbidity compared with patients undergoing on-pump coronary artery bypass grafting. Five RCTs showed a high conversion rate (>9%), and among them, one reported lower morbidity of the OPCAB patients, three were not able to show any benefit in terms of morbidity of the OPCAB, and one reported worse survival and patency graft rate of the OPCAB group. Four RCTs reported conversion rates ranging from 3.7 to 7.0%, describing a wide spectrum of results. We conclude that RCTs with a high off-pump to on-pump conversion rate were often associated with a lower experience in OPCAB of the surgeons participating in the trials. These studies were also mostly unable to show any benefit in terms of mortality or morbidity of OPCAB over the on-pump strategy. On the contrary, a low conversion rate is mostly reported by RCTs with a high structured experience in OPCAB. These trials were mostly able to show a benefit, in terms of morbidity and survival, of the OPCAB over the on-pump strategy. © The Author 2011.
Sadaba J.R.,Hospital de Navarra |
Urso S.,Fundacion Jimenez Diaz
Interactive Cardiovascular and Thoracic Surgery | Year: 2011
Over the last few years, both sides of the North Atlantic have witnessed compulsory duty-hour restrictions for doctors. It has been suggested that the reduction in working hours for surgeons in training may have a negative impact on their exposure to surgical procedures and therefore, on the quality of training. A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: among surgeons enrolled in a training program, does the introduction of duty-hour restrictions have a negative impact on their exposure to surgical procedures and therefore, on the quality of training? In total, more than 74 papers were found using the reported search, of which 15 represented the best evidence to answer the question. All these manuscripts came from the USA. The authors, journal, date and country of publication, group studied, study type, relevant outcomes and results of these papers are tabulated. Studies from different surgical disciplines, such as general, orthopedic, pediatric, cardiothoracic and vascular surgery were included. Among the studies analysed, eight revealed a decrease, five showed no change, and two studies demonstrated an increase in the operative experience of residents following the introduction of the 80-hour limit. The changes appear to have more negatively affected junior residents in favor of more senior ones due to a shift in the surgical workload to the latter. Interestingly, some studies demonstrated better results in the in-training examinations (testing for clinical and basic science knowledge) following the duty-hour restrictions. We conclude that although most of the studies included in this review revealed that the introduction of working-hour restrictions in the USA has produced a decrease in number of cases performed by trainees, some have failed to do so. Changes in the residents' working patterns, such as 'night float' and 'leave early' models, may be useful to preserve exposure to surgical procedures. © 2011 Published by European Association for Cardio-Thoracic Surgery. All rights reserved.