Propensity Score-adjusted Cox Regression Research Articles

New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-comers, international, multicenter DELTA-2 registry

BackgroundPercutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. MethodsWe compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. ResultsOut of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00–3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45–0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67–1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). ConclusionsIn a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

Long-term clinical outcome and graft patency of radial artery and saphenous vein grafts in multiple arterial revascularization

ObjectiveThe long-term benefits of multiple arterial revascularization (MAR) in coronary artery bypass grafting remain uncertain. The aim of this study was to investigate the clinical outcome, graft patency, and need for subsequent target revascularization of radial artery (RA) versus saphenous vein graft in patients undergoing MAR in both patient- and graft-specific analyses. MethodsBetween 2001 and 2016, we followed 1654 patients over a median of 7.4 years in a prospective, longitudinal study. Major adverse cardiac and cerebrovascular events, graft patency, and need for revascularization were assessed through clinical manifestation, coronary angiography, or coronary computed tomography and analyzed with propensity score–adjusted Cox regression, general estimating equation, and competing risk models. ResultsBilateral internal thoracic artery (BITA) grafting was performed in 910 patients (55.0%), and 744 patients (45.0%) received a left internal thoracic artery graft together with at least 1 RA graft. Patients receiving BITA, of whom 187 received an additional RA, showed improved survival (hazard ratio, 0.57; 95% confidence interval [CI], 0.38-0.86; P = .009), major adverse cardiac and cerebrovascular event–free survival (hazard ratio, 0.33; 95% CI, 0.23-0.46; P < .001), and lower need for repeat revascularization (subhzhard ratio, 0.59; 95% CI, 0.39-0.90; P = .015). In a subgroup of 512 patients, comparing 419 RA with 487 saphenous vein grafts, RA grafting showed a lower risk for graft occlusion (odds ratio, 0.59; 95% CI, 0.47-0.73; P < .001) and target revascularization (subhazard ratio, 0.58; 95% CI, 0.43-0.78; P < .001). ConclusionsMAR with BITA and RA grafting revealed to be the recommended strategy in coronary artery bypass grafting to achieve long-term beneficial results. The use of saphenous vein graft showed less favorable outcomes regarding patency and the need for target-vessel revascularization.

Postoperative Small Bowel Obstruction Following Laparoscopic or Open Fundoplication in Children: A Retrospective Analysis Using a Nationwide Database.

Postoperative small bowel obstruction (SBO) is one of the most serious adverse events resulting in deteriorated quality of life in children. Numerous studies have shown that laparoscopic surgery significantly reduces the occurrence of SBO compared with open surgery in adults. However, evidence of the advantages of laparoscopic surgery over open surgery in terms of reducing SBO is lacking in children. Fundoplication is a common abdominal procedure in children. This study was performed to compare the occurrence of SBO after laparoscopic fundoplication (LF) versus open fundoplication (OF). Using the Diagnosis Procedure Combination database, a national inpatient database in Japan, we retrospectively identified patients aged 0-18years who underwent LF or OF from July 2010 to March 2016. Propensity score adjustment was used to compare the occurrence of SBO between the groups. We identified 1838 eligible patients who underwent LF (n = 1362) or OF (n = 476). The median age at surgery was 4.0 and 1.5years in the LF and OF group, respectively (P < 0.001). The median weight at admission was 11.4 and 7.5kg, respectively (P < 0.001). Nineteen (1.4%) patients in the LF group and 13 (2.7%) in the OF group had at least one episode of SBO (P = 0.11, log-rank test). In the propensity score-adjusted Cox regression analysis, SBO was significantly less likely to occur in the LF than OF group (hazard ratio, 0.36; 95% confidence interval 0.16-0.82; P = 0.01). In this retrospective nationwide study, LF was significantly associated with a reduction in SBO compared with OF in children.

Mortality associated with bevacizumab intravitreal injections in age-related macular degeneration patients after acute myocardial infarct: a retrospective population-based survival analysis.

Intraocular injections of antivascular endothelial growth factor (VEGF) agents are currently the main therapy in age-related macular degeneration (AMD). The safety of bevacizumab, an anti-VEGF compound frequently delivered off label, is debated, particularly for high-group risks. We aim to analyze the mortality associated with intravitreal injections of bevacizumab for AMD in patients previously diagnosed with acute myocardial infarct (MI). In a national database, we identified bevacizumab-treated AMD patients with a diagnosis of MI prior to their first bevacizumab injection, delivered between September 2008 and October 2014 (n = 2100). We then generated sub-groups of patients treated within 3months (n = 11), 6months (n = 24), 12months (n = 52), and 24months (n = 124) after MI. Those patients were compared to age- and gender-matched members that had a MI at the same time and had never been exposed to anti-VEGF. Survival analysis was performed using propensity score-adjusted Cox regression. Bevacizumab-treated patients were slightly and insignificantly older than controls (mean age 83.25 vs 83.19year, P = .75). Gender distribution was similar. In a Cox regression adjusted with propensity score, the following differences in mortality were found: within 3months between MI and initiation of bevacizumab treatment, OR = 6.22 (95% C.I 1.08-35.97, P < .05); within 6months, OR = 2.37 (95% C.I 0.93-6.02, P = .071); within 12months, OR = 3.00 (95% C.I 1.44-6.28, P < .01); within 24months after MI, OR = 2.24 (95% C.I 1.35-3.70, P < .01); and MI any time prior to first bevacizumab injection, OR = 1.71 (95% C.I 1.53-1.92, P < .001). We report increased mortality associated with the use of intravitreal bevacizumab in AMD patients after MI, compared to age- and gender-matched post-MI patients with no exposure to any anti-VEGF agent. Caution should be taken while offering bevacizumab to AMD patients after MI.

Early and late results of surgical treatment for isolated active native mitral valve infective endocarditis.

Native mitral valve infective endocarditis (IE) is a complicated disease with high mortality and morbidity rates. Mitral valve repair (MVRep) is feasible when limited valve destruction is present. However, recurrent valve dysfunction and reintervention are common. Between January 2000 and March 2016, 83 patients underwent surgery for isolated active native mitral valve IE. We applied an early surgery, MVRep-oriented approach with progressive utilization of patch techniques to secure a durable repair; MVRep was attempted in 67% of patients. Fifty-one (61%) patients underwent MVRep (including full-ring annuloplasty in 94%) and 32 (39%) patients underwent mitral valve replacement. Early mortality was 13%. No cases of early recurrent IE occurred. Predischarge echocardiography demonstrated good MVRep function in all, except 1 patient with residual (Grade 2+) regurgitation. The mean duration of follow-up was 3.7 years (interquartile range 1.5-8.4). For hospital survivors, 8-year overall survival rates were 92.4% (95% confidence interval 84.0-100%) and 74.2% (95% confidence interval 53.8-94.6%) for the MVRep and mitral valve replacement groups, respectively. Propensity score-adjusted Cox regression analysis revealed no significant difference in survival between the 2 groups (hazard ratio 0.359, 95% confidence interval 0.107-1.200; P = 0.096). Four reinterventions occurred, 2 in each group. Echocardiographic follow-up demonstrated excellent MVRep durability; no cases of mitral regurgitation and 1 case of mitral valve stenosis were seen. Native mitral valve IE is linked to high mortality and morbidity rates. A durable MVRep is feasible in most patients and provides excellent mid-term durability. Mitral valve replacement is a reasonable alternative when a durable repair is not likely.

Comparison of outcomes between emergent-start and planned-start peritoneal dialysis in incident ESRD patients: a prospective observational study

BackgroundThe clinical consequences of starting chronic peritoneal dialysis (PD) after emergent dialysis via a temporary hemodialysis (HD) catheter has rarely been evaluated within a full spectrum of treated end-stage renal disease (ESRD). We investigated the longer-term outcomes of patients undergoing emergent-start PD in comparison with that of other practices of PD or HD in a prospective cohort of new-onset ESRD.MethodsThis was a 2-year prospective observational study. We enrolled 507 incident ESRD patients, among them 111 chose PD (43 planned-start, 68 emergent-start) and 396 chose HD (116 planned-start, 280 emergent-start) as the long-term dialysis modality. The logistic regression model was used to identify variables associated with emergent-start dialysis. The Kaplan–Meier survival analysis was used to determine patient survival and technique failure. The propensity score-adjusted Cox regression model was used to identify factors associated with patient outcomes.ResultsDuring the 2-year follow-up, we observed 5 (4.5%) deaths, 15 (13.5%) death-censored technique failures (transfer to HD) and 3 (2.7%) renal transplantations occurring in the PD population. Lack of predialysis education, lower predialysis estimated glomerular filtration rate and serum albumin were predictors of being assigned to emergent dialysis initiation. The emergent starters of PD displayed similar risks of patient survival, technique failure and overall hospitalization, compared with the planned-start counterparts. By contrast, the concurrent planned-start and emergent-start HD patients with an arteriovenous fistula or graft were protected from early overall death and access infection-related mortality, compared with the emergent HD starters using a central venous catheter.ConclusionsIn late-referred chronic kidney disease patients who have initiated emergent dialysis via a temporary HD catheter, post-initiation PD can be a safe and effective long-term treatment option. Nevertheless, due to the potential complications and cost concerns, such practice of PD initiation would better be replaced with a planned-start mode by employing more effective predialysis therapeutic education and timely catheter placement.

Long-term allopurinol use decreases the risk of prostate cancer in patients with gout: a population-based study.

Clinical observations indicated an increased risk of developing prostate cancer in gout patients. Chronic inflammation is postulated to be one crucial mechanism for prostate carcinogenesis. Allopurinol, a widely used antigout agent, possesses potent anti-inflammation capacity. We elucidated whether allopurinol decreases the risk of prostate cancer in gout patients. We analyzed data retrieved from Taiwan National Health Insurance Database between January 2000 and December 2012. Patients diagnosed with gout during the study period with no history of prostate cancer and who had never used allopurinol were selected. Four allopurinol use cohorts (that is, allopurinol use (>365 days), allopurinol use (181-365 days), allopurinol use (91-180 days) and allopurinol use (31-90 days)) and one cohort without using allopurinol (that is, allopurinol use (No)) were included. The study end point was the diagnosis of new-onset prostate cancer. Multivariable Cox proportional hazards regression and propensity score-adjusted Cox regression models were used to estimate the association between the risk of prostate cancer and allopurinol treatment in gout patients after adjusting for potential confounders. A total of 25 770 gout patients (aged between 40 and 100 years) were included. Multivariable Cox regression analyses revealed that the risk of developing prostate cancer in the allopurinol use (>365 days) cohort was significantly lower than the allopurinol use (No) cohort (adjusted hazard ratio (HR)=0.64, 95% confidence interval (CI)=0.45-0.9, P=0.011). After propensity score adjustment, the trend remained the same (adjusted HR=0.66, 95% CI=0.46-0.93, P=0.019). Long-term (more than 1 year) allopurinol use may associate with a decreased risk of prostate cancer in gout patients.

Staging of pancreatic cancer based on the number of positive lymph nodes.

The International Study Group on Pancreatic Surgery has stated that at least 12 lymph nodes should be evaluated for staging of pancreatic cancer. The aim of this population-based study was to evaluate whether the number of positive lymph nodes refines staging. Patients who underwent pancreatectomy for stage I-II pancreatic cancer between 2004 and 2012 were identified from the Surveillance, Epidemiology, and End Results database. The predictive value of the number of positive lymph nodes for survival was assessed by generalized receiver operating characteristic (ROC) curve analysis and propensity score-adjusted Cox regression analysis. Some 5036 patients were included, with a median of 18 (i.q.r. 15-24) lymph nodes examined. Positive lymph nodes were found in 3555 patients (70·6 per cent). The median duration of follow-up was 15 (i.q.r. 8-28) months. ROC curve analysis revealed that two positive lymph nodes best discriminated overall survival. Patients with one or two positive lymph nodes (pN1a) and those with three or more positive lymph nodes (pN1b) had an increased risk of overall mortality compared with patients who were node-negative (pN0): hazard ratio (HR) 1·47 (95 per cent c.i. 1·33 to 1·64) and HR 2·01 (1·82 to 2·22) respectively. These findings were confirmed by propensity score-adjusted Cox regression analysis. The 5-year overall survival rates were 39·8 (95 per cent c.i. 36·5 to 43·3) per cent for patients with pN0, 21·0 (18·6 to 23·6) per cent for those with pN1a and 11·4 (9·9 to 13·3) per cent for patients with pN1b disease. The number of positive lymph nodes in the resection specimen is a prognostic factor in patients with pancreatic cancer.

Comparative effectiveness of dabigatran and rivaroxaban versus warfarin for the treatment of non-valvular atrial fibrillation

BackgroundEffectiveness data on novel oral anticoagulants (NOACs) versus warfarin for stroke prevention in non-valvular atrial fibrillation (NVAF) by prior warfarin use are limited. MethodsWe used data from the US MarketScan databases from 2009 to 2012. NVAF patients initiating dabigatran or rivaroxaban were matched with up to 5 warfarin users. Propensity score-adjusted Cox regression was used to calculate hazard ratios (HR) and 95% confidence intervals (95% CI) for relevant endpoints in NOACs versus warfarin users. Separate analyses were conducted to compare anticoagulant-naïve users of NOACs and those switching from warfarin. ResultsAmong 32,918 dabigatran, 3301 rivaroxaban, and 109,447 warfarin users with NVAF, 225 intracranial bleeds, 1035 ischemic strokes, 958 myocardial infarctions, and 1842 gastrointestinal bleeds were identified. Compared to warfarin users, patients initiating NOACs had similar ischemic stroke rates and lower intracranial bleeding rates, while the gastrointestinal bleeding rate was higher in dabigatran users than warfarin users. Associations of dabigatran with ischemic stroke risk differed between anticoagulant-naïve initiators and patients switching from warfarin; dabigatran was associated with lower ischemic stroke rates in naïve users (HR 0.65, 95% CI 0.52–0.82) but not in switchers (HR 1.20, 95% CI 0.95–1.51), compared to warfarin. Risk of stroke and bleeding was not different between rivaroxaban and warfarin users. ConclusionsReal-world effectiveness of NOACs (compared to warfarin) for diverse outcomes was comparable to efficacy reported in published clinical trials. However, harms and benefits of switching from warfarin to dabigatran need to be evaluated.

Warfarin Treatment and All‐Cause Mortality in Community‐Dwelling Older Adults with Atrial Fibrillation: A Retrospective Observational Study

To investigate the relationship between warfarin treatment and different strata of all-cause mortality risk assessed using the Multidimensional Prognostic Index (MPI) based on information collected using the Standardized Multidimensional Assessment Schedule for Adults and Aged Persons (SVaMA) in community-dwelling older adults with atrial fibrillation (AF). Retrospective observational study. Older community-dwelling adults who underwent a SVaMA evaluation establishing accessibility to homecare services and nursing home admission from 2005 to 2013 in the Padova Health District, Italy. Community-dwelling individuals with AF aged 65 and older (N = 1,827). Participants were classified as being at mild (MPI-SVaMA-1), moderate (MPI-SVaMA-2), or severe (MPI-SVaMA-3) risk of mortality using the MPI-SVaMA, a validated prognostic tool based on age, sex, comorbidity, cognitive status, mobility and functional disability, pressure sore risk, and social support. The association between warfarin treatment and mortality was tested using multivariate- and propensity score-adjusted Cox regression models, controlling for age, sex, all SVaMA domains, concomitant diseases, and drug treatments. Higher MPI-SVaMA scores were associated with lower rates of warfarin treatment and higher 3-year mortality. After adjustment for propensity score quintiles, warfarin treatment was significantly associated with lower 2-year mortality in individuals with MPI-SVaMA-1 (hazard ratio (HR) = 0.64, 95% confidence interval (CI) = 0.50-0.82), MPI-SVaMA-2 (HR = 0.68, 95% CI = 0.55-0.85), and MPI-SVaMA-3 (HR = 0.55, 95% CI = 0.44-0.67). Heterogeneity analyses confirmed that the effect of warfarin treatment was not different between MPI-SVaMA groups (P for heterogeneity = .48). Community-dwelling older adults with AF benefitted from anticoagulation in terms of lower all-cause mortality over a mean follow-up of 2 years, regardless of poor health and functional condition. Although this benefit can be ascribed to the treatment, it may also reflect better overall care.

Prior cancer does not adversely affect survival in locally advanced lung cancer: A national SEER-medicare analysis

IntroductionManagement of locally advanced non-small cell lung cancer is among the most highly contested areas in thoracic oncology. In this population, a history of prior cancer frequently results in exclusion from clinical trials and may influence therapeutic decisions. We therefore determined prevalence and prognostic impact of prior cancer among these patients. Materials and methodsWe identified patients>65years of age diagnosed 1992–2009 with locally advanced lung cancer in the Surveillance, Epidemiology, and End Results-Medicare linked dataset. We characterized prior cancer by prevalence, type, stage, and timing. We compared all-cause and lung cancer-specific survival between patients with and without prior cancer using propensity score-adjusted Cox regression. Results51,542 locally advanced lung cancer patients were included; 15.8% had a history of prior cancer. Prostate (25%), gastrointestinal (17%), breast (16%), and other genitourinary (15%) were the most common types of prior cancer, and 76% percent of prior cancers were localized or in situ stage. Approximately half (54%) of prior cancers were diagnosed within 5 years of the index lung cancer date. Patients with prior cancer had similar (propensity-score adjusted hazard ratio [HR] 0.96; 95% CI, 0.94–0.99; P=0.005) and improved lung cancer-specific (HR 0.84; 95% CI, 0.81–0.86; P<0.001) survival compared to patients with no prior cancer. ConclusionsFor patients with locally advanced lung cancer, prior cancer does not adversely impact clinical outcomes. Patients with locally advanced lung cancer and a history of prior cancer should not be excluded from clinical trials, and should be offered aggressive, potentially curative therapies if otherwise appropriate.

Rapid Early Triage by Leukocytosis and the Thrombolysis in Myocardial Infarction (TIMI) Risk Score for ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: An Observational Study.

The clinical utility of leukocytosis in risk assessment for ST-elevation myocardial infarction (STEMI) is still unclear. We aim to demonstrate the prognostic value of leukocyte counts independent from traditional risk factors and the TIMI risk score (TRS) for STEMI and to propose a practical model comprising leukocyte count for early triage in STEMI undergoing primary angioplasty.A prospective database (n = 796) of consecutive STEMI cases receiving primary angioplasty at a tertiary medical center was retrospectively analyzed in the period from February 1, 2007 through December 31, 2012. Primary endpoints were 30-day and 1-year mortality. Propensity score-adjusted Cox regression models and subdivision analysis were performed.Leukocytosis group (n = 306) had higher 30-day mortality (5.9% vs 3.1%, P = 0.048) and 1-year mortality (9.2% vs 5.1%, P = 0.022). After adjustment by propensity score and TRS, leukocyte count (per 103/μL) was an independent predictor of 1-year mortality (HR: 1.086, 95% CI: 1.034–1.140, P = 0.001). Subdivision analysis demonstrated the correlation between leukocytosis and higher 1-year mortality within both high and low TRS strata (divided by 4, the median of TRS). Additionally, 24% (191 out of 796) of patients were characterized by nonleukocytosis and TRS < 4, having 0% of mortality rate at 1-year follow-up.In conclusion, leukocyte count is an independent prognostic factor adding incremental value to TRS for STEMI. Nonleukocytosis in conjunction with TRS < 4 identifies a large patient group at extremely low risk and thus provides rapid early triage for STEMI patients undergoing primary PCI. This finding is worth validation in the future.

Acute kidney injury treated with renal replacement therapy and 5-year mortality after myocardial infarction-related cardiogenic shock: a nationwide population-based cohort study

BackgroundMyocardial infarction-related cardiogenic shock is frequently complicated by acute kidney injury. We examined the influence of acute kidney injury treated with renal replacement therapy (AKI-RRT) on risk of chronic dialysis and mortality, and assessed the role of comorbidity in patients with cardiogenic shock.MethodsIn this Danish cohort study conducted during 2005–2012, we used population-based medical registries to identify patients diagnosed with first-time myocardial infarction-related cardiogenic shock and assessed their AKI-RRT status. We computed the in-hospital mortality risk and adjusted relative risk. For hospital survivors, we computed 5-year cumulative risk of chronic dialysis accounting for competing risk of death. Mortality after discharge was computed with use of Kaplan-Meier methods. We computed 5-year hazard ratios for chronic dialysis and death after discharge, comparing AKI-RRT with non-AKI-RRT patients using a propensity score-adjusted Cox regression model.ResultsWe identified 5079 patients with cardiogenic shock, among whom 13 % had AKI-RRT. The in-hospital mortality was 62 % for AKI-RRT patients, and 36 % for non-AKI-RRT patients. AKI-RRT remained associated with increased in-hospital mortality after adjustment for confounders (relative risk = 1.70, 95 % confidence interval (CI): 1.59–1.81). Among the 3059 hospital survivors, the 5-year risk of chronic dialysis was 11 % (95 % CI: 8–16 %) for AKI-RRT patients, and 1 % (95 % CI: 0.5–1 %) for non-AKI-RRT patients (adjusted hazard ratio: 15.9 (95 % CI: 8.7–29.3). The 5-year mortality was 43 % (95 % CI: 37–53 %) for AKI-RRT patients compared with 29 % (95 % CI: 29–31 %) for non-AKI-RRT patients. The adjusted 5-year hazard ratio for death was 1.55 (95 % CI: 1.22–1.96) for AKI-RRT patients compared with non-AKI-RRT patients. In patients with comorbidity, absolute mortality increased while relative impact of AKI-RRT on mortality decreased.ConclusionAKI-RRT following myocardial infarction-related cardiogenic shock predicted elevated short-term mortality and long-term risk of chronic dialysis and mortality. The impact of AKI-RRT declined with increasing comorbidity suggesting that intensive treatment of AKI-RRT should be accompanied with optimized treatment of comorbidity when possible.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-015-1170-8) contains supplementary material, which is available to authorized users.

Transarterial bland versus chemoembolization for hepatocellular carcinoma: rethinking a gold standard

BackgroundTransarterial chemoembolization (TACE) is the most common procedure for the treatment of hepatocellular carcinoma (HCC). However, HCC is generally considered chemoresistant and data demonstrating the superiority of TACE over bland embolization (TAE) are lacking. Materials and methodsA nationwide, retrospective cohort study of HCC patients treated with first-line TACE or TAE within the Veterans Affairs health care system (2005–2012) was performed. The primary outcome was overall survival. Risk of death by treatment type (TACE or TAE) was evaluated using multivariate (adjusted for age, presence of cirrhosis, Barcelona Clinic Liver Cancer stage, and Charlson comorbidity score) and propensity score-adjusted Cox regression. ResultsThe cohort included 405 patients treated with first-line transarterial embolization. Among these patients, 32 (7.9%) underwent TAE. Most of the patients (76.8%) had intermediate or advanced stage at presentation. Similar proportions of patients (TACE 53.3% versus TAE 43.7%; P = 0.30) received more than one embolization procedure. There was no difference in median survival (20.1 versus 23.1 mo, respectively; log-rank P = 0.84). Compared to TACE, there was no difference in risk of death associated with TAE after multivariate (hazard ratio [HR] 0.92; 95% CI, 0.61–1.37) and propensity score adjustment (HR = 0.86; 95% CI = 0.58–1.29). ConclusionsThere is no clear benefit associated with chemotherapy infusion over bland embolization for HCC treatment. Given the rising incidence of HCC in the United States and considering the added costs associated with TACE compared to TAE, future work comparing these competing management strategies is needed.

A prognostic cytogenetic scoring system to guide the adjuvant management of patients with atypical meningioma.

The appropriate use of adjuvant therapy in patients with gross totally resected atypical meningioma requires an accurate assessment of recurrence risk. We sought to determine whether cytogenetic/genetic characterization may facilitate better estimation of the probability of recurrence. We first analyzed our clinical database, including high-resolution DNA copy number data, to identify 11 common copy number aberrations in a pilot cohort of meningiomas of all grades. We summed these aberrations to devise a cytogenetic abnormality score (CAS) and determined the CAS from archived tissue of a separate cohort of 32 patients with gross totally resected atypical meningioma managed with surgery alone. Propensity score adjusted Cox regression was used to determine whether the CAS was predictive of recurrence. An association between higher CAS and higher grade was noted in our pilot cohort with heterogeneity among atypical tumors. Among the 32 patients who underwent gross total resection of an atypical meningioma, the CAS was not significantly associated with age, gender, performance status, or tumor size/location but was associated with the risk of recurrence on univariable analysis (hazard ratio per aberration = 1.52; 95% CI = 1.08-2.14; P = .02). After adjustment, the impact of the dichotomized number of copy aberrations remained significantly associated with recurrence risk (hazard ratio = 4.47; 95% CI = 1.01-19.87; P = .05). The number of copy number aberrations is strongly associated with recurrence risk in patients with atypical meningioma following gross total resection and may inform the appropriate use of adjuvant radiation therapy in these patients or be useful for stratification in clinical trials.

Carbonic anhydrase-IX score is a novel biomarker that predicts recurrence and survival for high-risk, nonmetastatic renal cell carcinoma: Data from the phase III ARISER clinical trial

Introduction and objectiveWith a limited number of prognostic and predictive biomarkers available, carbonic anhydrase-IX (CAIX) has served as an important prognostic biomarker for patients with clear cell renal cell carcinoma (ccRCC). However, studies have recently called into question the role of CAIX as a biomarker for ccRCC. To investigate this uncertainty, we quantified the association of CAIX with lymphatic involvement and survival using data from ARISER study (WX-2007-03-HR)—a prospective trial involving subjects with high-risk nonmetastatic ccRCC. Methods and materialsWe reviewed the records of 813 patients enrolled in the ARISER study. Central review of histology, grade, and CAIX staining (frequency and intensity) was performed. CAIX score was derived by multiplying the staining intensity (1–3) by percent positive cells (0%–100%), yielding a range of 0 to 300. We quantified the association of CAIX expression and score with lymphatic spread and survival (disease-free survival [DFS] and overall survival [OS]) using Kaplan-Meier and multivariable propensity score adjusted Cox regression analyses. ResultsMedian follow-up of the cohort was 54.2 months. Although 56% of subjects with lymphatic involvement had CAIX>85%, only 33% had CAIX score≥200. On multivariable analysis, CAIX>85% was not a statistically significant predictor of DFS and OS (P = 0.06 and P = 0.15, respectively). However, CAIX score≥200, when compared with CAIX score≤100, was associated with improved DFS and OS (P = 0.01 and P = 0.01, respectively) on multivariable analysis. ConclusionsThe largest, multicenter, prospective analysis of patients with high-risk nonmetastatic ccRCC demonstrates the utility of CAIX score as a statistically significant prognostic biomarker for survival. We recommend that CAIX score be quantified for all patients with high-risk disease after nephrectomy.

Additional tricuspid annuloplasty in mitral valve surgery results in better clinical outcome

ObjectiveThe clinical benefit of tricuspid annuloplasty (TA) in patients undergoing mitral valve surgery (MVS) is still debated. We evaluated the immediate surgical success, postoperative outcome and the medium-term effect of...

Effect of prior cancer on outcomes in advanced lung cancer: implications for clinical trial eligibility and accrual.

Prior cancer is a common exclusion criterion in lung cancer trials. This practice reflects concerns that prior cancer may affect trial conduct or outcomes. However, the impact of prior cancer on survival in lung cancer is not known. We identified patients older than age 65 years with stage IV lung cancer diagnosed between 1992 and 2009 in the Surveillance, Epidemiology, and End Results-Medicare linked registry. Prior cancer was characterized by type, stage, and timing. All-cause and lung cancer-specific survival were compared between patients with and without prior cancer using propensity score-adjusted Cox regression. Overall, 102 929 patients with stage IV lung cancer were identified, of whom 14.7% had a history of prior cancer. More than two-thirds (76.0%) of prior cancers were localized or regional stage; most were diagnosed five or fewer years prior to the lung cancer diagnosis. In propensity score-adjusted analysis, patients with prior cancer had better all-cause (hazard ratio [HR] = 0.93, 95% confidence interval [CI] = 0.91 to 0.94) and lung cancer-specific (HR = 0.81, 95% CI = 0.79 to 0.82) survival. In a simulated clinical trial-eligible population (age <75 years, no comorbidity, treated with chemotherapy), similar trends were noted. In subset analyses according to stage, type, and timing of prior cancer, no group of patients with prior cancer had inferior survival compared with patients without prior cancer. Among patients with stage IV lung cancer, prior cancer does not convey an adverse effect on clinical outcomes, regardless of prior cancer stage, type, or timing. Broader inclusion in clinical trials of advanced lung cancer patients with a history of prior cancer should be considered.

Impact of aprepitant on emesis control, dose intensity, and recurrence-free survival in a population-based cohort of head and neck cancer patients receiving high-dose cisplatin chemotherapy

Standard care for locally advanced head and neck cancer (HNC) patients consists of high-dose cisplatin with radiation to prolong recurrence-free survival (RFS). However, poorly controlled emesis can compromise optimal dose intensity (DI) and affect disease control. To evaluate the impact of aprepitant on emesis control, DI, and RFS. HNC patients treated at the British Columbia Cancer Agency were analyzed. Kaplan-Meier method and adjusted Cox proportional hazard models were used to evaluate RFS in aprepitant users. To control for selection bias, a propensity score analysis was conducted. A total of 192 HNC patients were included: 141 received aprepitant prophylaxis. The aprepitant-treated and untreated groups were comparable in mean age (56.3 vs 58.1 years), male gender (82.3% vs 86.3%), tumor location, and number of metastatic sites. However, more patients in the aprepitant group than in the untreated group had surgically resectable disease (31.2% vs 15.7%, respectively) and better performance status (ECOG 0/1, 87.9% vs 76.4%). Less emesis was reported in the aprepitant group (21.3% vs 28.0%). Patients in the treated group were also more likely to complete 3 cycles of high-dose cisplatin (OR, 2.3; P = .03). The propensity score adjusted Cox regression analysis suggested a reduced risk of disease recurrence in patients who received aprepitant (HR, 0.47; 95% CI, 0.17- 1.28). Potential confounders such as other diseases or treatments that may have influenced the presence of nausea/emesis symptoms. Aprepitant contributed to improved emesis control, enhanced DI, and better adherence to cisplatin chemotherapy.

Anastomotic leakage is associated with impaired overall and disease-free survival after curative rectal cancer resection: a propensity score analysis.

Whether anastomotic leakage (AL) has a negative impact on survival remains a matter of debate. This study aimed to assess the impact of AL on the overall and disease-free survival of patients undergoing curative resection of stages 1-3 rectal cancer using propensity-scoring methods. In a single-center study, 570 patients undergoing curative resection of stages 1-3 rectal cancer between January 2002 and December 2011 were assessed. The mean follow-up period was 4.7 ± 2.9 years. Patients who did and did not experience AL were compared using Cox regression and propensity score analyses. Overall, 51 patients (8.9 %) experienced an AL. The characteristics of the patients were highly biased concerning AL (propensity score, 0.16 ± 0.12 vs. 0.09 ± 0.07; P < 0.001). Anastomotic leakage was uniformly associated with a significantly increased risk of mortality in unadjusted analysis [hazard ratio (HR) 2.30; 95 % confidence interval (CI) 1.40-3.76; P = 0.003], multivariable Cox regression (HR 2.27; 95 % CI 1.33-3.88; P = 0.005), and propensity score-adjusted Cox regression (HR 2.07; 95 % CI 1.21-3.55; P = 0.014). Similarly, disease-free survival was significantly impaired in patients who experienced AL according to unadjusted analysis (HR 1.88; 95 % CI 1.19-2.95; P = 0.011), multivariable Cox regression (HR 1.90; 95 % CI 1.17-3.09; P = 0.014), and propensity score-adjusted Cox regression (HR 2.31; 95 % CI 1.40-3.80; P = 0.002). This is the first propensity score-based analysis providing evidence that oncologic outcome may be impaired after curative rectal cancer resection in patients with AL.