Prior therapy and volume of disease are prognostic for metastatic hormone sensitive prostate cancer (mHSPC) in a hospital-based database.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 221-221 ◽  
Author(s):  
Edoardo Francini ◽  
Kathryn P. Gray ◽  
Wanling Xie ◽  
Philip W. Kantoff ◽  
Lauren Christine Harshman ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
De Novo ◽  
Local Therapy ◽  
Clinical Trial Design ◽  
High Volume ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Trend Test ◽  
Risk Of Death

221 Background: Recent reports have shown that patients (pts) with low volume (LV) mHSPC and those who relapse after prior local therapy (PLT) have median overall survival (OS) longer than 5 years with androgen deprivation therapy (ADT) alone. Using data from our prospectively collected hospital-based database, we aimed to detail the outcomes of pts with mHSPC by combining PLT or de novo (DN) and LV or high volume (HV) of disease. Methods: A cohort of mHSPCpts treated with ADT between 1990 and 2013 was identified in the Dana-Farber Cancer Institute IRB approved database and categorized as DN or PLT and HV or LV, at time of ADT start. HV was defined as visceral metastases and/or ≥ 4 bone metastases (BM) with at least 1 BM beyond the pelvis and axis. The analysis endpoints included OS, defined as time from ADT start to death from all causes. Kaplan-Meier method estimated the time to events distribution with median (95% CI). Cox proportional hazards model evaluated patient and disease volume groups on disease outcomes and provided estimates of hazard ratio (95% CI) for the comparison by groups. Results: Of the 354 pts included and classified as LV or HV, 202 (57%) had PLT, while 152 (43%) presented with DN metastases. The distributions of the 4 groups are 38% (PLT/LV), 19% (PLT/HV), 14% (DN/LV) and 29% (DN/HV). Compared to pts in PLT/LV group, those in the other 3 cohorts had a significantly higher risk of death. In particular, a statistically significant gradient in OS was noted (Trend test P < 0.001) within the groups in favor of PLT, primarily, and LV, secondarily. Conclusions: Consistent with the results seen in clinical trials, our hospital database informs us that disease volume and history of PLT define 4 distinct subgroups with different outcomes. This classification can be routinely used for counseling pts and future clinical trial design including oligometastatic disease. [Table: see text]

scholarly journals Dementia Adjudication Triggers Associated With Increased Mortality for Older Australians: Evidence From ASPREE

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 161-161
Author(s):  
Jane Banaszak-Holl ◽  
Xiaoping Lin ◽  
Jing Xie ◽  
Stephanie Ward ◽  
Henry Brodaty ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
The Elderly ◽  
Cox Proportional Hazards ◽  
Service Planning ◽  
Cox Proportional Hazards Model ◽  
Cognitive Test ◽  
Risk Of Death ◽  
Hazards Model ◽  
Using Data

Abstract Research Aims: This study seeks to understand whether those with dementia experience higher risk of death, using data from the ASPREE (ASPirin in Reducing Events in the Elderly) clinical trial study. Methods: ASPREE was a primary intervention trial of low-dose aspirin among healthy older people. The Australian cohort included 16,703 dementia-free participants aged 70 years and over at enrolment. Participants were triggered for dementia adjudication if cognitive test results were poorer than expected, self-reporting dementia diagnosis or memory problems, or dementia medications were detected. Incidental dementia was adjudicated by an international adjudication committee using the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) criteria and results of a neuropsychological battery and functional measures with medical record substantiation. Statistical analyses used a cox proportional hazards model. Results: As previously reported, 1052 participants (5.5%) died during a median of 4.7 years of follow-up and 964 participants had a dementia trigger, of whom, 575 (60%) were adjucated as having dementia. Preliminary analyses has shown that the mortality rate was higher among participants with a dementia trigger, regardless of dementia adjudication outcome, than those without (15% vs 5%, Χ2 = 205, p &lt;.001). Conclusion: This study will provide important analyses of differences in the hazard ratio for mortality and causes of death among people with and without cognitive impairment and has important implications on service planning.

One-Year Risk of Recurrent Stroke and Death Associated with Vertebrobasilar Artery Stenosis and Occlusion in a Cohort of 10,515 Patients

2019 ◽  
Vol 47 (1-2) ◽  
pp. 40-47 ◽  
Author(s):  
Adnan I. Qureshi ◽  
Mushtaq H. Qureshi ◽  
Li-Ming Lien ◽  
Jiunn-Tay Lee ◽  
Jiann-Shing Jeng ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Recurrent Stroke ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Large Artery ◽  
Stroke Registry ◽  
Risk Of Death ◽  
Vertebrobasilar Artery

Background: The natural history of vertebrobasilar artery (VBA) stenosis or occlusion remains understudied. Methods: Patients with diagnosis of ischemic stroke or transient ischemic attack (TIA) who were noted to have VBA stenosis based on computed tomography or magnetic resonance imaging or catheter-based angiogram were selected from Taiwan Stroke Registry. Cox proportional hazards model was used to determine the hazards ratio (HR) of recurrent stroke and death within 1 year of index event in various groups based on severity of VBA stenosis (none to mild: 0–49%; moderate to severe: 50–99%: occlusion: 100%) after adjusting for differences in demographic and clinical characteristics between groups at baseline evaluation. Results: None to mild or moderate to severe VBA stenosis was diagnosed in 6972 (66%) and 3,137 (29.8%) among 10,515 patients, respectively, and occlusion was identified in 406 (3.8%) patients. Comparing with patients who showed none to mild stenosis of VBA, there was a significantly higher risk of recurrent stroke (HR 1.21, 95% CI 1.01–1.45) among patients with moderate to severe VBA stenosis. There was a nonsignificantly higher risk of recurrent stroke (HR 1.49, 95% CI 0.99–2.22) and significantly higher risk of death (HR 2.21, 95% CI 1.72–2.83), among patients with VBA occlusion after adjustment of potential confounders. Conclusions: VBA stenosis or occlusion was relatively prevalent among patients with TIA or ischemic stroke and associated with higher risk of recurrent stroke and death in patients with ischemic stroke or TIA who had large artery atherosclerosis.

G CSF association with prolonged survival in HIV infected patients with disseminated Mycobacterium avium complex infection

1998 ◽  
Vol 9 (7) ◽  
pp. 394-399 ◽  
Author(s):  
Philip Keiser ◽  
Steven Rademacher ◽  
James Smith ◽  
Daniel Skiest
Keyword(s):  
Mycobacterium Avium ◽  
Mycobacterium Avium Complex ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Cd4 Count ◽  
Risk Of Death ◽  
Hazards Model

Summary: Clarithromycin can ameliorate symptoms and improve survival in disseminated Mycobacterium avium complex DMAC infection. Optimal combina tions of this drug with other agents remain unknown. Granulocyte colony stimulating factor G CSF is a cytokine that can improve phagocytosis of M. avium complex in vitro . We aim to determine if G CSF administration is associated with improved survival in patients with DMAC in a retrospective, cohort study. Case records from 1991 to 1995 of 91 patients with DMAC at Parkland Memorial Hospital were reviewed for date of initial DMAC diagnosis, baseline CD4 count, race, sex, antiretroviral use, G CSF use, therapy for DMAC clarithromycin, ethambutol, ciprofloxacin and rifabutin and date of death. Of 91 cases identified, 25 were treated with G CSF and 66 never received this drug. Baseline characteristics were similar in each group including CD4 count 40 cells mm 3 vs 33 cells mm 3, P =0.68 , clarithromycin use 18 patients vs 52 patients, P =0.90 , and antiretroviral use 20 patients vs 42 patients, P =0.21 . Subjects treated with G CSF lived longer than those who did not receive this drug 355 days vs 211 days, P 0.01 . In the subgroup treated with clarithromycin, G CSF was also associated with increased survival 377 days vs 252 days, P 0.01 . Cox proportional hazards model showed a decreased risk of death in patients treated with G CSF RH=0.22, P 0.01 , clarithromycin RH=0.13, P 0.01 and ethambutol RH=0.51, P =0.02 . Ciprofloxacin and rifabutin use did not influence survival. These data support the use of clarithromycin and ethambutol in the treatment of DMAC. Addition of G CSF to a regimen of clarithromycin and ethambutol may increase survival in DMAC and should be studied prospectively.

Use and impact of perioperative chemotherapy in patients with resectable colorectal cancer metastases.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 159-159
Author(s):  
Amy Body ◽  
Margaret Lee ◽  
Hui-Li Wong ◽  
Alun Pope ◽  
Azim Jalali ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
De Novo ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Biologic Agent ◽  
Separate Analysis ◽  
Perioperative Chemotherapy ◽  
Variable Approach

159 Background: There is conflicting evidence regarding benefit of perioperative chemotherapy (p-chemo) for metastatic colorectal cancer (mCRC) patients (pts) undergoing resection of metastases (mets). Aims: To describe use of and outcomes from p-chemo in mCRC pts who underwent resection of isolated liver or lung mets. Methods: Pts were identified from the TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a multi-centre registry of mCRC pts. P-chemo was defined as chemotherapy within 12 weeks of surgery. Multivariate (MV) analysis using a Cox proportional hazards model was undertaken. Results: 371 pts were identified. Median age was 64 (27 – 90), 169 (45%) had de novo stage IV disease, 96% were ECOG 0-1. 284 (77%) had liver-only and 87 (23%) lung-only mets. 242 (65%) pts received p-chemo (58 pre-op alone, 134 post-op alone, 50 both). 62 (19%) pts also received a biologic agent (47/62 pre-op). Median age was 68 and 61 years in no p-chemo and p-chemo groups, respectively (p<0.0001). 53% of no p-chemo pts and 23% of p-chemo pts had had prior adjuvant chemotherapy (p<0.001). On MV analysis, p-chemo was a significant predictor of survival (HR 0.52, 95% CI 0.32-0.88, p=0.014). The other significant predictor of improved survival was ECOG PS of 0 (HR 0.58, p=0.019). Predictors of worse survival were rectal primary (HR 1.98 p=0.009), male gender (HR 1.69 p=0.03) and de-novo metastatic disease (HR 2.63, p=0.006). Prior adjuvant chemo, age, liver vs lung mets, use of perioperative biologics, BRAF and RAS status had no significant impact. In an exploratory analysis, the group considered “resectable” upfront (n=281) was analysed separately, perioperative chemotherapy was not a significant predictor of survival in this subgroup (HR 0.69, p=0.26). Conclusions: In routine care there is a variable approach to the use of p-chemo in pts with potentially resectable liver or lung mets. P-chemo is associated with improved survival in this analysis, although this was not confirmed in the separate analysis of the “resectable” subgroup. Due to the retrospective nature of the study confounding by unmeasurable factors is possible. This study supports ongoing consideration of P-chemo in pts with resectable mets.

scholarly journals Fish intake and the risk of fatal prostate cancer: findings from a cohort study in Japan

2009 ◽  
Vol 12 (5) ◽  
pp. 609-613 ◽  
Author(s):  
Truong-Minh Pham ◽  
Yoshihisa Fujino ◽  
Tatsuhiko Kubo ◽  
Reiko Ide ◽  
Noritaka Tokui ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cohort Study ◽  
Fish Consumption ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Inverse Association ◽  
High Intake ◽  
Risk Of Death

AbstractObjectiveWe investigated the relationship between the intake of fish and the risk of death from prostate cancer.DesignData were derived from a prospective cohort study in Japan. Fish consumption obtained from a baseline questionnaire was classified into the two categories of ‘low intake’ and ‘high intake’. The Cox proportional hazards model was used to estimate hazard ratios (HR) and 95 % confidence intervals.SubjectsData for 5589 men aged 30–79 years were analysed.ResultsA total of twenty-one prostate cancer deaths were observed during 75 072 person-years of follow-up. Mean age at baseline study of these twenty-one subjects was 67·7 years, ranging from 47 and 79 years old. Results showed a consistent inverse association of this cancer between the high v. low intake groups. The multivariate model adjusted for potential confounding factors and some other food items showed a HR of 0·12 (95 % CI 0·05, 0·32) for the high intake group of fish consumption.ConclusionsThese results support the hypothesis that a high intake of fish may decrease the risk of prostate cancer death. Given the paucity of studies examining the association between prostate cancer and fish consumption, particularly in Asian populations, these findings require confirmation in additional cohort studies.

Effects of Azacitidine (AZA) Vs Conventional Care Regimens (CCR) in Elderly (≥75 years) Patients (Pts) with Myelodysplastic Syndromes (MDS) from the AZA-001 Survival Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3629-3629 ◽  
Author(s):  
John F Seymour ◽  
Pierre Fenaux ◽  
Lewis B. Silverman ◽  
Ghulam J Mufti ◽  
Eva Hellström-Lindberg ◽  
...  
Keyword(s):  
Active Treatment ◽  
Subgroup Analysis ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Performance Status ◽  
Treatment Options ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Risk Of Death

Abstract Background. A recent phase III trial (AZA-001) showed AZA is the first treatment to significantly extend overall survival (OS) in higher-risk MDS patients (pts) (Blood2007;110:817). MDS incidence increases with age resulting in limited treatment options, particularly for those ≥75 years of age, given the poor tolerability and ineffectiveness of cytotoxic therapies. This subgroup analysis compared the effects of AZA vs CCR on OS, hematologic improvement (HI), transfusion independence (TI), and tolerability in pts ≥75 yrs of age. Methods. Higher-risk MDS (FAB: RAEB, RAEB-T, CMML and IPSS: Int-2 or High) pts were enrolled. All pts were pre-selected by site investigators – based on age, performance status, and comorbidities – to receive 1 of 3 CCR: best supportive care only (BSC); lowdose ara-C (LDAC), or intensive chemotherapy (IC). Pts were then randomized to AZA (75 mg/m2/d SC × 7d q 28d), or to CCR. Those randomized to AZA received AZA; those randomized to CCR received their pre-selected treatment. Randomization was stratified based on FAB subtype (RAEB and RAEB-T) and IPSS (Int-2 or High). Erythropoiesis stimulating agents were disallowed. OS was assessed using Kaplan-Meier (KM) methods and HI and TI were assessed per IWG 2000. To adjust for baseline imbalances, a Cox proportional hazards model was used, with ECOG status, LDH, number of RBC transfusions, Hgb, and presence or absence of -7/del(7q) at baseline as variables in the final model. Adverse events (AEs) were evaluated using NCI-CTC v. 2.0. Results. Of all enrolled pts (N=358, median age 69 yrs), 87 pts (24%) were ≥75 yrs of age (AZA n=38, CCR n=49 [BSC, n=33; LDAC, n=14; IC, n=2]). The majority of pts randomized to CCR received BSC only, suggesting clinicians are generally reticent to use active treatment in this population. Similar to the overall AZA-001 results, treatment with AZA was associated with prolonged survival in pts ≥75 yrs of age, with KM median OS in the AZA group not reached at 17.7 months of follow-up, vs KM median OS for CCR at 10.8 months (HR: 0.48 [95%CI: 0.26, 0.89]; p=0.0193). In these pts, OS rates at 2 years were significantly higher in the AZA group vs CCR: 55% vs 15% (p=0.0003). Two-fold more RBC transfusion-dependent pts at baseline in the AZA group achieved TI vs CCR: 10/23 (44%) vs 7/32 (22%), p=0.1386, respectively. Similarly, more pts in the AZA group achieved HI (major + minor) vs CCR: 58% vs 39%, (p=0.0875), respectively. As previously reported, AZA was generally well tolerated. Anemia, neutropenia, and thrombocytopenia were seen in 42%, 66%, and 71% of pts in the AZA group, respectively, vs 47%, 26%, and 40% in the CCR group, who were predominately receiving BSC only. Infections were reported by 79% and 60% of AZA and CCR pts, respectively. Discontinuations due to an AE occurred in 13% of AZA and 8% of CCR pts ≥75 yrs of age. Conclusion. Data from this subgroup analysis indicate pts ≥75 yrs of age with higher-risk MDS receiving active treatment with AZA experience significantly prolonged 2-year OS and reduced risk of death. AZA is generally well tolerated in this elderly patient population.

Clinical Evaluation of the European LeukemiaNet Criteria for Resistance/Intolerance to Hydroxyurea In Essential Thrombocythemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4086-4086
Author(s):  
Carles Besses ◽  
Alberto Alvarez-Larrán ◽  
Montserrat Gómez ◽  
Anna Angona ◽  
Paula Amat ◽  
...  
Keyword(s):  
Platelet Count ◽  
Essential Thrombocythemia ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Conflicts Of Interest ◽  
Univariate Analysis ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Leg Ulcers ◽  
Risk Of Death

Abstract Abstract 4086 Definition of resistance/intolerance to hydroxyurea (HU) in essential thrombocythemia (ET) has been proposed by the European LeukemiaNet (ELN) however its clinical utilility has not been validated yet. We have retrospectively evaluated such criteria in 166 ET patients treated with HU for a median of 4.5 years. Response to HU treatment was categorized using the ELN criteria. The ELN definitions of resistance/intolerance to HU required the fulfillment of at least one of the following criteria: platelet count greater than 600 × 109/L after 3 months of at least 2 g/day of HU (2.5 g/day in patients with a body weight over 80 kg); platelet count greater than 400 × 109/L and leukocytes less than 2.5 × 109/L or hemoglobin (Hb) less than 100 g/L at any dose of HU; presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of HU; HU-related fever. Survival and time-to-event curves were estimated using the Kaplan-Meier method.Variab les attaining a significant level at the univariate analysis were included in a Cox proportional hazards model. Overall, 134 patients achieved a complete clinicohematologic response (CR) and 25 a partial response. Thirty-three patients met at least one of the ELN criteria defining resistance (n=15) or intolerance (n=21) to HU. Fifteen cases developed anemia with thrombocytosis. Other definitions of resistance were less useful. When compared with the others, resistant patients were more likely to display hyperproliferative features at ET diagnosis, such as higher levels of leukocytes (p= 0.05), platelets (p=0.004) and serum LDH (p=0.02). Eleven patients developed leg ulcers leading to a permanent discontinuation of the drug in 8 cases. No distinctive clinical profile could be ascribed to patients exhibiting leg ulcers, with the exception of a high prevalence of cardiovascular risk factors. Other unacceptable mucocutaneous manifestations occurred in 9 patients. Hematologic and mucocutaneous complications were unrelated, with only two patients presenting both types of toxicities. With a median follow-up from ET diagnosis of 7 years (range: 0.5–23), 38 patients (23%) had died, resulting in a survival probability of 65% at 10 years from HU start. The risk of death from any cause was increased by 6.2-fold (95%CI: 2.3–16.7, P<0.001) in patients who met any of the ELN criteria of resistance to HU. Anemia was in all instances the first finding qualifying for resistance to HU, with the median subsequent survival of patients with anemia being only 2.4 years (range, 0.01–4.9). A remarkable incidence of myelofibrosis was observed in patients fulfilling the ELN criteria for resistance, since this complication was recorded in 7 of 15 such cases (p>0.001). In conclusion, the best discriminating ELN criterion of resistance to HU is based on the detection of anemia. Moreover, such criterion is particularly useful since it also identifies a subset of ET patients with a poor prognosis. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Laxative use and mortality in patients on haemodialysis: a prospective cohort study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yu Honda ◽  
Seiji Itano ◽  
Aiko Kugimiya ◽  
Eiji Kubo ◽  
Yosuke Yamada ◽  
...  
Keyword(s):  
Cohort Study ◽  
Missing Values ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Risk Of Death ◽  
Number Of Patients ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Background Patients on haemodialysis (HD) are often constipated. This study aimed to assess the relationship between constipation and mortality in such patients. In this study, constipation was defined as receiving prescription laxatives, based on the investigation results of “a need to take laxatives is the most common conception of constipation” reported by the World Gastroenterology Organization Global Guidelines. Methods This cohort study included 12,217 adult patients on HD enrolled in the Japan-Dialysis Outcomes and Practice Patterns study phases 1 to 5 (1998 to 2015). The participants were grouped into two based on whether they were prescribed laxatives during enrolment at baseline. The primary endpoint was all-cause mortality in 3 years, and the secondary endpoint was cause-specific death. Missing values were imputed using multiple imputation methods. All estimations were calculated using a Cox proportional hazards model with an inverse probability of treatment weighting using the propensity score. Results Laxatives were prescribed in 30.5% of the patients, and there were 1240 all-cause deaths. There was a significant association between laxative prescription and all-cause mortality [adjusted hazard ratio (AHR), 1.12; 95% confidence interval (CI): 1.03 to 1.21]. Because the Kaplan-Meier curves of the two groups crossed over, we examined 8345 patients observed for more than 1.5 years. Laxative prescription was significantly associated with all-cause mortality (AHR, 1.35; 95% CI: 1.17 to 1.55). The AHR of infectious death was 1.62 (95% CI: 1.14 to 2.29), and that of cancerous death was 1.60 (95% CI: 1.08 to 2.36). However, cardiovascular death did not show a significant inter-group difference. Conclusions Constipation requiring use of laxatives was associated with an increased risk of death in patients on HD. It is important to prevent patients receiving HD from developing constipation and to reduce the number of patients requiring laxatives.

Recurrent Vascular Access Dysfunction as a Novel Marker of Cardiovascular Outcome and Mortality in Hemodialysis Patients

2016 ◽  
Vol 44 (1) ◽  
pp. 71-80 ◽  
Author(s):  
Hyo Jin Kim ◽  
Hajeong Lee ◽  
Dong Ki Kim ◽  
Kook-Hwan Oh ◽  
Yon Su Kim ◽  
...  
Keyword(s):  
Risk Factor ◽  
Propensity Score ◽  
Vascular Access ◽  
Independent Risk Factor ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
De Novo ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Patients Âgés

Background: Vascular access (VA) is essential for hemodialysis (HD) patients, and its dysfunction is a major complication. However, little is known about outcomes in patients with recurrent VA dysfunction. We explored the influence of recurrent VA dysfunction on cardiovascular (CV) events, death and VA abandonment. Methods: This is a single-center, retrospective study conducted in patients who underwent VA surgery between 2009 and 2014. VA dysfunction was defined as VA stenosis or thrombosis requiring intervention after the first successful cannulation. Patients with ≥2 interventions within 180 days were categorized as having recurrent VA dysfunction. Outcomes were analyzed using Cox proportional hazards model before and after propensity score matching. Results: Of 766 patients (ages 59.6 ± 14.3 years, 59.7% male), 10.1% were in the recurrent VA dysfunction group. Most baseline parameters after matching were similar between the recurrent and non-recurrent groups. A total of 213 propensity score-matched patients were followed for 28.7 ± 15.8 months, during which 46 (21.6%), 30 (14.1%) and 14 (6.6%) patients had de novo CV outcomes, died and abandoned VA, respectively. Recurrent VA dysfunction after adjustment remained an independent risk factor for CV events (adjusted hazards ratio (aHR), 2.71; 95% CI 1.48-4.98; p = 0.001). Moreover, recurrent VA dysfunction predicted composite all-cause mortality (ACM)/CV events (aHR 1.99; 95% CI 1.21-3.28; p = 0.007). Conclusions: Recurrent VA dysfunction was a novel independent risk factor for CV and composite ACM/CV events in HD patients, but not for VA abandonment. Patients with recurrent vascular dysfunction should be carefully monitored not only for VA patency but also for CV events.

scholarly journals Antithrombotic therapy after femoropopliteal artery stenting: 12-month results from Japan Postmarketing Surveillance

Heart Asia ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. e011114 ◽  
Author(s):  
Osami Kawarada ◽  
Michikazu Nakai ◽  
Kunihiro Nishimura ◽  
Hideki Miwa ◽  
Yusuke Iwasaki ◽  
...  
Keyword(s):  
Antithrombotic Therapy ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
De Novo ◽  
Target Lesion ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Postmarketing Surveillance ◽  
Kaplan Meier ◽  
Clinical Benefits

ObjectiveTo investigate the effects of antithrombotic therapy on target lesion revascularisation (TLR) and major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months after femoropopliteal intervention with second-generation bare metal nitinol stents.MethodsA total of 277 lesions in 258 limbs of 248 patients with de novo atherosclerosis in the above-the-knee femoropopliteal segment were analysed from the Japan multicentre postmarketing surveillance.ResultsAt discharge, dual antiplatelet therapy (DAPT) was prescribed in 68.5% and cilostazol in 30.2% of patients. At 12 months of follow-up, prescriptions of DAPT significantly (p=0.0001) decreased to 51.2% and prescription of cilostazol remained unchanged (p=0.592) at 28.0%. Prescription of warfarin also remained unchanged (14.5% at discharge, 13.3% at 12 months, p=0.70). At 12 months, freedoms from TLR and MACCE were 89.4% and 89.7%, respectively. In a multivariate Cox proportional hazards model, neither DAPT nor cilostazol at discharge was associated with both TLR and MACCE at 12 months. However, warfarin at discharge was only independently associated with TLR at 12 months. Kaplan-Meier estimates demonstrated that warfarin at discharge yielded a significantly (p=0.013) lower freedom from TLR at 12 months than no warfarin at discharge. Freedom from TLR at 12 months by the Kaplan-Meier estimates was 77.8% (95% CI 59.0% to 88.8%) in patients with warfarin at discharge and 91.2% (95% CI 86.3% to 94.3%) in those without warfarin at discharge.ConclusionsClinical benefits of DAPT or cilostazol might be small in terms of TLR and MACCE at 12 months. Anticoagulation with warfarin at discharge might increase TLR at 12 months.

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