One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study

Abstract Background Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. Methods This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). Results One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan–Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan–Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. Conclusion In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan–Meier estimation was 82.1%.

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Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

Journal of International Medical Research ◽

10.1177/03000605211006546 ◽

2021 ◽

Vol 49 (4) ◽

pp. 030006052110065

Author(s):

Hao Ren ◽

Jie Liu ◽

Jiwei Zhang ◽

Baixi Zhuang ◽

Weiguo Fu ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Outcome Data ◽

Primary Patency ◽

Cox Regression Analysis ◽

Femoropopliteal Artery ◽

Artery Disease

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

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Morphological Lesion Types Are Associated with Primary and Secondary Patency Rates after High-Pressure Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas

Blood Purification ◽

10.1159/000516883 ◽

2021 ◽

pp. 1-10

Author(s):

Li Chen ◽

Weichen Zhang ◽

Jinyun Tan ◽

Min Hu ◽

Weihao Shi ◽

...

Keyword(s):

Patency Rate ◽

Cox Regression ◽

Neointimal Hyperplasia ◽

Primary Patency ◽

Secondary Patency ◽

Type I ◽

Type Ii ◽

Cox Regression Analysis ◽

Type Iii ◽

Kaplan Meier

Background: Neointimal hyperplasia (NIH) is believed to be the main reason for arteriovenous fistula (AVF) dysfunction, but other mechanisms are also recognized to be involved in the pathophysiological process. This study investigated whether different morphological types of AVF lesions are associated with the patency rate after percutaneous transluminal angioplasty (PTA). Methods: This retrospective study included 120 patients who underwent PTA for autogenous AVF dysfunction. All the cases were evaluated under Doppler ultrasound (DU) before intervention and divided into 3 types: Type I (NIH type), Type II (non-NIH type), and Type III (mixed type). Prognostic and clinical data were analyzed by Kaplan-Meier analysis and the Cox proportional hazards model. Results: There was no statistical difference in baseline variables among groups, except for lumen diameter. The primary patency rates in Type I, Type II, and Type III groups were 78.4, 93.2, and 83.2% at 6 months and 59.5, 84.7, and 75.5% at 1 year, respectively. The secondary patency rates in Type I, Type II, and Type III groups were 94.4, 97.1, and 100% at 6 months and 90.5, 97.1, and 94.7% at 1 year, respectively. The Kaplan-Meier curve showed that the primary and secondary patency rates of Type I group were lower than those of Type II group. Multivariable Cox regression analysis demonstrated that postoperative primary patency was correlated with end-to-end anastomosis (hazard ratio [HR] = 2.997, p = 0.008, 95% confidence interval [CI]: 1.328–6.764) and Type I lesion (HR = 5.395, p = 0.004, 95% CI: 1.730–16.824). Conclusions: NIH-dominant lesions of AVF evaluated by DU preoperatively were a risk factor for poor primary and secondary patency rate after PTA in hemodialysis patients.

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Abstract 13533: 1-Year Results of Paclitaxel-Coating Nitinol Stent Placement for Chronic Total Occlusion in the Femoropopliteal Artey

Circulation ◽

10.1161/circ.130.suppl_2.13533 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Naotaka Murata ◽

Yoshimitu Soga ◽

Yusuke Tomoi ◽

Seiichi Hiramori ◽

Yohei Kobayashi ◽

...

Keyword(s):

Chronic Total Occlusion ◽

Ankle Brachial Index ◽

Primary Patency ◽

Lesion Length ◽

Total Occlusion ◽

Femoropopliteal Artery ◽

Nitinol Stent ◽

Kaplan Meier ◽

Zilver Ptx

Introduction: The mid-term outcomes of paclitaxel-coating nitinol stent (Zilver PTx) placement for chronic total occlusion (CTO) in the femoropopliteal artery have not been assessed. Hypothesis: Zilver PTx placement for CTO in the femoropopliteal artey is reliable. Methods: All patients enrolled in this prospective, single center study underwent Zilver PTx placement for de novo or restenotic CTO and non-CTO in the superficial femoral and/or popliteal artery. Baseline and follow-up Rutherford classification and Ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 3, 6, 12 months. Results: There were 61 of CTO and 58 of non-CTO treated. Mean age was 74 ± 8 years and male was 82 % in overall. Patients characteristics and degree of lesion calcification was not different significantly between two groups. CTO group had a longer mean lesion length than non-CTO group (209 mm ± 93 mm vs 131 mm ± 87 mm, P < .0001). Procedural success in both treatments was over 98 %. The operative complications were 3 cases in CTO group and 2 cases in non-CTO group. The primary patency of CTO group was significantly lower than non-CTO group in Kaplan-Meier estimate curves at 12 months (75 % vs 82 %, Log-rank P < 0.05). There were no significant differences in event-free survival or freedom from target lesion revascularization in Kaplan-Meier estimate curves at 12 months (68 % vs 70 %; Log-rank P = 0.82, 63 % vs 65 %; Log-rank P = 0.47, respectively). Both groups experienced a significant improvement in Rutherford classification and ABI after treatment, and these improvements were sustained to 12-months follow-up. Based on multivariate analysis, CTO was the negative predictor for primary patency at 12 months (HR 2.37, 95 % CI 1.02 to 5.9, adjusted P < 0.05). Conclusions: CTO influences negatively the primary patency of Zilver PTx placed in the femoropopliteal artery. However, Improvement of Rutherford classification and ABI at 12-months after CTO- intervention is sustained.

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Stent Protrusion >20 mm Into the Aorta: A New Predictor for Restenosis After Kissing Stent Reconstruction of the Aortoiliac Bifurcation

Journal of Endovascular Therapy ◽

10.1177/1526602818794959 ◽

2018 ◽

Vol 25 (5) ◽

pp. 632-639 ◽

Cited By ~ 5

Author(s):

Miklós Vértes ◽

Ildikó Zsófia Juhász ◽

Tin Dat Nguyen ◽

Dániel Sándor Veres ◽

Artúr Hüttl ◽

...

Keyword(s):

Cox Regression ◽

Ankle Brachial Index ◽

Limb Ischemia ◽

Primary Patency ◽

Aortic Diameter ◽

Aortoiliac Occlusive Disease ◽

Cox Regression Analysis ◽

Kissing Stent

Purpose: To determine the long-term patency of aortoiliac kissing stents and to identify predisposing factors for the development of in-stent restenosis (ISR). Methods: A retrospective analysis was conducted of 105 patients (median age 60.9 years; 64 women) with symptomatic aortoiliac occlusive disease who had kissing stents implanted between 2001 and 2015. The indication for kissing stents was severe claudication in 91 (86.7%) patients and critical limb ischemia in 14 (13.3%). Lesions were TASC A in 52 (49.5%), B in 29 (27.6%), C in 4 (3.8%), and D in 20 (19%) patients. Twenty-five (23.8%) patients had heavily calcified lesions. In all, 210 stents were deployed [180 (85.7%) self-expanding and 30 (14.3%) balloon-expandable]. Follow-up included clinical evaluation, ankle-brachial index measurement, and duplex ultrasonography. Results: The median follow-up was 45 months. The primary patency rates were 93%, 86%, and 77% at 12, 24, and 60 months, respectively. Significant ISR developed in 23 (21.9%) patients (12 unilateral and 11 bilateral). Univariate Cox regression analysis revealed older age [hazard ratio (HR) 0.5, 95% confidence interval (CI) 0.31 to 0.81, p=0.004] and larger aortic diameter (HR 0.42, 95% CI 0.25 to 0.7, p<0.001) to be variables favoring long-term patency, while a longer aortic stent segment (HR 1.56, 95% CI 1.16 to 2.09, p=0.003) and a larger discrepancy between the summed stent diameters and the aortic diameter (HR 1.64, 95% CI 1.01 to 2.65, p=0.043) were associated with ISR development. Multivariate analysis showed a longer aortic stent segment to be the only significant determinant of ISR (HR 1.44, 95% CI 1.02 to 2.01, p=0.035). Conclusion: The kissing stent technique can be performed with good long-term patency. Patients whose iliac stents protrude too far into the aorta need closer follow-up.

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Hybrid treatment of multilevel revascularization in patients with peripheral arterial disease – a multi-centre study in Korea

VASA ◽

10.1024/0301-1526/a000694 ◽

2018 ◽

Vol 47 (3) ◽

pp. 235-241 ◽

Cited By ~ 2

Author(s):

Soon Cheon Lee ◽

Jin Hyun Joh ◽

Jeong-Hwan Chang ◽

Hyung-Kee Kim ◽

Jang Yong Kim ◽

...

Keyword(s):

Endovascular Treatment ◽

Combined Treatment ◽

Ankle Brachial Index ◽

Primary Patency ◽

Limb Ischaemia ◽

University Hospitals ◽

Multi Centre Study ◽

Free Survival ◽

Technical Success Rate ◽

Hybrid Treatment

Abstract. Background: Endovascular treatment is an alternative first-line management for peripheral artery disease (PAD). Hybrid treatment (HT) is defined as a combined treatment for patients with PAD using endovascular and open surgery, simultaneously performed in an operating room. The results of HT are reportedly good for multilevel revascularization (MR) in patients with chronic limb ischaemia, and even in older high-risk patients. The goal of this study was to examine the clinical and haemodynamic outcomes of HT in patients who need MR. Patients and methods: Nine university hospitals in Korea participated in this multicentre study. A total of 134 patients with multilevel PAD underwent HT and MR. Patients were enrolled from July 2014 to June 2015 and were followed for 18 months. Results: The mean age of the patients was 68.8 ± 9.93 years and 88.1 % were men. Patients with Rutherford category 2 to 3 and 4 to 6 comprised 59.0 % and 42.0 % of the group, respectively. The technical success rate was 100 %. The primary patency rates at 12 and 18 months were 77.6 % and 63.9 %, respectively. The primary-assisted patency rates at 12 and 18 months were both 90.0 %. The pre-operative mean ankle brachial index (0.43 ± 0.23) increased to 0.87 ± 0.23 at six months post-operatively (t-test, p < 0.05). The amputation free survival rate was 97.1 %. Conclusions: Although outcomes of multilevel PAD are reportedly poor when endovascular treatment alone is used, we have shown that HT is a feasible alternative modality for patients with multilevel PAD, with satisfactory amputation-free survival and freedom from re-intervention rates.

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Prognostic role of aberrant mTOR activation in patients with stage II and III colorectal cancer

Biomarkers in Medicine ◽

10.2217/bmm-2020-0141 ◽

2020 ◽

Vol 14 (12) ◽

pp. 1127-1137

Author(s):

Tong-Tong Zhang ◽

Yi-Qing Zhu ◽

Hong-Qing Cai ◽

Jun-Wen Zheng ◽

Jia-Jie Hao ◽

...

Keyword(s):

Colorectal Cancer ◽

Cox Regression ◽

Disease Free Survival ◽

Stage Ii ◽

Poor Prognostic Factor ◽

Cox Regression Analysis ◽

Kaplan Meier ◽

Potential Biomarker ◽

Risk Predictor

Aim: This study aimed to develop an effective risk predictor for patients with stage II and III colorectal cancer (CRC). Materials & methods: The prognostic value of p-mTOR (Ser2448) levels was analyzed using Kaplan–Meier survival analysis and Cox regression analysis. Results: The levels of p-mTOR were increased in CRC specimens and significantly correlated with poor prognosis in patients with stage II and III CRC. Notably, the p-mTOR level was an independent poor prognostic factor for disease-free survival and overall survival in stage II CRC. Conclusion: Aberrant mTOR activation was significantly associated with the risk of recurrence or death in patients with stage II and III CRC, thus this activated proteins that may serve as a potential biomarker for high-risk CRC.

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P-Cresyl Sulfate Is a Valuable Predictor of Clinical Outcomes in Pre-ESRD Patients

BioMed Research International ◽

10.1155/2014/526932 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 7

Author(s):

Cheng-Jui Lin ◽

Chi-Feng Pan ◽

Chih-Kuang Chuang ◽

Fang-Ju Sun ◽

Duen-Jen Wang ◽

...

Keyword(s):

Clinical Outcomes ◽

Cardiovascular Event ◽

Cox Regression ◽

Medical Center ◽

Serum Biochemistry ◽

Cox Regression Analysis ◽

Kaplan Meier ◽

Valuable Marker ◽

Valuable Predictor

Background/Aims. Previous studies have reported p-cresyl sulfate (PCS) was related to endothelial dysfunction and adverse clinical effect. We investigate the adverse effects of PCS on clinical outcomes in a chronic kidney disease (CKD) cohort study.Methods. 72 predialysis patients were enrolled from a single medical center. Serum biochemistry data and PCS were measured. The clinical outcomes including cardiovascular event, all-cause mortality, and dialysis event were recorded during a 3-year follow-up.Results. After adjusting other independent variables, multivariate Cox regression analysis showed age (HR: 1.12,P=0.01), cardiovascular disease history (HR: 6.28,P=0.02), and PCS (HR: 1.12,P=0.02) were independently associated with cardiovascular event; age (HR: 0.91,P<0.01), serum albumin (HR: 0.03,P<0.01), and PCS level (HR: 1.17,P<0.01) reached significant correlation with dialysis event. Kaplan-Meier analysis revealed that patients with higher serum p-cresyl sulfate (>6 mg/L) were significantly associated with cardiovascular and dialysis event (log rankP=0.03, log rankP<0.01, resp.).Conclusion. Our study shows serum PCS could be a valuable marker in predicting cardiovascular event and renal function progression in CKD patients without dialysis.

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Thigh intramuscular fat predicts the prognosis in patients in non-ischemic cardiomyopathy with reduced ejection fraction

European Heart Journal ◽

10.1093/ehjci/ehaa946.0925 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

T Yoshida ◽

A Shibata ◽

A Tanihata ◽

H Hayashi ◽

Y Ichikawa ◽

...

Keyword(s):

Adverse Events ◽

Ischemic Cardiomyopathy ◽

Cox Regression ◽

Intramuscular Fat ◽

Left Ventricular ◽

Skeletal Muscle Atrophy ◽

Measured Quantity ◽

Ectopic Fat ◽

Cox Regression Analysis ◽

Kaplan Meier

Abstract Background Skeletal muscle atrophy is an independent prognostic predictor for patients with chronic heart failure, and the concept of sarcopenia is drawing attention. Furthermore, the importance of not only muscle mass but also intramuscular fat (IMF) has been pointed out. However, there is a lack of consensus on the implications of ectopic fat for the prognosis in patients with non-ischemic cardiomyopathy. Purpose We investigated whether ectopic fat in the thigh affects the prognosis with non-ischemic cardiomyopathy. Methods We recruited 105 patients who were diagnosed with non-ischemic cardiomyopathy by cardiac catheterization and echocardiographic date between September 2017 and November 2019. Finally 73 patients with reduced EF (EF 40% or less) enrolled in this prospective study. Functional status was evaluated by using cardiopulmonary exercise test at baseline. All patients were measured quantity of epicardial fat and thigh IMF percentage (%IMF) using computed tomography scan. Demographic, laboratory and echocardiographic date were collected from the patients' medical records. Clinical endpoints were unexpected readmission. Results During the follow-up period 18 patients had adverse events. The %IMF was significantly higher in the group with adverse events than without (5.57±5.70 and 3.02±2.44%, respectively; p<0.01). Spearman correlation coefficient analysis showed a modest correlation between %IMF and lower limb extension strength (Spearman r=−0.280; p=0.0315), but there was no significant correlation between %IMF and exercise tolerance such as anaerobic threshold and peak oxygen uptake. Patients were divided into 2 groups according to the median values of %IMF. Kaplan-Meier analysis demonstrated that events were significantly higher in the high %IMF group (log-rank p=0.033). Multivariate Cox regression analysis adjusted for left ventricular end-diastolic diameter and peak ventricular oxygen consumption found %IMF as an independent factor of adverse events (hazard ratio 1.545; 95% confidential interval 1.151–2.087; p=0.004). Conclusions In non-ischemic cardiomyopathy patients with reduced EF, %IMF may have important adverse consequences such as increased cardiac-related events. Kaplan-Meier curves Funding Acknowledgement Type of funding source: None

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Prognostic values, ceRNA network, and immune regulation function of SDPR in KRAS-mutant lung cancer

Cancer Cell International ◽

10.1186/s12935-021-01756-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Xiaoqing Luo ◽

Shunli Peng ◽

Sijie Ding ◽

Qin Zeng ◽

Rong Wang ◽

...

Keyword(s):

Lung Cancer ◽

Immune Checkpoint ◽

Cox Regression ◽

Tissue Array ◽

Lung Cancers ◽

Cox Regression Analysis ◽

Immune Checkpoint Molecules ◽

Cerna Network ◽

Kaplan Meier ◽

Infiltration Models

Abstract Background Serum Deprivation Protein Response (SDPR) plays an important role in formation of pulmonary alveoli. However, the functions and values of SDPR in lung cancer remain unknown. We explored prognostic value, expression pattern, and biological function of SDPR in non-small cell lung cancer (NSCLC) and KRAS-mutant lung cancers. Methods SDPR expression was evaluated by quantitative real-time PCR (RT-qPCR), immunohistochemistry (IHC), and Western blot on human NSCLC cells, lung adenocarcinoma tissue array, KRAS-mutant transgenic mice, TCGA and GEO datasets. Prognostic values of SDPR were evaluated by Kaplan–Meier and Cox regression analysis. Bioinformatics implications of SDPR including SDPR-combined transcription factors (TFs) and microRNAs were predicted. In addition, correlations between SDPR, immune checkpoint molecules, and tumor infiltration models were illustrated. Results SDPR expression was downregulated in tumor cells and tissues. Low SDPR expression was an independent factor that correlated with shorter overall survival of patients both in lung cancer and KRAS-mutant subgroups. Meanwhile, ceRNA network was constructed to clarify the regulatory and biological functions of SDPR. Negative correlations were found between SDPR and immune checkpoint molecules (PD-L1, TNFRSF18, TNFRSF9, and TDO2). Moreover, diversity immune infiltration models were observed in NSCLC with different SDPR expression and copy number variation (CNV) patterns. Conclusions This study elucidated regulation network of SDPR in KRAS-mutant NSCLC, and it illustrated correlations between low SDPR expression and suppressed immune system, unfolding a prognostic factor and potential target for the treatment of lung cancer, especially for KRAS-mutant NSCLC.

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Fast-Track Programs in Total Hip and Knee Replacement at Swedish Hospitals—Influence on 2-Year Risk of Revision and Mortality

Journal of Clinical Medicine ◽

10.3390/jcm10081680 ◽

2021 ◽

Vol 10 (8) ◽

pp. 1680

Author(s):

Urban Berg ◽

Annette W-Dahl ◽

Anna Nilsdotter ◽

Emma Nauclér ◽

Martin Sundberg ◽

...

Keyword(s):

Fast Track ◽

Cox Regression ◽

Cox Regression Analysis ◽

Total Hip ◽

Total Knee Replacements ◽

Risk Of Death ◽

Kaplan Meier ◽

Increased Risk ◽

Hip And Knee Arthroplasty ◽

Total Knee

Purpose: We aimed to study the influence of fast-track care programs in total hip and total knee replacements (THR and TKR) at Swedish hospitals on the risk of revision and mortality within 2 years after the operation. Methods: Data were collected from the Swedish Hip and Knee Arthroplasty Registers (SHAR and SKAR), including 67,913 THR and 59,268 TKR operations from 2011 to 2015 on patients with osteoarthritis. Operations from 2011 to 2015 Revision and mortality in the fast-track group were compared with non-fast-track using Kaplan–Meier survival analysis and Cox regression analysis with adjustments. Results: The hazard ratio (HR) for revision within 2 years after THR with fast-track was 1.19 (CI: 1.03–1.39), indicating increased risk, whereas no increased risk was found in TKR (HR 0.91; CI: 0.79–1.06). The risk of death within 2 years was estimated with a HR of 0.85 (CI: 0.74–0.97) for TKR and 0.96 (CI: 0.85–1.09) for THR in fast-track hospitals compared to non-fast-track. Conclusions: Fast-track programs at Swedish hospitals were associated with an increased risk of revision in THR but not in TKR, while we found the mortality to be lower (TKR) or similar (THR) as compared to non-fast track.

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