scholarly journals Endovascular Therapy Versus Bypass Surgery as First-Line Treatment Strategies for Critical Limb Ischemia

2016 ◽  
Vol 9 (24) ◽  
pp. 2557-2565 ◽  
Author(s):  
Theodosios Bisdas ◽  
Matthias Borowski ◽  
Konstantinos Stavroulakis ◽  
Giovanni Torsello ◽  
Farzin Adili ◽  
...  
2018 ◽  
Vol 25 (3) ◽  
pp. 320-329 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Matthias Borowski ◽  
Giovanni Torsello ◽  
Theodosios Bisdas ◽  
Farzin Adili ◽  
...  

Purpose: To examine the outcomes of all first-line strategies for the treatment of critical limb ischemia (CLI), identify factors that influenced the treatment choice, and determine the risk of amputation or death after each treatment. Methods: CRITISCH ( ClinicalTrials.gov identifier NCT01877252) is a multicenter, national, prospective registry evaluating all available treatment strategies applied in 1200 consecutive CLI patients in 27 vascular centers in Germany. The recruitment started in January 2013 and was completed in September 2014. Treatment options were endovascular revascularization (642, 53.5%), bypass surgery (284, 23.7%), femoral artery patchplasty (126, 10.5%) with or without concomitant peripheral intervention, conservative treatment (118, 9.8%), and primary major amputation (30, 2.5%). The primary endpoint of this study was amputation-free survival (AFS). The Society of Vascular Surgery’s suggested objective performance goal (OPG) for AFS (71%) was used as the effectiveness criterion. Multivariable regression methods were employed to identify variables that influenced the treatment selection and AFS after each treatment; results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 12-month AFS estimates following endovascular therapy, bypass grafting, femoral patchplasty, and conservative treatment were 75%, 72%, 73%, and 72%, respectively. Factors influencing treatment choice were age, chronic kidney disease (CKD), diabetes, smoking, prior vascular procedures in the index leg, TransAtlantic Inter-Society Consensus II C/D lesions, and absence of runoff vessels. Cox regression analysis identified CKD (HR 2.07, 95% CI 1.26 to 3.41, p=0.004), the use of a prosthetic bypass conduit (HR 1.97, 95% CI 1.23 to 3.14, p=0.004), and previous vascular intervention in the index limb (HR 1.52, 95% CI 0.94 to 2.43, p=0.085) as independent risk factors for diminished AFS after bypass surgery. CKD (HR 1.47, 95% CI 1.09 to 1.99, p=0.012) and Rutherford category 6 (HR 1.81, 95% CI 1.30 to 2.52, p<0.001) compromised the performance of endovascular revascularization. Conclusion: CRITISCH registry data revealed that all first-line treatment strategies selected and indicated by the treating physicians met the suggested OPGs. CKD was an important determinant of patient prognosis after treatment regardless of the revascularization method.


2015 ◽  
Vol 62 (4) ◽  
pp. 965-973.e3 ◽  
Author(s):  
Theodosios Bisdas ◽  
Matthias Borowski ◽  
Giovanni Torsello ◽  
Farzin Adili ◽  
Kai Balzer ◽  
...  

2019 ◽  
Vol 58 (6) ◽  
pp. e53-e54
Author(s):  
Mohammad Abualhin ◽  
Mauro Gargiulo ◽  
Alessia Sonetto ◽  
Gianluca Faggioli ◽  
Rodolfo Pini ◽  
...  

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 551-551
Author(s):  
Peter Borchmann ◽  
Sven Trelle ◽  
Michaela Rancea ◽  
Heinz Haverkamp ◽  
Volker Diehl ◽  
...  

Abstract Abstract 551 Background: The best treatment strategy for advanced stage Hodgkin lymphoma (HL) is still a matter of debate. The German Hodgkin Study Group (GHSG) advocates aggressive treatment with BEACOPPescalated (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) to cure as many patients as possible with first-line therapy. However, BEACOPPescalated may expose patients to excessive toxicity. Treatment with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) is supposed to be better tolerable. Proponents of primary ABVD therapy acknowledge a lower progression-free survival (PFS) compared to BEACOPPescalated. However, they argue that relapsing patients can subsequently be cured by high-dose chemotherapy resulting in comparable overall survival (OS). All trials evaluating these two strategies directly were either very small or included patient subgroups only. Although they congruently showed a significant PFS advantage for BEACOPPescalated, they were not powered to detect differences in OS, which obviously is the most important endpoint. Purpose: To assess the benefits and risks of different initial treatment strategies for adult patients with advanced stage HL and to provide patients and physicians with a high-level evidence for treatment decisions. Methods: Data Sources: We developed sensitive search strategies for CENTRAL, MEDLINE, and conference proceedings (searched from 01/1980 to 03/2012). Missing data was obtained from investigators. Study selection: Randomized trials that compared at least two out of twelve pre-defined chemotherapy regimens in adults with advanced stage HL. Two authors independently assessed studies for eligibility. Data extraction: We extracted data and assessed quality of trials in duplicate. The primary outcome was OS. Secondary outcomes included freedom-from-treatment failure (FFTF) and secondary malignancies. Data relates to four or five years of follow-up depending on the status of the trial. Data synthesis: We pooled data using network meta-analysis. Direct comparisons within trials were combined with indirect evidence from other trials by using a Bayesian random-effects model. Results are reported relative to ABVD with a hazard ratio (HR) >1 indicating superiority of ABVD. Results: 1,984 references were identified, of which 77 publications, reporting 14 trials, evaluating 11 different regimens were included. A total of 10,011 patients with 59,000 patient-years of follow-up were evaluable for the analyses of survival outcomes. Six cycles of BEACOPPescalated and 8 cycles of BEACOPP-14 were associated with the lowest risk for death of any cause (HR 0.38, 95%-CrI 0.20 to 0.75 and HR 0.43, 95%-CrI 0.22 to 0.86, respectively). Assuming a five-year survival rate of 89% for ABVD this would result in a 5-year survival benefit of 7% and 6% for 6 cycles of BEACOPPescalated and 8 cycles of BEACOPP-14, respectively (95%-CrI 3% to 9% and 2% to 9%, respectively). Eight cycles of BEACOPPescalated were also statistically significantly better as compared to ABVD but the effect was less pronounced. All other treatment strategies showed no statistically significant difference to ABVD. Similar results were obtained for FFTF. Between-trial heterogeneity was negligible in both analyses (tau-square 0.01 and 0.05, respectively). Overall, 327 secondary malignancy and 109 leukemia events accumulated over 57,529 patient-years of follow-up. Given the low number of events we were not able to accurately quantify the risk associated with each regimen; however, Stanford V might be associated with the lowest risk and C(M)OPP/EBV/CAD with the highest risk for secondary leukemias. Limitations: Some of the regimens were only evaluated in one trial. The number of secondary malignancies, especially leukemias, was low. Conclusions: The comparison of different first-line treatment strategies for advanced stage HL in this network meta-analysis shows a significant and relevant OS benefit for both, 6 cycles of BEACOPPescalated and 8 cycles of BEACOPP-14 over standard ABVD treatment. This analysis provides the currently best available evidence on OS of different initial treatment strategies for advanced stage HL patients and therefore adds valid and important information for both, patients and physicians. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3068-3068
Author(s):  
Laurence Simon ◽  
Xavier Leleu ◽  
Jehan Dupuis ◽  
Therese Aurran ◽  
Lauris Gastaud ◽  
...  

Abstract Background: Bing-Neel syndrome (BNS) is a rare complication of Waldenström Macroglobulinemia (WM) defined as the direct involvement of central nervous system (CNS) by neoplastic cells. Because of its rarity, few data are currently available in the literature, which is mostly based on case-reports descriptions. The management of these patients is challenging with no consensus about the best treatment strategies to use. Patients and Methods: We retrospectively analyzed 37 patients out of 15 French centers databases, treated for a BNS between 1995 and 2014. Results: At the time of BNS diagnosis, the median age was 64 years. In 13 cases (35%), BNS was the first manifestation of WM. In others cases, median time between WM diagnosis and BNS was 96 months (range 2-300).BNS occurrence was correlated with a systemic progression of WM in 30% of cases. For the others patients with no systemic progression of WM, median time between the end of the last treatment of WM and BNS diagnosis was 30 months (range 10-72). The median IgM level was 11.25 g/L (range 0.35-60.8) at the time of BNS onset. Clinical manifestations: the most frequent symptoms at the time of BNS diagnosis were cognitive impairment (32%), motor or sensory deficits (30% and 16% respectively), pain (16%), cranial nerves involvement (30%), headache (21%), poor performance status (32%) and cauda equina syndrome (18%). The median interval between appearance of neurological symptoms and diagnosis of BNS was 4 months. Cerebrospinal fluid (CSF) analysis showed a lymphocytic meningitis in 81% of cases with a median of 33 cells/mm3 (range 7-3900), all with monoclonal B-cell population when phenotyping was available (except one case). Protein level was elevated in 94% (1,77 g/L in median, range 0,52-7,23). Magnetic resonance imaging (MRI) showed abnormalities in 83% (n=29/35) of cases. Meningeal enhancement was present in 52% of cases with conus medullaris infiltration in half of these patients. Cerebral enhancement was present in 45 % of cases and a normal pressure hydrocephalus in 3 cases. In 17% of cases, MRI was normal. Based on MRI results and CSF analysis, the majority of patients (81%, n=30/37) had an infiltrative form with only 7 patients presenting with a pseudotumoral involvement of brain parenchyma. The diagnosis was made on CSF analysis in the majority of cases (82%, n= 28/34). In four cases the diagnosis required a brain biopsy. First-line treatment comprised systemic chemotherapy in 89% (n=33/37) of cases. Treatment of CNS involvement was based on high-dose chemotherapy in 17 cases (methotrexate and/or aracytine). Intra-thecal chemotherapy was used in 70% of cases, and rituximab in 58% of cases. Autologous stem-cell transplantation (ASCT) in first-line was performed in 4 cases. 4 patients were treated up-front by whole-brain radiotherapy (in combination with systemic chemotherapy by fludarabine, cyclophosphamide and rituximab in 1 case). Outcome: 31 patients were assessable for first-line treatment response: overall response rate (ORR) was 68% (n=21/31) including 7 complete remissions; 7 patients had a progressive disease. 9 patients died. Median follow-up of alive patients was 23 months. At 5 years after BNS diagnosis, 79% of the patients were alive. Conclusion: Up to now, this is the most important retrospective cohort of patients presenting with Bing-Neel syndrome. In more than one third of the cases, BNS was the first manifestation of WM disease. Noteworthy is the late occurrence of some cases, up to 25 years. No correlation was observed between systemic progression of WM and BNS occurrence. BNS should be considered even in the context of a stable WM disease. In order to define the best treatment strategies, collection of additional cases is currently ongoing, and data will be up-dated at time of the meeting. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 27 (4) ◽  
pp. 608-613
Author(s):  
Shin Okamoto ◽  
Osamu Iida ◽  
Mitsuyoshi Takahara ◽  
Yosuke Hata ◽  
Mitsutoshi Asai ◽  
...  

Purpose: To determine in a chronic limb-threatening ischemia (CLTI) population who underwent endovascular therapy (EVT) how many patients would have been categorized as preferred for bypass surgery according to the Global Vascular Guidelines (GVG) and ascertain their surgical risk. Materials and Methods: The current study analyzed 1043 CLTI patients who presented WIfI (wound, ischemia, and foot infection) stage ≥2 and underwent EVT between April 2010 and December 2017. Of these, 176 were excluded for lack of angiographic or other data, leaving 867 CLTI patients (mean age 74±10 years; 523 men) for stratification according to the GVG into bypass-preferred, indeterminate, or EVT-preferred groups. The GVG recommend bypass as the first-line treatment when the wound is severe (WIfI stage ≥3) and lesions are complex (GLASS stage III). Surgical risk was estimated using the modified PREVENT III risk score. To further stratify the bypass-preferred population according to mortality risk, a survival decision tree was constructed using recursive partitioning. Results: The bypass-preferred group accounted for 55% [95% confidence interval (CI) 51% to 58%] of the overall population. The decision tree analysis extracted a low-mortality risk subgroup with a survival rate of 99% (95% CI 98% to 100%) at 1 month and 80% (95% CI 73% to 87%) at 2 years. According to the PREVENT III score, 34% (95% CI 27% to 42%) of the low mortality risk subgroup were classified as high surgical risk. Conclusion: A high proportion of patients undergoing EVT were considered bypass preferred based on the GVG, and the survival of these patients was not significantly different whether they were high or low surgical risk.


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