Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (allo-SCT) for Patients with Acute Myeloid Leukemia (AML): Long Term Results of a “Donor” Versus “No Donor” Comparison.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1090-1090
Author(s):  
Mohamad Mohty ◽  
Hugues de Lavallade ◽  
Jean El-Cheikh ◽  
Patrick Ladaique ◽  
Catherine Faucher ◽  
...  
Keyword(s):  
Long Term Results ◽  
Donor Group ◽  
No Donor ◽  
Actual Performance ◽  
Intention To Treat ◽  
Related Donor ◽  
The Difference ◽  
Treat Analysis

Abstract RIC regimens have emerged as an attractive modality to decrease transplant-related toxicity (TRM). However, the potential higher relapse rate after RIC allo-SCT is still under considerable debate. This report describes the long term results of 95 consecutive AML patients, diagnosed between Nov. 1999 and Dec. 2003 in a single institution, and who were considered as potential candidates for RIC-allo-SCT. Using a genetic randomization through a “donor” versus “no donor” comparison, the aim was to assess the real benefit of RIC-allo-SCT for adult AML and its impact on outcome. In this series, 35 patients (37%; “donor” group) had an “identified” HLA-identical sibling donor, while the remaining 60 patients had no HLA-matched related donor (“no donor” group). As per institutional policy, HLA-matched unrelated donors were not considered during the study period. No significant differences in patients or AML features were found between the two groups. In the “donor” group, 25 patients (71%; median age, 51 (range, 26–60)) could actually proceed to the RIC-allo-SCT. The 10 remaining patients with an identified donor did not receive allo-SCT because of early relapse after CR (n=2), patient or donor refusal (n=6), and psychiatric disorders appearing before allo-SCT (n=2). The current median follow-up is 60 months. In an “intention-to-treat” analysis, the KM estimate of leukemia-free survival (LFS) was significantly higher in the “donor” group as compared to the “no donor” group (P=0.003; 60% versus 23% at 7 years). When restricting the analysis to patients who could actually receive the RIC-allo-SCT (median follow-up, 40 months from time of allo-SCT), the difference in LFS was also significant between this group of 25 patients (“transplant” group) and the remaining 70 patients (“no transplant” group) who did not receive allo-SCT (P=0.0002; 72% versus 24% at 7 years). In the “transplant” group, RIC-allo-SCT was performed at a median of 209 (range, 119–413) days after diagnosis. No major toxicities were encountered during RIC administration (fludarabine, busulfan and ATG), and only 3 patients died from TRM, for a cumulative incidence of 12% (95%CI, 3–32%) at last follow-up. This relatively low TRM translated towards a significantly higher overall survival (OS) in the “transplant” group as compared to the “no transplant” group (P=0.0003). In the “intention-to-treat” analysis, OS was still significantly higher in the “donor” group as compared to the “no donor” group (P=0.003; Figure below). After controlling for relevant factors, in the multivariate analysis, only actual performance of RIC-allo-SCT (P=0.0005; RR=4.1; 95%CI, 1.8–9.1), was significantly predictive of an improved LFS, further confirming the overall benefit of RIC-allo-SCT for adult AML patients. We conclude that if a matched related donor is identified, RIC-allo-SCT should be proposed since it represents a valid and potentially curative option for AML patients not eligible for standard myeloablative allo-SCT. Figure Figure

Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (allo-SCT) for Patients with Acute Myeloid Leukemia (AML): A Donor Versus No Donor Comparison.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5413-5413
Author(s):  
Mohamad Mohty ◽  
Hugues de Lavallade ◽  
Patrick Ladaique ◽  
Catherine Faucher ◽  
Norbert Vey ◽  
...  
Keyword(s):  
Cumulative Incidence ◽  
High Risk Population ◽  
Donor Group ◽  
No Donor ◽  
Intention To Treat ◽  
Related Donor ◽  
The Difference ◽  
And Performance ◽  
Treat Analysis

Abstract Standard myeloablative allo-SCT is an established therapy for adult patients with AML. However, because of the high incidence of TRM, this procedure is often limited to younger patients. RIC regimens allow decreasing transplant-related toxicity. No randomized studies between RIC-allo-SCT for AML and chemotherapy alone are yet available. This report describes 95 consecutive AML patients from a single institution, who were considered as potential candidates for RIC-allo-SCT. Using a genetic randomization through a "donor" vs. "no donor" comparison, the aim of this analysis was to assess the real benefit of RIC-allo-SCT for adult AML. In this study, 35 patients (37%; "donor" group) had an "identified" HLA-identical sibling donor, while 60 had no related donor ("no donor" group). No significant differences in patients or AML features were found between the 2 groups. In the "donor" group, 25 patients (71%) could actually proceed to the RIC-allo-SCT. The 10 remaining patients with an identified donor did not receive allo-SCT because of early relapse after CR (n=2), patient or donor refusal (n=6), and psychiatric disorders appearing before allo-SCT (n=2). With a median overall follow-up of 31 months, the median LFS in the whole study population was 21 months. In an "intention-to-treat" analysis, the KM estimate of LFS was significantly higher in the "donor" group as compared to the "no donor" group (P=0.01; 54% versus 30% at 4 years). When restricting the analysis to patients who could actually receive the RIC-allo-SCT (median follow-up, 14 months from time of transplantation), the difference in LFS was also significant between this group of 25 patients ("transplant" group) and the remaining 70 patients ("no transplant" group) who did not receive allo-SCT (P=0.001; 62% versus 31% at 4 years). In the "transplant" group, RIC-allo-SCT was performed at a median of 209 (range, 119–413) days after diagnosis. No grade 3 or 4 toxicities were encountered during RIC administration, and only 3 patients died from transplant-related toxicity, for an overall cumulative incidence of TRM of 12% (95%CI, 3–32%). This relatively low TRM translated towards a significantly higher overall survival (OS) in the "transplant" group as compared to the "no transplant" group (P=0.01). In the "intention-to-treat" analysis, OS was still significantly higher in the "donor" group as compared to the "no donor" group (P=0.04). Overall, 41 patients (43%; 95%CI, 33–53%) had relapsed at a median of 295 (range, 116–823) days after diagnosis, with the 4-year cumulative incidence of relapse being significantly higher in the "no transplant" group as compared to the "transplant" group (P=0.0002; 54% vs. 12%). After controlling for all relevant factors, in the multivariate analysis, only an intermediate cytogenetic risk group (P=0.01; RR=1.2; 95%CI, 1.2–4.7), and performance of RIC-allo-SCT (P=0.001; RR=4.0; 95%CI, 1.7–9.6), were significantly predictive of an improved LFS, further confirming the overall benefit of RIC-allo-SCT for adult AML patients. Based on these results, and given the low overall TRM rate observed in this high risk population, we conclude that if a matched related donor is identified, RIC-allo-SCT should be proposed since it represents a valid option for AML patients not eligible for standard myeloablative allo-SCT.

scholarly journals DOP07 Long-term results of 4.5 years of faecal microbiota transplantation for treatment of refractory ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S045-S045
Author(s):  
A Uygun ◽  
M F Karakaya ◽  
H Erdal ◽  
G Celebi ◽  
Y S Sakin ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Protocol Analysis ◽  
Long Term Results ◽  
Faecal Microbiota ◽  
Intention To Treat ◽  
Tnf Α ◽  
Treat Analysis

Abstract Background Faecal microbiota transplantation (FMT) provides replacement of pathogenic bacteria with more favourable microbiomes in recipients with dysbiosis. The aim of the present study was to prospectively investigate the efficacy of FMT by assessing the clinical and endoscopic response in patients with ulcerative colitis (UC) who had failed anti-inflammatory, immunosuppressive and TNF-α inhibitors (Infliximab, Adalimumab, Vedolizumab) therapy. Methods In this prospective and uncontrolled study, 116 patients with UC were enrolled. All medications except mesalazine were discontinued 1 week before FMT. Colonoscopy was performed both before and after FMT. To assess the efficacy of FMT, Mayo scores were calculated at weeks 0, 24 and 48. A total of 400–600 ml of extracted fresh faecal suspension was administered into the 20 to 30  cm of terminal ileum of recipients. Results After 4.5 years of FMT experience with 116 patients, who have completed their 6 months after 236 procedures of FMT for treatment of UC, 42 of the 116 patients showed full clinical response (100% clinical + laboratory + endoscopically full response) (per-protocol analysis 37.1%), (intention-to-treat analysis 36.2%) at Week 48 and 33 of the 116 patients achieved clinical and endoscopic remission (laboratory 70%, clinically and endoscopically 50–75% improvement) (per-protocol analysis 29.2%), (intention-to-treat analysis 28.4%) at Week 48. Thirty-eight of the 116 patients were accepted as nonresponders at the end of Week 48 (per-protocol analysis 29.2%), (intention-to-treat analysis 32.7%) and 3 patients (2.5%) were lost to follow-up. There was no significant difference among donors concerning both the rate of clinical remission and clinical response. At 4.5 years, serious side effects were observed on 2 patients, 1 colon perforation and 1 toxic megacolon; both were directed to surgery. In 48 weeks’ follow-up, 31 patients (26.7%) experienced mild adverse events after FMT, such as elevated white blood cell counts and ESR, nausea, abdominal pain and high fever, all were managed conservatively. Conclusion FMT could be considered as a promising rescue treatment modality before surgery in patients with refractory UC. Our research is the first in the world for the treatment of UC resistant to medical treatment before surgery. Also, it is the first research to show the long-term results of FMT. FMT appears to be significantly safer and more tolerable than the immunosuppressive and TNF-α inhibitors therapy in patients with UC.

Abstract 2752: Pulmonary Vein Isolation With And Without Additional Ablation Of Complex Fractionated Electrograms In Paroxysmal Atrial Fibrillation: Long-term Results Of A Prospective Randomized Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Randomized Study ◽  
Intention To Treat ◽  
Long Term Follow Up ◽  
Treat Analysis

Introduction: Segmental pulmonary vein isolation (PVI) leads to elimination of paroxysmal atrial fibrillation (AF) in approximately 75% of patients. Ablation of complex fractionated atrial electrograms (CFAE) is an alternative ablation strategy. In this prospective randomized study the long-term effect of PVI alone is compared to the effect of combined PVI and CFAE ablation in paroxysmal AF. Methods: 98 patients with paroxysmal AF (57±10 years, 74 male) were randomly assigned to PVI (48 patients) or PVI+CFAE ablation (50 patients). Additional CFAE ablation was performed in the PVI+CFAE group if AF was still inducible after PVI. Follow-up results were assessed with repetitive 7 days Holter ECG and clinical evaluation including repeat ablations. Results: Additional CFAE ablation was performed in 30/50 (60%) patients of the PVI+CFAE group with still inducible AF after PVI. In each group, 2 patients were lost to long term follow-up. In the intention-to-treat analysis at 3 months and after 19±8 months, there was no significant difference between both groups (36/48 [75%] and 34/46 [74%] patients in the PVI and 37/50 [73%] and 40/48 [83%] of patients in the PVI+CFAE ablation group in sinus rhythm [p=0.32]). In subgroup analysis, patients actually treated with the combined PVI+CFAE ablation approach had a significantly better long-term success (25/28; 89%) than patients with still inducible AF who underwent PVI only (22/30;73%; p=0.02). In both groups repeat ablations were performed in 31% (PVI group; 15/48 patients) and 35% (PVI+CFAE group; 17/48 patients) (p=n.s). After 9 months, significantly more patients in the PVI+CFAE group experienced sustained regular atrial tachycardia than in the PVI group (6/44 versus 1/39 patients, P=0.02). Conclusion: The combination of PVI and CFAE ablation was equally effective than PVI alone in reaching freedom of AF in the intention-to-treat analysis. During long-term follow-up, patients actually treated with combined PVI+CFAE ablation had a significantly better outcome (89% vs. 73%). However, the rate of ablation-induced regular atrial tachycardias is inreased.

Self-management of oral anticoagulation reduces major outcomes in the elderly

2008 ◽  
Vol 100 (12) ◽  
pp. 1089-1098 ◽  
Author(s):  
Ivo Rakovac ◽  
Caroline Kleespies ◽  
Brigitte Piso ◽  
Ulrike Didjurgeit ◽  
Andrea Siebenhofer ◽  
...  
Keyword(s):  
Oral Anticoagulation ◽  
The Elderly ◽  
Routine Care ◽  
Self Management ◽  
Bleeding Complications ◽  
Care Group ◽  
Intention To Treat ◽  
Treat Analysis

SummaryAlthough many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N=99) or routine care group (RCG) (N=96).The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 ± 1.2 and 3.0 ± 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p=0.049).

Long-Term Results of the Imatinib GRAAPH-2003 Study in Newly-Diagnosed Patients with De Novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia..

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3080-3080 ◽  
Author(s):  
Aline Tanguy-Schmidt ◽  
Adrienne de Labarthe ◽  
Philippe Rousselot ◽  
Francoise Huguet ◽  
Eric Delabesse ◽  
...  
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Lymphoblastic Leukemia ◽  
Philadelphia Chromosome ◽  
Long Term Results ◽  
Newly Diagnosed ◽  
No Donor ◽  
Good Outcome ◽  
Philadelphia Chromosome Positive

Abstract Abstract 3080 Poster Board III-17 Introduction The combination of imatinib with high-dose chemotherapy has been shown as very promising in patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) by several groups. Reported studies all demonstrated a higher response rate and an improved outcome as compared to the pre-imatinib era, but generally with a short follow-up. This was also observed in our GRAAPH-2003 study with complete remission (CR) rate, 18-month disease-free survival (DFS), and 18-month overall survival (OS) of 96%, 51%, and 65%, respectively (de Labarthe et al. Blood 2007). We report here the long-term results of this study with a longer median follow-up of 46 months. Patients & Methods From 2004 to 2005, 45 patients with newly-diagnosed Ph+ ALL (median age, 45 years; range, 16-59 years; 25 males and 20 female) were included in the GRAAPH-2003 study. Briefly, imatinib was started with HAM consolidation in good early responders (corticosensitive and chemosensitive ALL) or earlier during the induction course in combination with dexamethasone and vincristine in poor early responders. Imatinib was administered until allogeneic (if a matched familial donor or an unrelated donor matched at 9 or 10 of 10 HLA antigens) or autologous (if no donor and a good molecular response) stem cell transplantation (SCT). Results were compared with the results of the previous pre-imatinib LALA-94 trial (Dombret et al. Blood 2002). Results When compared to the former LALA-94 study, 4-year OS and DFS were estimated at 52% (36-66) versus 20% (14-26) (p=0.0001) and 43% (27-58) versus 20% (14-28) (p=0.002) in the GRAAPH versus LALA cohorts, respectively. In the GRAAPH-2003, all the 22 CR patients with a donor may receive allogeneic SCT in first CR. In addition, 10 CR patients without a donor but low post-HAM BCR-ABL level received autologous SCT. No significant differences were observed between the donor and the no-donor groups in terms of OS (55% versus 54% at 4 years; p=0.80) and DFS (47% versus 39% at 4 years; p=0.40). This result was partly explained by the good outcome observed in patients who received autologous SCT. The 4-year OS in the allogeneic SCT, autologous SCT, and no SCT groups were 55%, 80%, and 25%, respectively (auto versus allo, p=0.16; auto versus no SCT, p=0.008; allo versus no SCT, p=0.05). The 4-year DFS in the allogeneic SCT, autologous SCT, and no SCT groups were 47%, 50%, and 25%, respectively (auto versus allo, p=0.91; auto versus no SCT, p=0.27; allo versus no SCT, p=0.17). Overall, 4-year cumulative incidences of relapse and death in CR were estimated at 24% (14-40) and 32% (20-49), respectively, underlying the toxicity of the whole GRAAPH-2003 strategy. Notably, 7 of the 22 allografted patients died in CR, as compared to only 1 of the 10 autografted patients. Conclusion We show here that the beneficial impact of the combination of imatinib with chemotherapy is not transient and is preserved in the long term. Taking into account the good outcome of patients receiving autologous SCT and the toxicity of allogeneic SCT, the place and timing of SCT, as well as the optimal chemotherapy to be delivered with imatinib prior to SCT, must be carefully re-evaluated in further prospective trials. Disclosures Dombret: cejgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Effect of Related and Unrelated Donor Haemopoietic Stem-Cell Transplantation on Outcome In Adults with High Risk Acute Leukemia: An Intention-to-Treat Analysis at a Single Center Institution

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2385-2385
Author(s):  
Maria Teresa Lupo-Stanghellini ◽  
Magda Marcatti ◽  
Milena Coppola ◽  
Barbara Forno ◽  
Cinzia Bitetti ◽  
...  
Keyword(s):  
High Risk ◽  
Outcome Analysis ◽  
Intention To Treat ◽  
Haemopoietic Stem Cell ◽  
The Status ◽  
Haemopoietic Stem Cell Transplantation ◽  
Treat Analysis ◽  
Donor Source

Abstract Abstract 2385 Background. Allogeneic haemopoietic stem cell transplantation (HSCT) is the best therapeutic option for high-risk hematological disease (HRHD), particularly acute myeloid and lymphoblastic leukemia (AML/ALL). A widely application of HSCT is limited by lack of availability of a suitable donor for every candidate patients (pts). In order to offer a donor to every candidate pts, several centers had developed in the last decade alternative strategy of HSCT, such as umbilical cord blood (UCB) or family haploidentical HSCT (haplo-HSCT). With the aim to treat high-risk leukemia in the ideal appropriate time by allogeneic HSCT, we adopted a policy relying upon HLA typing at entry of every pts diagnosed with HRHD, followed, in absence of a MRD, by the prompt activation of the MUD search. Patients lacking a MRD or a MUD at the appropriate timing are proposed for haplo-HSCT. Methods. Here we report an intention-to-treat analysis of alternative donor HSCT at our Institution for pts diagnosed with high risk AML or ALL. Data were obtained from local institutional database. Results. Between Jan-2004 and July-2010 241 pts (median age 48y, r 15–72) with diagnosis of ALL (60 pts; median age 33y, r 15–64; male 39) or AML (181 pts, median age 51y, r 19–72; male 83) were defined as “high risk status” and received an indication to HSCT according to EBMT (European Group for Blood and Marrow Transplantation) and Northern Italy Leukemia Group (NILG, www.nilg.it) recommendations. In the ALL group 3 pts died before proceed to HSCT, 5 pts are waiting for the identification of a donor. Overall, 52/60 (86%) pts underwent HSCT, the status of disease at transplant was of complete remission (CR) for 27 pts, persistence of disease (PD) for 25. In the AML group 6 pts died before proceed to HSCT, 15 pts are waiting for the identification of a donor. Overall, 160/181 (88%) pts underwent HSCT, the status of disease at transplant was of CR for 97 pts, PD 63. Overall 92 pts activated the research of a MUD, 42 proceed to transplant, 7 received a UCB, 26 received a haplo-HSCT due to absence of a suitable donor in the appropriate time frame or failure to met the criteria to engage a MUD donor. The median time from diagnosis to registry activation was 69 days (r 5–876), the median time from activation to transplant 84 days (r 28–348). In the group of pts in CR at transplant, 37 underwent HSCT from a MRD and 36 from a MUD, 4 pts received a UCB and 47 a haplo-HSCT. Seventy-two pts are alive and in CR at last follow-up, 3/72 after a second transplant from a different donor (haplo-HSCT) and 3/72 after chemotherapy and adoptive immunotherapy to treat hematological relapse. Fifty-two pts died and the causes of death were: relapse (27), infection-related (19), graft-versus-host-disease (GvHD; 5), acute myocardial infarction (1). In the group of pts in PD at transplant, 16 underwent HSCT from a MRD and 6 from a MUD, 3 pts received UCB and 63 a haplo-HSCT. Fifteen pts are alive, 14 in CR, 1 pts under adoptive immunotherapy; 1/14 pts received a second transplant from a different donor (haplo-HSCT) to treat hematological relapse. Seventy-three pts died and the causes of death were: relapse (43), infection (23), GvHD (7). Overall, the median survival is 382 days and the median follow-up for pts alive is 548 days. The 1-year overall survival (OS)/transplant related mortality (TRM)/relapse incidence (RI) are 50,76% 26,96% and 40% respectively. For pts transplanted in CR the 1y OS/TRM/RI are 77,2%, 20,01% and 25% respectively. The outcome analysis per donor source (MRD vs MUD vs haplo-HSCT) is comparable (p=ns). For pts transplanted in PD the 1y OS/TRM/RI are 19,7%, 41% and 67% respectively. The outcome analysis per donor source (MRD vs MUD vs haplo-HSCT) shows a trend of lower RI and TRM in the haplo-SCT vs MRD. Conclusion. The policy adopted provided an allogeneic HSCT in > 80% of candidate high-risk acute leukemia patients. No significant differences were registered in outcome for patients transplanted from matched-related, unrelated or family haploidentical donors. Further evaluation and a long-term follow-up will add important evaluation in term of long-term disease control and long-term toxicities. Disclosures: Bonini: MolMed: Consultancy. Bordignon: Molmed: Employment.

scholarly journals ‘New Medicine Service’: supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial

2019 ◽  
Vol 29 (4) ◽  
pp. 286-295 ◽  
Author(s):  
Rachel Ann Elliott ◽  
Matthew J Boyd ◽  
Lukasz Tanajewski ◽  
Nick Barber ◽  
Georgios Gkountouras ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Link Type ◽  
Medicine Service ◽  
Randomised Controlled ◽  
Treat Analysis ◽  
New Medicine Service

ObjectiveTo examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.MethodsPragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective).ResultsUnadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: −£104 (95% CI −£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI −0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of −£113.9 (−1159.4, 683.7). The incremental cost-effectiveness ratio was −£2758/QALY (2.5% and 97.5%: −38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY.ConclusionsAt 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high.Trial registration numberNCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

A Comparison of Balloon-Mounted and Self-Expanding Stents in the Carotid Arteries: Immediate and Long-Term Results of More Than 500 Patients

2003 ◽  
Vol 10 (2) ◽  
pp. 171-181 ◽  
Author(s):  
Michael Henry Wholey ◽  
Mark Henry Wholey ◽  
Walter A. Tan ◽  
Gustave Eles ◽  
Chester Jarmolowski ◽  
...  
Keyword(s):  
Carotid Arteries ◽  
Duplex Ultrasound ◽  
Carotid Stenting ◽  
Neurological Complications ◽  
Long Term Results ◽  
Duplex Scan ◽  
Intention To Treat ◽  
Vessel Patency

Purpose: To compare the rates of neurological complications and restenosis for balloon-mounted (BM) versus self-expanding (SE) stents deployed in the extracranial carotid arteries. Methods: Among 513 patients (312 men; mean age 71.3 years, range 27–91) who underwent carotid artery stent placement, 496 received 520 stents. The patients were followed with periodic duplex ultrasound examinations; angiography was performed whenever the duplex scan identified a >50% stenosis or symptoms warranted investigation. Periproce-dural data on complications were analyzed on an intention-to-treat basis, while intermediate-term neurological complications were compared in stented patients. Results: In the periprocedural period, there were 19 (3.7%) transient ischemic attacks, 10 (1.9%) minor strokes, 6 (1.2%) major strokes, and 8 (1.6%) deaths among the 513 patients. Five (1.0%) of the deaths were related to neurological complications (3.9% all stroke/neurological death rate). Among the 496 patients receiving 247 (48%) BM stents and 273 (52%) SE stents in 518 arteries, the all stroke/neurological death rates were 3.6% and 4.0%, respectively (p>0.05). During a mean follow-up of 20.6 months (range to 5.6 years), the 3-year freedom from all fatal and ipsilateral nonfatal strokes excluding the 30-day periprocedural period was 95.0% for BM stents and 95.2% for SE devices. Vessel patency (>50%) at 3 years was 92.0% in the population: 96.3% for BM stents and 83.7% for SE stents (p=0.0422). Conclusions: The rate of neurological complications following carotid stenting has been relatively low overall, and no differences were found relative to the type of stent deployed. Vessel patency was excellent at 3 years, with slightly better patency in BM stents, but because of their vulnerability to compression, they will not replace SE stents.

Surgical reconstruction for unilateral iliac artery lesions in patients younger than 50 years

VASA ◽  
2011 ◽  
Vol 40 (6) ◽  
pp. 474-481 ◽  
Author(s):  
Radak ◽  
Babic ◽  
Ilijevski ◽  
Jocic ◽  
Aleksic ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Limb Salvage ◽  
Iliac Artery ◽  
Graft Patency ◽  
Long Term Results ◽  
Surgical Reconstruction ◽  
Safe Procedure ◽  
Term Survival

Background: To evaluate safety, short and long-term graft patency, clinical success rates, and factors associated with patency, limb salvage and mortality after surgical reconstruction in patients younger than 50 years of age who had undergone unilateral iliac artery bypass surgery. Patients and methods: From January 2000 to January 2010, 65 consecutive reconstructive vascular operations were performed in 22 women and 43 men of age < 50 years with unilateral iliac atherosclerotic lesions and claudication or chronic limb ischemia. All patients were followed at 1, 3, 6, and 12 months after surgery and every 6 months thereafter. Results: There was in-hospital vascular graft thrombosis in four (6.1 %) patients. No in-hospital deaths occurred. Median follow-up was 49.6 ± 33 months. Primary patency rates at 1-, 3-, 5-, and 10-year were 92.2 %, 85.6 %, 73.6 %, and 56.5 %, respectively. Seven patients passed away during follow-up of which four patients due to coronary artery disease, two patients due to cerebrovascular disease and one patient due to malignancy. Limb salvage rate after 1-, 3-, 5-, and 10-year follow-up was 100 %, 100 %, 96.3 %, and 91.2 %, respectively. Cox regression analysis including age, sex, risk factors for vascular disease, indication for treatment, preoperative ABI, lesion length, graft diameter and type of pre-procedural lesion (stenosis/occlusion), showed that only age (beta - 0.281, expected beta 0.755, p = 0.007) and presence of diabetes mellitus during index surgery (beta - 1.292, expected beta 0.275, p = 0.026) were found to be significant predictors of diminishing graft patency during the follow-up. Presence of diabetes mellitus during index surgery (beta - 1.246, expected beta 0.291, p = 0.034) was the only variable predicting mortality. Conclusions: Surgical treatment for unilateral iliac lesions in patients with premature atherosclerosis is a safe procedure with a low operative risk and acceptable long-term results. Diabetes mellitus and age at index surgery are predictive for low graft patency. Presence of diabetes is associated with decreased long-term survival.

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