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Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease Bibombe P. Mwipatayi, MMed (Surg), FCS (SA), FRACS, Surabhi Sharma, MBBS, Ali Daneshmand, MD, Shannon D. Thomas, BMedSc, FRACS, Vikram Vijayan, MRCS, FRCS, Nishath Altaf, PhD, FRCS, Marek Garbowski, MB BS, FRACS, Mark Jackson, MD, FRACS Dr Glen Benveniste, A/Prof Michael Denton, Dr John Anderson, Dr Steve Dubenec, Dr Michael Neale, Dr Vikram Puttaswamy, Prof John Fletcher Bibombe P. Mwipatayi, MMed (Surg), FCS (SA), FRACS, Surabhi Sharma, MBBS, Ali Daneshmand, MD, Shannon D. Thomas, BMedSc, FRACS, Vikram Vijayan, MRCS, FRCS, Nishath Altaf, PhD, FRCS, Marek Garbowski, MB BS, FRACS, Mark Jackson, MD, FRACS Dr Glen Benveniste, A/Prof Michael Denton, Dr John Anderson, Dr Steve Dubenec, Dr Michael Neale, Dr Vikram Puttaswamy, Prof John Fletcher Journal of Vascular Surgery Volume 64, Issue 1, Pages e1 (July 2016) DOI: /j.jvs Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 1 Kaplan-Meier curve of overall primary patency rates of both stent groups. The overall patency rate was 74.7% in the covered stent (CS) group vs 62.9% in the bare-metal stent (BMS) group at 60 months of follow-up (log-rank test, P = .01). n at risk, Number of stents at risk of severe restenosis. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 2 Kaplan-Meier curve of assisted primary patency rates of both stent groups. The overall patency rate was 83.7% in the covered stent (CS) group vs 76.1% in the bare-metal stent (BMS) group at 60 months of follow-up (log-rank test, P = .017). n at risk, Number of stents at risk of severe restenosis. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 3 Kaplan-Meier curve of secondary patency rates of both stent groups. The overall patency rate was 96.3% in the covered stent (CS) group vs 87.3% in the bare-metal stent (BMS) group at 60 months of follow-up (log-rank test, P = .033). n at risk, Number of stents at risk of severe restenosis. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 4 a, Kaplan-Meier curve of primary patency for TransAtlantic Inter-Society Consensus (TASC) B lesion. Kaplan-Meier survival estimates showed that there was no significant difference between the stent types used in TASC B lesions (hazard ratio [HR], 1.663; 95% confidence interval [CI], ; P = .197). b, Kaplan-Meier curve of primary patency for TASC C/D lesion. The Kaplan-Meier survival estimates showed a statistically significant benefit when a covered stent (CS) was used in TASC C and D lesions compared with a bare-metal stent (BMS; HR, 3.302; 95% CI, ; P = .003) in terms of the primary patency. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 5 a, Kaplan-Meier curve of assisted primary patency for TransAtlantic Inter-Society Consensus (TASC) B lesion. Subgroup analysis of assisted primary patency between both groups according to classification showed no statistically significant difference (hazard ratio [HR], 2.101; P = .146) for TASC B lesion. b, Kaplan-Meier curve of assisted primary patency for TASC C/D lesion. Subgroup analysis of assisted primary patency between both groups according to classification showed no statistically significant difference (HR, 3.614; P = .057) for TASC C and D lesions. BMS, Bare-metal stent. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 6 a, Kaplan-Meier curve of secondary patency for TransAtlantic Inter-Society Consensus (TASC) B lesion. Analysis of secondary patency demonstrated no statistically significant difference between the stent types for patients with TASC B lesions (hazard ratio [HR], 2.359; P = .125). b, Kaplan-Meier curve of secondary patency for TASC C/D lesion. Analysis of secondary patency was statistically significant in TASC C and D lesions (HR, 5.959; P = .015). BMS, Bare-metal stent. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 7 Receiver operating characteristic (ROC) curves for factors interacting with primary patency. Null hypothesis is defined as a true area = 0.5 (significant at P < .05). The ROC assessment for each risk factor affecting primary patency confirmed that only the type of stent used and Rutherford-Becker classification were significant factors. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 8 Receiver operating characteristic (ROC) curves for factors affecting secondary patency. Null hypothesis is defined as a true area = 0.5 (significant at P < .05). The ROC assessment for each risk factor affecting the overall adjusted secondary patency showed that only the stent type used, Rutherford-Becker classification, and smoking had statistically significant ROC values, with areas under the curve (AUCs) > 0.5 and P values < .05. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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Fig 9 Kaplan-Meier curve of overall mortality rates of patency according to stent type allocation. The overall mortality rate per stent type allocation was 19.5% (16 patients) for the Advanta V12 stent group and 23.5% (19 patients) for the bare-metal stent (BMS) group at 84-month follow-up (log-rank test, P = .524). Cumulative event*, Number of patients who had died per stent type allocation added at each follow-up period. Journal of Vascular Surgery , e1DOI: ( /j.jvs ) Copyright © 2016 Society for Vascular Surgery Terms and Conditions
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