Collagen- versus gelatine-coated Dacron versus stretch PTFE bifurcation grafts for aortoiliac occlusive disease: Long-term results of a prospective, randomized multicenter trial

Prager, Manfred; Hoblaj, T.; Nanobashvili, J.; Sporn, Emanuel; Polterauer, P; Wagner, Otto; Böhmig, H. J.; Teufelsbauer, H.; Ploner, Meinrad; Huk, Ihor

doi:10.1067/msy.2003.179

Cited by 58 publications

(21 citation statements)

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“…1 The study, however, included not only femoropopliteal but also femorofemoral, 4,5 axillofemoral, 5 and aortoiliac 6 bypass grafting. It also did not meta-analyze RCTs of femoropopliteal bypass grafting exclusively.…”

mentioning

confidence: 99%

A contemporary meta-analysis of Dacron versus polytetrafluoroethylene grafts for femoropopliteal bypass grafting

Takagi

Goto

Matsui

et al. 2010

Journal of Vascular Surgery

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mentioning

confidence: 99%

A contemporary meta-analysis of Dacron versus polytetrafluoroethylene grafts for femoropopliteal bypass grafting

Takagi

Goto

Matsui

et al. 2010

Journal of Vascular Surgery

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“…75 During OR the aneurysmal portion of the aorta is replaced with a graft, usually made of DACRON ® (Invista™, Wichita, KA, USA) or polytetrafluoroethylene. 76 The graft is sutured within the aorta. The DACRON is anastomosed to the aortic neck and either to the aortic bifurcation below (tube graft) or to the two iliac arteries (bifurcation device).…”

Section: Open Surgical Repairmentioning

confidence: 99%

The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis

Patel

Powell

Sweeting

et al. 2018

Health Technol Assess

103

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BackgroundShort-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years.ObjectiveTo assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention.DesignTwo national, multicentre randomised controlled trials: EVAR-1 and EVAR-2.SettingPatients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004.ParticipantsMen and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1 : 1 to either EVAR (n = 626) or OR (n = 626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (n = 197) or no intervention (n = 207) in EVAR-2. There was no blinding.InterventionsEVAR, OR or no intervention.Main outcome measuresThe primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness.ResultsIn EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 1.27;p = 0.14]. At 0–6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0.61, 95% CI 0.37 to 1.02 for total mortality; HR 0.47, 95% CI 0.23 to 0.93 for aneurysm-related mortality;p = 0.031), but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality (adjusted HR 1.25, 95% CI 1.00 to 1.56,p = 0.048 for total mortality; HR 5.82, 95% CI 1.64 to 20.65,p = 0.0064 for aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture, with increased cancer mortality also observed in the EVAR group. Overall, aneurysm reintervention rates were higher in the EVAR group than in the OR group, 4.1 and 1.7 per 100 person-years, respectively (p < 0.001), with reinterventions occurring throughout follow-up. The mean difference in costs over 14 years was £3798 (95% CI £2338 to £5258). Economic modelling based on the outcomes of the EVAR-1 trial showed that the cost per quality-adjusted life-year gained over the patient’s lifetime exceeds conventional thresholds used in the UK. In EVAR-2, patients died at the same rate in both groups, but there was suggestion of lower aneurysm mortality in those who actually underwent EVAR. Type II endoleak itself is not associated with a higher rate of mortality.LimitationsDevices used were implanted between 1999 and 2004. Newer devices might have better results. Later follow-up imaging declined, particularly for OR patients. Methodology to capture reinterventions changed mainly to record linkage through the Hospital Episode Statistics administrative data set from 2009.ConclusionsEVAR has an early survival benefit but an inferior late survival benefit compared with OR, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. EVAR does not prolong life in patients unfit for OR. Type II endoleak alone is relatively benign.Future workTo find easier ways to monitor sac expansion to trigger timely reintervention.Trial registrationCurrent Controlled Trials ISRCTN55703451.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and the results will be published in full inHealth Technology Assessment; Vol. 22, No. 5. See the NIHR Journals Library website for further project information.

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“…Thus the AIOD patients were excluded and analysed separately [7]. Nevertheless, the AAA patients include some with additional occlusive disease.…”

Section: Methodsmentioning

confidence: 99%

Dacron grafts dilate more than Stretch PTFE grafts after abdominal aortic aneurysm repair – long-term results of a prospective randomized trial

et al. 2008

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Dacron-Prothesen haben eine größere Dilatationsneigung als Stretch-PTFE-Prothesen als Ersatz beim abdominellen AortenaneurysmaLangzeitergebnisse einer prospektiv randomisierten Studie Zusammenfassung. Grundlagen: Wir analysieren die Langzeitergebnisse einer prospektiv randomisierten Multizenterstudie, bei der Patienten mit abdominellen Aortenaneurysmen mit gelatin-beschichteten DoppelVelour-Dacronprothesen (GEL-D), kollagen-beschichteten Doppel-Velour-Dacronprothesen (COL-D) oder Stretch-PTFE-Bifurkationsprothesen behandelt wurden. Das Dilatationsverhalten der Prothesen wird mittels Computertomographie evaluiert.Methodik: Zwischen 1991 und 1998 wurden 164 Patienten nach Alter, Geschlecht, Diabetes, Abfluss und Nikotinabusus randomisiert. 55 Patienten erhielten GEL-D, 51 COL-D und 58 Stretch-PTFE-Prothesen. Bei 30 Patienten wurde eine Computertomographie zur Evaluierung des Dilatationsverhaltens der Prothese durchgeführt.Ergebnisse: Die mediane Nachbeobachtungszeit war 77 Monate. Es fanden sich keine statistisch signifikanten Unterschiede zwischen den drei Gruppen hinsichtlich medianem Patientenüberleben und Offenheitsraten der Prothesen. Die primäre Offenheitsraten war 98% in der PTFE, 94% in der COL-D und 92% in der GEL-D Gruppe (p ¼ 0,4). In 30 Patienten wurde mit einer medianen Nachbeobachtungszeit von 61 Monaten eine Computertomographie durchgeführt und hierbei eine signifikant geringere Dilatationsneigung bei PTFE-Prothesen festgestellt. Der mittlere Durchmesser im Bereich des Prothesenkörpers war 110% AE 25% bei PTFE, 132% AE 12% bei GEL-D und 131% AE 9% bei COL-D-Prothesen verglichen mit der auf der Verpackung angegebenen Ausgangsgröße.Schlussfolgerungen: Trotz einer geringeren Dilatationsneigung der Stretch-PTFE-Prothesen sind die 3 unterschiedlichen Materialien gleichwertig hinsichtlich Funktion und Komplikationsraten in der Langzeitbeobachtung.Summary. Background: In this long-term follow-up of a prospective randomized multicentric trial, warp-knitted gelatin-coated double-velour Dacron (GEL-D), warp-knitted collage-coated double-velour Dacron (COL-D) and stretch PTFE bifurcation grafts implanted in patients with abdominal aortic aneurysms (AAA) were compared for their long-term results and their dilatation was evaluated by CT.Method: Between 1991 and 1998, 164 AAA patients were prospectively randomized and stratified for age, gender, diabetes, run-off and nicotine consumption. Of these, 55 received GEL-D grafts, 51 COL-D grafts and 58 stretch PTFE grafts. Thirty of them underwent follow-up CT (Computerized Tomography) and graft dilatation was evaluated.Results: The median follow-up time was 77 months. No significant differences were found between the 3 graft materials in median survival and patency rates. The primary 8-year patency rate was 98% for PTFE, 94% for COL-D and 92% for GEL-D (p ¼ 0.4). In 30 patients who had CT scan at a median follow-up at 61 months, graft dilatation 66 2/2008 Dacron grafts dilate more than Stretch PTFE grafts after abdominal aortic aneurysm repair Eur SurgOriginal Scientif...

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Collagen- versus gelatine-coated Dacron versus stretch PTFE bifurcation grafts for aortoiliac occlusive disease: Long-term results of a prospective, randomized multicenter trial

Cited by 58 publications

References 18 publications

A contemporary meta-analysis of Dacron versus polytetrafluoroethylene grafts for femoropopliteal bypass grafting

A contemporary meta-analysis of Dacron versus polytetrafluoroethylene grafts for femoropopliteal bypass grafting

The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis

Dacron grafts dilate more than Stretch PTFE grafts after abdominal aortic aneurysm repair – long-term results of a prospective randomized trial

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