PURPOSE: The newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder. MATERIALS AND METHODS: A retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death. RESULTS: Primary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18–26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34). CONCLUSION: The initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.
Aneurysm ; Aortic Aneurysm ; Aortic Aneurysm, Abdominal* ; Blood Vessel Prosthesis* ; Case-Control Studies* ; Contrast Media ; Endoleak ; Follow-Up Studies ; Freedom ; Humans ; Neck ; Prospective Studies ; Research Design ; Retrospective Studies ; Stents* ; Transplants

BACKGROUND: Ezetimibe-statin combination therapy has been found to reduce low density lipoprotein cholesterol levels and the risk of major adverse cardiovascular events (MACEs) in large trials. We sought to examine the differential effect of ezetimibe on MACEs when added to statins according to the presence of diabetes. METHODS: Randomized clinical trials with a sample size of at least 50 participants and at least 24 weeks of follow-up that compared ezetimibe-statin combination therapy with a statin- or placebo-controlled arm and reported at least one MACE, stratified by diabetes status, were included in the meta-analysis and meta-regression. RESULTS: A total of seven trials with 28,191 enrolled patients (mean age, 63.6 years; 75.1% men; 7,298 with diabetes [25.9%]; mean follow-up, 5 years) were analysed. MACEs stratified by diabetes were obtained from the published data (two trials) or through direct contact (five trials). No significant heterogeneity was observed among studies (I 2=14.7%, P=0.293). Ezetimibe was associated with a greater reduction of MACE risk in subjects with diabetes than in those without diabetes (pooled relative risk, 0.84 vs. 0.93; P heterogeneity=0.012). In the meta-regression analysis, the presence of diabetes was associated with a greater reduction of MACE risk when ezetimibe was added to statins (β=0.87, P=0.038). CONCLUSION: Ezetimibe-statin combination therapy was associated with greater cardiovascular benefits in patients with diabetes than in those without diabetes. Our findings suggest that ezetimibe-statin combination therapy might be a useful strategy in patients with diabetes at a residual risk of MACEs.
Arm ; Cholesterol, LDL ; Diabetes Mellitus ; Ezetimibe ; Follow-Up Studies ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Male ; Myocardial Infarction ; Population Characteristics ; Sample Size ; Stroke