Galectin-3, Carotid Plaque Vulnerability, and Potential Effects of Statin Therapy.

OBJECTIVES: Galectin-3, a member of galectines, a family of b-galactoside-specific lectins, has been reported to propagate vascular inflammation. The role of galectin-3 in carotid atherosclerosis is controversial. The aim of this study was to investigate the relationship of galectin-3 with plaque vulnerability in patients with high grade carotid stenosis. METHODS: This was a cross sectional study of patients undergoing carotid endarterectomy (CEA). Carotid plaques obtained from 78 consecutive patients (40 symptomatic [SG], 38 asymptomatic [AG]) undergoing CEA were histologically analyzed for galectin-3, macrophages (CD68) and laminin. Pre-operatively the biochemical profile and plaque echogenicity (gray-scale median, GSM) score were determined. RESULTS: There were no significant differences in clinical and demographic parameters between SG and AG(p > .05). The SG had a lower GSM score (44.21 ± 18.24 vs. 68.79 ± 28.79, p < .001) and a smaller positive stained area for galectin-3 (4.89 ± 1.60% vs. 12.01 ± 5.91%, p < .001) and laminin (0.88 ± 0.71% vs. 3.46 ± 2.12%, p < .001) than the AG. On the other hand, intra-plaque macrophage content was increased in SG (p < .001). For the whole cohort, symptomatic status was independently associated with intra-plaque contents of both galectin-3 (OR=0.634, p < .001), and GSM score (OR=0.750, p < .001). Notably, patients on long term statin treatment had elevated galectin-3 and lowered macrophage intra-plaque concentrations compared with those on short term treatment (p < .05). CONCLUSIONS: A low galectin-3 intra-plaque concentration seems to correlate with clinically and ultrasonically defined unstable human carotid plaques. Long term statin treatment may induce increase of intra-plaque galectin-3 concentration mediating plaque stabilization.

Factors Predisposing to Endograft Limb Occlusion after Endovascular Aortic Repair.

OBJECTIVES: The aim of this study was to investigate risk factors for endograft limb occlusion after endovascular abdominal aneurysm repair (EVAR), using a case control design. METHODS: All patients presenting with endograft limb occlusion after elective EVAR between January 2010 and June 2013, along with age, sex, and type of endograft matched controls were included in the study. The impact of atherosclerotic risk factors, anatomic characteristics of the aneurysm, procedural details, and antiplatelet therapy was investigated. Multivariate logistic regression analysis and conditional logistic regression analysis for 1:3 matched pairs deriving adjusted odds ratios (ORs) with 95% confidence intervals (CIs) in order to detect significant risk factors for endograft limb occlusion among cases and controls were modeled. RESULTS: Of the 439 patients treated by EVAR, 18 patients (4.1%) presented with endograft limb occlusion. These patients were compared to 54 matched controls. Limb occlusion was associated with iliac artery angulation ≥ 60° (OR = 5.76, 95% CI =1.24-26.74; p = .03) or perimeter calcification ≥ 50% (OR =5.87, 95% CI = 1.10-31.32; p = .04). Limb occlusion was also associated with ≥ 15% endograft oversizing in the common iliac artery (OR = 5.54, 95% CI = 1.11-27.60; p = .04). No other risk factors for limb occlusion were recognized. CONCLUSIONS: The presence of significant angulation and calcification of the iliac arteries as well as excessive limb oversizing appear to be independent predictors of endograft limb occlusion after EVAR.

The impact of type 2 diabetes and atorvastatin treatment on serum levels of MMP-7 and MMP-8.

AIM: Novel members of matrix metalloproteinases (MMPs), MMP-7 and MMP-8, have emerged as predictors of cardiovascular events. Our study aimed to evaluate serum MMP-7 and MMP-8 concentrations in patients with type 2 diabetes mellitus (T2DM) and the effects of atorvastatin on them. METHODS: We enrolled 85 statin-free subjects with concomitant T2DM and hypercholesterolemia, but without overt micro-/macro-vascular complications (diabetic group - DG). 42 age- and gender-matched healthy subjects without chronic diseases or therapy served as healthy group (HG). All diabetic patients received fix dose of atorvastatin (20 mg/day). Clinical and anthropometrical parameters, lipids, fasting plasma glucose (FPG), serum MMP-7, MMP-8, their inhibitor (TIMP-1), IL-18, hsCRP and insulin resistance (HOMA-IR) were assayed at baseline in all participants and after 3 months in the DG. RESULTS: At baseline, DG showed higher levels of BMI, systolic blood pressure, insulin resistance and FPG compared to HG (p<0.05). Similarly, DG appeared with elevated concentrations of MMP-7 (4.28±1.01 ng/ml vs 2.63±1.11 ng/ml, p<0.001), MMP-8 (73.07±21.96 ng/ml vs. 21.27±10.49 ng/ml, p<0.001) and inflammatory markers (WBC, hsCRP, IL-18, p<0.010). Importantly, atorvastatin treatment improved lipid profile, significantly reduced the concentrations of MMP-7, MMP-8 and inflammatory markers (p<0.01). Moreover, there was considerable suppression of both MMP-7/TIMP-1 and MMP-8/TIMP-1 ratios (p<0.01). In standard multiple regression analysis, the atorvastatin-induced reduction in MMP-7 was independently associated with LDL and IL-18 downregulation (R(2)=0.648, p=0.017). Similarly, IL-18 changes emerged as an independent determinant of MMP-8 alterations (R(2)=0.678, p=0.007). CONCLUSIONS: Hypercholesterolemic patients with T2DM showed elevated MMP-7 and MMP-8 serum concentrations. Atorvastatin reduced the latter concentrations and their ratio with TIMP-1. Those effects seemed mediated by the atorvastatin-induced suppression of inflammatory mediators. ClinicalTrials.gov Identifier: NCT00636766.

New possibility of AAA treatment with E-vita abdominal device.

The most dramatic shift in the management of abdominal aortic aneurysms (AAAs) occurred in 1991, when the first endovascular AAA repair was reported. Endovascular aneurysm repair has revolutionized the treatment of infrarenal AAAs. In the last few years, the companies have developed renewed models of grafts and have modified delivery systems tending to make them more atraumatic and flexible in order to deal with difficult anatomies and severely atheromatous and tortuous vessels. The aim of the present paper was to analyze the technical characteristics and properties of the new stent-graft system E-vita abdominal XT and to review the current literature. The E-vita abdominal XT stent-graft seems to be safe and reliable; however, long-term results are needed.

Critique of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): flaws in CREST and its interpretation.

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) has been used to support the equivalence of carotid artery stenting (CAS) and carotid endarterectomy (CEA) in the treatment of carotid stenosis in both symptomatic and asymptomatic patients. This inclusion of two different forms of the disease decreased the power and significance of the CREST results and weakened the trial. Other flaws in CREST were the equal weighting of mostly minor myocardial infarctions (MIs) with strokes and death in the peri-procedural, composite 'end' point, but not in the 4-year, long-term 'end' point. Although CAS was associated with 50% fewer peri-procedural MIs compared with CEA, there were >2.5-fold more MIs after CAS than CEA at 4 years. The 4-year MI rate, however, was not a component of the primary 'end' point. Additionally, although the initial CREST report indicated that there was no difference in the outcomes of CAS and CEA according to symptomatic status or sex, subsequent subgroup analyses showed that CAS was associated with significantly higher stroke and death rates than CEA in symptomatic patients, in females and in individuals ≥ 65 years of age. The present article will examine these and other flaws and the details of CREST's results derived from the trial's preplanned subanalyses to show why the claims that CREST demonstrates equivalence of the two therapeutic procedures are unjustified.

The anti-inflammatory effects of exercise training promote atherosclerotic plaque stabilization in apolipoprotein E knockout mice with diabetic atherosclerosis.

Physical exercise is the cornerstone of cardiovascular disease treatment. The present study investigated whether exercise training affects atherosclerotic plaque composition through the modification of inflammatory-related pathways in apolipoprotein E knockout (apoE(-/-)) mice with diabetic atherosclerosis. Forty-five male apoE(-/-) mice were randomized into three equivalent (n=15) groups: control (CO), sedentary (SED), and exercise (EX). Diabetes was induced by streptozotocin administration. High-fat diet was administered to all groups for 12 weeks. Afterwards, CO mice were euthanatized, while the sedentary and exercise groups continued high-fat diet for 6 additional weeks. Exercising mice followed an exercise program on motorized-treadmill (5 times/week, 60 min/session). Then, blood samples and atherosclerotic plaques in the aortic root were examined. A considerable (P<0.001) regression of the atherosclerotic lesions was observed in the exercise group (180.339 ± 75.613 x10(3)µm(2)) compared to the control (325.485 ± 72.302 x10(3)µm(2)) and sedentary (340.188 ± 159.108 x 10(3)µm(2)) groups. We found decreased macrophages, matrix metalloproteinase-2 (MMP-2), MMP-3, MMP-8 and interleukin-6 (IL-6) concentrations (P<0.05) in the atherosclerotic plaques of the exercise group. Compared to both control and sedentary groups, exercise training significantly increased collagen (P<0.05), elastin (P<0.001), and tissue inhibitor of matrix metalloproteinase-2 (TIMP-2) (P<0.001) content in the atherosclerotic plaques. Those effects paralleled with increased fibrous cap thickness and less internal elastic lamina ruptures after exercise training (P<0.05), while body-weight and lipid parameters did not significantly change. Plasma MMP-2 and MMP-3 concentrations in atherosclerotic tissues followed a similar trend. From our study we can conclude that exercise training reduces and stabilizes atherosclerotic lesions in apoE-/- mice with diabetic atherosclerosis. A favorable modification of the inflammatory regulators seems to explain those beneficial effects.

The differential anti-inflammatory effects of exercise modalities and their association with early carotid atherosclerosis progression in patients with type 2 diabetes.

OBJECTIVE: Adipokines, visfatin, apelin, vaspin and ghrelin have emerged as novel cardiovascular risk factors. We aimed to evaluate the effects of different exercise modalities on the aforementioned novel adipokines and carotid intima-media thickness in patients with Type 2 diabetes mellitus. METHODS: One hundred patients with Type 2 diabetes were equivalently (n = 25) randomized into four groups: (1) a control group with patients encouraged to perform self-controlled exercise; (2) a supervised aerobic exercise group (exercise four times/week, 60 min/session, 60-75% of maximum heart rate); (3) a resistance training group (60-80% baseline maximum load achieved in one repetition); and (4) a combined aerobic exercise plus resistance training group, as in groups 2 and 3. All participants had HbA(1c) levels ≥ 48 mmol/mol (≥ 6.5%), without overt diabetic vascular complications. Blood samples, clinical characteristics, peak oxygen uptake and carotid intima-media thickness measurements were obtained at baseline and at the end of the study, after 6 months. RESULTS: At baseline, there were non-significant differences between groups. All active groups significantly ameliorated glycaemic profile, insulin sensitivity and triglycerides levels compared with the control group (P < 0.05). Aerobic training further improved lipids, systolic blood pressure and exercise capacity compared with the resistance training and the control groups (P < 0.05). Moreover, high-sensitivity C-reactive protein and visfatin decreased, while vaspin and apelin circulating levels increased within the aerobic exercise group and the aerobic exercise plus resistance training group, and compared with the other groups (P < 0.05). Within- and between-group comparisons showed negligible alterations in ghrelin serum levels and body weight after all exercise modalities. Finally, aerobic training attenuated the carotid intima-media thickness progression (0.017 ± 0.006 mm) compared with the control subjects (0.129 ± 0.042 mm, P < 0.001). That effect was independently associated with visfatin and amelioration of peak oxygen uptake. CONCLUSIONS: In subjects with Type 2 diabetes, all exercise training modalities improved metabolic profile. Importantly, aerobic training predominantly ameliorated adipokines concentrations and carotid intima-media thickness progression.

Current knowledge on EVAR with the ultra-low profile Ovation Abdominal Stent-graft System.

Endovascular aneurysm repair (EVAR) has revolutionized the treatment of infrarenal abdominal aortic aneurysms (AAAs). The continuous collaboration of surgeons and bioengineers in the improvement of the devices the last two decades, lead to a continuous redesigning and improvement of the various endografts. In the last few years, the majority of companies have developed renewed models of grafts and have modified delivery systems tending to lower profile in order to deal with difficult anatomies. The ultra low profile 14F OD Ovation (Trivascular) Abdominal Stent-graft System with innovative sealing technology achieved through inflatable sealing rings, allows treatment of AAAs with small in diameter access vessels that might be unsuitable for EVAR with other currently available stent-grafts. The aim of the present paper was to analyze the technical characteristics and properties of this endograft and to review the current literature.

The chimney graft technique for preserving renal arteries in stent-graft sealing zones.

Patients with juxtarenal aneurysms require complex surgical open repair, which is associated with increased mortality and morbidity. An alternative procedure that can be used is the "chimney graft" technique. Three cases of abdominal aortic aneurysms were successfully treated in our department with this technique. One type-Ia endoleak occurred which was successfully treated with coiling and biological glue infusion. All of the chimney grafts have remained patent for the period of observation. The "chimney" technique has good results as a bail out procedure in complex EVAR or in well planned difficult cases. Long-term data is necessary to determine the efficacy of this technique.

The European Society for Vascular Surgery guidelines for carotid intervention: an updated independent assessment and literature review.

BACKGROUND AND PURPOSE: Many medical societies now recommend carotid stenting as an alternative to endarterectomy which raises the question of whether the ESVS guidelines are still valid. This review addresses the validity of the ESVS guidelines that refer to carotid stenting based on the evidence available today. METHODS: We conducted a review and meta-analysis based on the original ESVS guidelines paper and articles published over the past 2 years. RESULTS: For symptomatic patients, surgery remains the best option, since stenting is associated with a 61% relative risk increase of periprocedural stroke or death compared to endarterectomy. However, centres of excellence in carotid stenting may achieve comparable results. In asymptomatic patients, there is still no good evidence for any intervention because the stroke risk from an asymptomatic stenosis is very low, especially with the best modern medical treatment. CREST and CAVATAS have verified that mid-term stroke prevention after successful stenting is similar to endarterectomy. EVA-3S, SPACE, ICSS and CREST have provided additional evidence regarding the role of age in choosing therapeutic modality. The role of the cerebral protection devices is challenged by the imaging findings of small randomised trials but supported by large systematic reviews. CONCLUSIONS: The ESVS guidelines that refer to carotid stenting not only remain valid but also have been further strengthened by the latest available clinical data. An update of these guidelines including all of the recent evidence is needed to provide an objective and up-to-date interpretation of the data.

Association between plaque echogenicity and embolic material captured in filter during protected carotid angioplasty and stenting.

OBJECTIVES/DESIGN: The aim of the study was to investigate debris captured in filter embolic protection devices (EPDs) during carotid artery stenting (CAS) and its possible correlation with plaque echogenicity and other risk factors. MATERIALS/METHODS: Between June 2010 and March 2011, 51 consecutive CAS patients (11 females, mean age 71.2 ± 7, 10 symptomatic) who underwent 53 procedures were included in this prospective study. Ultrasonographic Gray-Weale plaque type (I-V, echolucent to echogenic) characterisation was obtained in all cases. The same type of stent and filter EPD was used. Filters were collected and, after macroscopic evaluation, they were examined using the Thin-Prep(®) liquid-based cytology (LBC) technique. RESULTS: Technical success was 100%. Thirty-day stroke and death rates were 1.8% (1/53) and 0%, respectively. Visible debris was detected in eight (15%) filters, whereas LBC revealed the presence of embolic material particles in 30 filters (56.6%). The presence of embolic material into the filter EPD was 2.38-fold increased for every category change from type IV to type I carotid plaques (OR = 2.38, 95%CI = 1.15-4.93). This association remained robust even after adjustment for age, gender and known atherosclerotic disease risk factors (OR = 2.26, 95%CI = 1.02-5.02). In multivariate analysis for risk factors, hypertension was associated with increased presence of embolic material detection in filter EPD (OR = 20.4, 95%CI = 1.28-326.1). The time distance from symptom to CAS was inversely correlated with debris quantity in EPD (Spearman rho -0.716; p = 0.02). CONCLUSIONS: Echolucent plaques, smaller time frame from last symptom and hypertension were associated with increased presence of embolic material.

The critical role of the external carotid artery in cerebral perfusion of patients with total occlusion of the internal carotid artery.

AIM: The ipsilateral external carotid artery (ECA) can potentially provide an important collateral pathway for cerebral blood flow in the presence of occlusion or severe stenosis of the internal carotid artery (ICA), recovering up to 15% of the middle cerebral arterial flow. The aim of the study is to elucidate the role of ECA in cerebral flow of patients with total ICA occlusion. METHODS: Retrospective study of prospectively collected data of 139 patients with total ICA occlusions. The patients were divided to symptomatic and asymptomatic and were categorized in four subgroups according to the stenosis rates: A) ipsilateral ECA<70% and contralateral internal carotid artery stenosis <70%; B) ipsilateral ECA stenosis <70% and contralateral internal carotid artery stenosis ≥70%; C) ipsilateral ECA stenosis ≥70% and contralateral ICA stenosis <70%; D) ipsilateral ECA stenosis ≥70% and contralateral ICA stenosis ≥75%. RESULTS: Fifty eight (41.7%) patients were asymptomatic. The highest rate (48.2%) of asymptomatic patients was in Group A. Among patients with strokes, the highest rate belonged in groups C and D (44.4% and 50% respectively) where ipsilateral ECA stenosis was ≥70% irrespectively of the contralateral ICA patency. Ipsilateral external carotid artery stenosis ≥70% proved to be and independent risk factor for symptom presentation (P=0.013). CONCLUSION: The study reveals the significant role of ECA patency in cerebral flow in patients with ICA occlusion.

Eversion versus conventional carotid endarterectomy: a meta-analysis of randomised and non-randomised studies.

BACKGROUND: To compare eversion (ECEA) and conventional (CCEA) carotid endarterectomy from randomised and non-randomised studies. METHODS: Pooled odds ratios (ORs) with 95% confidence intervals (95%CIs) and numbers needed to treat (NNTs) were appropriately calculated. A sub-analysis was performed on studies directly comparing ECEA vs. patch CEA (PCEA). Meta-regression analysis was performed to examine the effect of potentially meaningful patient-related, procedure-related and definition-related modifiers. Power calculations were also conducted. RESULTS: A total of 21 studies were deemed eligible (8530 ECEA and 7721 CCEA procedures), seven of which were randomised and 14 non-randomised. ECEA was associated with significant reduction in perioperative stroke (OR = 0.46, 95%CI: 0.35-0.62, NNT = 68, 95%CI: 56-96), death (OR = 0.49, 95%CI: 0.34-0.69, NNT = 100, 95%CI: 85-185) and stroke-related death (OR = 0.40, 95%CI: 0.23-0.67, NNT = 147, 95%CI: 115-270); the results were replicated at the sub-analysis on PCEA. Concerning long-term outcomes, ECEA presented with a significant reduction in late carotid artery occlusion (OR = 0.48, 95%CI: 0.25-0.90, NNT = 143, 95%CI: 100-769) and late mortality (OR = 0.76, 95%CI: 0.61-0.94, NNT = 40, 95%CI: 25-167); the sub-analysis on PCEA replicated only the finding on late mortality. Meta-regression analysis did not point to significant effects mediated by the examined modifiers. Power calculations suggested adequate statistical power. CONCLUSIONS: ECEA compared to CCEA may be associated with a lower incidence in both short-term and long-term outcomes, which does not seem to be hampered by potentially meaningful modifiers.

Open or endovascular repair of aortoenteric fistulas? A multicentre comparative study.

OBJECTIVES: To compare aortoenteric fistula (AEF) outcome after endovascular (EV-AEFR) or open repair (O-AEFR). DESIGN: Multicentre retrospective comparative study. MATERIALS/METHODS: 25 patients with AEF (24 secondary, 23 males, median age 75 years) after aortic surgery (median four years). Preoperative sepsis was evident in 19 cases. Eight patients were managed with EV-AEFR and 17 with O-AEFR. RESULTS: The two groups were comparable in preoperative characteristics. In-hospital mortality after EV-AEFR was lower compared to O-AEFR (0% and 35%, respectively, p = 0.13). Similarly, morbidity after EV-AEFR was lower compared to O-AEFR (25% and 77%, respectively, p = 0.028). There was a trend for worse recurrence-free, sepsis-free, re-operation-free and AEF-related death-free rates after EV-AEFR, while the early survival advantage of EV-AEFR was lost after two years and the overall long-term survival rates (perioperative mortality included) of the two groups were similar. Preoperative sepsis had no effect on recurrence and sepsis-free rates (p = 0.94 and p = 0.92, respectively), but it was associated with worse two year overall survival (24% vs 50%, p = 0.32). On multivariate analysis, the number of symptoms (two vs one) at presentation was the single predictor of worse re-operation rates, AEF-related and overall survival. CONCLUSIONS: EV-AEFR was associated with no postoperative mortality in this study and can achieve satisfactory short and long-term results, comparable to O-AEFR. Further trials should focus on the role of EV-AEFR in patients at high risk for O-AEFR, due to shock or co-morbidities, or as a bridging procedure.

Vascular surgery training and its relationship to other surgical specialties.

During the last 50 years vascular surgery has met an enormous evolution, paving the way for the development of modern vascular and endovascular surgery. Although, vascular surgery (VS) has emerged from general (GS) and cardiothoracic surgery (CTS), the need for specialized training has been recognized and gradually practice patterns are shifting towards vascular independence, but yet not in all countries. In these countries VS training is either permitted only after prerequisite GS certification, or as a non accredited surgical specialty, VS might be included in GS or CTS training and certification. Such a policy raises two main issues: the efficiency of vascular training within the GS or CTS curricula and the performance of vascular interventions by general or cardiothoracic surgeons. Meanwhile, the explosion of endovascular procedures has brought new disciplines into play, each one wanting to maintain its stake in the future. Interventional radiologists and a significant number of cardiologists become increasingly involved in the treatment of vascular diseases. The question of which specialist among those qualified should carry out medical treatment, open, and endovascular procedures is still suspended. Under this prism, vascular training issues arise as an important component of the future of vascular surgeons.

Heparin-induced thrombocytopenia: what a vascular surgeon needs to know.

The use of unfranctioned heparin and low molecular weigh heparins is very common in general medical practice and moreover in angiology and vascular surgery. Heparin-induced thrombocytopenia is a rare, yet catastrophic complication, with an incidence of 1-5% of patients receiving heparin therapy. Clinical presentation may include deep vein thrombosis, pulmonary embolism, arterial thrombosis, and skin lesions. Hemorrhage may also be present as a result of thrombocytopenia. Current diagnostic criteria include clinical scoring systems as well as laboratory tests for the identification of the specific antibodies. Efficient new alternative anticoagulant agents have been developed and are currently indicated for the treatment of such patients. The syndrome curies up to 53% thrombosis risk in untreated patients, and 28% mortality risk in patients complicated with thrombosis. This article aims in a comprehensive review of the literature for newly emerged data in the pathogenesis, diagnosis and management of heparin-induced thrombocytopenia.

Effects of rosiglitazone/metformin fixed-dose combination therapy and metformin monotherapy on serum vaspin, adiponectin and IL-6 levels in drug-naïve patients with type 2 diabetes.

OBJECTIVE: Vaspin, adiponectin and interleukin-6 (IL-6) constitute novel adipose-tissue derivatives, known as adipokines, which mediate insulin resistance. The aim of the present study was to evaluate the effects of metformin and rosiglitazone on serum levels of those novel adipokines in drug-naïve patients with type 2 diabetes mellitus (T2DM). METHODS: 140 patients with T2DM, already treated with diet, but without adequate glycemic control (HbA1c > 7%), were randomly assigned to: RSG+MET group, (n = 70): Combination therapy with fixed dose of 4 mg rosiglitazone plus 500 mg metformin. MET group, (n = 70): Half-maximum dose of metformin monotherapy (1 700 mg/day). Before and after 6-month treatment, body-mass index (BMI), blood pressure (BP), fat-mass, fasting plasma glucose (FPG), HbA1c, insulin resistance indexes (HOMA-IR, insulin), lipids, high-sensitivity CRP (hsCRP), vaspin, adiponectin, and interleukin-6 (IL-6) were measured. RESULTS: Glucose regulation and insulin resistance were equivalently improved from baseline within both groups (p < 0.05). There was a considerable amelioration of hsCRP, WBC, adiponectin, IL-6, systolic and diastolic BP with rosiglitazone/metformin combined treatment as compared to baseline (p < 0.05) and MET group (p < 0.05). In contrast, metformin monotherapy significantly reduced BMI (p < 0.001), total-cholesterol (p = 0.012) and LDL (p = 0.020) levels compared to RSG+MET group. Importantly, serum vaspin concentration was equivalently decreased from baseline in both RSG+MET (-0.96 ± 0.75 ng/ml, p < 0.001) and MET (-0.92 ± 0.57 ng/ml, p=0.001) group. The aforementioned vaspin changes correlated with changes in WHR, HbA1c, FPG, HOMA-IR, insulin, IL-6 (only in the RSG+MET group) and fat-mass. In standard multiple regression analysis, FPG, HbA1c, HOMA-IR and insulin remained independent determinants of serum vaspin levels changes (R² = 0.836, p = 0.004). CONCLUSIONS: Both rosiglitazone/metformin combination therapy and metformin monotherapy decreased serum vaspin levels through glucose and insulin sensitivity regulation, while they exerted differential effects on adiponectin, IL-6 and other cardiovascular risk factors in drug-naïve patients with T2DM.