Agreement of duplex ultrasonography vs. computed tomography angiography for evaluation of native and in-stent SFA re-stenosis--findings from a randomized controlled trial.

BACKGROUND: Multidetector CT angiography (CTA) is a non-invasive imaging technique for evaluation of peripheral vascular disease. CTA might be particularly useful for assessment of intermediate- and long-term morphological outcome after endovascular treatment. Validation of CTA vs. the current imaging standard, colour Doppler ultrasonography (CDUS), for quantification of native and in-stent re-stenosis in the superficial femoral artery (SFA) is required. METHODS: Seventy randomized patients who underwent stent implantation (n=47) or balloon angioplasty (n=23) underwent 6-month follow-up with CDUS and CTA. CTA was compared with CDUS in both sub-groups of patients in terms of binary re-stenosis (>50% lumen narrowing) and re-occlusion. Agreement between CTA and CDUS was assessed using Kappa (κ) statistics with 95% confidence intervals, and correlation coefficients. RESULTS: Binary re-stenosis was detected in 16/70 (22.9%) patients by CTA and 17/70 (24.3%) patients by CDUS (κ=0.88, 95% CI: 0.80-0.96). Re-stenosis rates after balloon angioplasty were 39.1% (9/23) on CTA and CDUS (κ=0.82, 95% CI: 0.66-0.98), and after stent implantation 14.9% (7/47) on CTA and 17.0% (8/47) on CDUS (κ=0.92, 95% CI: 0.84-1.00). Re-occlusions were detected in 3/70 (4.3%) patients by both CTA and CDUS (κ=0.65; 95% CI 0.54-0.76). Significant correlations (r=0.85, p<0.001) were noted between degree of re-stenosis on CTA and peak velocity ratio on CDUS. The correlation coefficient was higher in patients after balloon angioplasty (r=0.94, p<0.001) than in patients after stent implantation (r=0.71, p<0.001). CONCLUSION: CTA and CDUS show excellent agreement for evaluation of native and in-stent re-stenosis after endovascular treatment of SFA obstructions. CTA is an appropriate non-invasive imaging modality for follow-up after endovascular therapy.

Cystatin C and the risk for cardiovascular events in patients with asymptomatic carotid atherosclerosis.

BACKGROUND AND PURPOSE: Renal dysfunction is a risk factor for cardiovascular events in patients with atherosclerosis. Unlike serum creatinine or estimated glomerular filtration rate, cystatin C reflects renal dysfunction independent of factors such as sex, weight, and race. We investigated whether baseline serum levels of cystatin C predict major cardiovascular events in patients with asymptomatic carotid atherosclerosis and compared the predictive value of cystatin C to these established markers of renal function. METHODS: We prospectively studied 1004 of 1286 consecutive patients with carotid ultrasound scanning. Patients were followed for the occurrence of major cardiovascular events, a composite of myocardial infarction, percutaneous coronary intervention, coronary bypass graft, stroke, and death. RESULTS: During a median of 3 years of follow-up, we recorded 346 major cardiovascular events in 311 patients. The risk for a first major cardiovascular event increased significantly with increasing quintiles of cystatin C; hazard ratios ranged from 1.18 to 1.94 for the highest versus the lowest quintile (P<0.001 for trend). Creatinine levels showed no significant association with major cardiovascular events, and for glomerular filtration rate, only the lowest quintile was moderately associated with adverse cardiovascular outcome. CONCLUSIONS: Cystatin C was significantly and gradually associated with future cardiovascular events in patients with carotid atherosclerosis. In contrast, neither serum creatinine nor estimated glomerular filtration rate were significant predictors of adverse cardiovascular outcomes.

Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions.

BACKGROUND: Recent randomized trials investigating stent implantation compared with balloon angioplasty for treatment of superficial femoral artery (SFA) disease have given divergent results in short (mean 5 cm) and intermediate (mean 10 cm) lesions. We reinvestigated whether primary nitinol stenting is associated with a morphologic and clinical benefit when compared with percutaneous transluminal angioplasty with optional stenting (PTA) in intermediate-length lesions. METHODS: We randomly assigned 73 patients with severe claudication or chronic limb ischemia and average 8 cm long (range 3-20 cm) SFA stenosis or occlusion to primary stent implantation (n = 34) or PTA (n = 39). Restenosis >50% and clinical outcome were assessed at 3, 6, and 12 months postintervention. RESULTS: Average length of the treated segments was 98 + or - 54 mm and 71 + or - 43 mm in the stent and PTA groups (P = 0.011), respectively. In the PTA group, secondary stenting was performed in 10 of 39 patients (26%) due to a suboptimal result after balloon dilation. Restenosis rates in the stent and PTA groups were 21.9% versus 55.6% (P = 0.005) at 6 months by CT-angiography, and 2.9% versus 18.9% (P = 0.033), 18.2% versus 50.0% (P = 0.006), and 34.4% versus 61.1% (P = 0.028) at 3, 6, and 12 months by sonography, respectively. Clinically, patients in the stent group reported a significantly higher maximum walking capacity compared with the PTA group at 6 and 12 months. CONCLUSION: In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.

Inflammation and adverse cardiovascular outcome in patients with renal artery stenosis and peripheral artery disease.

OBJECTIVES: We hypothesized that high sensitivity C-reactive protein (hs-CRP) and the presence of renal artery stenosis (RAS) might conjointly predict future major adverse cardiovascular events (MACE) in patients with peripheral artery disease (PAD). BACKGROUND: Clinical outcome in PAD is determined by the extent of atherosclerosis affecting additional vascular beds and the activity of the atherosclerotic process reflected by inflammatory serum markers. Data on the predictive value of hs-CRP on outcome in PAD patients with RAS is limited. METHODS: We prospectively enrolled 447 PAD patients who were admitted to our institution for angioplasty. Preintervention hs-CRP was assessed and renal angiograms were obtained. Patients were then followed clinically for the occurrence of MACE for median 15.6 months. Serum creatinine was obtained in all patients at 12 months. RESULTS: Incidental RAS >or=60% at baseline was found in 68 patients (15.2%), MACE were recorded in 111 patients during follow-up. Hs-CRP was significantly associated with the occurrence of MACE (p<0.001) and with 12 months creatinine levels (p=0.005). Adjusted hazard ratios for MACE for increasing quartiles of hs-CRP as compared to the lowest quartile were 1.11 (95% CI 0.53-2.35), 1.06 (95% CI 0.50-2.26) and 2.79 (95% CI 1.47-5.28). Analyzing joint effects of hs-CRP and RAS, we observed no significant interaction. CONCLUSION: Hs-CRP predicts cardiovascular and renal outcome in PAD patients irrespective of the presence of RAS. Patients with hs-CRP levels above 0.88 mg/dL were at particularly high risk for MACE.

Access site management after peripheral percutaneous transluminal procedures: Neptune pad compared with conventional manual compression.

PURPOSE: To investigate the safety and efficacy of the procoagulant wound dressing Neptune Pad (Biotronik, Berlin, Germany) compared with those of conventional manual compression for access site management after peripheral percutaneous interventions. MATERIALS AND METHODS: The study was approved by the institutional ethics committee, and all patients gave written informed consent. Two hundred one consecutive patients were enrolled and were randomly assigned to be treated with the Neptune Pad (n = 100) or conventional manual compression (n = 101). Patients were followed up clinically until hospital discharge and with duplex ultrasonography at 24 hours after the procedure to evaluate occurrence of access site complications. Time to hemostasis and time to ambulation were recorded, and patient and physician discomfort were measured by using a visual analogue scale. RESULTS: The risk for access site complications was not significantly different between the Neptune Pad group and the conventional compression group (adjusted odds ratio, 1.15; 95% confidence interval: 0.47, 2.84; P = .76). Time to hemostasis was marginally reduced in the Neptune Pad group. Patient and physician discomfort were lessened with use of the device. CONCLUSION: The hemostatic device Neptune Pad does not improve the safety of access site management after peripheral percutaneous procedures. Markedly improved comfort was noted among patients in the Neptune Pad group and by the physicians obtaining hemostasis.

Complications after peripheral vascular interventions in octogenarians.

PURPOSE: To investigate the incidence of complications after peripheral vascular interventions in patients aged 80 years and older compared to patients below the age of 80. METHODS: During a 20-month period, 619 consecutive patients (354 men; mean age 67 years, range 59-87) undergoing balloon angioplasty and stenting for lower limb revascularization were enrolled in the study. The incidence of procedure-related, access-site, and major complications within 30 days post intervention were recorded and compared between patients aged 80 years and older (n=72, 11.6%) and those under 80 years of age. RESULTS: Complication rates were significantly higher in octogenarians compared to patients below 80 years, including the rates of overall complications (18.1% versus 8.5%, p=0.010), major complications (11.1% versus 1.8%, p<0.001), all access site complications (12.5% versus 4.9%, p=0.009), and access site bleeding complications (12.5% versus 2.2%, p<0.001). By multivariable analysis, octogenarians had a 2.49-fold increased adjusted risk (95% CI 1.10 to 5.65, p=0.029) for any postintervention complication and a 10.99-fold increased adjusted risk (95% CI 2.76 to 45.74, p=0.001) for major complications compared to patients below 80 years. No specific risk factor for complications or major complications within the octogenarian population could be identified. CONCLUSION: Patients aged 80 years and older have a dramatically increased risk, particularly for major complications, after peripheral vascular interventions. Identification of risk factors and development of preventive strategies are urgently needed to improve procedure safety in this extremely vulnerable population.

Increasing carotid plaque echolucency is predictive of cardiovascular events in high-risk patients.

PURPOSE: Carotid plaque echolucency seen at ultrasonography (US) is a potential indicator of plaque instability and may help identify patients at risk for major adverse cardiovascular events (MACEs). The authors performed this study to determine whether decreasing gray-scale median (GSM) levels at repeat carotid US examinations are associated with future MACEs. MATERIALS AND METHODS: The study was approved by the institutional ethics committee and all patients provided informed consent. The authors prospectively studied 574 patients with carotid plaques of at least 30% from a group of 1268 consecutive patients who were initially asymptomatic with respect to carotid disease. GSM levels were determined with carotid US at baseline and after a median of 7.5 months (range, 6-9 months), and the mean change of the GSM was calculated. Patients were then followed up clinically for a median of 3.2 years for the occurrence of composite MACE. RESULTS: During the initial period, the median change in carotid GSM was 2.9 (interquartile range [IQR], -6.9 to 11.0). Of 574 study participants, 230 (40%) showed a reduction of GSM levels and 344 (60%) showed an increase. MACEs were observed in 177 (31%) of the 574 patients. Adjusted hazard ratios for the lowest quartile (GSM change less than -6.9), the second quartile (GSM change between -6.9 and 2.9), and the third quartile (GSM change between 3.0 and 11.0) were 1.71 (95% confidence interval [CI]: 1.09, 2.66), 1.36 (95% CI: 0.86, 2.16), and 1.22 (95% CI: 0.77, 1.95), respectively, compared with the highest quartile (GSM change greater than 11.0) (P = .018). CONCLUSION: Increasing echolucency of carotid artery plaques within a 6- to 9-month interval is predictive of midterm clinical adverse events of atherosclerosis.

Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience.

PURPOSE: To prospectively determine whether cutting balloon angioplasty, when compared with conventional balloon angioplasty (CBA), improves morphologic and clinical outcome in patients with femoropopliteal in-stent restenosis. MATERIALS AND METHODS: Patients with symptomatic femoropopliteal in-stent restenosis were randomly assigned to undergo CBA or peripheral cutting balloon angioplasty (PCBA) for treatment of lesions up to 20 cm in length. Patients were followed up clinically and with duplex ultrasonography (US) at 1, 3, and 6 months for occurrence of a restenosis of 50% or higher. The Fisher exact test and Mann Whitney U test were used for statistical analyses. RESULTS: Forty patients were enrolled; one patient was lost to follow-up. In the remaining patients, CBA was performed in 22 patients; PCBA was used in 17 patients. Average lesion length was 80 mm +/- 68 (standard deviation). Restenosis rates at 6 months were 65% (11 of 17; 95% confidence interval: 42%, 88%) after PCBA versus 73% (16 of 22; 95% confidence interval: 54%, 92%) after CBA (P = .73). Ankle brachial index (0.83 vs 0.75, P = .26) and maximum walking capacity on the treadmill (117 m vs 103 m, P = .97) at 6 months were also not significantly different between the two groups. CONCLUSION: PCBA failed to prove superiority compared with CBA for treatment of femoropopliteal in-stent restenosis in this pilot study. In restenotic lesions with an average length of approximately 8 cm, both treatment modalities yielded disappointing 6-month patency rates.

De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates--randomized controlled trial.

PURPOSE: To prospectively determine, in a randomized controlled trial, whether cutting balloon angioplasty (CBA) yields superior morphologic and clinical outcomes at 6 months compared with the 6-month outcomes after conventional percutaneous transluminal angioplasty (PTA) in patients with short de novo superficial femoropopliteal artery (SFA) lesions. MATERIALS AND METHODS: This study was approved by the ethics committees of the two participating centers, and informed consent was obtained from all patients. The authors randomly assigned 43 patients (26 men, 17 women; median age, 69 years) who had 5 cm or shorter de novo SFA lesions in association with intermittent claudication or chronic limb ischemia to undergo CBA or PTA. The patients were followed up clinically, and restenosis was assessed with duplex ultrasonography (US) at 6 months. chi(2) and Mann-Whitney U tests were used to compare data between the two treatment groups. RESULTS: The US-determined 6-month restenosis rate was 32% (seven patients) in the PTA group versus 62% (13 patients) in the CBA group (P = .048). Sixteen (73%) PTA group patients versus eight (38%) CBA group patients were asymptomatic at follow-up (P = .059). There was no significant difference in ankle-brachial index (median, 0.83 vs 0.77 for PTA vs CBA group, respectively; P = .56) or pain-free walking distance (median, >1000 m vs 600 m for PTA vs CBA group, respectively; P = .17) between the two groups. CONCLUSION: CBA did not prove to be superior to conventional PTA for treatment of short de novo SFA lesions and yielded increased restenosis rates at 6 months.

Progression of carotid stenosis detected by duplex ultrasonography predicts adverse outcomes in cardiovascular high-risk patients.

BACKGROUND AND PURPOSE: The progression of carotid stenosis reflects the activity of atherosclerotic disease and may indicate a risk for systemic atherothrombotic complications. We investigated whether progressive carotid stenosis determined by duplex ultrasonography predicts adverse outcomes in cardiovascular high-risk patients. METHODS: We prospectively studied 1065 of 1268 consecutive patients initially asymptomatic with respect to carotid disease. Carotid ultrasound investigations at baseline and after a median of 7.5 months (range, 6 to 9 months) were performed to identify patients with progressive stenosis as defined by Doppler velocity criteria. Patients were then followed up clinically for a median of 3.2 years for the occurrence of major adverse cardiovascular events (composite MACEs: myocardial infarction, percutaneous coronary or peripheral interventions, coronary or vascular surgery, amputation, stroke, and all-cause mortality). RESULTS: We found progressive carotid stenosis in 93 patients (9%) by ultrasound and thereafter recorded 495 MACEs in 421 patients (40%) during clinical follow-up. Patients with progressive carotid stenosis had a significantly increased risk for cardiovascular events compared with patients with nonprogressive disease: adjusted hazard ratios and confidence intervals were 2.01 for composite MACEs (95% CI, 1.48 to 2.67, P<0.001), 2.38 for myocardial infarction (95% CI, 1.07 to 5.35, P=0.044), 1.59 for any coronary event (95% CI, 1.10 to 2.28, P=0.011), 2.00 for stroke (95% CI, 1.02 to 4.11, P=0.035), 2.42 for any peripheral vascular event (95% CI, 1.61 to 3.62, P<0.001), and 1.75 for cardiovascular death (95% CI, 1.03 to 2.97, P=0.039). CONCLUSIONS: Progression of carotid stenosis within a 6- to 9-month interval detected by duplex ultrasound predicts midterm clinical adverse events of atherosclerosis in high-risk patients affecting the coronary, cerebrovascular, and peripheral circulations.

Quality of life after balloon angioplasty versus stent implantation in the superficial femoral artery: findings from a randomized controlled trial.

PURPOSE: To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL). METHODS: One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention. RESULTS: QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting. CONCLUSION: Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.

Duplex sonography versus angiography for assessment of femoropopliteal arterial disease in a "real-world" setting.

PURPOSE: To evaluate the agreement of duplex ultrasound (DUS) versus digital subtraction angiography (DSA) for assessment of femoropopliteal arterial disease in a real-world clinical setting. METHODS: Consecutive patients with peripheral artery disease who were scheduled for a percutaneous intervention were included in this retrospective study. During an 18-month period, 491 patients (276 men; median age 73 years, interquartile range 64-81) were enrolled. A peak systolic velocity ratio (PSVR)>2.4 was the optimal cutoff for detecting a >50% stenosis by DSA. Findings of preprocedural DUS in the proximal, middle, and distal ipsilateral superficial femoral artery and in the popliteal segment were analyzed for agreement with preprocedural femoropopliteal DSA using kappa statistics. Only the target limb in each patient was analyzed, for a total of 1964 vascular segments. RESULTS: Agreement for the degree of stenosis in 10% increments was only moderate (weighted kappa 0.67, 95% CI 0.65 to 0.69). Using the PSVR>2.4 cutoff, agreement between DUS and DSA for a >50% stenosis was good (kappa 0.79, 95% CI 0.77 to 0.81). Sensitivity, specificity, positive predictive value, and negative predictive value for correctly detecting a >50% stenosis by DUS were 0.81 (0.78 to 0.84), 0.93 (0.91 to 0.94), 0.84 (0.81 to 0.87), and 0.91 (0.87 to 0.95), respectively. Comparable findings were observed within different patient subgroups. CONCLUSION: Agreement between DUS and DSA in the femoropopliteal segment is only moderate with respect to the absolute degree of stenosis. However, detection of a >50% stenosis can be done with acceptable precision in routine clinical practice using PSVR>2.4 as a threshold.

Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting.

BACKGROUND: Primary stenting with self-expanding nitinol stents of the superficial femoral artery yielded improved morphological and clinical results compared with balloon angioplasty with optional stenting until 12 months in a randomized controlled trial. We now report 2-year data on restenosis and clinical outcomes of these patients. METHODS AND RESULTS: Of 104 patients with chronic limb ischemia and superficial femoral artery obstructions, 98 (94%) could be followed up until 2 years after intervention for occurrence of restenosis (>50%) by duplex ultrasound and for clinical and hemodynamic outcome by treadmill walking distance and ankle brachial index. Restenosis rates at 2 years were 45.7% (21 of 46) versus 69.2% (36 of 52) in favor of primary stenting compared with balloon angioplasty with optional secondary stenting by an intention-to-treat analysis (P=0.031). Consistently, stenting (whether primary or secondary; n=63) was superior to plain balloon angioplasty (n=35) with respect to the occurrence of restenosis (49.2% versus 74.3%; P=0.028) by a treatment-received analysis. Clinically, patients in the primary stent group showed a trend toward better treadmill walking capacity (average, 302 versus 196 m; P=0.12) and better ankle brachial index values (average, 0.88 versus 0.78; P=0.09) at 2 years, respectively. Reintervention rates tended to be lower after primary stenting (17 of 46 [37.0%] versus 28 of 52 [53.8%]; P=0.14). CONCLUSIONS: At 2 years, primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting.

Complement component C5a predicts restenosis after superficial femoral artery balloon angioplasty.

PURPOSE: To investigate whether balloon angioplasty of the superficial femoral artery (SFA) increases serum levels of C5a and whether C5a predicts risk of restenosis. METHODS: C5a antigen was measured at baseline and 8 hours after intervention in 131 consecutive patients (76 women; median age 72 years) with intermittent claudication who underwent successful primary SFA balloon angioplasty. Patients were followed for a median 10 months [interquartile range (IQR) 6 to 14] for the occurrence of >50% restenosis by duplex ultrasound. RESULTS: Median C5a levels increased significantly from 39.7 ng/mL (IQR 27.8 to 55.0) at baseline to 53.8 ng/mL (IQR 35.6 to 85.1, p<0.001) 8 hours post intervention. During the follow-up period, 70 (53%) patients developed restenosis. Increasing levels of C5a (quartiles) at baseline were significantly associated with an increased risk for restenosis (p=0.0092). Adjusted hazard ratios (95% confidence intervals) for restenosis with increasing quartiles of baseline serum C5a levels were 1.24 (0.60 to 2.58), 1.93 (0.95 to 3.93), and 2.08 (1.02 to 4.21), respectively, compared to the lowest quartile. This effect was independent of nonspecific inflammation as reflected by plasma levels of C-reactive protein. CONCLUSION: Inflammatory mechanisms play a major role in the development of restenosis after angioplasty. The complement component C5a exerts strong chemotactic and proinflammatory effects. Enhanced complement activation prior to PTA, as measured by higher levels of C5a, was significantly associated with restenosis after SFA balloon angioplasty. Pathways of complement inhibition thus may be worth investigating with respect to improving patency rates.

C-reactive protein predicts future cardiovascular events in patients with carotid stenosis.

BACKGROUND AND PURPOSE: Atherosclerosis is a systemic inflammatory disease. We demonstrated previously that high-sensitivity C-reactive protein (hs-CRP) is associated with short-term progression of carotid atherosclerosis. We now investigated whether baseline levels of hs-CRP predict midterm clinical outcome in these patients. METHODS: We prospectively studied 1065 of 1268 consecutive patients who were initially asymptomatic with respect to carotid artery disease and were investigated with serial carotid ultrasound examinations at baseline and after a 6- to 9-month interval. Patients were followed-up clinically for the occurrence of cardiovascular events, a composite of myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, stroke, and death. RESULTS: We recorded progression of carotid stenosis in 93 patients (9%) after 6 to 9 months, and 381 cardiovascular events in 337 patients (27%) during a median of 3 years of clinical follow-up (interquartile range, 2.5 to 3.5 years). The hs-CRP levels were significantly elevated in patients with progressive carotid stenosis (P<0.001), and hs-CRP was significantly associated with the occurrence of a first future cardiovascular event (P<0.001). Adjusted hazard ratios for a first cardiovascular event for increasing quintiles of hs-CRP were 1.41 (95% confidence interval, 0.92 to 2.17), 1.76 (95% confidence interval, 1.17 to 2.66), 2.22 (95% confidence interval, 1.48 to 3.32), and 2.41 (95% confidence interval, 1.61 to 3.60) as compared with the lowest quintile, respectively. This association was independent of traditional cardiovascular risk factors and the baseline degree of carotid stenosis. CONCLUSIONS: Inflammation was associated with morphological and clinical progression of atherosclerotic disease. Patients with elevated levels of hs-CRP exhibit an increased risk for adverse cardiovascular outcome attributable to clinical adverse events of progressive atherosclerotic disease.

Dental and periodontal status and risk for progression of carotid atherosclerosis: the inflammation and carotid artery risk for atherosclerosis study dental substudy.

BACKGROUND AND PURPOSE: Dental and periodontal disease are potentially involved in the pathogenesis of atherosclerosis. We investigated whether dental and periodontal status is associated with the presence and future progression of carotid stenosis. METHODS: We randomly selected 411 of 1268 participants from the prospective Inflammation and Carotid Artery Risk for Atherosclerosis Study and evaluated dental and periodontal status and oral hygiene at baseline measuring three World Health Organization-validated indices: DMFT (decayed, missing, filled teeth), SLI (Silness-Löe Index), and CPITN (community periodontal index for treatment needs), respectively. The degree of carotid stenosis was measured by duplex ultrasound at baseline and after median 7.5 months (range=6 to 9 months) to identify patients with progressive carotid stenosis. RESULTS: DMFT (P<0.01), SLI (P=0.048), CPITN (P=0.007), and edentulousness (P=0.007) were associated with the baseline degree of carotid stenosis. Atherosclerosis progression was observed in 48 of 411 patients (11.7%). DMFT (adjusted odds ratio [OR]=1.11, 95% CI=1.01 to 1.22, P=0.032) and SLI (adjusted OR=1.77, 95% CI=1.09 to 2.79, P=0.021), but not CPITN (adjusted OR=1.51, 95% CI=0.89 to 2.45, P=0.16) were significant predictors of disease progression, irrespective of traditional cardiovascular risk factors and the baseline degree of stenosis. Edentulous patients had a significantly increased risk for disease progression as compared with patients with teeth (adjusted OR=2.10, 95% CI=1.06 to 4.16, P=0.33). CONCLUSIONS: Dental status, oral hygiene, and particularly tooth loss are associated with the degree of carotid stenosis and predict future progression of the disease.

Asymmetric dimethylarginine predicts major adverse cardiovascular events in patients with advanced peripheral artery disease.

OBJECTIVE: Circulating concentrations of asymmetric dimethylarginine (ADMA), an endogenous inhibitor of nitric oxide synthesis, are elevated in conditions associated with increased cardiovascular risk. We investigated whether elevated ADMA concentrations predict major adverse cardiovascular events (MACE) in patients with advanced peripheral artery disease (PAD). METHODS AND RESULTS: We prospectively enrolled 496 of 533 consecutive patients with PAD (median age 70 years, 279 males). ADMA and L-arginine were assessed at baseline by high performance liquid chromatography. The occurrence of MACE (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, stroke, carotid revascularization, death) was evaluated during a follow-up of median 19 months (interquartile range 11 to 25). One hundred eighty-two MACE were observed in 141 patients (28%). MACE occurred in 39% of the patients in the highest quartile and 26% of those in the lowest quartile of ADMA (P=0.016, log-rank test for all quartiles). Adjusted hazard ratios for occurrence of MACE for increasing quartiles of ADMA compared with the lowest quartile were 0.87 (95% confidence interval [CI], 0.51 to 1.48), 1.12 (95% CI, 0.62 to 1.90), and 1.70 (95% CI, 1.02 to 2.88), respectively. We observed no association between cardiovascular outcome and L-arginine. CONCLUSIONS: High ADMA plasma concentrations independently predict MACE in patients with advanced PAD. This indicates that ADMA may be a new cardiovascular risk marker in these patients.

Prediction of iatrogenic pseudoaneurysm after percutaneous endovascular procedures.

PURPOSE: To prospectively evaluate the accuracy of using physical examination to identify puncture-related groin pseudoaneurysms, as assessed by using duplex ultrasonography (US), after percutaneous transluminal procedures and to prospectively evaluate the association between preinterventional platelet count, antiplatelet medication, and the occurrence of pseudoaneurysms. MATERIALS AND METHODS: This study was approved by the local ethics committee, and informed consent was obtained from all patients. The study prospectively included 273 consecutive patients (161 men, 112 women; age range, 34-90 years) who were referred for duplex US evaluation of the inguinal arterial puncture site 1 day after endovascular procedures. Prior to duplex US, all patients underwent physical examination of the groin. In addition, clinical characteristics and preinterventional laboratory parameters were assessed. Statistical significance was determined by using chi2 tests, the Fischer exact test, and unpaired t tests. RESULTS: Twenty-three pseudoaneurysms were found in 273 patients by using duplex US. Pulsatile groin masses that were detected at physical examination were used to correctly identify all pseudoaneurysms (positive predictive value, 100%; negative predictive value, 100%). Painful pulse palpation had a slightly lower predictive power (positive predictive value, 92% [95% confidence interval: 81%, 100%]; negative predictive value, 100% [95% confidence interval: 100%, 100%]). Other clinical parameters, such as the presence of superficial hematomas, systolic bruits, or nonpulsatile groin masses, had no adequate predictive properties. Interobserver agreement was excellent between observers (97% agreement [95% confidence interval: 92%, 100%]). All patients with pseudoaneurysms had a preprocedural platelet count of less than 200 x 10(9)/L. No subacute complications were observed at the access site in patients with a platelet count of more than 200 x 10(9)/L. CONCLUSION: Physical examination revealed sufficient predictive capability in facilitating the identification of iatrogenic pseudoaneurysms after percutaneous vascular procedures. A platelet count of less than 200 x 10(9)/L was associated with high predictive capability, thereby warranting further assessment in a larger series of patient.

Covered versus bare self-expanding stents for endovascular treatment of carotid artery stenosis: a stopped randomized trial.

PURPOSE: To investigate whether filter-protected carotid artery stenting (CAS) using a covered self-expanding stent reduces the risk of cerebral embolization. METHODS: Fourteen asymptomatic patients (13 men; median age 77 years, IQR 73-83) were enrolled in a randomized pilot trial comparing the rates of cerebral microembolism during and after filter-protected CAS using either a self-expanding covered (n=8) or a bare (n=6) carotid stent. Transcranial Doppler (TCD) monitoring was done during and for 90 minutes after the procedure. Diffusion-weighted magnetic resonance imaging (DW-MRI) was performed before and 24 hours after CAS. Patients were followed for 6 months for neurological events and occurrence of restenosis. RESULTS: A significant reduction in ipsilateral microembolic signals by TCD was observed with the covered (median 1, IQR 0-4) versus the bare stent (median 6, IQR 3-8; p=0.043). Comparison of the preprocedural and 24-hour postprocedural DW-MRI images showed no new ipsilateral lesions but 1 new lesion in the contralateral hemisphere in the covered stent group, resulting in an overall 7% (95% CI 0%-20%) rate of new ischemic lesions. No neurological complications occurred up to 6 months. Restenosis (>70%) occurred in 3 (38%) of 8 patients with the covered versus none of the bare stents (p=0.21). The trial was stopped when the third restenosis of a covered stent was detected. CONCLUSION: Self-expanding covered stents potentially reduce the risk of cerebral microembolism during and after carotid stenting. However, the problem of in-stent restenosis has to be resolved before these devices can be considered for further investigation.

Myeloperoxidase predicts progression of carotid stenosis in states of low high-density lipoprotein cholesterol.

OBJECTIVES: We investigated the effect of myeloperoxidase (MPO) on progression of carotid stenosis in states of high and low high-density lipoprotein-cholesterol (HDL-C) and low-density lipoprotein-cholesterol (LDL-C) levels. BACKGROUND: Myeloperoxidase is pivotally involved in the pathogenesis of atherosclerosis. In vitro data suggest that MPO exerts deleterious effects via oxidative modulation of lipoproteins. METHODS: We prospectively studied 1,019 of 1,268 consecutive patients who were asymptomatic with respect to carotid artery disease. Patients underwent serial carotid ultrasound investigations at baseline and after a follow-up interval of median 7.5 months (range 6 to 9 months), categorizing carotid arteries as 0% to 29%, 30% to 49%, 50% to 69%, 70% to 89%, or 90% to 99% stenosed or occluded. The MPO, HDL-C, and LDL-C levels were measured at baseline, grouped by medians, and correlated with progression of carotid atherosclerosis. RESULTS: Progression of carotid atherosclerosis was found in 100 of 1,019 patients (9.8%). Myeloperoxidase (p = 0.014) but not HDL-C (p = 0.95) or LDL-C (p = 0.30) were associated with progressive disease. However, MPO > or =310 ng/ml was significantly associated with progressive disease (adjusted odds ratio [OR] 2.57, 95% confidence interval [CI] 1.39 to 4.75) only in patients with HDL-C levels <49 mg/dl. Otherwise, in patients with higher HDL-C levels (> or =49 mg/dl), MPO > or =310 ng/ml did not predict disease progression (adjusted OR 1.42, 95% CI 0.72 to 2.78). No interaction of MPO with LDL-C was observed. CONCLUSIONS: Myeloperoxidase was associated with progression of carotid atherosclerosis in patients with HDL cholesterol levels below 49 mg/dl.