Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.

BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

Prevalence of Synchronous and Metachronous Aneurysms in Women With Abdominal Aortic Aneurysm.

BACKGROUND: Abdominal aortic aneurysm (AAA) is three to five times more common among men compared with women, yet up to 38% of all aneurysm related deaths affect women. The aim of this study was to estimate the prevalence of synchronous or metachronous aneurysms among women with AAA, as diagnosis and treatment could improve survival. PATIENTS AND METHODS: This is a retrospective study of prospectively registered patients. All women operated on, or under surveillance for, AAA were identified at two Swedish hospitals. Aneurysms in different locations were identified using available imaging studies. Aneurysms were defined according to location: thoracic ascending aorta ≥42 mm, descending ≥33 mm, abdominal aorta ≥30 mm, common iliac artery ≥20 mm or 50% wider than the contralateral artery, common femoral artery ≥12 mm, popliteal artery ≥10 mm. RESULTS: A total of 339 women with an AAA were included. The median follow up was 2.8 (range 0-15.7) years. Thirty-one per cent had an aneurysm in the thoracic aorta (67 of 217 investigated, 84% were located in the descending aorta), 13 (19%) underwent repair. Twelve per cent had a common iliac artery aneurysm (24/259, 76% were investigated). Common femoral artery aneurysms were identified in 4.3% (8/184, 54% investigated). Popliteal artery aneurysms were identified in 4.0% (6/149, 44% investigated). The prevalence of infrainguinal aneurysms was higher among patients with synchronous iliac aneurysms (40% vs. 1.6%, OR 42, 95% CI 6.4-279, p < .001). CONCLUSIONS: Thoracic aortic aneurysms are common among women with AAA, most commonly affecting the descending aorta, and detection frequently results in repair. Popliteal and femoral aneurysms are not rare among women with AAA, and even common if there is a synchronous iliac aneurysm.

ABO blood groups and abdominal aortic aneurysm.

Earlier studies have indicated an association between blood group non-O and atherosclerosis related vascular diseases. Abdominal aortic aneurysm (AAA) is traditionally regarded as a consequence of atherosclerosis. The aim of the present study was to investigate the association between ABO blood groups and AAA with special regard to a relation to AAA rupture. Prospectively, 504 patients operated on for AAA were investigated. Patients operated on for AAA have similar ABO blood group distributions as a population based control group. Furthermore, there was no significant difference in distribution of ABO blood group between patients operated on for ruptured AAA (n=174) and non-ruptured AAA (n=330). In conclusion, this study fails to demonstrate an association between ABO blood groups and AAA.

Patients' perspective on prostatic artery embolization: A qualitative study.

OBJECTIVES: The aim was to describe the patients' experience of undergoing prostatic artery embolization. METHODS: A retrospective qualitative interview study was undertaken with 15 patients of mean age 73 years who had undergone prostatic artery embolization with a median duration of 210 min at two medium sized hospitals in Sweden. The reasons for conducting prostatic artery embolization were clean intermittent catheterization (n = 4), lower urinary tract symptoms (n = 10) or haematuria (n = 1). Data were collected through individual, semi-structured telephone interviews 1-12 months after treatment and analysed using qualitative content analysis. RESULTS: Four categories with sub-categories were formulated to describe the results: a diverse experience; ability to control the situation; resumption of everyday activities and range of opinions regarding efficacy of outcomes. Overall, the patients described the procedure as painless, easy and interesting and reported that while the procedure can be stressful, a calm atmosphere contributed to achieving a good experience. Limitations on access to reliable information before, during and after the procedure were highlighted as a major issue. Practical ideas for improving patient comfort during the procedure were suggested. Improved communications between treatment staff and patients were also highlighted. Most patients could resume everyday activities, some felt tired and bruising caused unnecessary worry for a few. Regarding functional outcome, some patients described substantial improvement in urine flow while others were satisfied with regaining undisturbed night sleep. Those with less effect were considering transurethral resection of the prostate as a future option. Self-enrolment to the treatment and long median operation time may have influenced the results. CONCLUSIONS: From the patients' perspective, prostatic artery embolization is a well-tolerated method for treating benign prostate hyperplacia.

Proinflammatory and anti-inflammatory cytokine balance in patients with abdominal aortic aneurysm and the impact of aneurysm size.

Abdominal aortic aneurysm is a common condition with high mortality due to rupture; however, the condition also is associated with nonaneurysmal cardiovascular mortality. A possible contributing mechanism for the cardiovascular mortality is an imbalance between the proinflammatory and anti-inflammatory systemic response. In the present study, 78 patients with abdominal aortic aneurysm and 41 controls without aneurysm matched by age, gender and smoking habits were investigated. Cytokines such as interleukin-6, interleukin-10, and monocyte chemoattractant protein-1 were measured in plasma. There was significantly higher level of interleukin-6 in patients with AAA compared to controls. The interleukin-6/ interleukin-10 ratio was highest in patients with large compared to small abdominal aortic aneurysm. In conclusion, the present data indicate a proinflammatory response and a proinflammatory to antiinflammatory imbalance in patients with abdominal aortic aneurysm which is dependent by aneurysm size.

Soluble urokinase plasminogen activator receptor in patients with abdominal aortic aneurysm.

INTRODUCTION: In the present study we investigated the impact of soluble urokinase plasminogen activator receptor (suPAR) as a biomarker in patients with abdominal aortic aneurysm (AAA) in relation to conventional inflammatory markers, aneurysm size, and rupture. METHODS: suPAR and conventional inflammatory markers were measured in 119 patients with AAA and 36 controls without aneurysm matched by age, gender and smoking habit. RESULTS: The results support earlier studies suggesting a state of activated inflammatory response in patients with nonruptured AAA as expressed by elevated CRP and IL-6 compared with the controls. In contrast, suPAR showed similar levels in patients with nonruptured AAA compared with the controls. Unexpectedly, all follow-up patients (n=16) have significant (p<0.001) elevated suPAR levels three years postoperatively compared preoperatively. CONCLUSIONS: suPAR does not seem to be a useful biomarker in the AAA disease. The role of the postoperative elevation of suPAR needs to be further elucidated.

Discovery of a novel circulating biomarker in patients with abdominal aortic aneurysm: a pilot study using a proteomic approach.

Abdominal aortic aneurysm (AAA) is a common condition with high mortality when ruptured. Most clinicians agree that small AAAs are best managed by ultrasonographic surveillance. However, it has been stated in recent reviews that a serum/plasma biomarker that predicts AAA rupture risk would be a powerful tool in stratifying patients with small AAA. Identification of such circulating biomarkers has been to date unsuccessful. In this study, we used a proteomic approach to find new, potential plasma AAA biomarker candidates. Prefractionated plasma samples were analyzed by two-dimensional differential in-gel electrophoresis to identify differentially expressed proteins between four patients with small AAA and four controls without aneurysm. Protein spots that differed significantly between patients and controls were selected and identified by mass spectrometry. Three protein spots had significantly different expression between patients and controls. The most interesting finding was that patients with small AAA had increased levels of the enzyme glycosylphosphatidylinositol-specific phospholipase D (GPI-PLD) compared with the controls without aneurysm. In conclusion, by using a proteomic approach, this pilot-study provides evidence of GPI-PLD as a novel potential plasma biomarker for AAA.

Plasma glycosylphosphatidylinositol phospholipase D (GPI-PLD) and abdominal aortic aneurysm.

Recent reviews state that a circulating biomarker predicting aortic rupture risk would be a powerful tool to stratify patients with small screen-detected abdominal aortic aneurysm (AAA). In a current proteomic pilot-study elevated levels of the enzyme Glycosylphosphatidylinositol-specific phospholipase D (GPI-PLD) was shown in patients with small AAA compared with controls without aneurysm. In the present study we investigated the impact of plasma GPI-PLD as a biomarker in patients with AAA in relation to aneurysm size, and rupture. Plasma GPI-PLD was measured in patients with AAA (nonruptured, n=78 and ruptured, n=55) and controls without aneurysm (n=41) matched by age, sex and smoking habit. The plasma GPI-PLD levels were significantly lower in patients with ruptured compared nonruptured AAA which we interpreted as a result of hemodilution due to hemorrhage in patients with ruptured AAA. The plasma GPI-PLD levels were similar in patients with nonruptured AAA compared to the controls without aneurysm. Furthermore, there was no correlation between plasma GPI-PLD and aneurysm size in the group of patients with nonruptured AAA. In conclusion, the present study fails to show a connection between GPI-PLD and AAA. However, the definite role of GPI-PLD as a predictive marker needs to be further clarified in a follow-up cohort study.

Early inflammatory response in patients with ruptured abdominal aortic aneurysm.

Multiorgan failure is the main cause of death in patients operated for ruptured abdominal aortic aneurysm (rAAA). The systemic inflammatory response plays a central role in the generation and maintenance of multiorgan dysfunction. The aim of the current study was to investigate the inflammatory response preoperatively in patients with ruptured and nonruptured AAA in relation to the clinical outcome. A total of 95 patients about to undergo repair of AAA (43 ruptured with shock, 12 ruptured without shock, and 40 elective) and 41 controls without aneurysm matched by age, gender, and smoking habits were investigated by inflammatory markers. There were significantly higher levels of interleukin 6 (IL-6; proinflammatory cytokine) and IL-10 (anti-inflammatory cytokine) in patients operated for ruptured compared to nonruptured AAA. In conclusion, the current data indicate that rupture of an AAA activates the inflammatory system with a compensatory anti-inflammatory response.

Haemostatic markers in patients with abdominal aortic aneurysm and the impact of aneurysm size.

INTRODUCTION: Abdominal aortic aneurysm is a common condition with high mortality when rupturing. However, the condition is also associated with nonaneurysmal cardiovascular mortality. A possible contributing mechanism for the thrombosis related cardiovascular mortality is an imbalance between the activation of the coagulation system and the fibrinolytic system. The aim of the present study was to investigate haemostatic markers in patients with nonruptured abdominal aortic aneurysm with special regard to the influence of aneurysm size and smoking habits. METHODS: Seventy-eight patients with infrarenal aortic aneurysm and forty-one controls without aneurysm matched by age, gender and smoking habits were studied. Thrombin-antithrombin (TAT), prothrombin fragment 1+2 (F 1+2)--markers of thrombin generation, and von Willebrand factor antigen (vWFag)--considered as a reliable marker of endothelial dysfunction--were measured. Plasma levels of tissue plasminogen activator antigen (tPAag), and plasminogen activator inhibitor type 1 (PAI-1) were measured as markers of fibrinolytic activity. D-dimer, a marker of fibrin turnover, was also measured. RESULTS: There were significantly higher levels of TAT and D-dimer in patients with abdominal aortic aneurysm. The highest level of TAT and D-dimer were detected in patients with large compared to small AAA. CONCLUSIONS: The present data indicate a state of activated coagulation in patients with abdominal aortic aneurysm which is dependent by aneurysm size. The activated coagulation in AAA patients could contribute to an increased cardiovascular risk in patients also with small AAA. The possible impact of secondary prevention apart from smoking cessation has to be further evaluated and is maybe as important as finding patients at risk of rupture.