Design and testing of the safety of the SARUS-CPR hood for novice resuscitators.

BACKGROUND AND AIMS: Bystanders should be protected against aerosols, droplets, saliva, blood and vomitus during resuscitation after cardiac arrest The SARUS (safer - airway - resuscitation) CPR airway hood™ is a clear plastic cover and integrated mask that envelopes the head and torso. Our objectives were to test leakage using saline aerosol generation tests, then assess the performance of the hood during mock cardio-pulmonary resuscitation on a manikin. METHODS: A checklist was validated by comparing the performance of 10 novices against 10 experts during mock resuscitation. Thereafter, 15 novices were tested with and without the hood, in a randomised cross-over study, one week apart. RESULTS: Laboratory analysis showed a > 99% reduction of saline particles detected 5 cm, 75 cm and 165 cm above volunteers wearing the hood. On manikins, experts scored better compared to novices, 8.5 (0.7) vs 7.6 (1.2), difference (95%CI) 0.9 (0.4-1.3), P = 0.0004. Novice performance was equivalent using the hood and standard equipment, 7.3 (1.4) vs 7.3 (1.1) respectively, difference (90%CI) 0.0 (-0.3 - 0.3), P = 0.90. CONCLUSION: Aerosol transmission reduced in the breathing zone. Simulated resuscitation by novices was equivalent with and without the hood.

Spiral Laminar Flow: a Survey of a Three-Dimensional Arterial Flow Pattern in a Group of Volunteers.

OBJECTIVE: Spiral laminar flow was suggested as potentially the predominant arterial blood flow pattern many years ago. Computational fluid dynamics and flow rig testing have suggested there are advantages to spiral laminar flow. The aim of this study was to identify whether spiral laminar is the predominant flow pattern in a cohort of volunteers. METHODS: This study included 42 volunteers (mean age 66.8 years). Eleven arterial sites were examined, comprising bilateral examination of the common carotid artery, internal carotid artery, external carotid artery, common femoral artery, superficial femoral artery, and the infra renal aorta. The presence or absence of spiral laminar flow, the peak systolic velocity, and the rotational velocity were assessed by colour Duplex scanning. RESULTS: The incidence of spiral laminar flow ranged from 81% in the internal carotid artery to 90% in the common carotid artery and the infra renal aorta. Overall, in 58% of all right-sided arteries the rotation was clockwise and 42% anticlockwise. In all left-sided arteries these numbers were reversed. Analysis on the basis of volunteer rather than examination site showed that 41/42 (97%) had more sites with spiral laminar flow than without. Only one volunteer had more sites exhibiting non-spiral laminar flow. CONCLUSION: Spiral laminar flow was the predominant flow pattern in the study population. This observation raises questions and suggests a need for further studies concerning the form and function of the left ventricle, the geometry of the arterial system, and the function of the arterial wall.

Detecting diabetes and impaired glucose tolerance in patients with atherosclerotic peripheral arterial disease.

AIM: In patients with peripheral arterial disease (PAD), diabetes mellitus is associated with increased mortality rates. The aim of this study was to estimate the prevalence of undiagnosed diabetes in PAD patients, and to assess whether a glucose tolerance test is more sensitive than a simple fasting glucose measurement for diagnosis in this group. METHODS: A standard glucose tolerance test and fasting glucose measurements were performed in 53 patients with PAD, who were then categorised into diagnostic groups according to each test result. RESULTS: Using the glucose tolerance test results, 11.5% of patients were diagnosed with diabetes mellitus and 28.8% had either impaired fasting glucose or impaired glucose tolerance. Using fasting glucose levels only, 7.7% received a diagnosis of diabetes mellitus and 17.3% had impaired fasting glucose. The glucose tolerance data and the fasting glucose data were in agreement in 82.7% of cases, but the glucose tolerance test identified an additional 3.8% of cases with diabetes and an additional 13.5% of cases with impaired glucose tolerance. CONCLUSION: Undiagnosed diabetes and impaired glucose homeostasis are common in patients with PAD. Routine screening using a simple glucose tolerance test should be considered in the clinical assessment of this group.

Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial.

OBJECTIVE: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting. METHODS: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD) were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100 mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite of index-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safety endpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries [GUSTO] classification). RESULTS: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151 of 426 patients in the placebo (plus ASA) group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.78-1.23). In a prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR, 0.65; 95% CI, 0.45-0.95; P = .025) but not in venous graft patients (HR, 1.25; 95% CI, 0.94-1.67, not significant [NS]). A significant statistical interaction between treatment effect and graft type was observed (P(interaction) = .008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the rates of severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1% vs 1.2%). CONCLUSION: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.

The value of vein graft surveillance in bypasses performed with small-diameter vein grafts.

We assessed the impact of preoperative diameter of the venous conduit on reintervention rate and outcome following infrainguinal vein graft bypass. Consecutive infrainguinal vein bypasses between January 2001 and December 2006 were reviewed. All patients underwent preoperative measurement of vein graft diameter (VGD). Grafts were classified into those with VGD <3.5 mm and those with VGD > or =3.5 mm. All patients were enrolled in a duplex surveillance program. The association between VGD and reintervention rate was assessed. Graft patency and amputation rates were compared. There were 377 bypasses followed up for a median of 23 months (range 8-67). VGD was <3.5 mm in 139 grafts (36.9%) and > or =3.5 mm in 238 grafts (63.1%). A higher proportion of smaller vein grafts (32.3%) required reintervention to maintain graft patency compared with larger conduits (20.2%) (chi(2) = 7.7, p < 0.001). VGD (odds ratio [OR] = 2.87, 95% confidence interval [CI] 1.63-3.81; p < 0.001), smoking (OR = 1.83, 95% CI 1.39-3.20; p = 0.02), and type of bypass (OR = 1.86, 95% CI 1.49-2.47; p = 0.02) were variables associated with higher reintervention rate. There was no difference in graft patency (p = 0.13) or amputation rates (p = 0.35) between the two groups. Use of smaller vein grafts was associated with a higher reintervention rate. Provided that these grafts are surveyed and where necessary repaired, the use of smaller vein grafts is successful and expands the availability of autogenous conduit for infrainguinal arterial reconstruction.

Balloon angioplasty as the primary treatment for failing infra-inguinal vein grafts.

BACKGROUND: We sought to evaluate the role of balloon angioplasty as the primary modality in the management of vein graft stenoses. METHODS: Patients who underwent infrainguinal vein graft bypass from January 2002 to December 2007 were enrolled into a surveillance program. Grafts which developed critical stenoses were identified and underwent urgent angiography with a view to angioplasty of the stenotic lesion. Lesions which were deemed unsuitable for angioplasty underwent urgent surgical repair. RESULTS: Four hundred and eleven grafts were followed up for a median of 19 months (range: 2-61). Ninety-six grafts (22.6%) developed critical stenosis. Twelve grafts occluded prior to repair and one was not intervened upon electively. Eight grafts underwent primary surgical repair. Seventy-six grafts underwent 99 endovascular procedures. Technical success was achieved in 60 grafts (78.9%). Of the grafts in which technical success had not been achieved, eight underwent repeat angioplasty and three were surgically repaired. Twenty-four grafts underwent repeat angioplasty for re-stenosis with a technical success rate of 71%. No difference was observed in graft patency (P=0.08) or amputation rates (P=0.32) between the grafts requiring intervention to maintain patency, and grafts which did not. Smoking [OR: 2.61 (95% CI: 1.51-4.53), (P=0.006)], diabetes [OR: 2.55 (95% CI: 1.49-4.35), (P=0.006)], renal failure [OR: 1.89 (95% CI: 1.19-3.38), (P=0.040)] and recurrent stenosis [OR: 3.22 (95% CI: 1.63-4.69), (P<0.001)] were risk factors for graft occlusion. CONCLUSIONS: Balloon angioplasty of failing infrainguinal vein bypass grafts is safe and can be performed with an acceptable medium term patency rate, albeit with a significant risk of re-stenosis which can be successfully treated in most patients using repeat endovascular intervention.

Outcome from abdominal aortic aneurysms in Scotland, 1991-2006.

BACKGROUND: This study assessed the impact of sex, presentation and treatment on outcome from abdominal aortic aneurysm (AAA) in Scotland. METHODS: All patients admitted from January 1991 to December 2006 with a primary diagnosis of AAA were identified. Patients were stratified by age, sex, admission diagnosis (ruptured versus intact) and procedure performed (endovascular versus open repair). Multivariable logistic regression analysis was used to determine predictors of mortality. RESULTS: Some 9779 men and 2927 women were admitted with a principal diagnosis of AAA. Women were significantly older than men (median (range) age 75 (35-97) versus 71 (17-96) years; P < 0.001). A higher proportion of women presented with a ruptured AAA (29.5 versus 27.5 per cent; P = 0.043). Age (odds ratio (OR) 2.52 (95 per cent confidence interval 2.36 to 2.74); P < 0.001), female sex (OR 1.63 (1.48 to 1.78); P < 0.001) and admission diagnosis (OR 10.49 (9.53 to 11.54); P < 0.001) were independent predictors of early death, whereas endovascular repair predicted survival (OR 0.67 (0.58 to 0.76); P < 0.001). CONCLUSION: Women presenting with an AAA were older and more likely to be admitted with a ruptured aneurysm. Female sex was an independent risk factor for death from AAA.

Could sequential individual peer reviewed mortality audit data be used in appraisal?

BACKGROUND: Surgeons have traditionally monitored mortality as part of their surgical practice. The aim of this study was to determine whether peer review surgical mortality data might be useful in appraisal. METHODS: Since 1994, the Scottish Audit of Surgical Mortality (SASM) has performed critical event analysis of deaths under surgical care in Scotland. The anonymised, peer reviewed records of 16 consenting surgeons from a single Trust were reviewed over a three year period (2000-2002). RESULTS: Compliance with this voluntary audit was high at 97%. Individual surgeon profiles and comparison with colleagues in similar surgical practice demonstrated adverse events were infrequent and usually due to problems with the process of care rather than individual surgeon errors. The number of case note reviews requested increased significantly over the three years (chi square 9.5, p<0.01) although there was no significant change in the mean number of deaths per surgeon (18) or mean number of adverse events per surgeon (4). CONCLUSIONS: The use of sequential individual peer reviewed mortality data for anonymised comparison with local colleagues is now in use in appraisal and has potential for the revalidation process. This could provide reassurance that individual surgeons are complying with the General Medical Council concept of "good clinical practice" and highlight local problems in the process of care.

Mapping changes in surgical mortality over 9 years by peer review audit.

BACKGROUND: There is increasing public scrutiny of deaths among surgical patients. This analysis sought evidence of changes in practice over time in the management of patients who died under surgical care. METHODS: The surgeons and anaesthetists in National Health Service hospitals providing the care of all surgical patients in Scotland participated in the Scottish Audit of Surgical Mortality (SASM). Data from peer review audit, critical event analysis and individual feedback of deaths while in surgical care over 9 years (1994-2002) were examined for trends over time. RESULTS: Over a 9-year period, 40,448 patients died while in surgical care. Consultant surgeon and anaesthetist involvement in decision making and operating increased significantly (P < 0.001), and death after elective surgery declined to 0.27 per cent of elective operations. Adverse events were more frequently due to failures of hospital systems or process than to individual clinician errors. Fewer adverse events were identified as having contributed to or caused the death of patients over time (P < 0.001). Failure to use deep vein thrombosis (DVT) prophylaxis and failure to use high-dependency or intensive therapy units (HDU/ITU) became less common, once highlighted by the SASM. CONCLUSION: Through continuous peer review audit, the SASM has mapped and may have contributed to changes in surgical and anaesthetic practice over a 9-year period, indicating that the rate of adverse events can be decreased by changing clinician practice (DVT prophylaxis) and provision of facilities (HDU/ITU). Similar approaches should be considered by other medical specialties.

Randomized clinical trial of distal anastomotic interposition vein cuff in infrainguinal polytetrafluoroethylene bypass grafting.

BACKGROUND: The aim was to examine the effect of a Miller vein cuff at the distal anastomosis on the medium- to long-term patency and limb salvage rates of femoral to above-knee and femoral to below-knee popliteal artery polytetrafluoroethylene (PTFE) bypasses. METHODS: This study involved extended follow-up of the original cohort of patients included in a previously reported multicentre randomized clinical study. Outcome measures were bypass graft patency and limb salvage. RESULTS: Two hundred and sixty-one bypass operations were originally randomized. For this study, full data were available on 235 (120 with a Miller cuff, 115 without). The cumulative 5-year patency rate for above-knee bypasses with a Miller cuff was 40 per cent, compared with 42 per cent for non-cuffed bypasses (P = 0.702). The cumulative 3-year patency rate for below-knee bypasses with a Miller cuff was 45 per cent, compared with 19 per cent for non-cuffed bypasses (P = 0.018). A Miller cuff had no significant effect on limb salvage for above-knee or below-knee bypasses. CONCLUSION: Three-year patency rates of femoral to below-knee popliteal PTFE bypasses were improved by a Miller cuff. Miller cuffs had no effect on patency rates for femoral to above-knee popliteal bypasses at 5 years and did not improve limb salvage in either group.

Non spiral and spiral (helical) flow patterns in stenoses. In vitro observations using spin and gradient echo magnetic resonance imaging (MRI) and computational fluid dynamic modeling.

AIM: Physiological blood flow patterns are themselves poorly understood despite their impact on arterial disease. Stable spiral (helical) laminar flow (SLF) has been observed in normal subjects. The purpose of the present study is to develop a method of magnetic resonance (MR) flow pattern visualization and to analyze spiral and non-spiral flow patterns with and without luminal narrowing in vitro. The flow conditions were then modeled using computational fluid dynamics (Star-CD). METHODS: Laminar integrity was examined in a flow-rig using spin and gradient echo magnetic resonance imaging (MRI) in non-stenosed and stenosed conduits in the presence of non-spiral and spiral flow. RESULTS: No difference was observed in a non-stenosed conduit between non-spiral and spiral flow. In the presence of a stenosis spiral flow preserves flow velocity coherence whereas non-spiral flow increasingly lost coherence beginning proximal to the stenosis. Computational fluid dynamic modeling of the in vitro experiment showed marked differences between the 2 flow patterns. Non-spiral flow produced greater inwardly directed forces just beyond the stenosis and greater outward pressures at more distal sites. The near wall turbulent energy was up to 700% less with spiral flow over non-spiral flow beyond the stenosis. CONCLUSIONS: Spiral flow appears to offer clear flow profile stabilizing advantages over non-spiral flow, by significantly reducing the turbulence caused by a stenosis. Spiral flow also produces lower forces acting on the vessel wall.

Analysis of 153 deaths after upper gastrointestinal endoscopy: room for improvement?

BACKGROUND: Upper gastrointestinal (GI) endoscopy is a widely used procedure that is generally considered to be safe. METHODS: Of a total of 33,854 patients who underwent upper gastrointestinal endoscopy during 1999 under the care of surgeons in Scotland, 153 (0.004%) died. We reviewed the case notes of these 153 patients. RESULTS: Death was directly related to endoscopy in 20 of 153 cases (13%), most commonly due to gastrointestinal perforation or acute pancreatitis. Ninety-one percent (139) of the patients undergoing endoscopy were American Society of Anesthesiologists grades (ASA) 3-5, and 88% received intravenous sedation; an anesthetist was present in 31 cases (20%). Oxygen was administered to 45% of patients during the endoscopy. In 56% of the procedures, there was monitoring of electrocardiograms (ECG), pulse oximetry, or blood pressure readings. CONCLUSIONS: Although deaths after endoscopy may be unavoidable, clinicians undertaking upper GI endoscopy or endoscopic retrograde cholangiopancreatography (ERCP) in ASA 3-5 patients should provide oxygen therapy and cardiovascular monitoring, and keep accurate records. The involvement of an anesthetist in airway management and the administration of intravenous sedation should be actively considered.

Antiplatelet and anticoagulant therapy to prevent bypass graft thrombosis in patients with lower extremity arterial occlusive disease.

The incidence of graft failure for above knee femoropopliteal grafts is described by the European Consensus Document on Critical Limb Ischaemia. It occurs in approximately 15% of patients when vein is used for the grafting procedure and in 20% of patients when PTFA (polytetrafluoroethylene) or other prosthetic material is used. Femorodistal grafts have a much poorer outcome with 45% and 75% failure rates for vein and prosthetic grafts, respectively. Prevention of primary graft failure and thus the need for surgical reintervention is of major clinical and economic importance. Early failure, occurring within one month of operation, is usually due to technical error such as poor patient selection or operative technique. Approximately 10% of graft failures will fall into this time period. When grafts thrombose after two years, progression of native atherosclerosis either proximally or distally is the usual cause. This accounts for 2-3% of all graft failures each year. The most common time for grafts to fail is between one month and two years (80% of all failures) and this is the same period in which graft stenoses are now known to develop. There are few evidence-based recommendations for the use of pharmacological agents in maintaining graft patency following peripheral vascular surgery. This article reviews the evidence for or against the use of anticoagulant and antiplatelet therapy for the prevention of bypass graft thrombosis in patients with peripheral arterial occlusive disease.

Elevated levels of soluble E-selectin in diabetic patients with severe symptomatic peripheral arterial occlusive disease requiring angioplasty. A possible role in diabetic vascular disease?

BACKGROUND: To study levels of E-selectin in patients with peripheral arterial occlusive disease who were undergoing percutaneous transluminal angioplasty. METHODS: Experimental design and setting: Cross sectional case control study, conducted in a teaching hospital. SUBJECTS: Seven patients with type-2 (non-insulin dependent) diabetes mellitus undergoing transluminal angioplasty for symptomatic peripheral arterial occlusive disease, had blood tests for sE-selectin measurement, and were compared to a similar groups of age and sex matched non-diabetic patients with arteriopathy who are undergoing the same procedure. Also evaluated were a group of diabetic patients and healthy non-diabetics with no peripheral arterial disease. RESULTS: The levels of sE-selectin in the two diabetic groups were significantly higher than the non-diabetic groups measuring at 77 ng/ml (53-120) and 79 ng/ml (43-98) (median, range) vs 54 ng/ml (24-104) in the non-diabetic with arteriopathy, and 42 ng/ml (35-66) in the normal healthy controls, p<0.04, p<0.003 respectively, Mann Whitney "U" test. CONCLUSIONS: We have demonstrated significantly high values of soluble E-selectin in patients with diabetes mellitus requiring angioplasty for symptomatic peripheral arterial occlusive disease. This suggests that sE-selectin may be involved in the diabetic angiopathic process. It may act as a precursor for smooth muscle proliferation.

Tibial and peroneal artery bypasses using polytetrafluoroethylene (PTFE) with an interposition vein cuff.

UNLABELLED: The combined results of femoro-distal bypasses using prosthetic material with vein cuffs from two separate vascular units is presented. METHOD: Over the last five years, 89 infrainguinal bypasses using polytetrafluoroethylene (PTFE) with a distal interposition vein cuff to a tibial artery have been performed in two centres. All operations were for critical limb ischaemia. The mean age was 72 years (47-90), there were 46 males and 43 females, 27 of whom were diabetic. Twenty-eight patients had a history of angina and/or previous myocardial infarct. The median follow-up was 12 months (0-68 months). RESULTS: During the follow-up period there were 28 deaths, 35 major limb amputations and 44 graft failures. The graft patency rates at 12 and 24 months were 50 and 32%, and limb salvage rates were 53 and 44%, respectively. The patient survival rates were 66 and 61%, respectively. CONCLUSION: The authors believe that the likely improvement in pain free quality of life the patient may enjoy with a successful bypass shifts the balance in some individuals towards bypass surgery using PTFE with a vein cuff to a tibial artery when such an option is possible.

Interleukin-8 (IL-8) may contribute to the activation of neutrophils in patients with peripheral arterial occlusive disease (PAOD).

OBJECTIVES: to investigate the levels of interleukin-8 (IL-8) in patients with peripheral arterial occlusive disease (PAOD) and healthy control subjects both before and after an acute exercise test. MATERIALS AND METHODS: twenty-six patients with intermittent claudication and 22 matched healthy control subjects each had IL-8 levels measured before and after a standard acute treadmill-exercise test. Subjects walked for 10 min or until stopped by claudication pain. Serum IL-8 levels were measured before exercise was commenced and 1, 5 and 10 min after exercise was stopped. RESULTS: patients with PAOD had statistically significantly higher levels of IL-8 than healthy control subjects, before and after an acute exercise test (p <0.00001, Mann-Whitney). Ratios of the change of IL-8 levels post-exercise showed a statistically significant difference at the post-5-min time point (p =0.005), showing a difference in the change of IL-8 levels at this time point between the patient group and control group. CONCLUSIONS: The increased levels and the failure of the cytokine levels to fall by the same extent after exercise in the patient group may be due to a combination of increased neutrophil activation, reduced blood flow and increased cytokine production during ischaemia-reperfusion, which is not observed in the healthy controls.

Lipid-lowering and skin vascular responses in patients with hypercholesterolaemia and peripheral arterial obstructive disease.

Elevated blood cholesterol is a major risk factor for atherosclerosis. Recent studies show that lowering cholesterol reduces the risk of vascular disease, but the precise mechanisms for vascular improvement are not fully understood. Furthermore, it is not known whether the beneficial effects of cholesterol lowering extend to the skin microvasculature. In this unrandomized, open design study, we used iontophoresis and laser Doppler flowmetry to examine forearm skin perfusion in hypercholesterolaemic patients with PAOD before and after cholesterol-lowering therapy with fluvastatin. Endothelium-dependent and -independent vasodilatation were measured following skin iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP), respectively. Before cholesterol-lowering, vascular responses to ACh and SNP were reduced significantly in patients compared with responses in control subjects (p < 0.001 and p < 0.05, ANOVA, respectively). Fluvastatin therapy (40 mg/day) for 24 weeks significantly reduced total cholesterol (7.3+/-0.3 to 6.0+/-0.2 mmol/l, p < 0.001) and LDL cholesterol (5.4+/-0.5 to 4.2+/-0.4 mmol/l, p < 0.01). Vasodilatation to SNP was significantly improved at week 24 (p < 0.05). In patients with hypercholesterolaemia and PAOD, cholesterol-lowering with statin therapy significantly improved endothelium-independent vascular responses to SNP in skin microvessels. The application of the non-invasive techniques of iontophoresis and laser Doppler flowmetry may provide useful markers for the assessment of microvascular function in this group of patients.

Completion of the journey of care: Scottish Audit of Surgical Mortality (SASM).

The ideal must be to audit all deaths as part of routine surgical and anaesthetic practice. We have examined the level of compliance of surgeons and anaesthetists participating in the Scottish Audit of Surgical Mortality (SASM) for the audit's first three years. The audit has achieved more than 92% compliance, unchanged over a three year period. As a consequence it can be regarded as a truly routine part of surgical and anaesthetic practice within Scotland.

Decrease in P-selectin levels in patients with hypercholesterolaemia and peripheral arterial occlusive disease after lipid-lowering treatment.

At sites of thrombosis and vascular injury, interactions occur among platelets, leucocytes and endothelial cells. Patients with peripheral arterial occlusive disease (PAOD) have been shown to have raised total serum cholesterol and serum triglycerides and increased sP-selectin levels when compared with controls. A total of 31 patients with PAOD and hypercholesterolaemia took part in this three-staged study. Soluble P-selectin (sP-selectin) levels were significantly lowered after 12 weeks of fluvastatin treatment (157.0 ng/ml versus 113.77 ng/ml, p = 0.01), whereas 12 weeks of placebo treatment had no statistically significant effect on sP-selectin levels (150.0 ng/ml versus 139.4 ng/ml). An unpaired t-test almost reached statistical significance (p = 0.051) when the levels by which sP-selectin fell after 12 weeks of active or placebo treatment were compared. The placebo group was then put onto long-term, active treatment and sP-selectin levels were significantly lowered by fluvastatin when compared to pre-treatment levels (150.0 ng/ml versus 110.0 ng/ml, p = 0.03). By lowering the levels of P-selectin, fluvastatin may not only attenuate atherosclerotic progression but may also decrease the platelet activation associated with PAOD.