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Propionyl-L-carnitine in intermittent claudication: double-blind, placebo-controlled, dose titration, multicenter study.

OBJECTIVES: The aim of this double-blind, placebo-controlled, dose titration, multicenter trial was to assess the efficacy and safety of propionyl-carnitine in intermittent claudication. BACKGROUND: Human and animal studies indicate that propionyl-L-carnitine increases carnitine content and improves energy metabolism in the ischemic skeletal muscle. METHODS: After a 2-week preliminary period to assess maximal walking distance, 245 patients were randomly assigned to receive propionyl-L-carnitine (n = 118) or placebo (n = 127). The initial oral dose of 500 mg twice daily was increased at 2-month intervals to 2 g/day and then to 3 g/day in patients showing improvement in treadmill performance < 30% over baseline. Efficacy analysis was conducted for the 214 patients who completed the 24 weeks of treatment by comparing the effect of placebo and propionyl-L-carnitine on day 180. RESULTS: Analysis of variance showed a significant improvement of 73 +/- 9% (mean +/- SE) in maximal walking distance with propionyl-L-carnitine (n = 99) compared with 46 +/- 6% for placebo (n = 115, p = 0.03). For distance walked at onset of claudication, propionyl-L-carnitine showed about double the improvement of placebo; however, the difference was not statistically significant. There were no changes in electrocardiographic and routine biochemical and hematologic tests that would indicate an adverse effect of propionyl-L-carnitine. Adverse events requiring drug discontinuation (11 in the propionyl-L-carnitine group, 3 in the placebo group) were unrelated to study medication. The dose titration design of the study also provided information on the dose-response relation. Slightly less than 67% of patients were expected to improve their maximal walking distance by at least 30%, assuming 2 g/day of propionyl-L-carnitine (95% confidence interval 0.51 to 0.70). The response rate during the entire titration course was significantly in favor of propionyl-L-carnitine compared with placebo. CONCLUSIONS: Although the precise mode of therapeutic action requires clarification, propionyl-L-carnitine, at a dose of 1 to 2 g/day, appears to be effective and well tolerated, with minimal adverse effects.

Administration, Oral↗

A marked decline in the prevalence and incidence of intermittent claudication in Icelandic men 1968-1986: a strong relationship to smoking and serum cholesterol--the Reykjavik Study.

The epidemiology of peripheral vascular disease has been studied much less extensively than the epidemiology of coronary heart disease (CHD). The prospective Reykjavik Study gave an opportunity to monitor secular trends from 1968 to 1986 of clinical intermittent claudication (IC) amongst Icelandic males, aged 34-80 and to assess the importance of possible risk factors. Both prevalence and incidence of IC decreased sharply after 1970 in all age groups, and this decline occurred a few years earlier than the decline of CHD in Iceland. The only significant risk factors for intermittent claudication, in addition to age, were smoking which increased the risk of IC 8- to 10-fold and serum cholesterol level. Approximately one-half of the striking decline in the incidence of IC can be explained by decreased smoking and cholesterol levels amongst Icelandic men. A follow-up study verified that IC patients stood twice the risk of cardiovascular and total mortality as non-IC patients, indicating that IC is a high risk group which should receive all possible preventive measures.

Adult↗

Colour duplex in assessing the infrainguinal arteries in patients with claudication.

Non-invasive assessment of the lower-limb vasculature may avoid unnecessary arteriography. Colour duplex scanning of the femoral and popliteal arteries was performed in claudicants who were potential candidates for endoluminal therapy. This was compared with the findings of biplanar conventional arteriography and intra-arterial digital subtraction angiography. In 112 lower limbs duplex gave the following results compared with angiography: the sensitivity, specificity, positive predictive value, negative predictive value and accuracy for occlusions (n = 48), stenoses (n = 31), atheromatous vessel (n = 21) and disease-free (n = 12) were all greater or equal to 94%. The lengths of the occlusions were accurately identified by duplex. Clinical examination and spectral analysis at the common femoral artery failed to identify two patients who had an iliac lesion. Colour duplex examination is the investigation of choice in assessing the major infrainguinal arteries in patients with claudication.

Adult↗

Oxidative damage to skeletal muscle following an acute bout of contractile claudication.

The purpose of this study was to determine the extent and sources of oxidative stress within skeletal muscle following an acute bout of contractile claudication. Twenty-four hours after unilateral ligation of the femoral artery, rat hind limbs were stimulated in vivo for 30 min, and force production measured. One-hour post-stimulation, animals were sacrificed and soleus and gastrocnemius muscles removed. There was significant reduction in force in the control limb (sham ligated/stimulated (SS)), while force in the ligated limb (ligated/stimulated (LS)) was reduced by 72%. There was an increase in skeletal muscle lipid hydroperoxides (53 and 47%) and protein carbonyls (57 and 54%) in the soleus and gastrocnemius muscles, respectively, and the muscle wet/dry weight ratio was increased in the gastrocnemius muscles. Total glutathione (GHS) was reduced, while xanthine oxidase (XO) activity and neutrophil levels were increased, in LS compared to SS in both soleus and gastrocnemius muscles. These data suggest that an acute bout of contractile claudication causes significant oxidative damage and edema to skeletal muscle. This is associated with both an increase in the activity of the radical-producing enzyme xanthine oxidase and an increase in activated neutrophils.

Analysis of Variance↗

Intermittent claudication: an overview.

Intermittent claudication (IC) is defined by leg muscle pain, cramping and fatigue brought on by ambulation/exercise; relieved on rest; and caused by inadequate blood supply and is the primary symptom of peripheral arterial disease (PAD). PAD has a detrimental effect on the quality of life. PAD is a debilitating atherosclerotic disease of the lower limbs and is associated with an increased risk of cardiovascular morbidity and mortality. IC is an extremely important marker of atheroma. Up to 60% patients with IC have significant underlying coronary and/or carotid disease and 40% of all patients suffering from IC die or suffer a stroke within 5 years of presentation. The therapeutic intervention of IC essentially aims at providing symptomatic relief and reducing the systemic cardiovascular complications. Although exercise therapy is one of the most efficacious conservative treatments for claudication, the pharmacotherapeutic goals can be best achieved through an increase in the walking capacity to improve quality of life and a decrease in rates of amputation. In the development of treatment for IC, an aggressive non-pharmacological intervention and pharmacological treatment of the risk factors associated with IC are considered. In the next 2 years, the results of major trials of drugs that stabilize and regress atherosclerosis such as statins and angiotensin converting enzyme inhibitors, and anti-platelet agents, recombinant growth factors and immune modulators will be available for IC. Levocarnitine (l-carnitine) and a derivative, propionyl levocarnitine, are emerging agents that increase the pain-free walking and improve the quality of life in IC patients by working at the metabolism and exercise performance of ischemic muscles. This article provides a comprehensive review of the pathophysiology involved, diagnosis of IC and existing and emerging pharmacotherapies with rationale for their use in its treatment.

Humans↗

Does supervised exercise offer adjuvant benefit over exercise advice alone for the treatment of intermittent claudication? A randomised trial.

OBJECTIVE: Exercise advice is the main treatment for symptom relief in the UK for patients with mild to moderate Intermittent Claudication (IC). Would a weekly exercise and motivation class for 6 months offer adjuvant benefit over written and verbal exercise advice alone? PATIENTS AND METHODS: Fifty-nine patients attending a regional vascular centre for whom IC was the main factor affecting mobility were randomised to either exercise advice alone (n=30) or exercise advice with a once a week 45 min supervised exercise/motivation class (n=29). The mean age was 68 years. Baseline and 6-month assessment included a Quality of Life Questionnaire--the Short-Form-36, the Charing Cross Symptom Specific Claudication Questionnaire (CCCQ) and treadmill walking distance (3.5 km/h 12%). RESULTS: At 6-month follow-up the supervised exercise group had improved their treadmill walking by 129% compared to 69% in the advice alone group (p=0.001). This significant improvement was maintained at the subsequent 9 and 12-month follow-up assessments. By the 9-month stage the advice only group CCCQ score had improved 16% from baseline, while the supervised exercise group had a significantly better 43% improvement in base line score (p<0.05). Self reported frequency of walks was higher in the exercise class group being significant for improvement in CCCQ score. CONCLUSION: A weekly, supervised exercise and motivation class for a 6-month period provides a significant improvement in patients' symptoms, quality of life, and distance walked compared with advice alone and this improvement continues after attendance at class has ceased.

Aged↗

Speed rather than distance: a novel graded treadmill test to assess claudication.

OBJECTIVE: To evaluate a new treadmill test, determining pain threshold speed (PTS) for use in assessment and measuring rehabilitation of patients with intermittent claudication. METHODS AND DESIGN: Twenty-nine patients with claudication were evaluated, and the ankle-brachial index (ABI) was assessed. PTS was determined with a treadmill protocol based on level walking, low starting speed, and progressive increments at a predetermined distance up to the onset of pain. Repeatability and equivalence with a time-based protocol were verified. PTS was compared to pain-free walking distance, 6-minute walking distance, and ABI. RESULTS: PTS was measured in all patients (3.6+/-1.1 km/h). Repeatability and equivalence between established tests were demonstrated. PTS showed a significant correlation with pain-free walking distance (r=0.833; P=0.0001), with 6-minute walking distance (r=0.724; P=0.005), and with ABI in the more ischemic limb (r=0.641; P=0.0001). CONCLUSIONS: PTS is a reliable parameter that correlates well with other established measures. It is useful for determining the degree of functional handicap and for designing and guiding rehabilitation protocols.

Aged↗

Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants.

PURPOSE: To assess the results of covered stents in the treatment of superficial femoral artery (SFA) occlusive disease. METHOD: From July 2000 till June 2003, 32 patients (34 limbs) were scheduled for procedures including Hemobahn deployment in the SFA. Indication for treatment was claudication (group I, N=15 patients and 16 limbs, 31.2% occlusions) or critical and acute ischemia (group II, N=17 patients and 18 limbs, 61.1% occlusions). TASC D SFA lesions were excluded. No limb artery was patent pre-operatively in 19% and 89% of limbs in groups I and II, respectively (p=0.00001). RESULTS: Outflow procedures were performed simultaneously in one limb in group I and 12 in group II (p=0.0003). The technical, hemodynamic and clinical success rates were 100, 100 and 94.1%, respectively. Mean follow-up was 18.1 months. Primary patency rates at 12 months were 81.3+/-10.6% in group I and 88.6+/-9.0% in group II (p=0.547). At 12 months, the secondary patency and limb salvage rates were, respectively, 87.5+/-8.9 and 100% in group I and 87.5+/-8.93 and 94.45+/-6.71% in group II. CONCLUSION: Treatment of SFA occlusive lesions (excluding TASC D lesions) with the Hemobahn covered stent yielded good results for both claudicants with good outflow and patients with critical or acute ischemia with bad outflow, if concomitant outflow-improving procedures were performed.

Acute Disease↗

A preliminary study on the effects of exercising to maximum walking distance on platelet and endothelial function in patients with intermittent claudication.

BACKGROUND: Platelet and endothelial activation has been shown to be increased in patients with intermittent claudication (IC). Recent studies have suggested that exercise may induce further platelet activation. The aims of this study were to investigate the effect of exercising to maximum walking distance on platelet and endothelial function in patients with intermittent claudication who were receiving statin and aspirin therapy compared with age matched healthy controls. METHODS: Platelet aggregation through COX-mediated and thrombin receptor activator peptide (TRAP)-stimulated GPIIb/IIIa pathways was measured by the Ultegra point of care system in 20 patients with IC on aspirin and 20 healthy volunteers before, immediately and 1h after exercising to treadmill maximal walking distance (MWD). Soluble P-selectin, vWF and sICAM were measured using an enzyme linked immuno-sorbent assay technique. RESULTS: Baseline platelet aggregation was significantly reduced in patients with IC compared to volunteers (p<0.05). In patients, exercising to MWD significantly reduced platelet aggregation (COX, median -5% [range -24 to 13%]; p = 0.02; GPIIIa/IIb, median -13% [range -72 to 33%]; p = 0.02) immediately post-exercise which returned to baseline values at 1 h. There was no change in the healthy volunteers following the same median duration of exercise. Baseline sP-selectin levels were higher in the patients with IC compared to the healthy volunteers [Median values (interquartile range), 42.72 (33.28-54.24) versus 29.16 (24.40-34.10), p = 0.0003] but there were no differences in vWF levels. Both sP-selectin and vWF levels increased significantly in the control and patient group following exercise (p<0.005). sICAM were higher at baseline in the patients with IC but were unchanged following exercise [Median values (interquartile range),560.9 (405.5-739.4) versus 467.0 (325.7-643.4), p<0.05]. CONCLUSION: This study is the first to show that platelet aggregation is reduced immediately following treadmill exercise to maximum walking distance in patients with IC despite a rise in sP-selectin and vWF, suggesting endothelial activation. The inhibition of platelet aggregation after exercise in subjects on antiplatelet and statin therapy suggests that exercise is unlikely to exacerbate platelet thrombus formation in patients with IC.

Aged↗

Blood pressure in patients with intermittent claudication increases continuously during walking.

OBJECTIVES: The purpose of this study was to compare the circulatory responses to walking in patients with peripheral atherosclerotic disease (PAD) and healthy controls. METHODS: The participants were eleven patients with diagnosed PAD, and a control group of six healthy age-matched adults. Blood pressure, heart rate (HR), and acral skin perfusion were recorded continuously before, during and after a walking exercise on a treadmill. RESULTS: The patients walked to maximum claudication distance (MCD) on a treadmill, median walking distance 103 (34-223) metres [median (range)], at 3.3 (1.0-4.5) km/h. There was a steep increase in HR and mean arterial pressure (MAP) while the patients were walking. At claudication the median rise in MAP was 46.6 (10.3-61.3) mmHg, systolic blood pressure (SP) increased by 84.9 (31.4-124.9) mmHg, and diastolic blood pressure (DP) by 21.7 (-2.1-31.7) mmHg. HR increased by 34.9 (12.9-48.1) beats/min. The control group walked for 5 minutes at 3.2 (3.0-3.3) km/h. In the control group the blood pressure initially increased moderately but stabilised thereafter. Median rise in MAP during walking was 8.5 (5.6-14.6) mmHg, SP increased by 30.9 (6.6-41.5) mmHg, and DP was reduced by -1.4 (-5.4-1.5) mmHg. HR increased by 27.1 (18.8-34.9) beats/min. We found no significant differences in acral skin perfusion during walking exercise between the patients and control group. CONCLUSIONS: In patients with PAD, blood pressure increased continuously and significantly when walking to MCD (dynamic exercise). The level of increase in blood pressure was similar to that caused in response to isometric exercise.

Aged↗

A non-randomised controlled trial of the clinical and cost effectiveness of a Supervised Exercise Programme for claudication.

OBJECTIVES: The main aims of treatment in patients with intermittent claudication (IC) are to improve the clinical indicators of lower limb ischaemia and patients' quality of life (QoL). The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme (SEP) in patients with IC. DESIGN: Non-randomised, controlled trial. SETTING: University teaching hospital. PATIENTS AND METHODS: Two groups of patients with IC were studied. Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit. Thirty-seven patients (median age 69 years, 26 men) received conservative medical therapy (CMT) and 33 patients (median age 67 years, 22 men) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes, three times each week. Patients were assessed prior to and at 6 months following treatment. At each assessment patient reported walking distances (PRWD), treadmill claudication and maximal distances (ICD and MWD), ankle brachial pressure indices (ABPI) pre & post exercise and patient reported QoL using the SF36 questionnaire were assessed. RESULTS: Prior to intervention the two groups were well matched. Following treatment, CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD. CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains, effect size >-0.5 for the domains of Physical Function and Emotional Role. SEP patients demonstrated significant improvement in PRWD, ICD and MWD. SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains. However, all QoL effect sizes following SEP were < +/-0.5. Intergroup differences in effect sizes were >0.5 for the SF36 domains of Physical Function, Physical Role, Emotion Role and SF36 index. SEP resulted in a 0.027 quality adjusted life year (QALY) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is pound1780 at 1 year. CONCLUSIONS: Compared to CMT, SEP increases walking distances, improves QoL and is a highly cost-effective treatment for IC.

Aged↗

The Oslo balloon angioplasty versus conservative treatment study (OBACT)--the 2-years results of a single centre, prospective, randomised study in patients with intermittent claudication.

OBJECTIVES: To compare the effect of optimal medical treatment only (OMT) with OMT combined with percutaneous transluminal angioplasty (OMT+PTA) in patients with intermittent claudication (IC). DESIGN: A single centre prospective, randomised study. Quality of life (QoL) was the primary outcome measure. Secondary measures were ankle-brachial-index (ABI), treadmill walking distances and mortality. METHODS: From a total of 434 patients considered for inclusion into the trial, only 56 patients with disabling IC fulfilled the inclusion criteria. The patients were randomised into treatment groups consisting of 28 patients each and followed for 2 years. ABI and treadmill walking distances were measured in addition to the visual analogue scale (VAS) for pain evaluation, and QoL assessment using the Short Form (SF-36 and Claudication Scale (CLAU-S). RESULTS: The demographic data in the 2 groups were almost identical. After 2 years of follow-up the ABI, the treadmill walking distances and the VAS were significant improved in the group treated with OMT+PTA, compared to the group treated with OMT only (p<0.01 for all). Furthermore, some variables from the QoL assessment also showed a significant improvement in favour of the OMT+PTA group (p<0.05 for all). CONCLUSION: The advantage of conducting a single centre study and adhering to very strict inclusion criteria was illustrated by the homogenous demographic data of the two groups. This partly outweighed the disadvantage of having included a relatively small number of patients. Early intervention with PTA in addition to OMT seems to have a generally more positive effect compared to OMT only, on haemodynamic, functional as well as QoL aspects during the first 2 years in patients with IC.

Aged↗

Primary stent-supported angioplasty for treatment of below-knee critical limb ischemia and severe claudication: early and one-year outcomes.

OBJECTIVES: The objective of this study was an investigation of the safety and efficacy of primary below-knee stent-supported angioplasty (BKSSA) for restoring straight inline arterial flow in patients with critical limb ischemia (CLI) or lifestyle-limiting claudication (LLC). BACKGROUND: Surgical tibial bypass for CLI and severe LLC is associated with significant morbidity, mortality, and graft failure, whereas percutaneous angioplasty is suboptimal. METHODS: Below-knee stent-supported angioplasty was attempted in 82 patients (92 limbs) with either CLI (68%) or severe LLC (32%). Patients received daily aspirin, thienopyridine, and glycoprotein IIb/IIIa agents during the procedure. One-month major adverse events (MAEs) were defined as death, myocardial infarction, major unplanned amputation, need for surgical revascularization, or major bleeding. Clinical success was defined as improved resting ankle brachial index by > or =0.10, relief of resting pain, healing of ulceration or amputation, and improvement of claudication. RESULTS: Mean age of patients was 74 +/- 17 years. In 86 limbs, straight inline flow was restored to at least one tibial vessel. Technical success was 94% for de novo lesions and there were no MAEs. Ankle brachial indexes increased for all groups (CLI = 0.32 +/- 0.13 to 0.9 +/- 0.14 and LLC = 0.65 +/- 0.09 to 0.95 +/- 0.12; p < or = 0.0001, pre vs. post). Relief of rest pain and healing of ulcerations and amputations were seen in 96% (47 of 49) of patients with CLI who underwent successful intervention. CONCLUSIONS: Below-knee stent-supported angioplasty for CLI and LLC improves ankle brachial indexes comparable to tibial bypass, heals amputations and ulcerations, relieves rest pain, and improves ambulation. Because BKSSA is associated with minimal MAE, it may hold promise as an alternative therapy for patients with CLI and LLC.

Aged↗

Intermittent claudication -- atypical presentation, diagnosis and treatment.

A unique case of a man with Fabry's disease and associated small vessel vasculopathy manifesting as recurrent episodes of intermittent claudication is described. The case highlights the concept that microvascular involvement due to local accumulation of glycosphingolipid in the smooth muscle fibres of vessel walls may be responsible for claudicant symptoms in such patients rather than the more classical macrovascular insufficiency.

Endothelial Cells↗

Clinical review of patients treated for atypical claudication: a 28-year experience.

PURPOSE: This article describes patient demographic data, as well as diagnosis and treatment of symptomatic lower extremity claudication that has no apparent vascular or orthopedic cause. METHODS: A retrospective review was performed of records for 843 patients who received surgical treatment between 1975 and 2003. All patients had a detailed history, and underwent physical examination and selected noninvasive vascular testing. Noninvasive popliteal entrapment screening tests and compartment pressure measurements for isolated superficial muscle pain were routine. Duplex scanning or arteriography were used only when arteriovenous disease or popliteal entrapment syndrome was suspected. RESULTS: The study population included 549 female patients (65%) and 294 male patients (35%). Their mean age was 29 years (range, 12-71 years). The most common symptoms were isolated lower extremity muscle cramping (100%), foot paresthesia (20%), and medial tibial bone pain (1%). Causes of symptoms included chronic compartment syndrome (796 patients, 94%), functional popliteal entrapment syndrome (33 patients, 4%), and medial tibial syndrome (14 patients, 2%). Pathologic findings included overuse injury (756 patients, 89%), blunt limb trauma (60 patients, 7%), or gait anomaly (34 patients, 4%). Surgery for compartment release included fasciotomy (100 patients, 12%) or fasciectomy (696 patients, 88%). Surgery for functional popliteal entrapment included excision of the plantaris muscle and soleal band (33 patients). Medial tibial release included soleal and transverse fasciectomy, with periosteal cautery of the tibial insertions. Complete symptomatic relief was achieved in 92% of compartment release procedures, 100% of popliteal entrapment release procedures, and 80% of medial tibial release procedures. CONCLUSION: Atypical claudication represents a collection of syndromes that can be permanently and effectively treated with surgical intervention.

Adolescent↗

The constitutive procoagulant and hypofibrinolytic state in patients with intermittent claudication due to infrainguinal disease significantly improves with percutaneous transluminal balloon angioplasty.

BACKGROUND: Patients with intermittent lower limb claudication (IC) exhibit a prothrombotic diathesis that is acutely exacerbated by exercise. This may occur because of ischemia/reperfusion injury within the leg muscles during walking and may contribute to the increased risk of thrombotic vascular events in this group of patients. This randomized study compared the effect of lower limb revascularization by percutaneous transluminal balloon angioplasty (PTA), supervised exercise, and best medical therapy (BMT) alone on this prothrombotic state. METHODS: Twenty-three patients (16 men and 7 women; median age, 67 years; range, 57-77 years) with IC due to infrainguinal disease were randomized to receive BMT alone (n = 7), BMT plus PTA (n = 9), or BMT plus supervised exercise (n = 7) as part of the Health Technology Assessment-funded EXercise vs Angioplasty in Claudication Trial (EXACT). Patients were assessed at baseline and at 3 and 6 months. Thrombin-antithrombin complex (TAT) was determined as a marker of thrombin generation, and plasminogen activator inhibitor (PAI) antigen was determined as a marker of fibrinolysis. Increased TAT indicates a procoagulant state, and increased PAI antigen indicates a hypofibrinolytic state. RESULTS: At 6 months, subjects randomized to BMT plus PTA demonstrated a significant improvement in ankle-brachial pressure index (P = .013) and maximal walking distance (P = .008), a significant decline in resting thrombin generation (median [interquartile range] TAT, 6.4 microg/L [2.7-13.5 microg/L] to 1.5 microg/L [0.3-2.9 microg/L]; P = .038), and an improvement in resting fibrinolysis (median [interquartile range] PAI-1, 10.0 ng/mL [1.0-20.5 ng/mL] to 1.0 ng/mL [1.0-14.8 ng/mL]; P = .043). There was no significant change in any of these parameters in patients randomized to BMT plus supervised exercise or to BMT alone. CONCLUSIONS: The addition of lower limb revascularization by PTA to BMT in patients with IC due to infra-inguinal disease results in a medium-term improvement in the resting procoagulant and hypofibrinolytic state. This may translate into a reduction in morbidity and mortality from thrombotic vascular events in this group of patients.

Aged↗

Successful percutaneous treatment of gluteal claudication secondary to isolated bilateral hypogastric stenoses.

We report an unusual case of bilateral buttock claudication at ambulation of less than two blocks in a 57-year-old man with normal lower-extremity segmental pressure on noninvasive exercise testing. He was found to have bilateral high-grade internal iliac artery stenoses on arteriography. Both sides were successfully treated in a staged fashion via a contralateral approach with percutaneous transluminal angioplasty and a balloon-expandable stent, with complete symptom resolution. A clinical vascular examination with normal findings of the common iliac, external iliac, and common and superficial femoral arteries eliminates significant vascular obstruction as a cause of claudication. However, internal iliac occlusive disease may be suspected when symptoms are limited to the gluteal musculature and other causes are eliminated. Percutaneous interventions can be of diagnostic and therapeutic value.

Angioplasty, Balloon↗

The effect of supervised exercise and cilostazol on coagulation and fibrinolysis in intermittent claudication: a randomized controlled trial.

BACKGROUND: The prothrombotic, hypofibrinolytic state that develops in patients with intermittent claudication (IC) upon walking due to ischemia-reperfusion injury (IRI) of the leg muscles may contribute to the high incidence of life- and limb-threatening thrombotic events observed in this patient group. Treatments, such as angioplasty, that obtund the IRI also ameliorate the procoagulant diathesis. The effect on this diathesis of supervised exercise and cilostazol, both of which provide symptomatic benefit in IC, but without significantly obtunding IRI, is unknown. METHODS: Thirty-four patients (27 men and 7 women; median age, 67 years; range, 63-72 years) were randomized to receive best medical therapy (BMT) plus supervised exercise (n = 9), BMT plus cilostazol (n = 9), BMT plus supervised exercise plus cilostazol (n = 7), or BMT alone (n = 9) in a 2 x 2 factorial design. Thrombin-antithrombin complex and prothrombin fragments 1 and 2, both markers of thrombin generation; plasminogen activator inhibitor antigen and tissue plasminogen activator antigen, both markers of fibrinolysis; ankle-brachial pressure index (ABPI); and initial and absolute claudication distance (ACD) were measured at baseline and then 3 and 6 months after randomization. RESULTS: At 6 months, when compared with receiving BMT only, supervised exercise and cilostazol resulted in improvements in ABPI of 18% and 13% and in ACD of 40% and 64%, respectively. The effects on ABPI and ACD of combining supervised exercise and cilostazol were additive. Supervised exercise, cilostazol, and supervised exercise combined with cilostazol had no significant effect on any of the four hemostatic markers. CONCLUSIONS: Treatment of IC by supervised exercise or cilostazol results in significant improvements in ABPI and ACD but has no demonstrable effect on the prothrombotic diathesis. This suggests that supervised exercise and cilostazol, unlike angioplasty, are unlikely to have a long-term beneficial effect on the thrombotic risks faced by these patients.

Aged↗