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PubMed2001

Design of the therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication (TRAFFIC) trial.

The Therapeutic Angiogenesis With Recombinant Fibroblast Growth Factor-2 for Intermittent Claudication (TRAFFIC) is a large, randomized, placebo-controlled, regimen-finding trial of intra-arterial recombinant fibroblast growth factor-2 in patients with intermittent claudication. This report describes the major design considerations and end points in TRAFFIC.

Double-Blind Method↗
PubMed2001

Intermittent claudication: magnitude of the problem, patient evaluation, and therapeutic strategies.

Intermittent claudication (IC), the symptom of exercise-induced muscle ischemia of peripheral arterial disease (PAD), afflicts and limits the activities of a significant number of patients. Incidence and prevalence of IC depends on the population studied and the diagnostic instruments used. In large studies, prevalence has ranged from 3% to 10%, with a sharp increase in those aged > or =70 years. Over the next 20 years, the total number of patients affected is expected to increase significantly due to anticipated demographic changes. Analysis of the natural history of IC demonstrates that the risk of cardiovascular morbidity and mortality far exceeds that of severe limb ischemia or limb loss. In fact, only 2% to 4% of all patients with IC will require a major amputation in their lifetime. However, life expectancy is approximately 10 years less than that of an age-matched cohort. By now, PAD is well recognized as a marker of systemic atherosclerosis. The cornerstone of patient evaluation is a history and physical examination, including a detailed atherosclerotic risk-factor assessment. In the differential diagnosis of IC, clinicians should consider etiologies such as arthritis, spinal stenosis, radiculopathy, venous claudication, or inflammatory processes. In >80% of all patients, it is possible to locate the responsible arterial segment by combining the location and severity of pain with a pulse examination. Noninvasive diagnostic studies help determine the level of disease, may unmask a hemodynamically significant stenosis, and are useful in follow-up. Arteriography is reserved for patients in whom the decision for revascularization has been made. Knowing the anatomic detail of a lesion allows the clinician to determine whether and what type of intervention is feasible. Standard therapy for all patients should be directed at both peripheral and systemic atherosclerosis, beginning with risk-factor modification in the form of smoking cessation, optimal diabetes control, and lipid normalization. The benefits of supervised exercise rehabilitation include significantly increased walking distance and enhanced quality of life. Platelet inhibition has been shown to reduce the risk of ischemic stroke, myocardial infarction, and vascular death and should be prescribed for all but those in whom it is medically contraindicated. Symptom-specific pharmacotherapy with a broad range of medications has yielded disappointing results in the past. However, recent studies have demonstrated that patients receiving the novel agent cilostazol experienced increases in walking distance and improvements in quality of life.

Diagnosis, Differential↗
PubMed2001

Endovascular and surgical revascularization for patients with intermittent claudication.

Intermittent claudication (IC), the most common symptom of peripheral arterial disease (PAD), most often results from flow-reducing lesions in the arteries of the lower extremity that cause exercise-induced muscle ischemia. Intermittent claudication has a significant impact on quality of life and calls attention to PAD, which is secondary to systemic atherosclerosis and a major marker for cardiovascular morbidity and mortality. Most IC patients improve with a regimen that includes aggressive risk-factor modification, exercise, platelet inhibition, and pharmacotherapy to improve walking distance. Selected patients may require endovascular or surgical intervention if it can be offered with low risk. Endovascular procedures, most often percutaneous balloon angioplasty with or without stenting, are recommended for short-segment stenotic lesions in the aortoiliac and infrainguinal arterial segments. Combined platelet inhibition and endoluminal radiation are under study and may be useful to improve long-term outcome with these procedures. Percutaneous hemostatic puncture closure devices can also be used to reduce bleeding complications and allow more aggressive and immediate antithrombotic therapy, further improving results. Operative revascularization is recommended for patients with long-segment and multisegment disease, especially if obstruction is present. Aortofemoral reconstruction is associated with a low operative mortality and an 80% to 85% 5-year patency rate. Iliac reconstruction is recommended for isolated unilateral iliac arterial disease. Infrainguinal arterial reconstruction is associated with a 60% to 80% 5-year patency rate, with better outcomes noted for autogenous conduits than for prosthetic devices. Mechanical modification and pharmacotherapy with platelet inhibitors and anticoagulants improve long-term patency.

Anastomosis, Surgical↗
PubMed2002

Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication.

We examined the effect of cilostazol, a type III phosphodiesterase inhibitor, on pain-free and maximal walking distance and quality of life measures. The present study examined adverse effects in 2,702 patients with stable, moderate to severe claudication enrolled in 8 randomized, double-blind, placebo-controlled trials. Treatment duration ranged from 12 to 24 weeks. Cilostazol therapy increased maximal and pain-free walking distances by 50% and 67%, respectively. In subgroup analysis, cilostazol increased pain-free and maximal walking distance similarly in men and women, in older (>/=65 years) and younger patients, and in patients with and without diabetes. Quality-of-life assessments revealed enhanced scores for physical well-being. Cilostazol-treated patients reported a higher incidence of headache, bowel complaints, and palpitations than patients given placebos. Cilostazol decreased triglycerides by 15.8% and increased high-density lipoprotein cholesterol by 12.8%, but there were no deleterious effects on any hematologic or serum markers. We conclude that cilostazol significantly increases walking distance and quality-of-life measures in patients with claudication without major adverse effects.

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PubMed2003

Effect of simvastatin versus placebo on treadmill exercise time until the onset of intermittent claudication in older patients with peripheral arterial disease at six months and at one year after treatment.

Simvastatin significantly increased treadmill exercise time until onset of intermittent claudication from baseline by 54 seconds (a 24% increase, p <0.0001) at 6 months after treatment and by 95 seconds (a 42% increase, p <0.0001) at 1 year after treatment. At 6 months and 1 year after treatment with placebo, treadmill exercise time until onset of intermittent claudication was not significantly different from baseline exercise time.

Aged↗
PubMed2000

A comparison of cilostazol and pentoxifylline for treating intermittent claudication.

PURPOSE: We performed a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the relative efficacy and safety of cilostazol and pentoxifylline. PATIENTS AND METHODS: We enrolled patients with moderate-to-severe claudication from 54 outpatient vascular clinics, including sites at Air Force, Veterans Affairs, tertiary care, and university medical centers in the United States. Of 922 consenting patients, 698 met the inclusion criteria and were randomly assigned to blinded treatment with either cilostazol (100 mg orally twice a day), pentoxifylline (400 mg orally 3 times a day), or placebo. We measured maximal walking distance with constant-speed, variable-grade treadmill testing at baseline and at 4, 8, 12, 16, 20, and 24 weeks. RESULTS: Mean maximal walking distance of cilostazol-treated patients (n = 227) was significantly greater at every postbaseline visit compared with patients who received pentoxifylline (n = 232) or placebo (n = 239). After 24 weeks of treatment, mean maximal walking distance increased by a mean of 107 m (a mean percent increase of 54% from baseline) in the cilostazol group, significantly more than the 64-m improvement (a 30% mean percent increase) with pentoxifylline (P <0.001). The improvement with pentoxifylline was similar (P = 0.82) to that in the placebo group (65 m, a 34% mean percent increase). Deaths and serious adverse event rates were similar in each group. Side effects (including headache, palpitations, and diarrhea) were more common in the cilostazol-treated patients, but withdrawal rates were similar in the cilostazol (16%) and pentoxifylline (19%) groups. CONCLUSION: Cilostazol was significantly better than pentoxifylline or placebo for increasing walking distances in patients with intermittent claudication, but was associated with a greater frequency of minor side effects. Pentoxifylline and placebo had similar effects.

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PubMed2002

Therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication (the TRAFFIC study): a randomised trial.

BACKGROUND: Recombinant fibroblast growth factor-2 (rFGF-2) improves perfusion in models of myocardial and hindlimb ischaemia. We investigated whether one or two doses of intra-arterial rFGF-2 improves exercise capacity in patients with moderate-to-severe intermittent claudication. METHODS: 190 patients with intermittent claudication caused by infra-inguinal atherosclerosis were randomly assigned (1:1:1) bilateral intra-arterial infusions of placebo on days 1 and 30 (n=63); rFGF-2 (30 microg/kg) on day 1 and placebo on day 30 (single-dose, n=66); or rFGF-2 (30 microg/kg) on days 1 and 30 (double-dose, n=61). Primary outcome was 90-day change in peak walking time. Secondary outcomes included ankle-brachial pressure index and safety. The main analysis was per protocol. FINDINGS: Before 90 days, six patients had undergone peripheral revascularisation and were excluded, and ten withdrew or had missing data. 174 were therefore assessed for primary outcome. Peak walking time at 90 days was increased by 0.60 min with placebo, by 1.77 min with single-dose, and by 1.54 min with double-dose. By ANOVA, the difference between groups was p=0.075. In a secondary intention-to-treat analysis, in which all 190 patients were included, the difference was p=0.034. Pairwise comparison showed a significant difference between placebo and single-dose (p=0.026) but placebo and double-dose did not differ by much (p=0.45). Serious adverse events were similar in all groups. INTERPRETATION: Intra-arterial rFGF-2 resulted in a significant increase in peak walking time at 90 days; repeat infusion at 30 days was no better than one infusion. The findings of TRAFFIC provide evidence of clinical therapeutic angiogenesis by intra-arterial infusion of an angiogenic protein.

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PubMed1977

Treatment of severe intermittent claudication by controlled defibrination.

Fifteen patients with severe intermittent claudication were treated by therapeutic defibrination with subcutaneous injections of ancrod for 5 weeks. Mean plasma-fibrinogen was maintained below 50% of the initial value throughout the treatment period. This reduction in plasma-fibrinogen was accompanied by a parallel fall in whole-blood viscosity and a pronounced clinical improvement. Objective measurements showed maximum benefit on the 21st day of treatment, when the mean resting ankle/arm pressure index had increased by 37%, the post-exercise pressure index had increased by 50%, and the time taken for the pressure index to return to a resting value after a constant exercise had decreased by 33%. (The claudication-count had increased by 59%).

Ancrod↗
PubMed2001

Model of neuropathic intermittent claudication in the rat: methodology and application.

In the present study we characterize a rat neurogenic intermittent claudication model which was accomplished by placing two pieces of silicone rubber of various sizes into the lumbar (L4 and L6) epidural space. After induction of spinal stenosis walking function was measured using a treadmill apparatus and sensory functions were tested by measuring thermal and tactile withdrawal threshold (von Frey filaments) for the period of 28 days after stenosis. In addition, local spinal cord blood flow (SCBF) was measured, periodically, before and after induction of stenosis using laser Doppler. After implantation of two pieces of silicone rubber (width 1.25 mm, height 1.0 mm, length 4.0 mm) a significant running dysfunction, as evidenced by shortening of running distance, was measured as soon as 24 h after stenosis (178.5+/-59.1 m vs 681.3+/-70.2 m). This effect persisted for 28 days after surgery. Similarly, a significant tactile (but not thermal) hypersensitivity was measured for a period of 28 days (1.2+/-0.3 g vs 14.9+/-0.2 g). In this experimental group the measurement of local SCBF revealed a significant (30-50%) reduction in the territory of spinal stenosis measured at 3,7,14 or 28 days after surgery. Implantation of larger pieces of silicon rubber (1.5 mm width) caused a significant increase in the incidence of urinary retention and mortality rate. These data show that chronic partial spinal compression at L4 and L6 spinal level lead to the development of significant motor/sensory dysfunction which resemble those seen in patients with neurogenic intermittent claudication. The lack of motor dysfunction under resting conditions but its appearance during forced exercise also suggest that the development of local spinal ischemia can represent one of the mechanisms.

Animals↗
PubMed2001

Intermittent claudication: an objective office-based assessment.

OBJECTIVES: We sought to compare standard lower extremity vascular laboratory treadmill exercise with the office-based active pedal plantarflexion technique. BACKGROUND: Intermittent claudication is relatively common in elderly patients and is an important predictor of cardiovascular morbidity and mortality. Noninvasive testing using resting and posttreadmill exercise ankle:brachial systolic blood pressure indices is often required to confirm the diagnosis and objectively assess the severity of lower extremity arterial occlusive disease. This is traditionally performed in a formal vascular laboratory setting. METHODS: Fifty consecutive patients (100 lower extremities) with known or suspected intermittent claudication referred for lower extremity treadmill exercise testing were also tested with active pedal plantarflexion using a prospective, randomized crossover design. Supine ankle:brachial systolic blood pressure indices were measured immediately before and after each form of exercise. RESULTS: There was an excellent correlation (r = 0.95, 95% confidence interval 0.93 to 0.97) between mean postexercise ankle:brachial systolic blood pressure indices for treadmill exercise and active pedal plantarflexion. There was no significant difference in outcome based on the order of testing or the severity of arterial occlusive disease. Symptoms of angina or dyspnea occurred in 11 patients (22%) with treadmill exercise versus zero patients with active pedal plantarflexion. CONCLUSIONS: Active pedal plantarflexion is an office-based test that compares favorably with treadmill exercise for the noninvasive, safe, objective and economical assessment of lower extremity arterial occlusive disease.

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PubMed1997

Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: results of a multicenter placebo-controlled double-blind trial.

For the first time efficacy and safety of a new prostaglandin E1 (PGE1) regimen in the treatment of intermittent claudication were evaluated in a randomized, double-blind, placebo-controlled multicenter clinical trial. The study involved 213 outpatients with a maximum walking distance of 50 to 200 m measured on the treadmill (3 km/hr, 12% grade). After a 2-week run-in phase they received a 2-hour intravenous infusion of 60 micrograms PGE1 or placebo 5 days a week for 4 weeks. It was followed by a 4-week interval treatment with the same medication administered only twice a week. Patients were monitored for 3 months when they received no study medication. In the PGE1 group the intention-to-treat analysis (n = 208) revealed an increase in walking distance after 4 weeks of 75% (placebo, 43%). At the end of the interval treatment the walking distance had improved to 101% (placebo, 60%). The results remained virtually constant during follow-up (PGE1, 104%, placebo, 63%). Between-group comparisons showed significant differences in favor of PGE1 for all three time points of measurement (p < 0.05, p < 0.01, and p < 0.05). PGE1 was well tolerated; the rate of adverse reactions related to the treatment was 12.8% (placebo, 7.7%). In summary, these results show that the new PGE1 regimen is effective and safe in the treatment of outpatients with intermittent claudication.

Aged↗
PubMed1998

Intermittent claudication: symptom severity versus health values.

OBJECTIVE: The objective of this study was to obtain health values from patients with intermittent claudication with five different instruments and to study the construct validity of these measures of health-related quality of life by examining their relation with symptom severity. METHODS: We included all patients with intermittent claudication who participated in an exercise program of the Department of Internal Medicine at our university hospital (n = 92). Health value instruments included the verbal rating scale, time trade-off, standard gamble, EuroQol, and the Health Utilities Index (Mark III). Symptom-free walking distance was used as a measure of symptom severity. RESULTS: For all instruments the average health values in groups of patients with a symptom-free walking distance < or = 150 m were lower than the average values in patients with a greater walk distance, but the differences for the time trade-off and the standard gamble were small, and only the differences for the verbal rating scale and the EuroQol were statistically significant. At the individual patient level considerable heterogeneity was seen, and the statistical association of the symptom-free walking distance with health values varied from poor to moderate (Spearman rank correlations, 0.03 to 0.48; p values, 0.003 to 0.78). CONCLUSION: At least for the verbal rating scale and the EuroQol, the results of our study provide evidence of the validity of the various health value instruments in a population of patients with peripheral arterial occlusive disease.

Aged↗
PubMed2001

The role of comorbidity in the assessment of intermittent claudication in older adults.

The prevalence of intermittent claudication (IC) in older adults by questionnaire is less than 5% while the prevalence of peripheral arterial disease (PAD) by non-invasive testing is 2-4-fold higher. Comorbid conditions may result in under-reporting intermittent claudication (IC) as assessed by the Rose Questionnaire. We examined characteristics of those who report leg pain in relationship to other comorbid conditions and disability in 5888 participants of the Cardiovascular Health Study (CHS). Older adults with exertional leg pain, not meeting criteria for IC, had a higher prevalence of PAD on non-invasive testing with the ankle-arm index than those without pain, as well as a higher prevalence of arthritis. The pattern of responses suggested that pain for both conditions was reported together. The Rose Questionnaire for IC is specific for PAD, but a negative questionnaire does not indicate a lack of symptoms, rather the presence of PAD along with other conditions that can cause pain.

Aged↗
PubMed1994

An objective assessment of intermittent claudication by near-infrared spectroscopy.

Changes in tissue oxygenation in the calf muscle were measured by near-infrared spectroscopy (NIRS) in 62 patients who complained of intermittent claudication in the calf during a treadmill test. Three distinctive patterns of oxygenated and deoxygenated haemoglobin were observed. None of the type 0 cases were severe (i.e., unable to walk for more than 5 minutes), while 37 and 82% of the type 1 and type 2 cases were severe, respectively. The mean maximum walking distance of type 1 was significantly longer than that of type 2 (179 +/- 70 m and 109 +/- 46 m, respectively; p < 0.005), while the mean ankle-brachial pressure index at rest of type 1 was not significantly different from that of type 2 (0.68 +/- 0.19 and 0.61 +/- 0.23, respectively). Our results indicate that NIRS can be used to accurately assess the severity of intermittent claudication.

Adult↗
PubMed1990

Is percutaneous transluminal angioplasty better than exercise for claudication? Preliminary results from a prospective randomised trial.

Percutaneous transluminal angioplasty (PTA) is a commonly performed procedure for the treatment of intermittent claudication despite the lack of controlled studies. The aim of this study was to compare PTA with supervised exercise therapy for patients with arterial occlusive disease judged suitable for PTA at angiography. Patients were assessed before treatment commenced and at three monthly intervals afterwards. Assessment included measurement of resting ankle brachial pressure indices (ABPI), and claudicating and maximum walking distances on a treadmill up a 10 degrees incline. Twenty patients were randomised to receive PTA and 16 exercise. The groups were similar in age, sex, smoking habits and arteriographic pattern of disease. In the PTA group two patients had angioplasties that were technically unsuccessful and two other patients subsequently required surgery. One patient in the exercise group subsequently had a PTA. After PTA, mean ABPI were significantly improved at 3, 6 and 9 months (P less than 0.01) without a corresponding significant increase in mean maximum walking distances. However in the exercise group despite no increase in mean ABPI, mean maximum walking distances increased progressively, with significant increases at 6, 9 and 12 months (P less than 0.01).

Aged↗
PubMed1992

Femoropopliteal arterial reconstruction with intraoperative iliac transluminal angioplasty for disabling claudication: results of a combined approach.

Seventeen patients with disabling claudication resulting from multilevel arteriosclerotic disease were treated by combined intraoperative iliac transluminal angioplasty and femoropopliteal arterial reconstruction. Clinical improvement or total relief of ischaemic symptoms was observed in 15 out of 17 patients. Iliac pressure gradients were reduced with balloon dilatation to < 2 mmHg in all cases. The mean (+/- S.D.) resting ankle-brachial systolic pressure index increased from 0.42 +/- 0.14 to 0.87 +/- 0.21. Complications from intraoperative angioplasty were not encountered and no early graft failures were seen. The primary actuarial graft patency at 1, 2 and 5 years was 100, 88 and 67%, respectively. Combined intraoperative iliac transluminal angioplasty and femoropopliteal arterial reconstruction is a useful alternative to conventional surgical revascularisation in the treatment of selected patients with disabling claudication in the presence of multilevel arteriosclerotic disease.

Aged↗
PubMed1992

Co-variation between walking ability and circulatory alterations in patients with intermittent claudication.

Unselected patients (n = 183) with subjective symptoms of intermittent claudication were examined clinically and by various circulatory tests (calf blood-flow, ankle, toe pressures). The aims of the present study were to evaluate to what extent the central or peripheral circulation is limiting in unselected patients with subjective symptoms of intermittent claudication, to determine the co-variation between the maximum walking capacity and traditional haemodynamical measures mentioned above and to evaluate to what extent a traditional bicycle ergometer exercise test and treadmill walking test give similar information regarding maximum performance. Eighty-five per cent of all patients were or had been smokers and 16% were diabetics. The mean ankle/brachial blood pressure index was 0.58 +/- 0.02 and the average post-ischemic maximum calf bloodflow was 13.3 +/- 0.6 ml/min/100 ml tissue. Leg arterial insufficiency was the limiting factor of walking capacity in 90% of all patients at 87 +/- 2 W corresponding to a walking distance of 282 +/- 13 m, while leg exhaustion was the limiting factor in 80% of the patients during test on the bicycle ergometer at maximum 84 +/- 2W. The mean maximum walking capacity for all patients was 86 +/- 3W and the mean maximum capacity on the bicycle ergometer was 87 +/- 2W. The ankle/brachial index showed only a weak correlation (r = 0.30, p < 0.002) to walking capacity. Our results demonstrate that the maximum walking capacity on a treadmill agrees with mean values of maximum exercise capacity on a bicycle ergometer.(ABSTRACT TRUNCATED AT 250 WORDS)

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PubMed1988

Systemic effects associated with intermittent claudication. A model to study biochemical aspects of vascular disease?

Patients with intermittent claudication were used as a clinical model to study the effects of transient episodes of ischaemia. Compared with age and sex matched controls significantly greater increases in serum lipid peroxides and urinary microalbumin occurred after exercise. These results suggest that even relatively minor ischaemic episodes, as occur with claudication, are sufficient to cause tissue damage which may be mediated by oxygen derived free radicals. There are also changes in renal permselectivity suggestive of a generalised increase in vascular permeability. These preliminary findings may have important diagnostic, aetiological and therapeutic implications for patients with vascular disease.

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