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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.

Aged↗
PubMed1993

A botanical compound, Padma 28, increases walking distance in stable intermittent claudication.

Thirty-six patients with a median age of sixty-seven years and a median duration of intermittent claudication of five years were randomized to either active treatment with Padma 28 or placebo. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) was calculated. The group randomized to active treatment received two tablets bid containing 340 mg of a dried herbal mixture composed according to an ancient lamaistic preparation (Padma 28). After active treatments, administered over a period of four months in a double-blinded, randomized design, the patients allocated to this group attained a significant increase in the pain-free walking distance from 52 m (20-106) to 86 m (24-164; P < 0.05) and in the maximal walking distance from 115 m (72-218) to 227 m (73- > 1,000; P < 0.05). The patient-group receiving placebo treatments did not show any significant changes in either the painfree or the maximal walking distance. The authors could not demonstrate any significant changes in the ankle pressure index either during active or during placebo treatment. In conclusion, this study has shown that treatment with Padma 28 over a period of four months significantly increased the walking distance in patients with stable, intermittent claudication of long duration.

Aged↗
PubMed1997

Effect of walking distance on the change in ankle-brachial pressure index in patients with intermittent claudication.

OBJECTIVES: The ankle-brachial pressure index (ABPI) responses to different exercise intensities on a treadmill were evaluated to clarify the relationship between intermittent claudication and the haemodynamics in the leg. PATIENTS AND METHODS: Thirty patients with intermittent claudication (32 symptomatic legs) due to peripheral arterial occlusive disease were exercised on a treadmill to determine their pain-free walking distance, maximum walking distance (MWD) and recovery time. Each subject was exercised at 25% and 50% of the MWD to determine the effect of work intensity on the drop in ABPI, and the recovery time. RESULTS: In the claudicating legs, 25% of the MWD resulted in almost the same reduction in ABPI as 50% of the MWD, and the MWD. In contrast, the ABPI in the asymptomatic legs (13) was significantly decreased in proportion to the walking distance. The recovery time increased linearly in both the groups, as the walking distance increased. CONCLUSION: The recovery time of the ABPI correlated well with the intensity of workload, while the drop in ABPI did not.

Aged↗
PubMed1989

Ultrasound screening of the abdominal aorta in patients with intermittent claudication.

The presence of abdominal aortic dilatations and aneurysms (AAA) among 372 patients (302 men and 70 women) who originally presented with intermittent claudication was studied. The cohort was analysed in two ways, first retrospectively from the date of diagnosis of intermittent claudication until 1st of August 1985 (mean follow-up time being 70 months), second those alive at that date and who had not been operated on were offered ultrasound screening of their aorta. Retrospectively nine male patients were found to have had an operation for an aneurysm, one because of a rupture. Of the 110 patients who died and had not had surgery, 88 (73 men, 15 women) were autopsied and AAA was found at autopsy in six males and one female. Two males died of rupture. Ultrasonographic screening of the abdominal aorta was performed in 183 patients (147 men and 36 women) and dilatation was found in 25 patients (24 men, 1 woman). In the male part of the total material (n = 257) there were 39 patients (15%) with aneurysm or dilatation. Male patients with AAA or dilated aortas were significantly heavier, with a lower ankle arm index and higher serum cholesterol values than patients without AAA or aortic dilatation.

Adult↗
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↗
PubMed2003

Pretreatment imaging workup for patients with intermittent claudication: a cost-effectiveness analysis.

PURPOSE: To determine the optimal imaging strategy in pretreatment workup of patients with intermittent claudication with use of noninvasive imaging modalities and intraarterial digital subtraction angiography (DSA). MATERIALS AND METHODS: A decision-analytic model that considered test characteristics such as sensitivity, complications induced by the test, implications of missing lesions, and the consequences of overtreating patients, was developed to evaluate the societal cost-effectiveness (CE) of magnetic resonance (MR) angiography, duplex ultrasonography (US), and DSA. Our main outcome measures were quality-adjusted life years (QALYs), lifetime costs (in dollars), and incremental CE ratios. The base-case analysis considered a cohort of 60-year old male patients without a history of coronary artery disease who presented with severe claudication to undergo pretreatment imaging workup. RESULTS: The range in effectiveness and lifetime costs among different diagnostic workup strategies was small (largest difference in effectiveness: 0.025 QALYs; largest difference in lifetime costs: $1,800). If treatment was limited to angioplasty in patients with suitable lesions, MR angiography had an incremental CE ratio of $35,000 per QALY compared with no diagnostic workup, and DSA had an incremental CE ratio of $471,000 per QALY compared with MR angiography. If treatment options included both angioplasty and bypass surgery, DSA had an incremental CE ratio of $179,000 per QALY compared with no diagnostic workup, and MR angiography and duplex US were less effective and more costly. CONCLUSIONS: The differences in costs and effectiveness among diagnostic imaging strategies for patients with intermittent claudication are slight and MR angiography or duplex US can replace DSA without substantial loss in effectiveness and with a slight cost reduction.

Angiography, Digital Subtraction↗
PubMed1980

Amyloid vascular disease: cord-like thickening of mucocutaneous arteries, intermittent claudication and angina in a case with underlying myelomatosis.

A patient with established myelomatosis and an IgG paraproteinaemia presented with intermittent claudication. Indurated cord-like structures were noted on the dorsum of the right hand and the buccal surface of the lower lip, and biopsy of the hand lesion revealed massive amyloid deposition within the wall of an artery. Cord-like thickening of mucocutaneous arteries as a presenting sign of systemic amyloidosis in the absence of glossomegaly or other cutaneous lesions has not been reported previously. The presence of intermittent claudication and angina suggested that amyloid involvement of large arteries was extensively distributed.

Amyloidosis↗
PubMed2004

Relationship between intermittent claudication, inflammation, thrombosis, and recurrent cardiac events among survivors of myocardial infarction.

BACKGROUND: Among coronary disease patients, concomitant peripheral arterial disease is a potent risk factor for future cardiac events and mortality. We sought to determine clinical and biochemical markers that might better elucidate the relationship between coronary and peripheral arterial disease. METHODS: Two months after an index myocardial infarction, 1045 patients provided detailed medical histories and underwent blood testing for selected hemostatic, lipid, and inflammatory markers. Patients were then followed up prospectively for a mean of 26 months. RESULTS: Compared with individuals without intermittent claudication (n = 966), those with claudication (n = 78) (information was unavailable for 1 individual) were significantly older and demonstrated an increased frequency of diabetes mellitus, tobacco use, prior cardiac and cerebrovascular events, and depressed left ventricular function. Individuals with claudication were less likely to receive beta-blocker therapy after the index infarction. Individuals with claudication had evidence of enhanced procoagulant and proinflammatory states manifested by relative elevations in plasma fibrinogen, D-dimer, C-reactive protein, and serum amyloid A concentrations. During follow-up, the presence of claudication was associated with an independent 2-fold increase in the combined end point of death or nonfatal cardiac event (38.5% vs 17.8%, P =.001) and a 5-fold increase in cardiac mortality (19.2% vs 3.6%, P =.001). Patients with intermittent claudication who were not treated with beta-blockers had a significant 3-fold mortality excess relative to those receiving beta-blockers. CONCLUSIONS: Following myocardial infarction, the added presence of intermittent claudication is associated with heightened procoagulant and proinflammatory states and an underuse of beta-blocker therapy and is a strong independent predictor of recurrent cardiovascular events.

Comorbidity↗
PubMed2003

Management of secondary risk factors in patients with intermittent claudication.

OBJECTIVES: The first line management of patients with intermittent claudication is "best medical therapy" i.e., smoking cessation, exercise, antiplatelet therapy and risk factors modification. The aim of this study was to assess the current management of risk factors in primary care and to compare General Practitioner (GP) attitudes and actual management. DESIGN AND METHODS: Postal questionnaire of all 336 GPs in the referral area (Grampian, Scotland). Questionnaire and measurement of serum cholesterol, blood glucose and HbA1c of new clinic patients (n = 104) with claudication referred by general practitioners. RESULTS: A 73% GP response rate was obtained. Ninety-five percent of GPs would treat risk factors. The vast majority would prescribe aspirin, yet 28% of patients were on no anti-platelet therapy. Eighty-nine percent of GPs would advise an increase in exercise but only 14% of patients recalled being told to do so. One in seven of the GPs would not check serum cholesterol, 18% considered cholesterol lowering therapy to be primary prevention and 41% would only treat levels above 5.5 mmol/l. Eighty-five percent of patients were on a statin or had a cholesterol above 5 mmol/L. Seventy-seven percent of GPs would check glucose levels, and 14% of patients were found to be previously undiagnosed diabetics. CONCLUSIONS: Risk factors in claudicants are suboptimally managed. Urgent guidelines for the specific management of claudicants by general practitioners, as well as strategies to ensure their implementation, are required.

Adult↗
PubMed1990

Myeloscopic study on lumbar spinal canal stenosis with special reference to intermittent claudication.

Twenty-five cases of lumbar spinal canal stenosis were investigated by dynamic myeloscopy to explain the pathophysiologic mechanism of intermittent claudication, one of the characteristic signs of the disorder. Myeloscopic examination revealed that, in accordance with postural alteration, the diameter of blood vessels on the cauda equinae showed significant changes in many patients in the stenosis group, but showed no changes in control group. In this series, it was suggested that the microcirculatory disturbance of vessels on cauda equinae might play an important role in the development of intermittent claudication.

Adult↗
PubMed2000

Exercise for intermittent claudication.

BACKGROUND: Exercise is an inexpensive, low risk option compared with other more invasive therapies for leg pain on walking (intermittent claudication). OBJECTIVES: The objective of this review was to determine the effects of exercise for leg pain. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register, Embase, reference lists of relevant articles, and contacted principal investigators of trials. SELECTION CRITERIA: Randomised trials of exercise regimens in patients with leg pain on walking (intermittent claudication). DATA COLLECTION AND ANALYSIS: At least two reviewers extracted and assessed data trial quality independently. The reviewers contacted investigators to obtain information or data needed for the review that could not be found in published reports. MAIN RESULTS: Fifteen trials were identified that met the inclusion criteria, but five were subsequently excluded because of poor quality. The remaining ten trials involved a total of almost 250 male and female patients with stable leg pain. The follow-up ranged from 12 weeks to 15 months. There was also some variation in the exercise regimens used, although all recommended at least two weekly sessions of, mostly, supervised exercise. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was generally good, though the trials were all small (20-49 patients). Exercise therapy significantly improved maximal walking time (minutes) (weighted mean difference 6.51, 95% confidence interval 4.36 to 8.66, fixed effect model [FE]), with an overall improvement in walking ability of approximately 150% (range 74% to 230%). Exercise produced significant improvements in walking time compared with both angioplasty at six months (weighted mean difference 3.30, 95% confidence interval 2.21 to 4.39, FE) and antiplatelet therapy (weighted mean difference 1.06, 95% confidence interval 0.15 to 1.97, FE), and did not differ significantly from surgical treatment. In one small trial, exercise was less effective than pentoxifylline (weighted mean difference -0.45, 95% confidence interval -0.66 to -0.24, FE). REVIEWER'S CONCLUSIONS: Exercise is of significant benefit to patients with leg pain.

Exercise Therapy↗
PubMed2004

Prostanoids for intermittent claudication.

BACKGROUND: Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity in the general population. While numerous studies have established the efficacy of prostanoids in PAOD stages III and IV the question of the role of prostanoids as an alternative or additive treatment in patients suffering from claudicatio intermittens (PAOD II) has not yet been clearly answered. OBJECTIVES: The aim of this review was to evaluate effects of prostanoids in patients with intermittent claudication. SEARCH STRATEGY: Computerised searches of the Cochrane Peripheral Vascular Diseases Specialised Register (last searched April 2003), The Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 1, 2003), MEDLINE and EMBASE were undertaken. In addition relevant journals were hand-searched. SELECTION CRITERIA: Randomized clinical trials describing the effects of prostanoids in the treatment of patients suffering from intermittent claudication have been considered for inclusion. DATA COLLECTION AND ANALYSIS: All reviewers assessed the quality of studies and extracted data unblinded. Statistical analysis including tests for heterogeneity and overall effect were performed by using MetaView of Review Manager 4.2. All numeric values are expressed as mean +/- Standard deviation (SD). MAIN RESULTS: Eighteen studies were included for analysis. A significant heterogeneity between the included studies was detected in most of the subgroup analysis. Five studies compared the effects of prostaglandin E1 (PGE1) versus placebo, and reported in their individual results significant increases in walking distances after the administration of PGE1. The attained increase in walking distances appears to be not merely a short-term effect because several studies reported that walking capacity remained increased even after termination of treatment. On the other hand, oral or intravenous prostacyclin did not increase the walking distances significantly. At least one adverse reaction was reported from 23.6% of the patients treated with prostacyclin (PGI2), and its analogues and from 13.7% of the patients treated with PGE1. REVIEWER'S CONCLUSIONS: Because of the heterogeneity between most of the included studies, we did not pool relevant parts of the data by meta-analysis. Based on the individual results of the published literature, patients with intermittent claudication seem to benefit from administration (intravenous or intra-arterial) of PGE1 by a significant improvement of their walking capacity. Further well-conducted randomized, double blinded trials, with a sufficient number of patients to provide statistical powerful information, should be performed to confirm the results of this review.

Alprostadil↗
PubMed2000

Influence of upper- and lower-limb exercise training on cardiovascular function and walking distances in patients with intermittent claudication.

PURPOSE: The effects of upper-limb (arm cranking) and lower-limb (leg cranking) exercise training on walking distances in patients with intermittent claudication was assessed. METHODS: Sixty-seven patients (33 to 82 years old) with moderate to severe intermittent claudication were recruited, and the maximum power generated during incremental upper- and lower-limb ergometry tests was determined, as were pain-free and maximum walking distances (by using a shuttle walk test). Patients were randomly assigned to an upper-limb training group (n = 26) or a lower-limb training group (n = 26). An additional untrained group (n = 15) was recruited on an ad hoc basis in parallel with the main trial by using identical inclusion criteria. This group was subsequently shown to possess a similar demographic distribution to the two exercise groups. Supervised training sessions were held twice weekly for 6 weeks. RESULTS: Both training programs significantly improved the maximum power generated during the incremental upper- and lower-limb ergometry tests (P <. 001), which may reflect an increase in central cardiovascular function that was independent of the training mode. More importantly, pain-free and maximum walking distances also improved in both training groups (P <.001). The improvements in the training groups were similar; there were no changes in the untrained control group. These findings suggest that the symptomatic improvement after upper-limb exercise training may result, in part, from systemic cardiovascular effects rather than localized metabolic or hemodynamic changes. CONCLUSION: Carefully prescribed upper-limb exercise training can evoke a rapid symptomatic improvement in patients with claudication, while avoiding the physical discomfort experienced when performing lower-limb weight-bearing exercise.

Adult↗
PubMed1994

Pentoxifylline for intermittent claudication. A critical review.

Pentoxifylline was first introduced in Germany twenty years ago. Today it is the best researched oral drug for intermittent claudication. A total of seventeen placebo-controlled trials could be retrieved from the world literature. The majority of these studies show that pentoxifylline will prolong the walking distance in a statistically significant way. Even though these trials are conducted with considerable scientific rigor, important flaws can be identified. Whether the symptomatic improvement is clinically relevant is difficult to say and may depend on the patient's individual situation. These collective data show that pentoxifylline prolongs the walking distance in patients with intermittent claudication.

Blood Viscosity↗
PubMed1989

Changes of walking distance in patients with intermittent claudication during six months intensive physical training.

Patients with intermittent claudication were treated with six months intensive physical training. They were instructed to walk with a speed of 6 km/h until they got complaints and then to rest for some time. This sequence was repeated until men below 65 years had walked 2 km. Men above the age of 65 years and women had to walk 1.5 km. This training session was performed 3 times a day. Every two months the claudication distances in a corridor and on a treadmill were measured. Out of 95 patients 65 completed the training. In 38 patients (59%) there was no substantial change in walking distance. Fourteen patients (22%) doubled their walking distance, seven (11%) could walk more than 1000 m, but their complaints remained. Six (9%) could walk more than 1000 m without claudication pain. Most patients gained their result during the last 2 months of the program. After the training 48% of the patients were satisfied with their walking distance.

Adult↗