TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial.

BACKGROUND: Experimental studies suggest that angiotensin II plays a central role in the pathogenesis of abdominal aortic aneurysm. This trial aims to evaluate the efficacy of the angiotensin receptor blocker telmisartan in limiting the progression of abdominal aortic aneurysm. METHODS/DESIGN: Telmisartan in the management of abdominal aortic aneurysm (TEDY) is a multicentre, parallel-design, randomised, double-blind, placebo-controlled trial with an intention-to-treat analysis. We aim to randomly assign 300 participants with small abdominal aortic aneurysm to either 40 mg of telmisartan or identical placebo and follow patients over 2 years. The primary endpoint will be abdominal aortic aneurysm growth as measured by 1) maximum infra-renal aortic volume on computed tomographic angiography, 2) maximum orthogonal diameter on computed tomographic angiography, and 3) maximum diameter on ultrasound. Secondary endpoints include change in resting brachial blood pressure, abdominal aortic aneurysm biomarker profile and health-related quality of life. TEDY is an international collaboration conducted from major vascular centres in Australia, the United States and the Netherlands. DISCUSSION: Currently, no medication has been convincingly demonstrated to limit abdominal aortic aneurysm progression. TEDY will examine the potential of a promising treatment strategy for patients with small abdominal aortic aneurysms. TRIAL REGISTRATION: Australian and Leiden study centres: Australian New Zealand Clinical Trials Registry ACTRN12611000931976 , registered on 30 August 2011; Stanford study centre: clinicaltrials.gov NCT01683084 , registered on 5 September 2012.

Plantar pressure in diabetic peripheral neuropathy patients with active foot ulceration, previous ulceration and no history of ulceration: a meta-analysis of observational studies.

AIMS: Elevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers. METHODS: Published articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310). RESULTS: Eight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, p<0.001; and 0.762, 95% CI 0.303-1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181- 0.753, p = 0.001). Statistical heterogeneity between studies was moderate. CONCLUSIONS: Plantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.

Illness beliefs and walking behavior after revascularization for intermittent claudication: a qualitative study.

PURPOSE: Patients with peripheral artery disease (PAD) are recommended to increase physical activity to reduce cardiovascular risk. Vascular intervention (surgery or angioplasty) treats the symptom (intermittent claudication), but not the underlying cardiovascular disease. This study aims to explore the beliefs and physical activity behavior of patients with PAD who have received vascular intervention. METHODS: Twenty participants who had received a vascular intervention for intermittent claudication between 6 months and 2 years previously participated in semistructured interviews. The interviews explored illness and treatment beliefs and walking behavior. Data were transcribed verbatim and analyzed thematically. RESULTS: Participants described a high level of ongoing symptoms (particularly pain) in their legs, despite having received vascular intervention. They viewed their illness as acute and treatable, and believed that pain was an indication of walking causing damage. They controlled their symptoms by avoiding walking and slowing their pace. Participants were generally unaware of the causes of the disease and were unaware of their increased risk of future cardiovascular health problems. There was a low level of congruence between participant beliefs about their illness and the recommendation to increase physical activity that may affect physical activity behavior. CONCLUSIONS: Our findings suggest that patients with PAD do not change physical activity behavior after diagnosis and treatment, because they hold dysfunctional and incongruous beliefs about PAD, treatment, and physical activity.

Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial.

IMPORTANCE: Approximately one-third of patients with peripheral artery disease experience intermittent claudication, with consequent loss of quality of life. OBJECTIVE: To determine the efficacy of ramipril for improving walking ability, patient-perceived walking performance, and quality of life in patients with claudication. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled trial conducted among 212 patients with peripheral artery disease (mean age, 65.5 [SD, 6.2] years), initiated in May 2008 and completed in August 2011 and conducted at 3 hospitals in Australia. INTERVENTION: Patients were randomized to receive 10 mg/d of ramipril (n = 106) or matching placebo (n = 106) for 24 weeks. MAIN OUTCOME MEASURES: Maximum and pain-free walking times were recorded during a standard treadmill test. The Walking Impairment Questionnaire (WIQ) and Short-Form 36 Health Survey (SF-36) were used to assess walking ability and quality of life, respectively. RESULTS: At 6 months, relative to placebo, ramipril was associated with a 75-second (95% CI, 60-89 seconds) increase in mean pain-free walking time (P < .001) and a 255-second (95% CI, 215-295 seconds) increase in maximum walking time (P < .001). Relative to placebo, ramipril improved the WIQ median distance score by 13.8 (Hodges-Lehmann 95% CI, 12.2-15.5), speed score by 13.3 (95% CI, 11.9-15.2), and stair climbing score by 25.2 (95% CI, 25.1-29.4) (P < .001 for all). The overall SF-36 median Physical Component Summary score improved by 8.2 (Hodges-Lehmann 95% CI, 3.6-11.4; P = .02) in the ramipril group relative to placebo. Ramipril did not affect the overall SF-36 median Mental Component Summary score. CONCLUSIONS AND RELEVANCE: Among patients with intermittent claudication, 24-week treatment with ramipril resulted in significant increases in pain-free and maximum treadmill walking times compared with placebo. This was associated with a significant increase in the physical functioning component of the SF-36 score. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00681226.

A meta-analysis of the outcome of endovascular and noninvasive therapies in the treatment of intermittent claudication.

PURPOSE: Intermittent claudication is a common symptom of peripheral arterial disease. Currently, there is a lack of consensus on the most effective therapies for this problem. We conducted a meta-analysis of randomized trials assessing the efficacy of endovascular therapy (EVT) compared with noninvasive therapies for the treatment of intermittent claudication. METHODS: Randomized trials comparing the efficacy of EVT and noninvasive therapies, such as medical therapy (MT) and supervised exercise (SVE) in patients with intermittent claudication were identified by a systematic search. Data were pooled, and combined overall effect sizes (standardized differences of mean values) were calculated for a random effect model in terms of ankle-brachial index (ABI) and treadmill walking for initial claudication distance (ICD) and maximum walking distance (MWD). Nine eligible trials (873 participants) were included: two compared EVT and MT alone, four compared EVT and SVE, and three trials compared EVT plus SVE vs SVE alone. RESULTS: Heterogeneity between studies was marked. Quantitative data analysis suggested that EVT improved outcomes over MT alone at early follow-up evaluations. Outcomes of EVT plus SVE were better than those of SVE alone in terms of both ABI and treadmill walking at immediate, early, and intermediate follow-up. No substantial differences in outcomes of EVT alone compared with SVE alone were found. CONCLUSION: In patients with intermittent claudication, current evidence supports improved ABI and treadmill walking when EVT is added to MT or SVE during early and intermediate follow-up. There is no evidence that EVT alone provides improved outcome over SVE alone. There is low confidence in these findings for a number of reasons, including the small number of trials, the small size of these studies, the heterogeneity in study design, and the limited use of quality of life tools in assessing outcomes. More consistent data from larger, more homogenous studies, including longer follow-up, are required.