[Show abstract][Hide abstract] ABSTRACT: This study sought to determine possible effects of different antiplatelet therapies on walking exercise performance in intermittent claudication. Aspirin, in contrast to clopidogrel, interferes with processes that increase collateral conductance in an ischemic animal model.
Patients with stable intermittent claudication were recruited from 21 centers in Switzerland and Germany and randomized to either aspirin or clopidogrel treatment. They participated in a 3-month rehabilitation program (electronically monitored, home-based, 1-hour daily walking sessions at a speed of approximately 120 steps/min). Walking distance was assessed by treadmill tests (3.2 km/h; 12% grade) at baseline and after 12 weeks. A total of 229 of 259 patients with a mean age of 66.2±7.7 years completed the study according to the protocol. A total of 24.5% were females, 20.1% diabetics, and 85.6% were active/ex-smokers. The baseline characteristics were a median (interquartile range) ankle/brachial index of 0.69 (0.57±0.8), an initial claudication distance (ICD) of 98 m (70 to 151 m), and an absolute claudication distance (ACD) of 162 m (113 to 302 m). Training resulted in a median increase of initial claudication distance by 33.5 m (33.3%) in the clopidogrel group and 29 m (33.9%) in the aspirin group. The values for absolute claudication distance were 60.5 m (34.9%) and 75 m (35.3%), respectively (p(ICD)=0.42 and p(ACD)=0.66).
Treatment with aspirin did not show a difference in initial claudication distance or absolute claudication distance improvements compared with clopidogrel after a 3-month walking rehabilitation program. (J Am Heart Assoc. 2012;1:51-56.)
URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00189618, URL: https://EudraCT.ema.europa.eu, Unique identifier: 2004-005041-35.
Journal of the American Heart Association. 02/2012; 1(1):51-6.
[Show abstract][Hide abstract] ABSTRACT: Colour coded duplex sonography (DS) is widely used for the assessment of renal artery stenosis (RAS). Different criteria have been specified for the detection of significant RAS. The aim of our study was to compare routinely used DS criteria, both with intra-arterial pressure gradients and arteriographic degree of stenosis, and to validate different cut-off points of these DS criteria for the assessment of haemodynamically significant RAS.
We retrospectively analysed forty-nine patients (median age 67 years, 29 male) with RAS documented by duplex sonography, referred for renal arterial subtraction arteriography and intra-arterial pressure measurement (93 renal arteries). DS measurement of peak systolic velocity (PSV) in the main renal artery, the renal/aortal velocity ratio (RAR) and the side-to-side differences of the intrarenal resistive indices (DeltaRI) were correlated to intra-arterial pressure measurements and arteriographic degree of stenosis. Receiver operating characteristics (ROC) were used to determine the best cut-off value of DS criteria.
39 (41 %) renal arteries had normal findings or non significant stenosis < 50 %, 23 (25 %) had a diameter reduction between 50 % and 69 %, and 31 (33 %) > or = 70 %. The systolic pressure gradient showed good correlation with the arteriographic degree of RAS (r = 0.77, p < 0.001) and the PSV measured by duplex sonography (r = 0.67, p < 0.001). Mean systolic pressure gradient was 24 mmHg at 50 % stenosis and 23 mmHg at PSV of 200 cm/sec. A PSV of > or = 200 cm/sec provided a sensitivity of 92 % and specificity of 81 % for detecting RAS of > or = 50 %. Similar results were found for RAR > or = 2.5 with a sensitivity of 92 % and specificity of 79 %. These cut-off values have a negative predictive value of 100 % for excluding high-grade RAS of > or = 70 %. A DeltaRI of > or =0.05 has low sensitivity of 31 %, but a high specificity of 97 % for detecting RAS of > or = 50 %.
DS measurements and the severity of arteriographic diameter reduction correlate well with systolic pressure gradients. Clinically expedient DS criteria for detecting RAS of > or = 50 % are a PSV of > or = 200 cm/sec or a RAR of > or =2.5. These criteria allow reliable exclusion of severe RAS of > or = 70 %.
Ultraschall in der Medizin 03/2007; 28(1):45-51. · 4.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Recently silver fiber-containing compression stockings for the use in patients with chronic venous insufficiency (CVI) were introduced to the market. In order to gain some first insight into the effects of these new fabrics on the cutaneous microcirculation, a double-blind, randomized cross-over trial was performed in 10 healthy volunteers. A 3 days run-in phase preceded the (2 x10 days) treatment phases and was used to assess the reproducibility of the primary endpoint, which was the transcutaneous partial oxygen pressure (tcpO(2)) measured at a probe temperature of 44 degrees C in the perimalleolar region of the reference leg in supine and dependent leg positions. Coefficients of variation for double measured tcpO(2) values were 4.2% (3.1 SD) and 5.8% (6.0 SD) for the leg in supine and dependent position. The intra-individual comparison of the effects from both treatment phases (value end of treatment - start of treatment) resulted in a negative tcpO(2) net balance for the regular hosiery (-0.93 (2.7 SD) mmHg, supine; -1.1 (3.5 SD) mmHg, dependent) but a positive net balance for the silver fibers containing stockings (0.25 (4.0 SD) mmHg, supine; 1.7 (3.9 SD) mmHg, dependent). The inter-treatment differences were statistically significant for the leg in a dependent position. The trial provides first evidence that interweaving silver threads into regular compression stockings may result in a positive effect regarding the nutritive skin perfusion.
Clinical hemorheology and microcirculation 02/2007; 36(1):65-73. · 3.40 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This paper introduces a proof-of-concept trial in progress, supposedly providing new important information on anti-platelet drugs used in patients with peripheral arterial disease (PAD). The Arteriogenesis Competence Network (Art.Net.) of the Universities of Basel, Berlin, and Freiburg could show in animal models that Aspirin (ASA), in contrast to Clopidogrel, inhibits the formation of an appropriate collateral network (arteriogenesis). This trial is supposed to reproduce the animal data in man.
In a prospective, double-blind, parallel-group, bi-national (D, CH), multicentre trial, 250 patients will be randomised to either 100 mg ASA or 75 mg Clopidogrel once daily. Patients will then enter a three months structured rehabilitation programme with daily physical training supposed to induce arteriogenesis. The claudication distances will be tested as the primary endpoint at baseline, 6 weeks, and at 3 months. Also, the 24h physical activity profile of all patients will be electronically documented.
This trial will provide information on potential disadvantages when using ASA in PAD patients. If data emerging from animal pharmacology can be reproduced in man, the present standard scheme of anti-aggregant treatment in PAD patients has to be reconsidered.