Franceline Alkine Frans

Systematic review of exercise training or percutaneous transluminal angioplasty for intermittent claudication.

The aim was to summarize the results of all randomized clinical trials (RCTs) comparing percutaneous transluminal angioplasty (PTA) with (supervised) exercise therapy ((S)ET) in patients with intermittent claudication (IC) to obtain the best estimates of their relative effectiveness.

SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction--a multicentre randomised controlled trial; SUPER study design and rationale.

INTRODUCTION Treatment of intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improving walking distance and includes secondary prevention of cardiovascular disease. Both supervised exercise therapy (SET) and percutaneous transluminal angioplasty (PTA) have proven to be effective in increasing maximum and pain-free walking distance in IC. However, the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear. OBJECTIVE To compare the (cost-) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction. DESIGN In a multicentre randomised controlled trial 400 consecutive patients with IC will be randomly assigned to PTA (with additional stent placement on indication) or SET. Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year. Secondary outcomes are pain-free walking distance, functional status, generic quality of life, complications related to each of the interventions, additional interventions, treatment failures and costs (cost-effectiveness and cost-utility) after 1 year. CONCLUSION AND IMPLICATIONS Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented (Clinical Trials.gov NCT01385774; Nederlands Trial Register NTR2776).

Statistical or clinical improvement? Determining the minimally important difference for the vascular quality of life questionnaire in patients with critical limb ischemia.

OBJECTIVE Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI). METHODS The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method. RESULTS A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit. CONCLUSIONS Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance.

Changes in functional status after treatment of critical limb ischemia

OBJECTIVE This study evaluated changes in functional status with the Academic Medical Center Linear Disability Score (ALDS) and in quality of life with the Vascular Quality of Life Questionnaire (VascuQol) in patients treated for critical limb ischemia (CLI). METHODS We conducted a prospective observational cohort study in a single academic center that included consecutive patients with CLI who presented between May 2007 and May 2010. The ALDS and VascuQol questionnaires were administered before treatment (baseline) and after treatment at 6 and 12 months of follow-up. Changes in functional status (ALDS) and quality of life (VascuQol) scores after 6 and 12 months, compared with baseline, were tested with the appropriate statistical tests, with significance set at P < .05. RESULTS The study included 150 patients, 96 (64%) were men, and mean (± standard deviation) age was 68.1 (± 12.4) years. The primary treatment was endovascular in 98 (65.3%), surgical in 36 (24%), conservative in 11 (7.3%), or a major amputation in five (3.3%). The ALDS was completed by 112 patients after 12 months. At that time, the median ALDS score had increased by 10 points (median, 83; range, 12-89; P = .001) in patients who achieved limb salvage, which corresponds with more difficult outdoor and indoor activities. In patients with a major amputation, the median ALDS score decreased by 14 points (median, 55; range, 16-89; P = .117) after 12 months, which corresponds with domestic activities only. VascuQol scores improved significantly in all separate domains for the limb salvage group (P < .001). All VascuQol scores, except for the activity and social domains, increased significantly after amputation. CONCLUSIONS Our study confirms the clinical validity of the ALDS in patients treated for CLI and shows that it is a valuable and sophisticated instrument to measure changes in functional status in these patients.

Letter by Frans and Koelemay Regarding Article, “Supervised Exercise Versus Primary Stenting for Claudication Resulting From Aortoiliac Peripheral Artery Disease: Six-Month Outcomes From the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Study”

To the Editor: With great interest we read the long-awaited report of the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study, a very relevant study for clinical practice. We compliment Murphy and colleagues for their well-written article and their effort in investigating the relative effectiveness of optimal medical care, supervised exercise, and stenting to relieve intermittent claudication resulting from an iliac artery obstruction.1 The bottom line of CLEVER is that at the 6-month follow-up, supervised exercise improves walking distance on a treadmill better, and that functional status and most domains of disease-specific quality of life improve more after …