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Objective: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only., Background: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up., Methods: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle., Results: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149)., Conclusions: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment., Trial Registration: Netherlands Trial Registry Identifier: NTR2249., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: Supervised exercise is recommended as a first-line treatment for intermittent claudication. Combination therapy of endovascular revascularization plus supervised exercise may be more promising but few data comparing the 2 therapies are available., Objective: To assess the effectiveness of endovascular revascularization plus supervised exercise for intermittent claudication compared with supervised exercise only., Design, Setting, and Participants: Randomized clinical trial of 212 patients allocated to either endovascular revascularization plus supervised exercise or supervised exercise only. Data were collected between May 17, 2010, and February 16, 2013, in the Netherlands at 10 sites. Patients were followed up for 12 months and the data were analyzed according to the intention-to-treat principle., Interventions: A combination of endovascular revascularization (selective stenting) plus supervised exercise (n = 106) or supervised exercise only (n = 106)., Main Outcomes and Measures: The primary end point was the difference in maximum treadmill walking distance at 12 months between the groups. Secondary end points included treadmill pain-free walking distance, vascular quality of life (VascuQol) score (1 [worst outcome] to 7 [best outcome]), and 36-item Short-Form Health Survey (SF-36) domain scores for physical functioning, physical role functioning, bodily pain, and general health perceptions (0 [severe limitation] to 100 [no limitation])., Results: Endovascular revascularization plus supervised exercise (combination therapy) was associated with significantly greater improvement in maximum walking distance (from 264 m to 1501 m for an improvement of 1237 m) compared with the supervised exercise only group (from 285 m to 1240 m for improvement of 955 m) (mean difference between groups, 282 m; 99% CI, 60-505 m) and in pain-free walking distance (from 117 m to 1237 m for an improvement of 1120 m vs from 135 m to 847 m for improvement of 712 m, respectively) (mean difference, 408 m; 99% CI, 195-622 m). Similarly, the combination therapy group demonstrated significantly greater improvement in the disease-specific VascuQol score (1.34 [99% CI, 1.04-1.64] in the combination therapy group vs 0.73 [99% CI, 0.43-1.03] in the exercise group; mean difference, 0.62 [99% CI, 0.20-1.03]) and in the score for the SF-36 physical functioning (22.4 [99% CI, 16.3-28.5] vs 12.6 [99% CI, 6.3-18.9], respectively; mean difference, 9.8 [99% CI, 1.4-18.2]). No significant differences were found for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions., Conclusions and Relevance: Among patients with intermittent claudication after 1 year of follow-up, a combination therapy of endovascular revascularization followed by supervised exercise resulted in significantly greater improvement in walking distances and health-related quality-of-life scores compared with supervised exercise only., Trial Registration: Netherlands Trial Registry Identifier: NTR2249.

Objectives: To determine the efficacy and costs of extracorporeal shock-wave lithotripsy (ESWL) compared with ureteroscopy (URS) in the treatment of mid- and lower ureteric calculi., Patients and Methods: The records of patients treated primarily by ESWL and URS were analysed retrospectively. Treatment with ESWL included 63 patients (42 men and 21 women, mean age 52 years, range 23-78, 19 mid- and 44 lower ureteric calculi). All patients received 4000 shock waves at a mean energy setting of 18.1 kV. URS was used in 105 patients, with a 7.2 F miniscope or the 7.1 F flexible scope. Stones were fragmented with a pulsed-dye laser lithotripter at 504 nm and a power of up to 130 mJ (mean 53 mJ) using a 200 or 320 microns fibre. All ureteroscopies were performed with the patient under general (n = 17) or spinal (n = 87) anaesthesia in a mean treatment duration of 34 min. Stones were located in the mid-ureter in 24 patients and in the lower ureter in 80. The outcome was assessed by stone-free rates, re-treatment rates, time to become stone-free, complication and costs., Results: ESWL for mid- and lower ureteric calculi resulted in a success rate of 90% and 81%, respectively, compared with 96% and 99% for URS. However, patients treated with URS were stone-free within 2 days, whereas patients in the ESWL group required up to 4 months. The best results for ESWL were achieved with stones of < 50 mm2. The costs of URS were higher than those for ESWL., Conclusions: ESWL provides a noninvasive, simple and safe option for the management of mid- and lower ureteric calculi, provided that the stones are < 50 mm2; larger stones are best treated by URS.