Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

Purpose: The minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC). Methods: In this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question. Results: For the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively. Conclusion: In this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care

Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease

BACKGROUND: Excimer laser coronary angioplasty is reported to give excellent procedural results for treatment of complex coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial. METHODS: Patients (n = 308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic endpoint was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. FINDINGS: Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4.6%, 10.6%, and 21.2%, respectively, of the patients in the laser angioplasty group compared with 5.7%, 10.8%, and 18.5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0.40 (0.69) mm in patients treated with laser angioplasty and 0.48 (0.66) mm in those treated with balloon angioplasty (p = 0.34). The restenosis rate (> 50% diameter stenosis) was 51.6% in the laser angioplasty group versus 41.3% in the balloon angioplasty group (p = 0.13). INTERPRETATION: Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery diseas

Type 2 Endoleak With or Without Intervention and Survival After Endovascular Aneurysm Repair

Objective: The aims of the present study were to examine the impact of type 2 endoleaks (T2EL) on overall survival and to determine the need for secondary intervention after endovascular aneurysm repair (EVAR). Methods: A multicentre retrospective cohort study in the Netherlands was conducted among patients with an infrarenal abdominal aortic aneurysm (AAA) who underwent EVAR between 2007 and 2012. The primary endpoint was overall survival for patients with (T2EL+) or without (T2EL-) a T2EL. Secondary endpoints were sac growth, AAA rupture, and secondary intervention. Kaplan–Meier survival and multivariable Cox regression analysis were used. Results: A total of 2 018 patients were included. The median follow up was 62.1 (range 0.1 – 146.2) months. No difference in overall survival was found between T2EL+ (n = 388) and T2EL- patients (n = 1630) (p =.54). The overall survival estimates at five and 10 years were 73.3%/69.4% and 45.9%/44.1% for T2EL+/T2EL- patients, respectively. Eighty-five of 388 (21.9%) T2EL+ patients underwent a secondary intervention. There was no difference in overall survival between T2EL+ patients who underwent a secondary intervention and those who were treated conservatively (p =.081). Sac growth was observed in 89 T2EL+ patients and 44/89 patients (49.4%) underwent a secondary intervention. In 41/44 cases (93.1%), sac growth was still observed after the intervention, but was left untreated. Aneurysm rupture occurred in 4/388 T2EL patients. In Cox regression analysis, higher age, ASA classification, and maximum iliac diameter were significantly associated with worse overall survival. Conclusion: No difference in overall survival was found between T2EL+ and T2EL- patients. Also, patients who underwent a secondary intervention did not have better survival compared with those who did not undergo a secondary intervention. This study reinforces the need for conservative treatment of an isolated T2EL and the importance of a prospective study to determine possible advantages of the intervention

Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry

Introduction Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. Methods and analysis This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1–3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient a