Influence of Statin Therapy on Aneurysm Sac Regression After Endovascular Aortic Repair

Abstract

claudication due to femoropopliteal occlusive disease. The addition of SEP to PTA can reduce the rate of symptomatic restenosis and reintervention.Summary: This is a randomized controlled trial "follow-up" of three treatments for claudication (PAT, SEP, or combination therapy). Inclusion criteria for the original study were patients with unilateral claudication due to femoropopliteal artery occlusive disease amenable to both PTA and supervised exercise. Suitable patients were treated for 3 months with best medical treatment and if their symptoms were stable were asked if they would be in the trial. After informed consent, they were randomization to PTA or SEP. The primary outcome was treadmill maximum walking distance (MWD) and Physical Function (PF) domain of the SF-36 Quality of Life questionnaire tool at 12 months. Secondary outcomes were ankle to brachial systolic blood pressure index (ABI), intermittent claudication distance (ICD), and patient-reported walking distance (PRWD), SF-36 domains except PF, King's College VascuQoL, restenosis and reintervention rates. This study was a call back to all participating patients who could be found. A detailed history cross checked by electronic and clinical records helped to ensure maximal capture of past data. A fixed load treadmill test (10 degree incline at 2.5 km/h) for a maximum of 5 minutes was conducted. All baseline variables were captured including ABI, MWD, ICD, and PRWD. The ceiling for MWD for those completing the treadmill test was 215 meters and the ceiling for PRWD was 1600 meters. The SF-36 questionnaire as well as the King's College VascuQoL for disease specific and generic evaluations were completed. All patients had an arterial duplex imaging of both legs in detail to determine any old or new lesions. The primary and secondary outcomes reflected those of the original study and by an intention to treat methodology. Of 178 patients who were initially recruited to the trial, 139 were alive at the time of follow-up (PTA, 46; SEP, 47; PTA + SEP, 46) and assessments were completed for 111 patients. Mortality before long-term evaluation was 24.4%, about 5% per year. Median time to long-term follow-up was 5.2 years. Patient demographics were similar between groups with median age 75. Sixty-nine patients (62.2%) were symptomatic and 18 (16.2%) had experienced a major cardiovascular event since their last follow-up visit. QoL outcomes demonstrated no significant difference between treatment groups. There was no significant difference observed in the primary end points of treadmill MWD or QoL outcomes, nor in the secondary end points of restenosis rates or new ipsilateral or contralateral lesions on duplex imaging. Improvement was observed in the ABI in all groups. PTA and PTA + SEP groups had a significantly higher ABI than the SEP group. Patients in all groups had subsequent interventions (PTA, 14; SEP, 10; PTA + SEP, 6). The total number of subsequent interventions was higher after PTA (n ¼ 29) compared with SEP (n ¼ 17) and PTA + SEP (n ¼ 9) but failed to r...