Over the past decade, supervised exercise therapy (SET) and endovascular revascularization (ER) have been shown in multiple trials to be equally effective with respect to improving walking distance and QoL. As SET is the non-invasive, less costly option, current (inter-)national guidelines recommend SET as primary treatment in the management of IC. The most recent guidelines of the Dutch Society of Vascular Surgery appoint a 6-month trial of SET, saving invasive treatment for patients unresponsive to exercise therapy.
The evidence regarding the IC population as a whole unequivocally appoints a trial of SET as primary treatment. Yet, most studies examining SET programs do not specify the anatomic distribution of disease. Therefore, some clinicians argue that for patients with aortoiliac disease a lower threshold to initiate invasive treatment is warranted. This claim is accompanied by two arguments:
(1) outcomes of ER for iliac stenosis are relatively favorable compared to femoropopliteal stenosis (with 4-year patency rates of 70%)
(2) individuals with aortoiliac PAD might experience less improvement with exercise training as they have more ischemic muscle mass with walking and are often more symptomatic than those with more distal obstruction.
Based on proposed working mechanisms and available evidence an inferior effect of SET due to lesion location cannot be assumed. To expand the clinical knowledge on this subject the current ELECT Registry is initiated.
Aim of this study?
The aim of the ELECT Registry is to determine the effect of the location of stenosis (femoropopliteal versus aortoiliac versus multilevel disease) on the outcomes of SET in patients with IC (PAD Fontaine 2, Rutherford I-III), by recording the clinical outcomes from ‘real world’ subjects treated with SET, applying a minimal amount of subject selection criteria.
The ELECT registry is a multicenter prospective cohort study. Study enrolment is open to consecutively enrolled subjects who, in the opinion of their treating vascular surgeon, are candidates for SET. This study will record diagnostic- and outcome measures that are performed as part of the usual clinical routine (described in vascular surgery and/or physical therapy guidelines, supplemented by a questionnaire with 9 predefined questions. This additional questionnaire is short, contains no intrusive questions, and will only be carried out at three time-points (1, 2, and 5 years after inclusion).
When your hospital participate in this research, the data will be filled in research manager. Click here to go to the site of research manager.
See our Study Protocol for more information.