1197 RandomSTOP Vessel Prep Trials – Real Life or Alternative Reality?
R Owen, N Fitzpatrick, A Sherazi, E Katsogridakis- Surgery
Abstract
Aim
During the last ten years there have been two notable studies within vessel preparation for peripheral vascular disease; the DEFINITIVE AR prospective multi-centre randomised study (evaluating the use of atherectomy prior to drug-eluting balloon catheters (DCB)) and the DISRUPT PAD III randomized control trial (evaluating the use of intravascular lithotripsy (IVL)). This study aimed to analyse a true cohort of vascular patients who underwent vessel prep and whether this reflects those included in the studies.
Method
Data was collected on patients with SFA disease in 14 countries across 17 centres. We applied the inclusion criteria for the DEFINITIVE AR and DISRUPT PAD III studies to our cohort.
Results
Data was collected on n = 974 patients who received at least one form of vessel prep. Of these patients, 202 (20.7%) underwent atherectomy and 22 (2.26%) underwent lithotripsy. 50.1% (n = 103) of those who underwent atherectomy would have been eligible to participate in the DEFINITVE AR study. 18% (n = 4) of patients who underwent lithotripsy would have been eligible to participate in the DISRUPT PAD III trial.
Conclusions
Both the DEFINITIVE AR and DISRUPT PAD III trials have shown promising results however in this large multicentre study we have shown that the study participants reflect only a small percentage of the patients seen within a real vascular ward. We would advise caution when interpreting the results from these studies considering the disparity, we have shown between the study cohorts and the real life vascular population.