P4197Evolution of vasomotor function and myocardial perfusion during three years follow-up after randomization between bioresorbable vascular scaffold and metal drug eluting stent: the VANISH trial

Abstract

Background: Although recent studies have shown that implantation of the bioresorbable everolimus‐eluting vascular scaffold (BVS) is accompanied by an increased scaffold thrombosis risk, long term regression of the BVS reinstates normal vessel geometry allowing for regeneration of the newly formed endothelium with revival of vasomotor functions. Purpose: The randomised clinical VANISH‐trial was conducted to assess myocardial blood flow (MBF) and coronary flow reserve (CFR) during stress and cold pressor testing (CPT) with quantitative positron emission tomography (PET) perfusion imaging after implantation of a metal drug eluting stent (DES) vs. BVS during 3‐year follow‐up. Methods: Sixty patients (age 18‐65) with a documented single vessel type A or B1 lesion, and without significant myocardial enzyme release (CK<180 U/L), were randomized to implantation of a DES or BVS (Xience Prime or ABSORB) in a one‐to‐one fashion. Approximately one month (m), one year (y), and three years after intervention patients underwent H215O cardiac PET to assess MBF and CFR during stress and CPT. Results: No culprit vessel events were registered between inclusion and 3‐year follow‐up. Fifty‐nine (98%), 56 (93%), and 51 (85%) patients successfully completed 1m, 1y, and 3y follow‐up PET imaging, respectively. Target vessel rest MBF, stress MBF, and CPT reserve at 1m, 1y, and 3y follow‐up were comparable between DES and BVS arm (all p>0.05). A strong trend was observed for a lower CFR within BVS arm at 1m follow‐up as compare to DES (DES vs. BVS: 3.57±0.85 vs. 3.09±0.94, p=0.05), whilst no difference was observed at 1y and 3y follow‐up between DES and BVS groups (1y: 3.45±0.97 vs. 3.17±0.99, p=0.35 and 3y: 3.07±0.84 vs. 2.87±0.86, p=0.96, respectively). Stress MBF and CFR in the DES arm was significantly lower at 3y, as compared to 1m and 1y (stress MBF 3y vs. 1m and 1y: 3.02±0.67 vs. 3.38±0.83 and 3.33±0.77 ml min‐1 g‐1, both p<0.05; CFR 3y vs. 1m and 1y: 3.07±0.84 vs. 3.57±0.85 and 3.45±0.97, both p<0.05). No differences in stress MBF, CPT reserve, and CFR were observed over time within the BVS arm (all p>0.05). Conclusions: The hypothesized beneficial long‐term effects of BVS resorption did not translate into improved MBF during stress or endothelium dependent vasodilation by cold pressor testing. Hyperemic MBF and CFR decreased significantly 3 years after implantation of metal DES, whilst no effect over time was observed for BVS.