(CCSP016) EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS COMPARED TO DRUG-ELUTING STENTS IN THE TREATMENT OF EXTENSIVE (MULTI-VESSEL OR DIFFUSE) CORONARY ARTERY DISEASE

Background: Revascularization of extensive CAD can be achieved by CABG or PCI. Bioresorbable vascular scaffolds (BVS) could offer long-term restoration of vasomotion and vascular remodeling while allowing subsequent bypass surgery. Data comparing BVS and DES in the treatment of extensive CAD (≥3 devices) are lacking and we hypothesize that, in extensive CAD, BVS will provide better outcomes than DES.

METHODS AND RESULTS: Between April 2013 and May 2017, 69 patients (224 lesions) underwent PCI with ≥3 BVS. Each BVS-patient was matched with 2 patients (138 patients; 473 lesions) who underwent PCI with ≥3 DES. In this retrospective study, we sought to compare the performance of BVS to DES in the setting of extensive CAD in our center. The baseline characteristics, the indications of the procedure and the SYNTAX scores (16±7 vs. 18±9, p=0.12) were similar between the groups. Patients with ≥3 lesions (70% vs. 83%, p=0.049), the use of clopidogrel (22% vs. 48%, p< 0.001) and the number of small vessels (3% vs. 12%, p< 0.001) were lower in the multiple-BVS group. The use of both pre- and post-dilation (74% vs. 55%, p< 0.001) and the use of OCT (8% vs. 0%, p< 0.001) were higher in the multiple-BVS group. After a follow-up of 1446±953 days, the rates of target lesion failure (TLF), target lesion revascularization (TLR), patient-oriented composite endpoint (POCE) and any revascularization in the multiple-BVS group were 17.4%, 14.5%, 27.5% and 21.7%, respectively. The multiple-DES group showed a 19.6% TLF rate (p=0.851), 13.0% TLR rate (p=0.943), 34.1% POCE rate (p=4290) and 24.6% any revascularization rate (p=0.773). No scaffold thrombosis occurred in the multiple-BVS group whereas 2 (1.45%) stent thrombosis occurred in the multiple-DES group (p=0.802), including one late and one very late thrombosis. The time-to-TLF [HR=0.72 (0.36-1.44), p=0.349], any revascularization [HR=0.67 (0.36-1.26), p=0.213] and POCE [HR=0.61 (0.35-1.06), p=0.078] were similar between the groups. Prior PCI [HR=59.7 (2.98-1198), p=0.007] and scaffold length ≥80mm [HR=10.49 (1.96-56.2), p=0.024] were independent predictors of POCE in the multiple-BVS group up to 9 years.

Conclusion: In this long-term cohort, the outcomes of multiple BVS were comparable to that of multiple DES and to that of BVS in the ABSORB III trial which included fewer lesions and scaffolds per patient. Our data suggest a directly proportional relationship between the length of the scaffold and the risk of POCE in the multiple BVS group. Longer term data from randomized trials are awaited.