Next-Generation Transcatheter Aortic Valve Replacement (TAVR) Clinical Outcomes in Low-Intermediate Risk Patients: Large Single-Centre Experience

Abstract

Background: Recent data suggest that risk of very-late (>1 year) stent thrombosis (ST) may persist in bioresorbable vascular scaffolds (BVS). We performed a meta-analysis to evaluate the safety and efficacy of the commercially available ABSORB BVS compared with everolimus-eluting metallic stents (EES) at mid-term follow-up. Method: Electronic databases and abstracts from international conferences were searched. Inclusion criteria were: (1) randomised trial or comparative observational study, (2) comparison of outcomes between BVS and EES, (3) ≥100 patients treated with BVS, (4) ≥2-year follow-up. Primary endpoint was target lesion failure (TLF); composite of cardiac death, target-vessel myocardial infarction (TV-MI) or ischaemic-driven target lesion revascularisation (ID-TLR). Secondary endpoints included individual TLF components, definite/probable ST and patient-oriented composite endpoint (POCE), consisting of all-cause death, any MI or repeat revascularisation. Summary statistics are reported as pooled odds ratios (OR) with 95% confidence intervals (CI). Results: 3 randomised trials and 2 observational studies met inclusion criteria, with 1,407 patients receiving BVS and 1,095 EES. There was no difference between groups for the primary endpoint of TLF (OR 1.31, 95%CI 0.93-1.83, I 2 = 0%, p = 0.12). However, TV-MI (OR 2.59, 95%CI 1.17-5.70, I 2 = 0%, p = 0.02), ID-TLR (OR 1.70, 95%CI 1.02-2.83, I 2 = 0%, p = 0.04) and ST (OR 2.35, 95%CI 1.14-4.86, I 2 = 0%, p = 0.02) were increased in patients receiving BVS. There was no difference in POCE (OR 1.06, 95%CI 0.67-1.67, I 2 = 54%, p = 0.81). Conclusion: First-generation BVS are associated with increased TV-MI and ID-TLR at mid-term follow-up, although POCE remains equivalent. Further assessment will be required to assess whether the potential benefits of BVS can be realised.