Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold: insights from the AIDA trial.

AIMS: Specific implantation strategies have been proposed for the Absorb bioresorbable vascular scaffold (Absorb BVS) to optimise outcomes. We aimed to analyse whether the occurrence of definite scaffold thrombosis (ScT) and target lesion revascularisation (TLR) in Absorb-treated AIDA patients was influenced by scaffold implantation techniques. METHODS AND RESULTS: Absorb BVS implantation in 1,074 lesions was graded according to definitions of optimal implantation based on predilatation, sizing, and post-dilatation (PSP). Lesion-oriented outcomes (definite ScT and TLR) that occurred during a median follow-up of 707 days were related to the presence or absence of PSP. Of 1,074 lesions, 158 (14.7%) lesions met PSP criteria. The most prevalent reason for not meeting PSP criteria was inadequate sizing: 863 (94.2%). Definite ScT occurred in four of 158 PSP-treated lesions compared with 27 of 916 non PSP-treated lesions, with two-year KM estimates of 3.0% vs. 4.1% and an HR of 1.14 (p=0.811). TLR occurred in eight of 158 PSP-treated lesions compared with 61 of 916 non PSP-treated lesions, with KM estimates of 5.6% vs. 7.1% and an HR of 1.29 (p=0.492). CONCLUSIONS: In AIDA, lesions that underwent scaffold implantation according to an optimised Absorb BVS implantation technique did not have lower rates of ScT and TLR compared to scaffold-treated lesions that did not meet PSP criteria.

Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents: a propensity-matched analysis.

AIMS: The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort. METHODS AND RESULTS: Patients from the REMEDEE registry (COMBO, n=1,000) were matched with patients from the DUTCH PEERS trial (PROMUS Element/Resolute Integrity, n=1,811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79). CONCLUSIONS: In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.