Outcomes of bioresorbable vascular scaffolds versus everolimus-eluting stents by coronary complexity: a sub-analysis of the AIDA trial.

AIMS: We aimed to evaluate the impact of the complexity of coronary disease as assessed by the SYNTAX score (SXscore) on the clinical outcomes in the AIDA trial. METHODS AND RESULTS: In the AIDA trial, we compared Absorb versus XIENCE in routine clinical practice. Clinical outcomes were stratified by SXscore tertiles: SXlow (SXscore ≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15). The SXscore was available in 1,661 of the 1,845 (90%) patients. The event rate of TVF was numerically lower in Absorb compared to XIENCE (3.7% versus 5.6%; p=0.257) in the SXlow tertile, numerically higher in Absorb in the SXmid tertile (11.4% versus 9.3%, p=0.421) and similar in the SXhigh tertile (15.5% versus 15.6%; p=0.960). The rates of definite/probable device thrombosis in Absorb versus XIENCE were significantly higher in the SXmid tertile (3.3% versus 0.8%, p=0.043) and in the SXhigh tertile (3.7% versus 0.8%, p=0.006). CONCLUSIONS: We found no significantly different rates of TVF between Absorb and XIENCE patients. Absorb-treated patients in the SXmid and SXhigh tertiles had an increased risk of device thrombosis when compared to XIENCE-treated patients. The rates of device thrombosis in the SXlow tertile, while still higher for Absorb, are more acceptable than in the SXmid and SXhigh score tertiles.

Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI.

AIMS: The aim of this report of the AIDA trial is to provide full two-year outcomes for the primary endpoint of target vessel failure (TVF) and an update on device thrombosis. METHODS AND RESULTS: AIDA was a single-blind, multicentre, investigator-initiated, non-inferiority, randomised (1:1) clinical trial. At complete two-year follow-up, the primary endpoint of TVF had occurred in 100 patients in the Absorb BVS arm versus 90 patients in the XIENCE EES arm (HR 1.12, 95% CI: 0.94-1.49; psuperiority=0.436). Estimated two-year Kaplan-Meier event rates of TVF were 11.0% and 9.9%, respectively (95% CI: -0.9%-3.0%; pnon-inferiority=0.003). Definite or probable device thrombosis at two years occurred in 30 patients in the Absorb BVS arm and in eight patients in the XIENCE EES arm. Kaplan-Meier estimates of device thrombosis were 3.3% in the Absorb BVS arm and 0.9% in the XIENCE EES arm (HR 5.22, 95% CI: 2.00-13.59; p<0.001). CONCLUSIONS: AIDA formally met its criterion for non-inferiority of Absorb BVS versus XIENCE EES in terms of the combined endpoint of TVF. The Absorb BVS, however, was associated with higher rates of scaffold thrombosis and target vessel myocardial infarction at complete two-year follow-up.

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.