Early and Midterm Data From GHOST-EU Registry Published

July 18, 2014—EuroIntervention Editor-in-Chief Patrick Serruys, MD, announced the publication of the early and midterm outcomes of GHOST-EU, the largest (N = 1,189) European multicenter experience with the Abbott Vascular Absorb bioresorbable vascular scaffold (BVS) in real-world patients undergoing percutaneous coronary intervention (PCI). The study by Davide Capodanno, MD, et al is available online ahead of print in EuroIntervention.

According to Dr. Serruys, the study adds to the growing debate concerning BVS with interesting early and midterm data on safety and efficacy. In particular, the invesitgators report for the first time on a nonnegligible rate of scaffold thrombosis, which may raise some note of caution over the unselected use of BVS in all-comers PCI. They were also able to report for the first time on the midterm predictors of target lesion failure (TLF) in patients treated with the Absorb BVS.

As summarized in EuroIntervention, the GHOST-EU investigators evaluated 1,189 patients who underwent PCI with one or more Absorb BVS at 10 European centers between November 2011 and January 2014. The primary outcome of interest was TLF, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. 

The investigators reported that a total of 1,731 Absorb BVS were implanted at a mean of 12.3 ± 3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 days (interquartile range, 8–227) after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at 6 months. The annualized rate of TLF was 10.1%. 

At 6 months, the rate of cardiac death was 1%, target vessel myocardial infarction was 2%, target lesion revascularization was 2.5%, and target vessel revascularization was 4%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio, 2.41; 95% confidence interval, 1.28–4.53; P = .006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at 6 months, with 16 of 23 cases occurring within 30 days.

“Real-world” outcomes of BVS showed acceptable rates of TLF at 6 months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible, concluded the investigators in EuroIntervention.