Original title: Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. Reference: Capodanno D et al. EuroIntervention. 2014 Jul 18. Epub ahead of print
The GHOST-EU registry, that included 1189 patients from 10 European centers between 2011 and 2014, is now the largest registry on Absorb everolimus-eluting bioresorbable scaffolds (Abbott Vascular; Santa Clara, CA).
One third of patients (34.8%) had multiple vessels disease and more than half of patients (51%) presented complex lesions. All patients received aspirin in addition to clopidogrel, prasugrel or ticagrelor for 6 to 12 months after procedure.
The number of bioresorbable scaffolds employed per patient was 1.73, and 18.4% required an additional conventional or drug eluting stent. Globally, technical success was 99.7%.
Primary end point, a combination of cardiac death, target vessel infarction or ischemia driven target lesion revascularization was 4.4% at 6 months. The only independent events predictor was diabetes (HR 2.41; IC 95% 1.28 to 4.53).
23 definite/probable thrombosis were observed, which represents 1.5% at 30 days and 2.1% at 6 months. Most cases (70%) occurred within 30 days, at a median of 5 days post procedure. 87% of patients presenting scaffold thrombosis were under a double antiagregation therapy at the time of the event.
Conclusion
The everolimus eluting bioresorbable scaffold showed acceptable outcomes at 6 months in a challenging “real world” population, even though thrombosis rate was not negligible, especially within the first 30 days after procedure.
Editorial Comment
Given the complexity of the treated lesions, many of the patients included in this study would not have met the ABSORB II and III inclusion criteria, which shows this registry reflects “real world” outcomes.
Thrombosis rate is higher than expected and exceeds reported data for second generation DES. The fact that most thrombosis were concentrated within the first days suggests the need to carefully select lesions, polish implantation techniques and systematically monitor patients after implantation with some kind of imaging (IVUS or OCT). A randomized long term study against the best DES is required to answer whether the greater risk of initial thrombosis can be counter balanced by a benefit after scaffold disappears.
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