Absorb® bioresorbable scaffold in "established" versus "off-label" coronary lesions: 5-year data from the GABI-R® registry.

Abstract

Background: The potential benefits of bioabsorbable stents can be better assessed over the long term. The implantation of bioresorbable scaffold (BRS) in situations with off-label indications provides real-world insights into how clinical events differ in contrast to standard proved indications.

Objectives: The study provides long-term follow-up data about the use of bioresorbable scaffold (BRS) for off-label compared with approved indications.

Methods: Five-year outcome data of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) were evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB-RegIstRy (GABI-R). The patients were enrolled from a total of 93 centers. Data processing and prospective follow-up were conducted centrally and independently of industry.

Results: A total of 3082 patients were enrolled between 2013 and 2016. Most patients were included into the off-label group (2317, 75.2%). ST-elevation myocardial infarction (STEMI) was significantly more common in the off-label group (35.9% vs. 27.8%, p = 0.003), and the extent of coronary heart disease was higher in the off-label group (coronary 3 vessel disease 28.4% vs. 22.4%, p < 0.001). Patients with off-label indications had statistically significant higher rates of stent thrombosis after 30 days (1.08% vs. 0.26%, p = 0.04) and target vessel failure (TVF) after 6 months (4.62% vs. 2.61%, p = 0.02).

Conclusions: The off-label use of BRS is associated with a higher rate of stent thrombosis in the short term and in the long term with higher MACE events considering more complex lesions and a higher morbidity. In the long term, there are no differences regarding stent thrombosis.