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

TL;DR

This study compares the long-term outcomes of using a bioresorbable stent in approved versus off-label coronary cases over five years.

Contribution

The study provides real-world, long-term data on bioresorbable scaffold use in off-label versus approved coronary indications.

Findings

Off-label BRS use was associated with higher stent thrombosis rates in the short term.

Patients with off-label indications had higher MACE events due to more complex lesions.

No long-term differences in stent thrombosis were observed between groups.

Abstract

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.

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

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.

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).

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.

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