Observational studyClinical research in cardiology : official journal of the German Cardiac Society2025
Absorb® bioresorbable scaffold in "established" versus "off-label" coronary lesions: 5-year data from the GABI-R® registry.
Observational study in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe 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.
objectivesThe study provides long-term follow-up data about the use of bioresorbable scaffold (BRS) for off-label compared with approved indications.
methodsFive-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.
resultsA 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).
conclusionsThe 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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