Key result
Off-label use of bioresorbable scaffolds was associated with a significantly higher rate of definite stent thrombosis at 30 days compared to on-label use (1.08% vs 0.26%), though rates equalized by 5 years.
Why the study?
Long-term data were needed to provide real-world insights into how clinical events differ with bioresorbable scaffold implantation for off-label compared with approved indications.
Does the use of everolimus-eluting bioresorbable scaffolds for off-label indications increase the risk of stent thrombosis and target lesion failure compared to on-label indications in patients with coronary artery disease?
Observational (n=3,082)
Yes
Does the use of everolimus-eluting bioresorbable scaffolds for off-label indications increase the risk of stent thrombosis and target lesion failure compared to on-label indications in patients with coronary artery disease?
Odds Ratio: 4.16 (95% CI 0.98–17.61)
Absolute Event Rate: 1.08% vs 0.26%
p-value: p=0.04
Off-label use of bioresorbable scaffolds is associated with increased short-term stent thrombosis and target vessel failure compared to on-label use, though long-term stent thrombosis rates converge by 5 years.
Off-label BRS use may warrant short-term caution; leaves open whether long-term TVF or thrombosis risks differ meaningfully from on-label use.
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.
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Huseynov et al. (2025) conducted an observational in Coronary artery disease (n=3,082). Off-label use of bioresorbable scaffold vs. On-label use of bioresorbable scaffold was evaluated on ARC definite stent thrombosis at 30 days (OR 4.16, 95% CI 0.98-17.61, p=0.04). Off-label use of bioresorbable scaffolds was associated with a significantly higher rate of definite stent thrombosis at 30 days compared to on-label use (1.08% vs 0.26%), though rates equalized by 5 years.
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