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Background <p>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.</p> Objectives <p>The study provides long-term follow-up data about the use of bioresorbable scaffold (BRS) for off-label compared with approved indications.</p> Methods <p>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.</p> Results <p>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%, <i>p</i> = 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%, <i>p</i> &lt; 0.001). Patients with off-label indications had statistically significant higher rates of stent thrombosis after 30&#xa0;days (1.08% vs. 0.26%, <i>p</i> = 0.04) and target vessel failure (TVF) after 6&#xa0;months (4.62% vs. 2.61%, <i>p</i> = 0.02).</p> Conclusions <p>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.</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月30日

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  • Aydin Huseynov,
  • Michael Behnes,
  • Holger Nef,
  • Thomas Riemer,
  • Steffen Schneider,
  • Thomas Pfannebecker,
  • Stephan Achenbach,
  • Julinda Mehilli,
  • Thomas Münzel,
  • Tommaso Gori,
  • Jochen Wöhrle,
  • Ralf Zahn,
  • Johannes Kastner,
  • Axel Schmermund,
  • Gert Richardt,
  • Christian W. Hamm,
  • Ibrahim Akin

摘要

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.

Graphical Abstract