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Bioresorbable stents: Is the game over?

Emanuele Gallinoro1, Marcel Almendarez2, Rut Alvarez-Velasco2

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Summary

Bioresorbable scaffolds (BRS) offer a metallic stent alternative but showed higher thrombosis and failure rates. Newer BRS aim to improve safety and efficacy for better patient outcomes.

Keywords:
Bioresorbable vascular scaffoldDrug eluting stentScaffold restenosisScaffold thrombosis

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Area of Science:

  • Cardiovascular research
  • Biomaterials science
  • Interventional cardiology

Background:

  • Bioresorbable scaffolds (BRS) were developed to overcome limitations of permanent metallic stents.
  • The Absorb BVS aimed to provide temporary vessel support and then resorb, potentially reducing inflammation and improving vessel function.
  • Theoretical benefits included reduced inflammation, restored vasomotor function, and improved surgical revascularization access.

Purpose of the Study:

  • To evaluate the clinical performance of the first widely studied bioresorbable scaffold, the Absorb BVS.
  • To compare the safety and efficacy of BRS against contemporary drug-eluting stents.
  • To identify mechanisms of scaffold failure and inform the development of next-generation BRS.

Main Methods:

  • Analysis of cumulative evidence from multiple randomized trials (ABSORB II, III, China, Japan).
  • Comparison of outcomes between Absorb BVS and everolimus drug-eluting stents.
  • Investigation into device-related, operator-related, and lesion-related factors contributing to scaffold failure.

Main Results:

  • The Absorb BVS demonstrated significantly higher rates of scaffold thrombosis, target lesion failure, and target vessel failure compared to drug-eluting stents.
  • Multiple mechanisms contributed to scaffold failures, including device design and procedural factors.
  • Concerns were raised regarding the safety and efficacy profile of early-generation BRS.

Conclusions:

  • Early bioresorbable scaffolds like the Absorb BVS faced significant clinical challenges, particularly regarding safety and efficacy.
  • Ongoing development focuses on next-generation BRS with thinner struts, improved mechanical properties, and faster resorption.
  • The quest for an ideal, fully resorbable stent continues with promising advancements.