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September 27, 2019

Absorb Bioresorbable Scaffolds—Out of the Woods After 3 Years?

Author Affiliations
  • 1Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts
JAMA Cardiol. 2019;4(12):1192-1193. doi:10.1001/jamacardio.2019.4098

Bioresorbable stents have the potential to be a transformative technology in treating coronary disease. The device has the promise to overcome many of the limitations of metal drug-eluting stents. They can provide a temporary scaffold during the initial healing period and then, once resorbed, allow the return of normal vascular vasomotion and favorable remodeling. The absence of permanent metallic struts allows noninvasive imaging of the treated lesions without stent shadowing. With resorption, jailed side branch obstruction is reduced and subsequent revascularization possible without any permanent stent present. The concept was introduced nearly 20 years ago by Stack et al,1 but it was not until the introduction of the Absorb bioresorbable vascular scaffold (BVS) stent (Abbott Vascular) that clinical trials were conducted that demonstrated promising results.2 Based on the favorable outcomes of observational trials and multiple randomized clinical trials, the device was approved by the US Food and Drug Administration (FDA) in 2016. However, shortly thereafter, clinical trials and pooled analysis of the randomized trials showed an excess of late-device thrombosis and major adverse cardiovascular events when compared with second-generation drug-eluting stents. Based on these studies, the FDA issued a warning letter in 2017 and Abbott Vascular decided to stop selling the product. A meta-analysis of the 3-year outcomes of 4 of the major ABSORB randomized clinical trials using individual patient data demonstrated that compared with the cobalt-chromium everolimus-eluting stent (EES), the Absorb BVS scaffold had higher 3-year rates of target lesion failure (TLF) driven by greater target vessel myocardial infarction and device thrombosis rates.3

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